Endometrial resection and ablation techniques for heavy menstrual bleeding

  • Review
  • Intervention

Authors


Abstract

Background

Heavy menstrual bleeding (HMB) is a significant health problem in premenopausal women; it can reduce their quality of life and cause anaemia. First-line therapy has traditionally been medical therapy but this is frequently ineffective. On the other hand, hysterectomy is obviously 100% effective in stopping bleeding but is more costly and can cause severe complications. Endometrial ablation is less invasive and preserves the uterus, although long-term studies have found that the costs of ablative surgery approach the cost of hysterectomy due to the requirement for repeat procedures. A large number of techniques have been developed to 'ablate' (remove) the lining of the endometrium. The gold standard techniques (laser, transcervical resection of the endometrium and rollerball) require visualisation of the uterus with a hysteroscope and, although safe, require skilled surgeons. A number of newer techniques have recently been developed, most of which are less time consuming. However, hysteroscopy may still be required as part of the ablative techniques and some of these techniques must be considered to be still under development, requiring refinement and investigation.

Objectives

To compare the efficacy, safety and acceptability of of endometrial destruction techniques to reduce heavy menstrual bleeding (HMB) in premenopausal women.

Search methods

We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of controlled trials, Cochrane Central Register of Controlled Trials CENTRAL), MEDLINE, EMBASE, CINAHL, and PsycInfo, (from inception to June 2013). We also searched trials registers, other sources of unpublished or grey literature and reference lists of retrieved studies, and made contact with experts in the field and pharmaceutical companies that manufacture ablation devices.

Selection criteria

Randomised controlled trials (RCTs) comparing different endometrial ablation techniques in women with a complaint of HMB without uterine pathology were eligible. The outcomes included reduction of HMB, improvement in quality of life, operative outcomes, satisfaction with the outcome, complications and need for further surgery or hysterectomy.

Data collection and analysis

Two review authors independently selected trials for inclusion, assessed trials for risk of bias and extracted data. Attempts were made to contact authors for clarification of data in some trials. Adverse events were only assessed if they were separately measured in the included trials. Comparisons were made with individual techniques and an overall comparison between first and second-generation ablation methods was also undertaken.

Main results

Twenty five trials (4040 women) with sample sizes ranging from 20 to 372 were included in the review. A majority of the trials had a specified method of randomisation, adequate description of dropouts and no evidence of selective reporting. Less than half had adequate allocation concealment and most were unblinded.

There was insufficient evidence to suggest superiority of a particular technique in the pairwise comparisons between individual ablation and resection methods.

In the overall comparison of the newer 'blind' techniques (second-generation) with the gold standard hysteroscopic ablative techniques (first-generation) there was no evidence of overall differences in the improvement in HMB (12 RCTs) or patient satisfaction (11 RCTs).

Surgery was an average of 15 minutes shorter (mean difference (MD) 14.9, 95% CI 10.1 to 19.7, 9 RCTs; low quality evidence), local anaesthesia was more likely to be employed (relative risk (RR) 2.8, 95% CI 1.8 to 4.4, 6 RCTs; low quality evidence) and equipment failure was more likely (RR 4.3, 95% CI 1.5 to 12.4, 3 RCTs; moderate quality evidence) with second-generation ablation. Women undergoing newer (second-generation) ablative procedures were less likely to have fluid overload, uterine perforation, cervical lacerations and hematometra than women undergoing the more traditional type of ablation and resection techniques (RR 0.18, 95% CI 0.04 to 0.79, 4 RCTs; RR 0.32, 95% CI 0.1 to 1.0, 8 RCTs; RR 0.22, 95% CI 0.08 to 0.61, 8 RCTs; and RR 0.32, 95% CI 0.12 to 0.85, 5 RCTs; all moderate quality evidence, respectively). However, women were more likely to have nausea and vomiting and uterine cramping (RR 2.0, 95% CI 1.3 to 3.0, 4 RCTs; and RR 1.2, 95% CI 1.0 to 1.4, 2 RCTs; both moderate quality evidence, respectively). The risk of requiring either further surgery of any kind or hysterectomy specifically was reduced with second-generation ablative methods compared to first-generation ablation up to 10 years after surgery (RR 0.69, 95% CI 0.48 to 0.99, 1 RCT; and RR 0.60, 95% CI 0.38 to 0.96, 1 RCT; both moderate quality evidence, respectively) but not at earlier follow up. Additional research is required to confirm this finding.

Authors' conclusions

Endometrial ablation techniques offer a less invasive surgical alternative to hysterectomy. The rapid development of a number of new methods of endometrial destruction has made systematic comparisons between individual methods and with the 'gold standard' first-generation techniques difficult. Most of the newer techniques are technically easier to perform than traditional hysteroscopy-based methods but technical difficulties with the new equipment need to be addressed. Overall, the existing evidence suggests that success, satisfaction rates and complication profiles of newer techniques of ablation compare favourably with hysteroscopic techniques.

Résumé scientifique

La résection endométriale et les techniques dablation pour les saignements menstruels abondants

Contexte

Les saignements menstruels abondants (HMB) sont un important problème de santé chez les femmes préménopausées, qui peut réduire leur qualité de vie et causer de l'anémie. Le traitement de première intention a toujours été un traitement médical, mais celui-ci est souvent inefficace. D'autre part, l'hystérectomie est évidemment efficace à 100% pour arrêter les saignements, mais elle est plus coûteuse et peut entraîner des complications graves. L'ablation de l'endomètre est moins invasive et préserve l'utérus, mais des études à long terme ont toutefois montré que les coûts de la chirurgie ablative approchent le coût de l'hystérectomie en raison du besoin de procédures répétées. Un grand nombre de techniques ont été développées pour 'ablater' (enlever) la muqueuse de l'endomètre. Les techniques de référence (laser, résection transcervicale de l'endomètre et bille roulante) exigent la visualisation de l'utérus avec un hystéroscope et, bien que sûres, nécessitent des chirurgiens qualifiés. Un certain nombre de nouvelles techniques ont été récemment développées, qui pour la plupart prennent moins de temps. L'hystéroscopie peut toutefois continuer à être requise dans le cadre des techniques d'ablation et certaines d'entre elles doivent être considérées comme étant encore en cours de développement, nécessitant perfectionnement et études.

Objectifs

Comparer lefficacité, linnocuité et lacceptabilité des méthodes utilisées pour détruire l'endomètre dans le but de réduire les saignements menstruels abondants (SMA) chez les femmes pré ménopausées.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre spécialisé des essais contrôlés du groupe Cochrane sur les troubles menstruels et l'hypofertilité, le registre Cochrane des essais contrôlés (CENTRAL), MEDLINE, EMBASE, CINAHL, et PsycInfo, (depuis leur création jusqu'en juin 2013). Nous avons également consulté des registres d'essais cliniques, d'autres sources de littérature non publiées ou grises et les références bibliographiques des études trouvées, nous avons aussi pris contact avec des experts dans le domaine et des laboratoires pharmaceutiques qui fabriquent des appareils d'ablation.

Critères de sélection

Les essais contrôlés randomisés (ECR) ont comparés différentes techniques d'ablation de l'endomètre chez les femmes se plaignant de SMA, sans présence de pathologie utérine. Les critères de résultat comprenaient la réduction des SMA, l'amélioration de la qualité de vie, les suites de l'opération, la satisfaction des résultats, les complications et la nécessité d'effectuer une nouvelle intervention chirurgicale ou une hystérectomie.

Recueil et analyse des données

Deux auteurs de la revue ont indépendamment sélectionné les essais à inclure, évalué le risque de biais des essais et extrait les données de manière indépendante. Nous avons tenté de contacter des auteurs afin de clarifier les données de certains essais. Les événements indésirables n'ont été évalués que s'ils avaient été mesurés séparément dans les essais inclus. Les comparaisons ont été effectuées avec des techniques individuelles. De plus, une comparaison globale entre la première et la deuxième génération des méthodes d'ablation a été effectuée.

Résultats principaux

Vingt-cinq essais (4040 femmes) avec des tailles d'échantillons allant de 20 à 372 ont été inclus dans la revue. La majorité des essais avaient leur propre méthode de randomisation, une description appropriée de toute étude abandonnée et navaient pas de rapport sélectif. Moins de la moitié dissimulaient une répartition adéquate et la plupart étaient ouverts.

Il n'y avait pas suffisamment de preuves permettant de suggérer la supériorité d'une technique particulière lors des comparaisons par paire entre les ablations individuelles et les méthodes de résection.

Dans la comparaison des nouvelles des techniques 'aveugles' (seconde génération) avec les techniques ablatives hystéroscopiques de référence (première génération), il n'y avait pas de preuve d'amélioration globale des SMA (12 ECR) ou de la satisfaction des patientes (11 ECR).

La chirurgie durait en moyenne 15 minutes de moins (différence moyenne (DM) 14,9 ; IC à 95%, entre 10,1 à 19,7, 9 ECR ; données de faible qualité), l'anesthésie locale était plus souvent utilisée (risque relatif (RR) de 2,8, IC à 95 % de 1,8 à 4,4, 6 ECR ; données de faible qualité) et les pannes d'équipement étaient plus fréquentes (RR de 4,3, IC à 95%, entre 1,5 à 12,4, 3 ECR ; données de qualité modérée) avec l'ablation de deuxième génération. Les femmes bénéficiant des nouvelles procédures d'ablation (deuxième génération) étaient moins susceptibles d'avoir une surcharge liquidienne, une perforation utérine, des déchirures cervicales et des hématomètres par rapport aux femmes soumises aux techniques d'ablation et de résection plus traditionnelles (RR 0,18, IC à 95 % 0,04 à 0,79, 4 ECR ; RR 0,32, IC à 95 % entre 0,1 et 1,0, 8 ECR ; RR 0,22, IC à 95 % 0,08 à 0,61, 8 ECR ; et RR 0,32, IC à 95 % 0,12 à 0,85, 5 ECR ; données de qualité modérée, respectivement). Toutefois, les femmes étaient plus susceptibles d'avoir des nausées, des vomissements et des crampes utérines (RR 2,0, IC à 95 % 1,3 à 3,0, 4 ECR ; et RR 1,2, IC à 95%, entre 1,0 et 1,4, 2 ECR ; données de qualité modérée, respectivement). Le risque de nécessiter une nouvelle intervention chirurgicale de tout type ou une hystérectomie a été réduit avec les méthodes d'ablation de deuxième génération par rapport à l'ablation de première génération jusqu'à 10 ans après la chirurgie (RR 0,69, IC à 95 % 0,48 à 0,99, 1 ECR ; données de qualité modérée, respectivement), mais pas au début du suivi. Des recherches supplémentaires sont nécessaires pour confirmer ce résultat.

Conclusions des auteurs

Les techniques d'ablation de l'endomètre offrent une alternative chirurgicale moins invasive que l'hystérectomie. Le développement rapide d'un certain nombre de nouvelles méthodes de destruction de l'endomètre ne facilite pas les comparaisons systématiques entre les méthodes individuelles et les techniques de référence de première génération. La plupart des nouvelles techniques sont plus faciles à réaliser que les méthodes basées sur l'hystéroscopie traditionnelle, mais les difficultés techniques dues au nouvel équipement doivent être aplanies. Dans l'ensemble, les données disponibles indiquent que les taux de réussite, la satisfaction et les profils de complication de nouvelles techniques d'ablation sont plus favorables aux techniques hystéroscopiques.

Plain language summary

Endometrial destruction techniques for heavy menstrual bleeding using newer global ablation techniques and established hysteroscopic techniques

Review question

This review compared the efficacy, safety and acceptability of methods used to destroy the lining of the womb in order to reduce heavy menstrual bleeding in premenopausal women.

Background

Drugs or hysterectomy (removing the womb) used to be the main options for women having problems with heavy menstrual bleeding. In recent decades, surgical techniques have been developed that remove only the lining of the womb (endometrium). These techniques involve either cutting out the endometrium (resection) or destroying it with thermal energy from a laser, electric instruments or other devices (ablation).

Study characteristics

This review identified 25 randomised controlled trials undertaken in 4040 women. Most of the women knew which treatment they were receiving, which may have influenced their judgements about menstrual blood loss and satisfaction. Other aspects of study quality varied among the trials. The evidence was current to June 2013. Eighteen of the 25 trials acknowledged receipt of funding, supply of equipment or technical assistance.

Key results

The review has not found that any of these procedures are better than any other in reducing heavy menstrual bleeding, and satisfaction was high with all procedures. The more modern devices (second-generation ablation) took less time to perform than the older first-generation devices and were more likely to be performed under local anaesthesia when the woman was awake. Side effects were generally similar and mostly mild.

Quality of the evidence

Studies were of low or moderate quality. Few studies were blinded, data were limited, and there was substantial heterogeneity in some outcomes, leading to downgrading of the quality of the evidence.

Résumé simplifié

Les techniques de destruction de l'endomètre pour les saignements menstruels abondants à laide de nouvelles techniques d'ablation globale et de techniques hystéroscopiques établies

Question danalyse

Cette revue a comparé l'efficacité, linnocuité et l'acceptabilité des méthodes utilisées pour détruire la muqueuse de l'utérus afin de réduire les saignements menstruels abondants chez les femmes pré ménopausées.

Contexte

Les médicaments ou l'hystérectomie (ablation de l'utérus) étaient autrefois les options principales pour les femmes ayant des problèmes de saignements menstruels abondants. Au cours des dernières décennies, des techniques chirurgicales ont été développées pour enlever seulement la muqueuse de l'utérus (endomètre). Ces techniques consistent soit à découper l'endomètre (résection) soit à le détruire au moyen d'une énergie thermique provenant d'un laser, d'instruments électriques ou d'autres appareils (ablation).

Les caractéristiques de l'étude

Cette revue a identifié 25 essais contrôlés randomisés réalisés chez 4040 femmes. La plupart des femmes savaient quel traitement elles recevaient, ce qui peut avoir influencé leurs jugements concernant les pertes de sang menstruel et leur satisfaction. D'autres aspects de la qualité de létude variaient entre les essais. Les preuves étaient à jour en juin 2013. Dix-huit des 25 essais ont obtenus une aide financière, un apport déquipements ou une assistance technique.

Les Résultats principaux

La revue n'a trouvé aucune procédure plus efficace qu'une autre pour réduire les saignements menstruels abondants et la satisfaction était très bonne avec toutes les procédures. Avec les appareils les plus modernes (ablation de deuxième génération), les procédures avaient pris moins de temps qu'avec les plus anciens appareils de première génération et étaient plus susceptibles d'être réalisées sous anesthésie locale, la femme étant éveillée. Les effets secondaires étaient généralement semblables et pour la plupart légers.

Qualité des preuves

Les études étaient de qualité faible à modérée. Peu détudes ont été réalisées en aveugle, les données étaient limitées et il y avait une hétérogénéité substantielle dans certains critères de jugement, conduisant à rétrograder la qualité des preuves.

Notes de traduction

Traduit par: French Cochrane Centre 12th November, 2013
Traduction financée par: Instituts de Recherche en Sant� du Canada, Minist�re de la Sant� et des Services Sociaux du Qu�bec, Fonds de recherche du Qu�bec-Sant� et Institut National d'Excellence en Sant� et en Services Sociaux;

Summary of findings(Explanation)

Summary of findings for the main comparison. Second-generation endometrial ablation compared to first-generation endometrial ablation for heavy menstrual bleeding
  1. 1 Substantial heterogeneity (I2 = 74%) that could not be explained
    2 Most studies had relatively small sample sizes and effects had wide confidence intervals
    3 As most trials were unblinded, participant knowledge of the treatment they received could bias their assessments of satisfaction
    4 Substantial heterogeneity (I2 = 97%) that is likely to be due to different methods of measuring the time taken in surgery, differing expertise of surgeons, and numerous other factors
    5 Substantial heterogeneity (I2 =85%) which is likely to be explained by different methods being pooled under the general headings of first and second-generation ablation
    6 Few events and wide confidence intervals
    7 Based on only one trial using specific types of first and second-generation ablative devices

Second-generation endometrial ablation compared to first-generation endometrial ablation for heavy menstrual bleeding
Patient or population: patients with heavy menstrual bleeding
Settings:
Intervention: second-generation endometrial ablation
Comparison: first-generation endometrial ablation
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
First-generation endometrial ablation Second-generation endometrial ablation
Amenorrhoea rate - At 1 year follow up
usually by questionnaire
376 per 1000 353 per 1000
(278 to 451)
RR 0.94
(0.74 to 1.2)
2085
(12 studies)
⊕⊝⊝⊝
very low 1,2
 
Satisfaction rate - At 1 year follow up
patient questionnaire
884 per 1000 884 per 1000
(858 to 902)
RR 1
(0.97 to 1.02)
1690
(11 studies)
⊕⊕⊕⊝
moderate 3
 
Success of treatment (PBAC<75 or acceptable improvement) - At 12 months follow up
Pictorial Blood Assessment Chart (PBAC)
808 per 1000 824 per 1000
(783 to 872)
RR 1.02
(0.97 to 1.08)
1375
(6 studies)
⊕⊕⊕⊕
high
 
Duration of operation (mins)
Measured in various ways by clinicians
 The mean duration of operation (mins) in the intervention groups was
14.86 lower
(19.68 to 10.05 lower)
 1762
(9 studies)
⊕⊕⊝⊝
low 4
 
Proportion having local anaesthesia (%)
Hospital staff
208 per 1000 578 per 1000
(366 to 915)
RR 2.78
(1.76 to 4.4)
1434
(6 studies)
⊕⊕⊝⊝
low 5
 
Operative or post-operative complication rate - Perforation 13 per 1000 4 per 1000
(1 to 13)
RR 0.32
(0.1 to 1.01)
1885
(8 studies)
⊕⊕⊕⊝
moderate 6
 
Requirement for any additional surgery - > 5 years follow up 381 per 1000 263 per 1000
(183 to 377)
RR 0.69
(0.48 to 0.99)
263
(1 study)
⊕⊕⊕⊝
moderate 7
 
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Description of the condition

Heavy menstrual bleeding (HMB), or menorrhagia, is a significant cause of ill health in premenopausal women and can substantially impair their quality of life (NICE 2007). It is clinically defined as blood loss greater than or equal to 80 ml per menstrual cycle (Cole 1971; Hallberg 1966). With a monthly blood loss of greater than 50 to 60 ml per cycle, most women consuming an average Western diet will develop a negative iron balance (Rybo 1966). However, it is the woman's perception of her own menstrual loss that is the key determinant in her referral and, indeed, subsequent treatment. One in 20 women in the UK aged between 30 and 49 years of age consult their general practitioner (GP) each year with HMB (Grant 2000), and the condition affects about 22% of otherwise healthy premenopausal women aged more than 35 years (Gath 1987). A comparable prevalence rate is likely in other Western countries. In New Zealand, for example, it is estimated that 2.3% of GP consultations for women younger than 50 years are for HMB (HMB Guidelines 1998). In the majority of cases no pathology (abnormality) is found to explain the HMB (NICE 2007). The causes of HMB, where there is no endometrial pathology, remain poorly understood and this has been a barrier to the development of new non-surgical therapies.

First-line therapy is usually with drugs prescribed by GPs (NICE 2007); in 1993 in the UK, 345,225 women were given 821,700 medical prescriptions, which cost the UK National Health Service over GBP 7 million, to control their HMB (EHC 1995). However, efficacy is variable and at best medication reduces menstrual blood loss by only 50%. The levonorgestrel-releasing intrauterine system, on the other hand, is more effective and reduces HMB by as much as 94% at three months (Irvine 1998). Nevertheless, HMB accounts for 12% of all gynaecology referrals in the UK (Bradlow 1992). A similar rate of referral (11%) is found in New Zealand (Waimedca 1994) and it is likely to be comparable in other Western countries.

Surgical treatment of HMB often follows failed or ineffective medical therapy, although it is also used as a first-line therapy. Hysterectomy has traditionally been regarded as the definitive surgical treatment for HMB but, in spite of a 100% success rate (complete cessation of menstruation) and high levels of satisfaction (Middleton 2010), it is a major surgical procedure with significant physical complications and social and economic costs. These include a high rate of major and minor post-operative complications (up to 67%) (Abbott 2002) and a long recovery time. Almost half of the hysterectomies performed worldwide were carried out for HMB (Maresh 2002). However, many women prefer less invasive surgical treatment even when they are made aware that the success of the treatment is not always assured (Nagele 1998).

Description of the intervention

Endometrial destruction techniques, which aim to destroy or remove endometrial tissue, have become increasingly popular, less invasive alternatives in the last two decades and, as a result, the number of hysterectomies in the UK declined by 64% between 1995 and 2002 (Reid 2005). The first effective ablation of the endometrium under hysteroscopic vision for the treatment of HMB was performed using laser photovapourisation (Goldrath 1981). Rollerball ablation (RB) with simple and cheap electrosurgical equipment rather than expensive lasers was performed a few years later (Lin 1988; Vaincaillie 1989). A method to excise rather than ablate the endometrium using an unmodified resectoscope (an instrument used for resection (excision)) was also developed and good results were reported (DeCherney 1983; DeCherney 1987). The technique transcervical resection of the endometrium (TCRE) is often used in conjunction with rollerball ablation. These methods of ablation, also termed first-generation methods, were the most commonly used and were widely regarded as the gold standard for endometrial ablation (Cooper 2000). They all require direct visualisation by a hysteroscope (an instrument for examining the uterine cavity), which may confer the additional advantage of diagnosis of polyps. Endometrial destruction techniques in use in the UK by 1995 included electrocautery, either loop or rollerball (80%), laser (18%) and radiofrequency, a procedure using electromagnetic energy (2%) (RCOG 1995).

The expectation was that these first-generation ablation methods would become an alternative to hysterectomy but, at least initially, the total number of operations for HMB increased (Bridgman 2000). More recent figures in the UK suggest that the rate of surgery for menorrhagia (based on data from 2004 to 2006) is 143 procedures per 100,000 premenopausal women (Cromwell 2009), of which approximately 60% are endometrial ablations. However, analyses of recent hospital statistics in the UK suggest that first-generation endometrial ablation has failed to have an impact on hysterectomy numbers (Reid 2007).

The drawbacks of these first-generation ablation techniques are the expertise needed and patient morbidity. A prospective national audit of hysteroscopic endometrial ablation and resection (10,686 cases) in England and Wales between 1993 and 1994 assessed the incidence of complications and reported a total complication rate of 4.4% (Overton 1997). Endometrial ablation by laser and rollerball were significantly safer than endometrial resection; the risk of immediate haemorrhage was three times greater and the risk of uterine perforation was four times greater with resection than with ablation. These complications are thought to be avoidable with good surgical technique and adequate training. However, hysteroscopic endometrial ablation requires an operating room environment, a skilled surgeon and general or regional anaesthesia.

Subsequently, second-generation non-hysteroscopic techniques have been developed, which are considered easier to perform, equally effective and safe (Madhu 2009). All of these techniques, with the exception of hydrothermal ablation and endometrial laser intrauterine thermal therapy, involve performing surgery without direct visualisation through a hysteroscope. They can potentially be used in outpatient settings and include cryoablation (Pitroff 1993), hot saline solution irrigation (Baggish 1995), diode laser hyperthermy (heating) (Donnez 1996), microwave ablation (Sharp 1995), a heated balloon system (Singer 1994) and photodynamic therapy (intrauterine light delivery) (Fehr 1995). Economic modelling also suggests that second-generation techniques may be more cost effective than first-generation methods (Garside 2004).

How the intervention might work

Endometrial destruction involves the removal of endometrial tissue. The endometrium has great powers of regeneration and to suppress menstruation successfully it is essential to remove the full thickness of this lining together with the superficial myometrium (wall of the uterus), including the deep basal glands. The latter are believed to be the primary foci for endometrial regrowth. This tissue may be removed under direct hysteroscopic view either by excision with an electrosurgical loop or by ablating the endometrium with some form of thermal energy of sufficient power to produce necrosis (cell death) of the full thickness of the endometrium when applied to its surface.

Why it is important to do this review

A wide range of techniques are available for ablating and destroying the endometrium to reduce HMB and it is not clear which approaches offer the best option in terms of effectiveness and safety. The aim of this review is to assess the efficacy, safety and acceptability of all methods, both by comparing individual techniques pairwise and by making overall comparisons between first and second-generation techniques. Other Cochrane reviews have compared endometrial ablation with hysterectomy for HMB (Lethaby 2009) and endometrial ablation with medical therapies (Marjoribanks 2010).

Objectives

To compare the effectiveness, safety and acceptability of endometrial destruction techniques to reduce heavy menstrual bleeding (HMB) in premenopausal women.

Methods

Criteria for considering studies for this review

Types of studies

All randomised controlled comparisons of techniques for the destruction of the endometrium and comparisons of endometrial destruction techniques for the reduction of HMB.

Types of participants

Source of recruitment:

  • primary care, family planning or specialist clinics.

Inclusion criteria:

  • women of reproductive years with regular heavy periods measured either objectively or subjectively.

Exclusion criteria:

  • postmenopausal bleeding (more than one year from the last period);

  • irregular menstruation and intermenstrual bleeding;

  • pathological causes of HMB (for example uterine cancer);

  • iatrogenic causes of HMB (for example intrauterine coil devices).

Types of interventions

Endometrial resection and ablation techniques (TCRE, laser ablation, rollerball ablation, saline irrigation, microwave ablation, radiofrequency ablation, heated balloon, photodynamic therapy, cryoablation and any other endometrial destruction techniques) compared to each other or grouped in the broad categories of first or second-generation techniques and used to reduce HMB.

Types of outcome measures

The assessment of most of the following outcomes was related to the duration of follow up after the initial surgical procedure. As the aim of endometrial resection and ablation therapies is to offer women a permanent solution to their bleeding problems, long-term follow up of these treatments is needed to enable informed decision making between surgical options. Thus, for the following outcomes, evaluation at different time points is considered important to assess effects over time: six months, 12 months, two years, two to five years and more than five years. Where trials measured outcomes at two different follow-up times within the categories (for example at three and five years), the longer follow-up time only was recorded in the category of two to five years.

Primary outcomes

1. Menstrual bleeding:

  • an objective assessment of improvement in menstrual blood loss (measured by the modified alkaline haematin method: modified by Newton 1977 from the original technique of Hallberg 1964);

  • a semi-objective or subjective assessment of improvement in menstrual blood loss (measured by the pictorial chart method (PBAC) (Higham 1990) or women's perception of improvement).

2. Rate of satisfaction with the outcome of the procedure (this outcome was moved from a secondary outcome to a primary outcome in the 2009 update).

Secondary outcomes
  1. Operative outcomes

    1. Duration of surgery (in minutes)

    2. Operative difficulties (such as difficulty of surgery, technical complications, abandoning procedure)

    3. Proportion having local rather than general anaesthesia

  2. Recovery

    1. Length of hospital stay

    2. Time or ability to return to normal activities or work

  3. Quality of life

    • Women's perceived change in quality of life, where this was recorded in a reproducible and validated format

  4. Improvement in menstrual symptoms, such as premenstrual syndrome (PMS) and dysmenorrhoea

  5. Complication rate, the frequency of specific adverse events both before and after discharge from hospital

  6. Requirement for further surgery for menstrual symptoms (by duration of follow up)

  7. Mortality as a direct result of surgery

Search methods for identification of studies

Electronic searches

The Menstrual Disorders and Subfertility Group (MDSG) Trials Search Co-ordinator searched the following electronic databases (from inception to 12 June 2013): MEDLINE (see Appendix 1 for full details), EMBASE (see Appendix 2), CINAHL (see Appendix 3), PsycInfo (see Appendix 4), the Cochrane Central Register of Controlled Trials (CENTRAL) (see Appendix 5) and the MDSG Specialised Register of Controlled Trials (see Appendix 6).

The MEDLINE search was combined with the Cochrane highly sensitive search strategy for identifying randomised trials, which appears in the searching chapter of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

The EMBASE search was combined with trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN) (SIGN 2008).

For the other database searches, filters were modified from those used for the MEDLINE and EMBASE searches.

The principal author of the review (AL) searched other electronic sources (trials registers and websites) to identify additional studies. These sources were the following.

  • Trials registers for ongoing and registered trials: 'Current Controlled Trials' (http://www.controlled-trials.com/), 'ClinicalTrials.gov' a service of the US National Institutes of Health (http://clinicaltrials.gov/ct2/home) and 'World Health Organization International Trials Registry Platform search portal'  (http://www.who.int/trialsearch/Default.aspx).

  • Citation indexes (http://scientific.thomson.com/products/sci/). 

  • Conference abstracts in the ISI Web of Knowledge (http://isiwebofknowledge.com/).

  • LILACS database, as a source of trials from the Portuguese and Spanish speaking world (http://bases.bireme.br/cgi-bin/wxislind.exe/iah/online/?IsisScript=iah/iah.xis&base=LILACS&lang=i&form=F).

  • PubMed (http://www.ncbi.nlm.nih.gov/pubmed/); the random control filter for PubMed was taken from the searching chapter of the Cochrane Handbook for Systematic.Reviews of Interventions.

  • OpenSIGLE database (http://opensigle.inist.fr/) and Google for grey literature.

Searching other resources

The reference lists of articles retrieved by the search were handsearched.

Some of the newer second-generation techniques are undergoing development and rigorous testing. Expert researchers in the field and companies that manufacture the newer devices were contacted to try and locate ongoing trials and unpublished data. Two experts in the field were contacted about ongoing research on endometrial ablation techniques: Dr David Parkin (Aberdeen Royal Infirmary, UK) and Dr Jed Hawe (South Cleveland Hospital, UK). A number of ongoing trials were described but insufficient details were provided to enable the review authors to initiate contact. Novasure, a company that manufactures the bipolar device Novacept, was also contacted but no reply was received. No new trials were identified from these methods.

Data collection and analysis

Data collection and analysis was conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Selection of studies

One review author (AL) screened the abstracts of all publications which were obtained by the search strategy for eligible RCTs; for the 2009 and 2013 updates this process was undertaken by two review authors (either AL and JB, AL and JP or AL and JM). Where the screened abstract was a potential RCT, the full article was obtained and inspected to assess its relevance to this review based on the criteria for inclusion. Uncertainty over eligibility was clarified by discussion between AL and either MH, JB or JP. Disagreements as to study eligibility were resolved by consensus and it was not necessary to involve a third author to arbitrate over selection.

Data extraction and management

Data extraction

Data extraction was performed independently by the two review authors (AL and either MH or JP) using forms designed according to Cochrane guidelines. The following details were collected.

Trial characteristics:

1. method of randomisation;
2. presence or absence of blinding to treatment allocation;
3. quality of allocation concealment;
4. number of women randomised, excluded or lost to follow up;
5. whether an intention-to-treat analysis was done;
6. whether a power calculation was done;
7. duration, timing and location of the study;
8. source of funding.

Characteristics of the study participants:

1. age and any other recorded characteristics of women in the study;
2. other inclusion criteria;
3. exclusion criteria.

Interventions used:

1. type of endometrial destruction technique.

Outcomes:

1. methods used to measure menstrual blood loss;
2. methods used to evaluate participant satisfaction, change in quality of life and menstrual symptoms.

Data management

Additional information on trial methodology and trial results was sought from the corresponding authors of some trials which appeared to meet the eligibility criteria. This was when aspects of methodology were unclear or where the data were in a form unsuitable for meta-analysis. Authors of the following trials provided extra information: Abbott 2003; Soysal 2001; and Gynecare (pharmaceutical company providing funding for Boujida 2002; Meyer 1998; Perino 2004; van Zon-Rabelink 2003). One of the authors (JP) provided additional information for Penninx 2010.

Assessment of risk of bias in included studies

Two independent review authors (AL and JP) assessed the risk of bias of each study using the risk of bias tool developed by The Cochrane Collaboration (Higgins 2011).

The following domains were assessed:
1) sequence generation (whether the allocation sequence was adequately generated, e.g. random number table, computer random number generator, coin tossing, throwing dice);
2) allocation concealment (whether the allocation was adequately concealed, e.g. sequentially numbered containers of identical appearance, central allocation, sequentially numbered opaque and sealed envelopes);
3) blinding of participants, personnel and outcome assessors (whether knowledge of the allocated intervention was adequately prevented during the study, e.g. by ensuring blinding or participants and key personnel or, where there was no blinding knowledge of the intervention, it was not likely to influence the outcomes);
4) incomplete outcome data (whether incomplete outcome data were adequately addressed, e.g. missing data balanced in numbers across intervention groups, proportion of missing outcomes insufficient to affect estimates, reasons for missing data unlikely to be related to the outcomes);
5) selective outcome reporting (whether the reports of the study were free of suggestion of selective outcome reporting, e.g. previous publication of a study protocol, other evidence that the study contains all of the prespecified outcomes);
6) other sources of bias (whether the study was apparently free of other problems that could put it at a high risk of bias, e.g. baseline imbalance, bias related to study design, early termination of study).

These domains were scored as either:

  • criterion met, i.e. low risk of bias;

  • unclear, i.e. uncertain risk of bias; or

  • criterion not met, i.e. high risk of bias.

Measures of treatment effect

Almost all of the outcomes were measured by either dichotomous or continuous data. Two authors extracted data to enable calculation of relative risks (RRs) for dichotomous data and mean differences (MDs) for continuous data, together with 95% confidence intervals (CIs). Some outcomes, such as satisfaction with treatment, were measured by ordinal data. These data were dichotomised to represent satisfaction with surgery (highly satisfied and satisfied combined) versus no satisfaction (doubtful or dissatisfied) by collapsing categories. Continuous data were inspected for evidence of skew, where possible, according to guidance in the Cochrane Handbook for Systematic Reviews of Interventions by calculating the observed mean minus the lowest (or highest) possible value divided by the standard deviation.

Assessment of heterogeneity

Differences between studies in terms of methodological factors and variations between participants, interventions and outcomes were analysed to determine whether it was appropriate to combine the studies in meta-analysis. If they were sufficiently homogeneous to consider pooling, statistical heterogeneity between the results of different studies was examined by inspecting the scatter in the data points on the graphs, the overlap in their confidence intervals and, more formally, by checking the results of the Chi2 tests (with P < 0.1 considered evidence of significant heterogeneity) and the I2 statistic. The I2 statistic is a measure of the consistency between trials in a meta-analysis (Higgins 2011). As a general rule, I2 values of up to 25% are evidence of low heterogeneity, values from 25% to 50% are considered moderate heterogeneity, and 75% or above is considered substantial heterogeneity.

Assessment of reporting biases

A comprehensive search was undertaken, along with careful inspection of the search results to identify duplicates, in order to reduce the risk of reporting bias. If sufficient trials were identified, it was planned to investigate publication bias by undertaking funnel plots of study results.

Data synthesis

Where there was no evidence of clinical heterogeneity between the studies and no evidence of major skew in the data, the outcomes were pooled statistically in a meta-analysis using RevMan software.

Relative risks (RRs) and 95% CIs were combined for meta-analysis using the Peto-modified Mantel-Haenszel method. For some dichotomous outcomes (for example the proportion of participants requiring further surgery) a higher proportion represented a negative consequence of that treatment, and for other outcomes (for example proportion with improvement in menstrual blood loss) a higher proportion was considered a benefit of treatment. This discrepancy between the categorising of outcomes should be noted when the summary graphs for the meta-analysis are viewed for the assessment of the benefits as opposed to the harms of treatment. Thus, for some of the dichotomous outcomes a treatment benefit is displayed as RRs and CIs to the left of the centre line while for others a treatment benefit is displayed to the right of the centre line. The forest plot for each outcome is labelled clearly for clarification.

Mean differences (MDs) and 95% CIs were combined for meta-analysis using the inverse variance method. For all continuous outcomes in this review, a high value represents a negative consequence of treatment, for example duration of surgery, amount of fluid deficit (difference between input and output fluid during surgery), pictorial menstrual blood loss assessment chart (PBAC) score. Thus, in the evaluation of the summary graphs means and CIs to the left are considered a benefit of the experimental or comparative treatment.

A fixed-effect model approach was used to calculate summary effect measures. Where there was substantial statistical heterogeneity, results from the fixed-effect model were compared with those from a random-effects model to determine whether results were altered substantially by choice of model. A priori it was expected that two of the outcomes, duration of surgery and proportion having local instead of general anaesthesia, would have heterogeneous results regardless of comparison. For these comparisons a random-effects model was initially used. For all overall comparisons where first-generation methods were compared with second-generation methods, a random-effects model was used because of the expected clinical heterogeneity between trials.

Where there was evidence of skewed data in the measurement of outcomes (for example summary trial results were expressed as median and range), the data for these outcomes were not pooled in the meta-analysis but included in table format.

Subgroup analysis and investigation of heterogeneity

Subgroup analyses were planned for different times of follow up after surgery, in particular for amenorrhoea rates, satisfaction and requirement for additional surgery. These outcomes were collected at six months, one, two, two to five years, and greater than five years after surgery.

Sensitivity analysis

A priori, it was intended that sensitivity analysis would be performed to test the robustness of pooled results in the meta-analysis based on:
(1) trials with good methodology (evidence of adequate allocation concealment and intention-to-treat analysis) versus all included trials;
(2) trials with and without power calculations for sample size;
(3) trials with participants who had confirmed objective heavy menstrual blood loss (more than 80 ml per cycle) versus all included trials;
(4) trials with participants who had initially failed medical treatment for HMB versus all included trials.

For most comparisons there was an insufficient number of included studies to be able to perform any of these sensitivity analyses.

Overall quality of the body of evidence

A summary of findings table for the overall outcome of first-generation versus second-generation ablation techniques was generated using GRADEpro software (Summary of findings for the main comparison). This table evaluates the overall quality of the body of evidence for each of the main review outcomes using GRADE criteria (study limitations (that is risk of bias), consistency of effect, imprecision, indirectness and publication bias). Judgements about the evidence quality (high, moderate, low or very low) have been documented and incorporated into the reporting of results for each outcome.

Results

Description of studies

Results of the search

2005 update: 23 studies were considered potentially eligible to be included in the review in the 2005 update and full copies of the papers were retrieved for closer inspection. One study (Vihko 2003) was excluded because it compared two types of balloon ablation, Menotreat and Cavaterm. Three other studies were later publications of trials that were already included in the review (Cooper 1999; Corson 2001; Meyer 1998). Thus, 19 studies, some of which had a number of different publications describing longer follow up or different outcomes, met the inclusion criteria of the review for the 2005 update.

2009 update: a further six potential studies were considered potentially eligible for the 2009 update and full copies of the papers were retrieved for closer inspection. One conference abstract and one Chinese trial are waiting assessment because it was unclear whether the two comparative groups were randomised. Of the remaining four studies, two were later publications of trials already included in the review. One of these studies was a five-year follow up of a trial comparing bipolar radiofrequency ablation to balloon ablation (Bongers 2004) and the other was a 10-year follow up of a trial comparing transcervical resection of the endometrium (TCRE) with rollerball ablation (Boujida 2002). Two new RCTs (21 studies overall) were eligible for the 2009 update (Brun 2006; Onoglu 2007).

2013 update: an additional 14 studies were considered potentially eligible for the 2013 update and the full texts of the papers (where available) were retrieved for closer inspection. Four were excluded; one because it compared different wave forms for rollerball ablation (Chang 2009), one because it was not randomised (El-Nashar 2009), and two because they compared similar types of endometrial ablation with or without a co-intervention (Abd Ek Hameed 2012; Cash 2012). One other study was a 10-year follow up of a study already included in the review (Cooper 1999). Four new trials, one of which had two publications, were included in the 2013 update (Clark 2011; Penninx 2010; Sambrook 2009b; Thabet 2010). Four studies were categorised as awaiting classification: two of these studies (Pados 2011; Yu 2009) have not yet published results and two had results available in abstract form and will be included in the next update of this review (Bongers 2011; Penninx 2012). The latter study is a 10-year follow up of a study already included in the review (Bongers 2004). One study awaiting assessment since the 2009 update has now been excluded as it was not randomised (Feng 2006). One study is ongoing (Cooper 2012).

Thus, a total of 25 studies (4040 women), with sample sizes ranging from 20 to 372, were eligible for the review. Full details of the studies can be found in the Characteristics of included studies table. A total of seven studies have been excluded and five are currently awaiting classification. Details of the screening and selection process are presented in Figure 1.

Figure 1.

Study flow diagram.

Study design

All of the trials had a parallel group design. Six large trials were multicentre, each with 200 to 300 participants and one smaller multicentre trial had 62 participants. Eighteen of the trials were single-centre studies (one each from Germany, Australia, Egypt and Denmark; two from Turkey; three from the Netherlands and Italy; and six from the UK). Six of the seven multicentre trials were based in the USA, with three having additional centres in Canada, UK or Australia and one multicentre trial had six centres all based in France.

Few of the studies had strict intention-to-treat (ITT) analyses or specified methods to deal with missing data. Twelve trials did not report an ITT analysis. Seven trials claimed that ITT analysis was performed but over time a percentage of participants were lost to follow up so the claim of ITT was misleading. However, ITT analysis was usually performed when assessing outcomes such as complication rates in these studies. Four trials had true ITT analyses and one trial had no reported dropouts. One other trial did not report ITT analysis and replaced dropouts with new cases. Seventeen trials reported either pharmaceutical or medical equipment company partial or complete funding, or had authors with a conflict of interest.

Participants

The 25 included studies contained 4056 premenopausal participants, mostly within the age range 30 to 50 years. In all of the studies women with a complaint of HMB were recruited from secondary or tertiary referral centres or clinics.

Presence of fibroids was an exclusion criterion in 12 studies and all trials required that the uterine cavity be normal in size with no uterine pathology. One trial required women to have myoma-induced menorrhagia (Soysal 2001) but excluded women with submucous fibroids greater than 3 cm or less than 50% intramural extension. One other trial (Brun 2006) excluded only submucous fibroids and one trial excluded both submucous fibroids and extracavity fibroids > 3 cm (Clark 2011). In one trial (Corson 2000), 637 women with self-assessed HMB were screened but, after the application of exclusion criteria, less than half (n = 276) were enrolled and randomised. Almost half of the excluded women had uterine pathology in the form of fibroids or polyps.

Nineteen trials required women to have completed their families and 14 trials included women who previously had not tolerated or had had ineffective medical therapy for their heavy bleeding. Twelve trials objectively confirmed the women's complaint of excessive bleeding by requiring them to record their blood loss. This was prior to surgery and before entry into the trial. Nine trials required women to have pictorial blood loss chart (PBAC) (Higham 1990) measurements of 150 or greater prior to entry, two trials required women to have PBAC measurements of 100 or greater prior to entry, one trial required a blood loss score of more than 185 and one trial included women only if their blood loss exceeded 70 ml per cycle (as measured by the alkaline haematin method (Hallberg 1964). All but one trial had comparable demographic characteristics between the comparison groups at baseline; in the Brun trial women undergoing balloon ablation had significantly heavier blood loss than those undergoing TCRE.

Interventions

Most of the studies (particularly first-generation techniques) had some kind of pretreatment prior to surgery. In 13 of the trials, participants had pre-operative gonadotropin-releasing hormone (GnRH) analogues to prepare and thin the endometrium prior to surgery, although in one of these studies pretreatment was given only to the TCRE group and not to the balloon group. Three months, 14 or seven days of preoperative treatment with progestogens was also used in three trials. One trial required two months of oral contraceptive therapy prior to surgery to ensure that women were scheduled at a similar time in their cycle. One trial required a dilation and curettage procedure prior to ablation surgery. Four other trials used non-steroidal anti-inflammatory drugs (NSAIDs) to prevent uterine cramping. The remaining three trials had no pre-operative therapy.

Five trials compared first-generation ablation methods: two compared laser ablation with TCRE (one argon laser, the other Nd:YAG (neodymium yttrium aluminium garnet)), one compared a vaporising electrode procedure with TCRE, and two compared rollerball with TCRE. All of the TCRE comparison groups also had rollerball ablation to treat the uterine cornua (a horn-like area in the uterus) and fundus (body of the uterus). It was claimed that the vaporising electrode (unlike rollerball) could be used to treat submucous fibroids. Another 14 trials compared second-generation methods with first-generation methods: four compared balloon ablation (three with Thermachoice, one with Cavaterm) with rollerball, one compared the Vesta system with rollerball, two compared microwave ablation with TCRE and rollerball, one compared heated saline (Hydro Thermablator) with rollerball, one compared cryoablation with rollerball, one compared thermal laser with TCRE, two compared electrode ablation with TCRE plus rollerball, one compared balloon (Cavaterm) with laser (Nd:YAG), and two compared balloon (Cavaterm) with TCRE plus rollerball. Five trials compared second-generation techniques, bipolar electrode ablation (Novasure) with either balloon or hydrotherm ablation or microwave compared with balloon ablation. All of the first-generation techniques (laser, rollerball, vaporising electrode and transcervical resection), which use the hysteroscope, were then combined and compared with all the second-generation techniques (balloon, microwave, Vesta system, cryoablation, thermal laser, bipolar electrode ablation and hydrothermal ablation), which are blind techniques. An additional trial compared overcurettage with ablative curettage (Thabet 2010).

Outcomes

Most of the trials assessed amenorrhoea (some included 'light' or 'normal' bleeding), satisfaction rates and frequency of complications. Eighteen trials compared the duration of surgery; 19 trials compared menstrual blood scores on the PBAC chart or success of treatment; 12 assessed the frequency of any additional surgery after treatment; 15 trials compared hysterectomy rates after treatment; 13 trials assessed quality of life measures such as SF-36, improvement in dysmenorrhoea or premenstrual syndrome (PMS) symptoms; and a few trials measured ability to work, difficulty of surgery, rate of acceptability, degree of fluid deficit and duration of hospital stay. The types of anaesthesia used ('local' versus 'general') were compared between first and second-generation techniques.

One trial assessed outcomes only after six months follow up. Eight trials assessed outcomes one year after surgery. Six trials assessed outcomes at both six months and one-year follow up. Three trials assessed outcomes at both one and two-year follow up and the remaining trials had longer-term follow up, at either three, five or 10 years. Two trials did not specify the time at which post-operative outcomes were assessed.

Risk of bias in included studies

The risk of bias in the included studies can be found in the table 'Characteristics of included studies' and is summarized in Figure 2 and Figure 3.

Figure 2.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Figure 3.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Allocation

Sixteen studies had adequate randomisation methods, either computer generated or lists of random numbers. In four studies no details were provided on the randomisation method. One study (Onoglu 2007) gave details of an inadequate randomisation method; participants were allocated to treatment in the order in which they came into the clinic. Ten studies provided evidence of adequate allocation concealment, either sequentially numbered opaque envelopes or a central method for allocation to groups. Ten studies did not provide any details as to whether allocation was concealed, and the remaining study was scored as having no concealment.

Blinding

In most of the trials blinding was either specifically denied or not reported; for all these trials blinding was unlikely due to the nature of the interventions. Two trials that compared second-generation techniques (bipolar radiofrequency versus balloon) (Abbott 2003; Bongers 2004) and one other comparing balloon with laser (Hawe 2003) had triple blinding (patients, investigators and assessors), and three other second-generation trials (Clark 2011; Penninx 2010; Sambrook 2009b) had double blinding (patients and assessors) (although in the Clark trial women were likely to have guessed allocation).

Incomplete outcome data

Eight trials did not report any dropouts after treatment (five of these had dropouts ranging from 1% to 4% after randomisation and before treatment). The remaining trials had dropout rates ranging from 3% to 18% after one-year follow up, from 9% to 17% after two-year follow up, from 2% to 16% after five-year follow up, and from 6% to 28% after 10-year follow up. In one of these trials, with a 9% dropout rate (Corson 2001), one arm of the trial (the hydro thermoblator (HTA) group) had a higher dropout rate than the other arm due to equipment failure. In another trial (Brun 2006) 18% of the study population were excluded from the study after randomisation and before treatment in unequal numbers per group, making randomisation unbalanced.

In assessments regarding incomplete outcome data, 16 trials were scored as having adequately addressed their missing data (if any), because there were no reported dropouts, missing data was balanced between groups or there was minimal loss to follow up that was unlikely to affect the calculation of estimates. For five studies it was unclear whether their missing data could cause bias, and for three studies missing data were highly likely to bias the estimates, two because of substantial loss to follow up and the other because there were imbalances in the loss of missing data between groups. One other trial had dropouts that were replaced by other cases, which is likely to also cause major bias (Thabet 2010).

Selective reporting

Most of the comparisons had insufficient trials to construct a funnel plot. However, the overall comparison of first with second-generation ablation for satisfaction rate had a large number of trials which assessed the outcome at different time points. For all time points except long-term follow up (10 years) there was no evidence of asymmetry. However, the addition of the single trial assessing satisfaction at 10 years suggested that there was a degree of asymmetry (Figure 4). Thus, long-term results should be considered with caution, until other long-term studies are published.

Figure 4.

Funnel plot of comparison: 16 Overall analyses: Second-generation endometrial ablation versus first-generation endometrial ablation, outcome: 16.2 Satisfaction rate.

Most trials were scored as at low risk of reporting bias as a result of selective reporting of outcomes. In these trials all prespecified outcomes were reported in the results sections.

Other potential sources of bias

Most studies had no evidence of any other potential source of bias. Three studies had potential sources of bias: one recruited participants over two different time periods and comparison of the two groups indicated substantial differences, one study used denominators for the outcomes that did not correspond to the denominators originally specified, and in another study the numbers in the two randomised groups differed substantially with no explanation given.

Effects of interventions

See: Summary of findings for the main comparison Second-generation endometrial ablation compared to first-generation endometrial ablation for heavy menstrual bleeding

First-generation technique comparisons

1. Laser versus transcervical resection of the endometrium (TCRE) (Comparison 1)

Primary outcomes: there was no evidence of significant differences between groups in the primary outcomes measured, that is amenorrhoea rate, combined amenorrhoea and hypomenorrhoea rate, menstrual blood loss at six months or satisfaction at 12 months.

Secondary outcomes: duration of laser surgery was an average of nine minutes longer than for TCRE (mean difference (MD) 9.15, 95% CI 7.2 to 11.1). The risks of equipment failure and fluid overload were also greater among women who had laser ablation when compared with TCRE (risk ratio (RR) 5.5, 95% CI 1.7 to 18.6; RR 4.9, 95% CI 1.4 to 16.6, respectively). There was no evidence of significant differences between laser ablation and TCRE for the other secondary outcomes: other types of operative difficulties, improvement in symptoms, improvement in dysmenorrhoea, requirement for further surgical treatment, other complications and general health after treatment.

2. Vaporising electrode ablation versus TCRE (Comparison 2)

Primary outcomes: there was no evidence of significant differences between TCRE and vaporising electrode ablation for measurement of bleeding or satisfaction, that is amenorrhoea or hypomenorrhoea (scanty menstruation) rate, pictorial chart method (PBAC) score at 12 months and satisfaction with treatment.

Secondary outcomes: the odds of 'difficult' surgery (assessed subjectively into three categories by surgeons) were less likely with vaporising electrode ablation when compared with TCRE (RR 0.29, 95% CI 0.10 to 0.82). The amount of fluid deficit was greater (MD 258 ml, 95% CI 173.9 to 342.1) and the duration of surgery longer (MD 1.5 min, 95% CI 0.35 to 2.65) in the TCRE group when compared with vaporising electrode ablation.

3. Rollerball versus TCRE (Comparison 3)

Primary outcomes: there were no primary outcomes measured in the included studies.

Secondary outcomes: there was no evidence of significant differences between these two first-generation ablation methods, rollerball and TCRE, in the proportion requiring either hysterectomy or any surgical intervention after two, five, and 10-year follow up, or in the complication rates measured (fluid deficit and perforation). Non-parametric analysis confirmed that the duration of surgery was significantly shorter with rollerball than with TCRE in one trial (median 13 minutes with rollerball versus 20 minutes with TCRE, P < 0.05) but this was not confirmed by another small trial that assessed mean difference between groups.

Second-generation versus first-generation technique comparisons

4. Thermal laser versus TCRE (Comparison 4)

Primary outcomes: the odds of amenorrhoea at one and three years after surgery was significantly greater for women in the thermal laser group when compared with women in the TCRE group (RR 2.5, 95% CI 1.5 to 4.0; OR 2.5, 95% CI 1.5 to 4.2, respectively) in one study with 111 participants. There was no evidence of statistical differences in the satisfaction rates between groups.

Secondary outcomes: mean length of surgery was an average of nine minutes shorter for women in the thermal laser group when compared with women in the TCRE group (MD 9.3, 95% CI 11.4 to 7.2). However, women appeared to experience more pain with thermal laser treatment (MD 0.7 units on pain scale, 95% CI 0.02 to 1.4,), which just reached significance (P = 0.05). There was no evidence of differences in the requirement for more surgical intervention or complication rates (urinary tract infection) between the groups.

5. Hydro thermoblator (HTA) versus rollerball (Comparison 5)

Primary outcomes: there was no evidence of significant differences between groups in amenorrhoea rate, other menstrual loss outcomes or success of treatment.

Secondary outcomes: the chance of having local rather than general anaesthesia was increased two-fold for women having HTA ablation (RR 2.0, 95% CI 1.3 to 3.1). Women in the HTA group were also less likely to experience the adverse event of haematometra (haemorrhage in the uterus) from surgery (RR 0.18, 95% CI 0.04 to 0.93) but more likely to experience abdominal pain (RR 1.4, 95% CI 1.0 to 1.9) and nausea and vomiting after surgery (OR 3.1, 95% CI 1.4 to 7.0). There was no evidence of significant differences between groups for the other outcomes, that is need for further surgery and other operative adverse events.

6. Cryoablation versus rollerball (Comparison 6)

Primary outcomes: women having cryoablation were less likely to have amenorrhoea one year after surgery than women having rollerball treatment (OR 0.5, 95% CI 0.36 to 0.69). There was no evidence of significant differences between groups for satisfaction with treatment at one or two-year follow up.

Secondary outcomes: women having cryoablation were more likely to have local rather than general anaesthesia when compared with women having rollerball ablation (RR 6.6, 95% CI 3.2 to 13.6). There was no evidence of significant differences between groups for the other secondary outcomes measured, that is requirement for further surgery or hysterectomy two years after ablation treatment and rates of intra-operative complications.

7. Electrode ablation (balloon or mesh) versus TCRE (Comparison 7)

Primary outcomes: there was no evidence of significant differences between groups for any of the primary outcomes measured, that is amenorrhoea rate, PBAC score < 75, PBAC score or satisfaction rate.

Secondary outcomes: the duration of the procedure was significantly longer for women having TCRE compared with Vesta or Novasure (MD 18.7 min, 95% CI 16.8 to 20.7). Women undergoing electrode ablation were also more likely to have local rather than general anaesthesia than women having TCRE (RR 3.9, 95% CI 2.9 to 5.0). Perforation and cervical tears or lacerations were less likely with electrode ablation than with TCRE (RR 0.13, 95% CI 0.02 to 1.0; RR 0.11, 95% CI 0.01 to 0.9, respectively). There was no evidence of significant differences between groups for the other secondary outcomes compared, that is other complication rates or requirement to have hysterectomy after two-year follow up.

8. Microwave versus TCRE plus rollerball (Comparison 8)

Primary outcomes: there was no evidence of significant difference between groups in the primary outcomes measuring menstrual blood loss, that is amenorrhoea rate or success of treatment measured by PBAC < 75, or the rates of satisfaction one or up to 10 years after surgery. However, with the follow up at two years, there was a significant benefit for microwave ablation in terms of satisfaction with treatment when compared with TCRE (RR 1.2, 95% CI 1.0 to 1.4) and this benefit was maintained at five years (RR 1.2, 95% CI 1.0 to 1.4) but not at longer follow up in the same trial.

Secondary outcomes: in one study, the duration of the procedure was significantly shorter with microwave when compared with TCRE (MD -3.6 min, 95% CI -1.4 to -5.7). In one study, the risk of equipment failure was higher in the microwave group when compared with the TCRE group (RR 3.8, 95% CI 1.1 to 13.3). Vomiting and uterine cramping were more likely with microwave treatment than with TCRE (RR 3.6, 95% CI 1.3 to 10.0; RR 1.2, 95% CI 1.0 to 1.4, respectively). Patients undergoing microwave ablation were more likely to have local anaesthesia than those undergoing TCRE (RR 2.5, 95% CI 1.7 to 3.7). At 10-year follow up, the risk of further surgery or hysterectomy was marginally reduced with microwave ablation (any surgery: RR 0.7, 95% CI 0.5 to 1.0; hysterectomy: RR 0.6, 95% CI 0.4 to 1.0).

For all other secondary outcomes there was no evidence of significant differences between groups: rate of other complications, abandoning the procedure, postoperative analgesia, improvement in dysmenorrhoea, change in most SF-36 scores (Short Form 36 scale, a generic measure of subjective health), duration of hospital stay, requirement for further surgery at other time points, inability to work, or improvement in symptoms.

9. Balloon versus rollerball (Comparison 9)

Primary outcomes: amenorrhoea was less likely after balloon ablation than after rollerball ablation at one-year follow up (RR 0.63, 95% CI 0.41 to 0.97, three studies) but there were no significant differences between groups two and up to five years after treatment, although a strong trend was shown in favour of rollerball ablation. There was no evidence of significant differences between groups for the other outcomes assessing menstrual blood loss, that is satisfaction, rate of amenorrhoea and hypomenorrhoea combined, success of treatment and PBAC score at one year, although one trial found a significantly lower PBAC score at two years in women having balloon ablation which was not confirmed by other trials assessing PBAC score at one year.

Secondary outcomes: the mean difference between duration of surgery for women in the balloon group and women in the rollerball group was 21 minutes (MD -20.9, 95% CI -19.3 to -22.5, three studies). There was no evidence of significant differences between groups for the other secondary outcomes compared, that is complication rates, inability to work, improvement in dysmenorrhoea or PMS, technical complication rate or requirement for further surgery or hysterectomy.

10. Balloon versus laser (Comparison 10)

Primary outcomes: there was no evidence of statistical differences in the amenorrhoea or satisfaction rates or in the PBAC score after treatment between groups.

Secondary outcomes: most outcomes were not significantly different between treatment groups. However, women having balloon treatment had a significantly greater pain score than women in the laser group (MD 32.7, 95% CI 23.7 to 41.7, one study). At 12 months after treatment, women in the balloon group had higher scores on the Euroquol 5D visual analogue scale (VAS) than women in the laser group (MD 10.1, 95% CI 2.4 to 17.8, one study), which was not found at earlier follow up or for other quality of life scores.

11. Balloon versus TCRE (Comparison 11)

Primary outcomes: there was no evidence of a difference between groups in amenorrhoea rates at six and 12 months follow up after surgery. Satisfaction with treatment was greater in the balloon group than in the TCRE group two years after surgery (RR 1.4, 95% CI 1.1 to 1.7, one study) but this difference was not found at six months or one year after surgery.

Secondary outcomes: duration of surgery was significantly shorter (35%) with balloon than with TCRE treatment in one trial (MD 13 min, 95% CI 10.8 to 15.2) but this finding was not confirmed by another trial which could not be pooled in the forest plot (Brun 2006). Mean intra-operative blood loss (measured in ml) was significantly less for balloon treatment compared to laser treatment in one small trial (MD -81.8, 95% CI -70.3 to -93.3). Post-operative pain (as measured by a continuous VAS scale) was significantly higher for women in the TCRE group than for women in the balloon group in one small trial (MD 0.6 points, 95% CI 0.3 to 0.9), which was confirmed by another trial that could not be included in the forest plot (Brun 2006). Recovery, as measured by stay in hospital and return to normal activities, was faster for women in the balloon group than for those in the TCRE group in one small trial (MD 0.3 of a day, 95% CI 0.1 to 0.5; MD 2.1 days, 95% CI 0.8 to 3.4, respectively). Another trial (Brun 2006) which could not be included in the forest plot confirmed the finding that balloon surgery was associated with a shorter hospital stay but there was no evidence of a difference in return to normal activities in this trial.

There was no evidence of differences between groups for the other secondary outcomes, that is other complication rates, equipment failure or requirement for further surgery.

Second-generation ablation comparisons

12. Bipolar electrode ablation versus balloon (Comparison 12)

Primary outcomes: amenorrhoea was more likely for women in the electrode ablation group than for those in the balloon group, both at six months and 12 months after treatment (RR 4.4, 95% CI 2.0 to 9.7, two studies; and RR 3.8, 95% CI 2.1 to 6.9, two studies); at five-year follow up a small trial did not find significant differences between treatment groups in amenorrhoea rates but a non-significant trend favouring bipolar ablation. One trial at 12-month follow up did not find a difference between groups in the PBAC scores after treatment.
There was no evidence of significant differences between groups in rates of satisfaction after treatment, although a trend at 12-month follow up favoured bipolar ablation.

Secondary outcomes: duration of procedure time was from five minutes to 19 minutes shorter with bipolar ablation when compared with balloon ablation in three trials (two of which recorded significant differences). For most of the quality of life scores, there was no evidence of significant differences between groups. However, women having balloon ablation had significantly higher scores on the SF-36 emotional role domain than women having bipolar ablation five years after their treatment (MD -9.0 points, 95% CI -3.6 to -14.5), but not at other follow-up times. Results were inconsistent for rates of dysmenorrhoea and PMS: two trials found no evidence of a difference in dysmenorrhoea rates between groups and one trial found no evidence of a difference in PMS symptoms. However, another trial found that bipolar ablation was associated with improved dysmenorrhoea and PMS symptoms (summary figures not provided). There was no evidence of significant differences between groups for the other secondary outcomes, that is technical complication rate or requirement for further surgery.

13. Microwave ablation versus balloon ablation (Comparison 13)

Primary outcomes: amenorrhoea rates were significantly higher with microwave ablation than balloon ablation at six months follow up (RR 1.5, 95% CI 1.1 to 2.1) but not at 12 months follow up. PBAC scores and satisfaction rates were not significantly different between groups at 12 months follow up.

Secondary outcomes: operation time was reduced by almost seven minutes with microwave ablation when compared to balloon ablation (MD -6.6 min, 95% CI -5.8 to -7.4) and the microwave device was less likely to fail (RR 0.1, 95% CI 0.01 to 0.7). There was no evidence of significant differences between groups for the other secondary outcomes, that is other device difficulties, proportion choosing local anaesthesia, quality of life scores, requirement for analgesia, overnight stay, need for further surgery or pain scores.

14. Bipolar electrode ablation versus hydrothermal ablation (Comparison 14)

Primary outcomes: amenorrhoea rates were significantly increased with bipolar ablation when compared to hydrothermal ablation at all time points (6 months: RR 2.3, 95% CI 1.3 to 4.1; 12 months: RR 2.0, 95% CI 1.2 to 3.2; 5 years: RR 1.6, 95% CI 1.1 to 2.3) and satisfaction rates were significantly increased (RR 1.3, 95% CI 1.1 to 1.5).

Secondary outcomes: There was a greater chance of eliminating dysmenorrhoea symptoms with bipolar ablation when compared to hydrothermal ablation (RR 1.3, 95% CI 1.0 to 1.7) at five years follow up but not at 12 months follow up. The duration of the procedure was significantly shorter with bipolar ablation (11.8 min with bipolar versus 27.8 min with hydrothermal ablation). There was a significantly reduced risk of requiring any surgery with bipolar ablation compared to hydrothermal ablation both at 12 months and up to five years of follow up (12 months: RR 0.3, 95% CI 0.1 to 0.7; 5 years: RR 0.4, 95% CI 0.2 to 0.8). There was no evidence of significant differences between groups for the other secondary outcomes, that is complications or future hysterectomy.

15. Ablative curettage versus overcurettage (Comparison 15)

Primary outcomes: ablative curettage resulted in significantly higher rates of amenorrheoa than overcurettage (RR 4.5, 95% CI 2.3 to 8.7) and rates of amenorrhoea and normal menses combined (RR 1.9, 95% CI 1.3 to 2.7). The authors stated that these outcomes were measured three years after surgery.

Secondary outcomes: bleeding complications were significantly less likely with ablative curettage than overcurettage (RR 0.21, 95% CI 0.07 to 0.70) and failure rates of the procedure were less likely (RR 0.29, 95% CI 0.12 to 0.74). Overcurettage was associated with a significantly reduced hospital stay in comparison to ablative curettage (MD 1.6 days, 95% CI 1.2 to 2.0). There was no evidence of significant differences between groups for the other secondary outcomes, that is other complications and requirement for further surgery.

Second-generation ablative techniques versus first-generation ablation techniques (overall) (Comparison 16)

Primary outcomes: there was no evidence of significant differences in the rates of amenorrhoea or successful treatment at any follow up time, from six months to 10 years after surgery. There was also no evidence of significant differences in satisfaction rates at any time point.

Secondary outcomes: on average, first-generation ablation techniques required an extra 15 minutes treatment time when compared with second-generation techniques (MD -14.9, 95% CI -10.1 to -19.7). There was also a greater risk of equipment failure with second-generation devices (RR 4.3, 95% CI 1.5 to 12.4) and greater chance of using local rather than general anaesthesia with second-generation devices (RR 2.8, 95% CI 1.8 to 4.4). Regarding complications, women undergoing second-generation ablation procedures were less likely to have fluid overload, perforation, cervical lacerations and haematometra as a result of their surgery than women undergoing first-generation ablation (RR 0.2, 95% CI 0.04 to 0.8; RR 0.3, 95% CI 0.1 to 1.0; RR 0.2, 95% CI 0.08 to 0.6; RR 0.3, 95% CI 0.1 to 0.9, respectively). They had a significantly greater risk of having nausea and vomiting and uterine cramping (RR 2.0, 95% CI 1.3 to 3.0; RR 1.2, 95% CI 1.0 to 1.4, respectively). There was no evidence of significant differences for the other secondary outcomes compared, that is inability to work, other complication rates and requirement for any additional surgery or hysterectomy.

The main outcomes for this overall comparison can be viewed in the Summary of findings for the main comparison.

Heterogeneity

1. Specific types of endometrial resection or ablation

Most of the forest plots comparing specific types of endometrial ablation were comparisons between groups in individual trials or pooled two or three studies at most, and there was little evidence of statistical heterogeneity. However, substantial statistical heterogeneity (I2 > 50%) was found for the following forest plots.

Comparison 1.5: duration of operation (laser versus TCRE).

Comparison 7.5: duration of operation (electrode ablation versus TCRE + rollerball).

Comparison 9.8: duration of operation (balloon versus rollerball).

Comparison 9.14: requirement for further surgery (two-year follow up) (balloon versus rollerball).

Comparison 12.3: satisfaction rate (six months follow up) (bipolar radiofrequency ablation versus balloon).

Comparison 12.33: requirement for further surgery (bipolar radiofrequency versus balloon).

Duration of operation is affected by numerous confounding factors, such as expertise of individual surgeons, hospital type and procedures, and differences between groups of women. For the comparison laser versus TCRE, the Bhattacharya study did not include the total time spent in theatre and the McClure study recorded the induction and reversal of anaesthesia in the estimate of operation time, which resulted in much larger estimates. In this latter trial, temporary laser malfunction prolonged two laser cases to 240 minutes. For the comparison electrode ablation versus TCRE + rollerball, differences between studies were likely to be explained by the two different systems used: the Corson study used the Vesta balloon ablation and the Cooper study used Novasure. In the comparison balloon versus rollerball, all three pooled studies used the Thermachoice balloon system. The operation time recorded for the rollerball ablation was similar in the three trials but times differed between studies for balloon ablation. The Meyer study had no pre-operative treatment to thin the endometrium whereas the other two studies had two months of GnRH agonist pretreatment. In the Soysal study, participants had both myomas and heavy menstrual bleeding. Other factors such as cavity length were correlated with operation time and it was not clear whether these were similarly distributed between the participants in the three trials. Another major confounding factor was the ability to use local rather than general anaesthesia, which was more likely in the trials comparing second-generation ablation to first-generation ablation methods.

Satisfaction is also likely to have varied because of different methods of measurement. In the comparison bipolar radiofrequency ablation versus balloon, satisfaction rates at six months in the small Abbott trial may have been related to a technical failure rate of the Novasure procedure, but rates at 12-month follow up were similar and not significantly different.

Significant heterogeneity was also found for the outcome requirement for further surgery in the comparison of balloon with rollerball and bipolar electrode ablation versus balloon. The different results in the two pooled trials for either comparison could not be explained by examination of their characteristics. Neither trial reported a significant difference in the outcome by ablation technique.

2. Overall analyses comparing first and second-generation techniques

Substantial heterogeneity was displayed for many of the outcomes where first-generation procedures were compared with second-generation procedures (comparison 16); in particular, amenorrhoea rate, duration of operation, and proportion having local as opposed to general anaesthesia. The I2 value for the outcome amenorrhoea at one year after surgery was 74%, at two years 50%, and at three years 80%. The rates of amenorrhoea ranged widely in the included trials and no statistical difference was reported between groups. Estimates calculated with the fixed-effect model were compared with estimates calculated with a random-effects model; the estimates did not change markedly but the CIs were wider with the latter approach. There was thus no evidence that amenorrhoea rates varied according to whether first or second-generation techniques were used to ablate the endometrium.

The forest plots of the outcomes, duration of surgery, and local versus general anaesthesia also indicated substantial heterogeneity. Since these two categories were very broad and they included a number of different ablative techniques, heterogeneity was expected and a random-effects model was used to display results. As previously explained, apart from differences between techniques, duration of surgery was likely to be affected by extraneous factors such as skill and expertise of the surgeon, hospital policy and the operating environment. However, each of the included trials reported separately that second-generation techniques took significantly less time to perform than first-generation techniques, regardless of the procedures compared. A random-effects model approach indicated significantly less time required for second-generation procedures; each of the trials individually indicated a statistically significant difference. The other comparison, proportion of women having local as opposed to general anaesthesia, also indicated highly significant heterogeneity. In all trials in the meta-analysis, the proportion of women undergoing ablation with first-generation techniques using local anaesthesia (either TCRE plus rollerball or rollerball alone) ranged from 8% to 23% while the proportion undergoing second-generation ablation using local anaesthesia (Vesta, HTA, Novasure, cryoablation or microwave) ranged from 45% to 86%. All trials separately reported large significant differences between first and second-generation techniques. A random-effects model confirmed these differences in the pooled result.

To sum up, random-effects model analyses confirmed the following.

(1) There was no evidence of a difference in the amenorrhoea when first-generation techniques were compared with second-generation techniques.
(2) Duration of surgery with second-generation techniques overall was less than with first-generation techniques. Because of heterogeneity, which was probably explainable by other factors such as experience of surgeons, the difference of 15 minutes between procedures represented an average which was not informative and this difference was unlikely to be clinically significant.
(3) Women undergoing ablation with second-generation techniques were more likely to have local anaesthesia compared to those having ablation with first-generation techniques.

Sensitivity analyses

Sensitivity analyses were performed only on the comparisons where five or more trials were pooled, specifically for the comparison of satisfaction and amenorrhoea rates at one-year follow up between first and second-generation ablation. There were no significant differences reported between randomised groups and the planned sensitivity analyses did not substantially change the results of the included trials, although heterogeneity was reduced.

Discussion

Summary of main results

A significant number of women with heavy menstrual bleeding (HMB) who seek treatment will not benefit from, or will not wish to continue with, medical treatment and are keen to preserve their uterus. Thus, there appears to be a distinct role for an effective, relatively minor surgical procedure such as endometrial ablation or resection which preserves the uterus yet reduces HMB. This review has assessed a wide range of efficacy, satisfaction and safety outcomes relating to different methods of ablating the endometrium for women who complain of excessive menstrual bleeding.

Comparison of different types of first-generation techniques

The first-generation ablation techniques have been traditionally acknowledged as the 'gold standard' by which other newer procedures are judged. Improvement in menstrual bleeding and satisfaction seems to be similar. The complication profile for the four techniques is slightly different; for example, fluid overload was more likely with laser ablation when compared to TCRE, and also more likely with TCRE when compared to vaporising electrode ablation. However, it is likely that operator safety is a much more important arbiter of patient safety than the instrument itself. Duration of surgery was longer with laser when compared to TCRE and was longer with TCRE when compared to vaporising electrode ablation. Equipment failure was more likely with laser ablation when compared to TCRE and the procedure was more difficult with TCRE when compared to vaporising electrode ablation.

Comparison of different types of first-generation with second-generation techniques

With reference to the comparisons of the different types of second-generation techniques with first-generation techniques, thermal laser was more effective than TCRE at reducing blood loss (as measured by amenorrhoea rates) but this did not result in any difference in the satisfaction that the women felt with their surgery. Although rollerball was more likely to result in amenorrhoea when compared to cryoablation, there was also no evidence that women were more satisfied. Similarly, the finding that rollerball was associated with significantly more amenorrhoea when compared to balloon ablation at some time points but not at others is not useful as there was no evidence that this benefit was confirmed by other bleeding outcomes of importance to women, such as PBAC score or scanty menstruation. Patients appeared to be more satisfied with microwave than TCRE at two and five years after surgery, but these findings were not significant at other time points.

With regards to secondary outcomes, duration of surgery was consistently shorter with second-generation ablation and local anaesthesia was more likely to be given. Pain was also more likely with some types of second-generation techniques, such as thermal laser, balloon and hydro thermoablator (HTA), but this outcome was not measured by all trials. The intra-operative and post-operative complication rates are summarised below.

Comparison of different types of second-generation techniques

Bipolar radiofrequency ablation was associated with significantly more amenorrhoea than balloon ablation but this was not confirmed by a comparison of PBAC scores or the extent to which women were satisfied with their surgery. Surgery was shorter with bipolar ablation and PMS scores reduced. There was no evidence that bipolar radiofrequency ablation resulted in less re-operation as a result of dissatisfaction with surgery. Bipolar ablation also increased amenorrhoea and satisfaction rates when compared with hydrothermal ablation. The procedure time was shorter with bipolar ablation and women were less likely to require additional surgery at later follow up. Amenorrhoea rates appeared to be increased with microwave when compared with balloon but no differences were found in PBAC scores or satisfaction. Operation time was also reduced with microwave ablation.

Comparison of curettage techniques

One small trial, with considerable risk of bias, found advantages for an ablative curettage (devised by the author of the trial) over overcurettage (where the curettage is continued beyond the gritty sensation felt at the basal endometrium) in terms of improved amenorrhoea and normal menstruation rates and reduced failure rate and bleeding complications, but with longer hospital stay. The objective of the study was to find effective techniques for developing countries which may not have the resources and skills to undertake other types of ablation discussed in this review, but the authors acknowledged that curettage may only have a temporary role.

Overall comparison of first-generation with second-generation techniques

Regarding the overall comparison of second-generation with first-generation techniques, there is no evidence that either broad category is more effective than the other in reducing HMB and there was no evidence that rates of satisfaction differed significantly. Overall, second generation techniques were at least as effective as first-generation methods but were often easier to perform with shorter surgery times and the ability to use local rather than general anaesthesia. Some types of intra-operative and post-operative complications, such as fluid overload, perforation, cervical lacerations and haematometra, were more common with first-generation ablation; and other types of complications, nausea and vomiting and uterine cramping and pain were more common with second-generation techniques. Concerns about these 'blind' methods leading to bowel injuries from undetected uterine perforations did not seem to be confirmed in the published studies. However, there are many anecdotal examples that such events can occur and great care must be taken to minimise the risk of such potentially serious complications. There was no evidence that rates of re-intervention, either repeat ablation or hysterectomy or both, differed between first and second-generation ablation. A recurrent comment about the newer techniques which rely on 'devices' inserted into the uterine cavity to destroy the endometrium was the incidence of equipment failure. This may represent expected 'teething problems' associated with new equipment. However, since the older methods are extremely simple (a loop, laser or diathermy to destroy the endometrium below it) and the newer techniques are potentially quite complex (microwaves, bags of fluid etc) the potential remains for mechanical breakdown to occur. In addition, considerable experience in intrauterine cavity assessment and manipulation is required to safely use any of these devices. There are potential disadvantages to stressing how little operator skill is required for a device, which has the capacity to cause extensive intra-abdominal trauma.

Overall completeness and applicability of evidence

A perennial and unresolved problem in the assessment of any treatment for HMB is the accuracy of the original diagnosis and the quandary that many women who complain of excessive bleeding will be shown to have menstrual losses (MBL) within normal population limits when blood loss is objectively measured (Chimbira 1980; Fraser 1984). The 'gold standard' technique for the measurement of MBL involves the collection of all menstrual pads and tampons as well as clots and other blood lost, which is impractical for many women. Also, the assessment of blood loss (via the alkaline haematin method) is a time consuming and laborious task, although objective data are helpful in the research setting. Consequently, a number of more pragmatic alternatives have been suggested to attempt to objectively assess MBL in a normal clinical setting, such as the pictorial blood loss assessment chart (PBAC). Unfortunately, none of these alternatives have been shown to reliably correlate with the gold standard. Some authors have accepted that it is the woman's subjective complaint of HMB which is of primary importance in directing intervention in a clinical setting. However, this subjectivity raises problems when used for the comparison of one treatment method with another and in assessing outcome over time. Participants in the trials included in this review all had complaints of HMB but there is likely to be a large variation in the extent of the problem because of the subjective nature of the condition.

To make matters more confusing, evidence from a large cross-sectional survey suggests that whilst many women are referred with menorrhagia, many of these women do not complain of HMB when directly questioned; suggesting a tendency for broad menstrual complaints to be reframed as excessive bleeding at referral and during management (Warner 2001). As the authors concluded, this is likely to result in women receiving inappropriate care and will also influence the actual and perceived efficacy of treatment modalities for HMB.

The published literature on endometrial destruction techniques for HMB covers a wide range of surgical methods and uses a variety of outcome measures to assess treatment success, making clear comparisons between studies difficult. The participant groups were varied and often potentially important clinical factors, such as the presence of uterine fibroids or a perimenopausal state, were not mentioned in the inclusion or exclusion criteria. This is particularly important with longer follow-up studies. Current clinical approaches to HMB advise that medical therapy should be offered in the first instance, and it would be unusual in normal practice to advise endometrial resection or ablation without trying any medical therapies. Indeed, since medical treatment with the levonorgestrel-releasing intrauterine system (Mirena, Schering) reduces MBL by 94% at three months (Irvine 1998), and has been shown to be as effective as endometrial ablation (Crosignani 1997; Istre 2001), it could be argued that endometrial surgery is only appropriate for those who are unsuitable or do not wish to have treatment with the intrauterine system. Fourteen published studies focused on women with failed medical management of HMB and there were insufficient studies within each comparison to determine whether the women in these studies differed systematically in their response to treatment compared with other women. Many researchers are aware of the difficulties in recruitment to randomised clinical trials, and the need to obtain sufficient participants to meet the requirements of power calculations. However, the inclusion of unsuitable or unrepresentative participants in trials does not add to our understanding of the role of new therapies in normal clinical practice.

The published studies show a wide variation in the outcome criteria used in assessing endometrial destruction techniques. Since HMB is the main indication for this procedure, we were surprised to find that only one trial (McClure 1992) objectively measured MBL. Several studies used the PBAC (Higham 1990), which does not correlate well with objective measurement (Reid 2000). In addition, the entry criteria for PBAC score varied widely between studies. However, if comparisons are made between studies of changes in PBAC scores following endometrial destruction, few differences were seen between treatment modalities. Some variations were seen in the number of women with amenorrhoea following treatment, but since menstrual destruction methods cannot guarantee amenorrhoea they are generally not suitable for women who feel strongly that they do not want any more bleeding. A number of studies attempted to quantify participant satisfaction with the procedure but used a variety of different measurements to do so, limiting comparisons between studies. Overall, participant satisfaction was high with most procedures and the differences found were unlikely to be clinically significant. Large study numbers would be needed in order to demonstrate a significant difference in satisfaction between different methods of endometrial destruction.

Quality of the evidence

The evidence base on which this review is based was of variable quality. In particular, few studies were blinded and in most of the comparisons between individual techniques a limited number of studies provided data. Lack of blinding is likely to influence more subjective outcomes, such as satisfaction rates, so findings of these types of outcomes should be viewed with caution.

Substantial heterogeneity was identified in some of the outcomes of the overall comparison between first and second-generation techniques, and the quality of the evidence has been downgraded to reflect the uncertainty around the summary effect estimates. See Summary of findings for the main comparison.

Potential biases in the review process

A comprehensive search for relevant studies, together with duplicate and independent study selection, data extraction and quality assessment of studies, has minimised the chances of potential bias in the review process.

Agreements and disagreements with other studies or reviews

Surprisingly, although there have been numerous RCTs and observational studies of specific types of endometrial ablation techniques, there have been few systematic reviews identified that have made overall comparisons of the specific endometrial ablation techniques for the reduction of HMB. Numerous narrative reviews have been published, together with comprehensive audits for first-generation techniques. Comparing the first-generation methods of endometrial ablation versus resection, the MISTLETOE study (Overton 1997) concluded that the methods produced similar outcomes in terms of bleeding and participant satisfaction, but that resection methods have significantly more complications, suggesting that ablation should be used in all women with a non-fibroid uterus.

Systematic reviews, one with individual patient data, have not been able to determine major differences between first and second-generation techniques in terms of effectiveness or satisfaction with treatment (Garside 2005; Middleton 2010). However, Middleton has confirmed the results of this review that second-generation techniques are faster, local anaesthesia is more likely to be used, and some complications are less frequent. The suggestion in this review that additional surgery may be less likely with second-generation techniques at longer follow up (10 years) is based on only one trial and needs confirmation from further research.

Of the-second generation techniques, the most studied have been Novasure, balloon and microwave ablation (NHS 2011). A recent network meta-analysis reported that bipolar radiofrequency and microwave ablation resulted in higher rates of amenorrhoea than thermal balloon ablation at 12 months after treatment (Daniels 2012), but there was no evidence of a convincing difference between the three techniques in satisfaction rates or the number of women still experiencing heavy bleeding. Other outcomes were not assessed. However, the lack of a consistent measure of effectiveness has made it difficult to adequately compare techniques and reach conclusions on the technique of choice. Other authors have suggested that there might be commercial resistance to comparing devices, given the likely effect on the market share for the inferior treatment (McGurgan 2007). It has also been suggested that a potential limitation of second-generation devices is the restrictions on the size and configuration of the endometrial cavity that may prevent general application of any device to the HMB population (Munroe 2006). Many of the included studies that evaluated these devices in this review had fairly strict inclusion criteria, limiting the applicability of results to women with large or distorted uteri. Thus, not all women with HMB may be candidates for second-generation ablation and it has been suggested that gynaecologists should retain their skills in hysteroscopic surgery for certain types of intrauterine pathology (Papadopoulos 2007).

An additional issue is the role of patient preferences in decision making on treatments for HBS. A recent review (Roberts 2011) suggested that reaching a decision on a 'one size fits all' approach may be elusive and that eliciting patient preferences, based on the evidence, is required to reach the decision on the 'best' approach.

Authors' conclusions

Implications for practice

Endometrial destruction by first or second-generation techniques should be considered for all women with normal uteri who wish to reduce their heavy menstrual bleeding and wish to retain their uterus.

The potential for second-generation methods to be performed under local anaesthesia is a considerable advantage and should be considered in cases a where general anaesthetic may confer particular risk.

There is sufficient evidence to confirm that, on average, second-generation techniques are technically more simple and quicker to perform than first-generation techniques, while satisfaction rates and reduction in heavy menstrual bleeding are similar. However, technical difficulties have not yet been completely resolved.

Implications for research

Future studies should aim to include women in whom medical treatment for heavy menstrual bleeding has been ineffective. Future studies should also pay more attention to reducing the risk of bias, as many studies had substantial shortcomings.

Menstrual blood loss should be objectively or semi-objectively measured in all comparative studies (by the alkaline haematin method or the PBAC), although assessment of the women in the clinical setting is nearly always based on more subjective criteria, such as perception of heavy bleeding.

Amongst first-generation techniques for endometrial destruction, there are good data to support the use of endometrial ablation rather than resection (Overton 1997). There is a need to systematically compare first-generation ablation methods with second-generation techniques using standardised criteria of participant satisfaction, quality of life and objectively measured menstrual blood loss in order to establish which of the newer methods has an established role, and when they should be the instruments of choice. This may require referral to another unit where such techniques are available. There was insufficient evidence in this review to determine the superiority of one type of second-generation technique over another.

Equipment reliability for the second-generation techniques needs to be established.

Acknowledgements

The review authors acknowledge and thank the Cochrane Menstrual Disorders and Subfertility Group for extensive support in the preparation of this review. Special thanks are due to Shauna Sylvester, Sarah Hetrick, Michelle Proctor, Jane Clarke and Helen Nagels (Managing Editors during the lifecycle of this review), Sue Furness, Ruth Withers and Marian Showell (Trials Search Co-ordinators), Neil Johnson (Editor) and Sue Hall (for secretarial assistance). The review authors also thank Amy Goodwin, Manager of Clinical Research, Gyncare for extra data and answering queries on the Meyer trial, authors from some of the other trials (Abbott 2003; Boujida 2002; Perino 2004; Soysal 2001; van Zon-Rabelink 2003), and Joerg Neumann for translating the relevant sections of the Romer trial. The review authors are also indebted to Sarah Hetrick of the Australasian Cochrane Centre who has helped with the update searching in 2004, extraction of data and addition of entries to the Characteristics of included studies.

Data and analyses

Download statistical data

Comparison 1. Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 6 months2348Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.66, 1.45]
1.2 At 12 months1306Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.70, 1.60]
2 Amenorrhoea/hypomenorrhoea rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 At 6 months1326Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.89, 1.05]
2.2 At 12 months1306Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.92, 1.22]
3 MBL at 6 months (descriptive data)  Other dataNo numeric data
4 Participant satisfaction at 12 months (very/moderately)1321Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.92, 1.06]
5 Duration of operation (mins)2386Mean Difference (IV, Fixed, 95% CI)9.15 [7.21, 11.09]
6 Operative difficulties (%)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
6.1 Procedure abandoned1366Risk Ratio (M-H, Fixed, 95% CI)1.47 [0.61, 3.51]
6.2 Failed instrumentation1366Risk Ratio (M-H, Fixed, 95% CI)0.20 [0.01, 4.05]
6.3 Equipment failure1366Risk Ratio (M-H, Fixed, 95% CI)5.54 [1.65, 18.60]
6.4 Immediate hysterectomy1366Risk Ratio (M-H, Fixed, 95% CI)0.33 [0.01, 7.95]
7 Good general health (proportion of women)1321Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.95, 1.12]
8 Improvement in symptoms (proportion of women)1321Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.87, 1.21]
9 Improvement in dysmenorrhea1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
9.1 At 6 months follow up1253Risk Ratio (M-H, Fixed, 95% CI)1.17 [1.00, 1.38]
9.2 At 12 months follow up1218Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.87, 1.15]
10 Complication rate (proportion of women)2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
10.1 Perforation1366Risk Ratio (M-H, Fixed, 95% CI)0.14 [0.01, 2.69]
10.2 Burns1366Risk Ratio (M-H, Fixed, 95% CI)4.89 [0.24, 101.21]
10.3 Bowel obstruction1366Risk Ratio (M-H, Fixed, 95% CI)2.94 [0.12, 71.59]
10.4 Urinary tract infection1366Risk Ratio (M-H, Fixed, 95% CI)1.96 [0.36, 10.55]
10.5 Pelvic sepsis1366Risk Ratio (M-H, Fixed, 95% CI)0.82 [0.25, 2.62]
10.6 Haematometra1366Risk Ratio (M-H, Fixed, 95% CI)0.20 [0.01, 4.05]
10.7 Glycine toxicity122Risk Ratio (M-H, Fixed, 95% CI)4.23 [0.23, 79.10]
10.8 Fluid overload (>1.5L)1366Risk Ratio (M-H, Fixed, 95% CI)4.89 [1.44, 16.61]
10.9 Uterine tamponade1366Risk Ratio (M-H, Fixed, 95% CI)1.14 [0.39, 3.33]
11 Requirement for further surgical treatment (within 12 mths)2388Risk Ratio (M-H, Fixed, 95% CI)0.84 [0.55, 1.29]
Analysis 1.1.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 1 Amenorrhoea rate.

Analysis 1.2.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 2 Amenorrhoea/hypomenorrhoea rate.

Analysis 1.3.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 3 MBL at 6 months (descriptive data).

MBL at 6 months (descriptive data)
StudyLaser ablationTCRE + RBResults
McClure 1992N=12
Mean MBL (SD) at 6 months:
50.6 (41.6) mls
N=10
Mean MBL (SD) at 6 months:
27.0 (34.8) mls
Mann Whitney test.
Not statistically significant difference between groups
Analysis 1.4.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 4 Participant satisfaction at 12 months (very/moderately).

Analysis 1.5.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 5 Duration of operation (mins).

Analysis 1.6.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 6 Operative difficulties (%).

Analysis 1.7.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 7 Good general health (proportion of women).

Analysis 1.8.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 8 Improvement in symptoms (proportion of women).

Analysis 1.9.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 9 Improvement in dysmenorrhea.

Analysis 1.10.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 10 Complication rate (proportion of women).

Analysis 1.11.

Comparison 1 Laser ablation (first generation) versus transcervical resection of the endometrium (TCRE) (first generation), Outcome 11 Requirement for further surgical treatment (within 12 mths).

Comparison 2. Vaporising electrode ablation (first generation) versus TCRE (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate at 12 months follow up191Risk Ratio (M-H, Fixed, 95% CI)0.76 [0.46, 1.24]
2 Amenorrhea/hypomenorrhoea rate at 12 months follow up191Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.80, 1.22]
3 PBAC score at 12 mths  Other dataNo numeric data
4 Satisfaction rate at 12 mths (very/moderately)191Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.93, 1.14]
5 Duration of operation (mins)191Mean Difference (IV, Fixed, 95% CI)-1.50 [-2.65, -0.35]
6 Operative difficulties191Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.10, 0.82]
6.1 Difficulty with surgery (moderate or severe)191Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.10, 0.82]
7 Degree of fluid deficit (ml)191Mean Difference (IV, Fixed, 95% CI)-258.0 [-342.05, -173.95]
Analysis 2.1.

Comparison 2 Vaporising electrode ablation (first generation) versus TCRE (first generation), Outcome 1 Amenorrhoea rate at 12 months follow up.

Analysis 2.2.

Comparison 2 Vaporising electrode ablation (first generation) versus TCRE (first generation), Outcome 2 Amenorrhea/hypomenorrhoea rate at 12 months follow up.

Analysis 2.3.

Comparison 2 Vaporising electrode ablation (first generation) versus TCRE (first generation), Outcome 3 PBAC score at 12 mths.

PBAC score at 12 mths
StudyVaporising electrodeTCREResults
Vercellini 1999N=47
Mean score (SD):
15 (24)
N=44
Mean score (SD):
20 (42)
Unpaired t test.
No significant difference between the 2 means.
Analysis 2.4.

Comparison 2 Vaporising electrode ablation (first generation) versus TCRE (first generation), Outcome 4 Satisfaction rate at 12 mths (very/moderately).

Analysis 2.5.

Comparison 2 Vaporising electrode ablation (first generation) versus TCRE (first generation), Outcome 5 Duration of operation (mins).

Analysis 2.6.

Comparison 2 Vaporising electrode ablation (first generation) versus TCRE (first generation), Outcome 6 Operative difficulties.

Analysis 2.7.

Comparison 2 Vaporising electrode ablation (first generation) versus TCRE (first generation), Outcome 7 Degree of fluid deficit (ml).

Comparison 3. Rollerball (first generation) versus TCRE (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Duration of operation (mins)145Mean Difference (IV, Fixed, 95% CI)-1.10 [-2.92, 0.72]
2 Duration of operation (descriptive data)  Other dataNo numeric data
3 Complication rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 Fluid deficit1120Risk Ratio (M-H, Fixed, 95% CI)0.32 [0.01, 7.76]
3.2 Perforation1120Risk Ratio (M-H, Fixed, 95% CI)0.32 [0.01, 7.76]
4 Requirement for further surgery (hyst or ablation)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
4.1 At 2 yrs follow up1120Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.55, 1.95]
4.2 2 to 5 yrs follow up1120Risk Ratio (M-H, Fixed, 95% CI)1.21 [0.70, 2.10]
4.3 More than 5 years1120Risk Ratio (M-H, Fixed, 95% CI)1.39 [0.82, 2.36]
5 Requirement for further surgery rate (hyst only)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
5.1 At 2 yrs follow up1120Risk Ratio (M-H, Fixed, 95% CI)1.45 [0.43, 4.88]
5.2 2 to 5 yrs follow up1120Risk Ratio (M-H, Fixed, 95% CI)1.21 [0.51, 2.85]
5.3 More than 5 years follow up1120Risk Ratio (M-H, Fixed, 95% CI)1.32 [0.66, 2.63]
Analysis 3.1.

Comparison 3 Rollerball (first generation) versus TCRE (first generation), Outcome 1 Duration of operation (mins).

Analysis 3.2.

Comparison 3 Rollerball (first generation) versus TCRE (first generation), Outcome 2 Duration of operation (descriptive data).

Duration of operation (descriptive data)
StudyRollerballTCREComment
Boujida 2002N=61
Median (range): 13 mins (6 to 105)
N=59
Median (range): 20 mins (4 to 45)
Mann Whitney test: P<0.05
Analysis 3.3.

Comparison 3 Rollerball (first generation) versus TCRE (first generation), Outcome 3 Complication rate.

Analysis 3.4.

Comparison 3 Rollerball (first generation) versus TCRE (first generation), Outcome 4 Requirement for further surgery (hyst or ablation).

Analysis 3.5.

Comparison 3 Rollerball (first generation) versus TCRE (first generation), Outcome 5 Requirement for further surgery rate (hyst only).

Comparison 4. Thermal laser (second generation) versus TCRE (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 1 year follow up1111Risk Ratio (M-H, Fixed, 95% CI)2.46 [1.50, 4.03]
1.2 2 to 5 years follow up1111Risk Ratio (M-H, Fixed, 95% CI)2.49 [1.48, 4.21]
2 Satisfaction rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 At one year follow up1111Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.94, 1.16]
2.2 2 to 5 years follow up1111Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.91, 1.14]
3 Duration of operation1111Mean Difference (IV, Fixed, 95% CI)-9.30 [-11.36, -7.24]
4 Pain score at 12 hrs after surgery (VAS: 1-10)1111Mean Difference (IV, Fixed, 95% CI)0.70 [0.02, 1.38]
5 Intraoperative complication rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
5.1 Perforation1111Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
5.2 UTI1111Risk Ratio (M-H, Fixed, 95% CI)0.49 [0.05, 5.26]
6 Requirement for further surgery rate (hyst only)1111Risk Ratio (M-H, Fixed, 95% CI)0.59 [0.15, 2.35]
6.1 2 to 5 years follow up1111Risk Ratio (M-H, Fixed, 95% CI)0.59 [0.15, 2.35]
Analysis 4.1.

Comparison 4 Thermal laser (second generation) versus TCRE (first generation), Outcome 1 Amenorrhoea rate.

Analysis 4.2.

Comparison 4 Thermal laser (second generation) versus TCRE (first generation), Outcome 2 Satisfaction rate.

Analysis 4.3.

Comparison 4 Thermal laser (second generation) versus TCRE (first generation), Outcome 3 Duration of operation.

Analysis 4.4.

Comparison 4 Thermal laser (second generation) versus TCRE (first generation), Outcome 4 Pain score at 12 hrs after surgery (VAS: 1-10).

Analysis 4.5.

Comparison 4 Thermal laser (second generation) versus TCRE (first generation), Outcome 5 Intraoperative complication rate.

Analysis 4.6.

Comparison 4 Thermal laser (second generation) versus TCRE (first generation), Outcome 6 Requirement for further surgery rate (hyst only).

Comparison 5. Hydrothermal ablation (second generation) versus rollerball (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 1 year follow up1250Risk Ratio (M-H, Fixed, 95% CI)0.79 [0.60, 1.05]
1.2 At 2 years follow up1225Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.75, 1.36]
1.3 2 to 5 years follow up1203Risk Ratio (M-H, Fixed, 95% CI)1.17 [0.86, 1.59]
2 PBAC </= 751250Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.82, 1.07]
2.1 At 1 year follow up1250Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.82, 1.07]
2.2 2 to 5 years follow up00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
3 Proportion with "normal" bleeding (PBAC </= 100)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 At 1 year follow up1250Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.86, 1.07]
3.2 At 2 years follow up1225Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.92, 1.09]
3.3 2 to 5 years follow up1203Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.95, 1.12]
4 Satisfaction rate1203Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.96, 1.06]
4.1 2 to 5 years follow up1203Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.96, 1.06]
5 Proportion having local anaesthesia (%)1269Risk Ratio (M-H, Fixed, 95% CI)2.02 [1.32, 3.09]
6 Intraoperative complication rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
6.1 Cervical lacerations1269Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.00, 1.92]
6.2 Endometritis1269Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.08, 10.05]
6.3 Urinary tract infection1269Risk Ratio (M-H, Fixed, 95% CI)1.15 [0.23, 5.83]
6.4 Hematometra1269Risk Ratio (M-H, Fixed, 95% CI)0.18 [0.04, 0.93]
6.5 First degree burn1269Risk Ratio (M-H, Fixed, 95% CI)2.32 [0.11, 47.89]
7 Postoperative complication rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
7.1 Abdominal pain (at 2 weeks)1269Risk Ratio (M-H, Fixed, 95% CI)1.40 [1.03, 1.90]
7.2 Uterine cramping1269Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.72, 1.74]
7.3 Nausea or vomiting1269Risk Ratio (M-H, Fixed, 95% CI)3.08 [1.36, 6.98]
8 Requirement for further surgery (any surgery)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 At 1 year follow up1269Risk Ratio (M-H, Fixed, 95% CI)2.32 [0.11, 47.89]
8.2 2 to 5 years follow up1262Risk Ratio (M-H, Fixed, 95% CI)1.26 [0.58, 2.73]
9 Requirement for further surgery rate (hyst only)1262Risk Ratio (M-H, Fixed, 95% CI)1.54 [0.58, 4.06]
9.1 At 1 year follow up00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
9.2 2 to 5 years follow up1262Risk Ratio (M-H, Fixed, 95% CI)1.54 [0.58, 4.06]
Analysis 5.1.

Comparison 5 Hydrothermal ablation (second generation) versus rollerball (first generation), Outcome 1 Amenorrhoea rate.

Analysis 5.2.

Comparison 5 Hydrothermal ablation (second generation) versus rollerball (first generation), Outcome 2 PBAC </= 75.

Analysis 5.3.

Comparison 5 Hydrothermal ablation (second generation) versus rollerball (first generation), Outcome 3 Proportion with "normal" bleeding (PBAC </= 100).

Analysis 5.4.

Comparison 5 Hydrothermal ablation (second generation) versus rollerball (first generation), Outcome 4 Satisfaction rate.

Analysis 5.5.

Comparison 5 Hydrothermal ablation (second generation) versus rollerball (first generation), Outcome 5 Proportion having local anaesthesia (%).

Analysis 5.6.

Comparison 5 Hydrothermal ablation (second generation) versus rollerball (first generation), Outcome 6 Intraoperative complication rate.

Analysis 5.7.

Comparison 5 Hydrothermal ablation (second generation) versus rollerball (first generation), Outcome 7 Postoperative complication rate.

Analysis 5.8.

Comparison 5 Hydrothermal ablation (second generation) versus rollerball (first generation), Outcome 8 Requirement for further surgery (any surgery).

Analysis 5.9.

Comparison 5 Hydrothermal ablation (second generation) versus rollerball (first generation), Outcome 9 Requirement for further surgery rate (hyst only).

Comparison 6. Cryoablation (second generation) versus rollerball (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate1228Risk Ratio (M-H, Fixed, 95% CI)0.50 [0.36, 0.69]
1.1 At 1 year follow up1228Risk Ratio (M-H, Fixed, 95% CI)0.50 [0.36, 0.69]
2 Satisfaction rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 At 1 year follow up1279Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.96, 1.17]
2.2 At 2 years follow up1137Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.91, 1.17]
3 Proportion having local anaesthesia (%)1279Risk Ratio (M-H, Fixed, 95% CI)6.62 [3.22, 13.63]
4 Intraoperative complication rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
4.1 Perforation1279Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 3.63]
4.2 Vaginal bleeding1279Risk Ratio (M-H, Fixed, 95% CI)1.35 [0.06, 32.70]
4.3 Abdominal cramping1279Risk Ratio (M-H, Fixed, 95% CI)2.24 [0.11, 46.21]
4.4 UTI1279Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 3.63]
4.5 Severe pelvic pain1279Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 3.63]
5 Requirement for further surgery (any surgery)1279Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.45, 2.22]
5.1 At 2 years follow up1279Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.45, 2.22]
6 Requirement for further surgery rate (hyst only)1279Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.34, 2.00]
6.1 At 2 years follow up1279Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.34, 2.00]
Analysis 6.1.

Comparison 6 Cryoablation (second generation) versus rollerball (first generation), Outcome 1 Amenorrhoea rate.

Analysis 6.2.

Comparison 6 Cryoablation (second generation) versus rollerball (first generation), Outcome 2 Satisfaction rate.

Analysis 6.3.

Comparison 6 Cryoablation (second generation) versus rollerball (first generation), Outcome 3 Proportion having local anaesthesia (%).

Analysis 6.4.

Comparison 6 Cryoablation (second generation) versus rollerball (first generation), Outcome 4 Intraoperative complication rate.

Analysis 6.5.

Comparison 6 Cryoablation (second generation) versus rollerball (first generation), Outcome 5 Requirement for further surgery (any surgery).

Analysis 6.6.

Comparison 6 Cryoablation (second generation) versus rollerball (first generation), Outcome 6 Requirement for further surgery rate (hyst only).

Comparison 7. Electrode ablation (second generation) versus TCRE + rollerball (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhea rate at 1 yr follow up2470Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.79, 1.31]
1.1 Balloon system1234Risk Ratio (M-H, Fixed, 95% CI)0.89 [0.62, 1.29]
1.2 Mesh system1236Risk Ratio (M-H, Fixed, 95% CI)1.16 [0.82, 1.64]
2 Proportion with successful Rx (PBAC<75)2470Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.98, 1.15]
2.1 Balloon system1234Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.94, 1.17]
2.2 Mesh system1236Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.96, 1.22]
3 PBAC score 12 months after treatment  Other dataNo numeric data
3.1 Balloon system  Other dataNo numeric data
3.2 Mesh system  Other dataNo numeric data
4 Proportion satisfied with treatment at 1 year1236Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.92, 1.06]
4.1 Balloon system00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
4.2 Mesh system1236Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.92, 1.06]
5 Duration of operation (mins)2520Mean Difference (IV, Fixed, 95% CI)-18.70 [-20.66, -16.75]
5.1 Balloon system1255Mean Difference (IV, Fixed, 95% CI)-16.20 [-19.55, -12.85]
5.2 Mesh system1265Mean Difference (IV, Fixed, 95% CI)-20.0 [-22.41, -17.59]
6 Proportion having local anaesthesia (%)2520Risk Ratio (M-H, Fixed, 95% CI)3.85 [2.94, 5.04]
6.1 Balloon system1255Risk Ratio (M-H, Fixed, 95% CI)3.66 [2.65, 5.07]
6.2 Mesh system1265Risk Ratio (M-H, Fixed, 95% CI)4.11 [2.61, 6.47]
7 Intraoperative complication rate2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
7.1 Perforation2532Risk Ratio (M-H, Fixed, 95% CI)0.13 [0.02, 1.01]
7.2 Bradycardia1265Risk Ratio (M-H, Fixed, 95% CI)1.55 [0.06, 37.70]
7.3 Cervical tear/stenosis2532Risk Ratio (M-H, Fixed, 95% CI)0.11 [0.01, 0.87]
7.4 Fluid overload1267Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.01, 6.93]
7.5 Procedure abandoned1267Risk Ratio (M-H, Fixed, 95% CI)2.57 [0.11, 62.41]
8 Postoperative complication rate2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 Fever1267Risk Ratio (M-H, Fixed, 95% CI)0.85 [0.05, 13.51]
8.2 Nausea/vomiting or severe pelvic pain2532Risk Ratio (M-H, Fixed, 95% CI)1.10 [0.37, 3.27]
8.3 UTI2532Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.39, 2.84]
8.4 Hematometra2532Risk Ratio (M-H, Fixed, 95% CI)0.43 [0.08, 2.23]
8.5 Myometritis1267Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.01, 6.93]
8.6 Urinary incontinence1267Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.01, 6.93]
8.7 PID1265Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.09, 11.19]
8.8 Haemorrhage1265Risk Ratio (M-H, Fixed, 95% CI)0.51 [0.03, 8.13]
8.9 Pelvic abscess1265Risk Ratio (M-H, Fixed, 95% CI)0.17 [0.01, 4.19]
8.10 Endometritis1265Risk Ratio (M-H, Fixed, 95% CI)0.34 [0.06, 2.01]
9 Requirement for further surgery at 2 years (hysterectomy)1255Risk Ratio (M-H, Fixed, 95% CI)0.52 [0.18, 1.50]
9.1 Balloon system1255Risk Ratio (M-H, Fixed, 95% CI)0.52 [0.18, 1.50]
9.2 Mesh system00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 7.1.

Comparison 7 Electrode ablation (second generation) versus TCRE + rollerball (first generation), Outcome 1 Amenorrhea rate at 1 yr follow up.

Analysis 7.2.

Comparison 7 Electrode ablation (second generation) versus TCRE + rollerball (first generation), Outcome 2 Proportion with successful Rx (PBAC<75).

Analysis 7.3.

Comparison 7 Electrode ablation (second generation) versus TCRE + rollerball (first generation), Outcome 3 PBAC score 12 months after treatment.

PBAC score 12 months after treatment
StudyElectrode systemTCRE + RBStat test for diff
Balloon system
Corson 2000N=122
Mean PBAC (SD): 18 (37)
N=112
Mean PBAC (SD): 28 (70)
Not significantly different
Mesh system
Cooper 2002N=154
Mean PBAC (SD): 26.8
N=82
Mean PBAC (SD): 36.4 (66.3)
No reported difference
Analysis 7.4.

Comparison 7 Electrode ablation (second generation) versus TCRE + rollerball (first generation), Outcome 4 Proportion satisfied with treatment at 1 year.

Analysis 7.5.

Comparison 7 Electrode ablation (second generation) versus TCRE + rollerball (first generation), Outcome 5 Duration of operation (mins).

Analysis 7.6.

Comparison 7 Electrode ablation (second generation) versus TCRE + rollerball (first generation), Outcome 6 Proportion having local anaesthesia (%).

Analysis 7.7.

Comparison 7 Electrode ablation (second generation) versus TCRE + rollerball (first generation), Outcome 7 Intraoperative complication rate.

Analysis 7.8.

Comparison 7 Electrode ablation (second generation) versus TCRE + rollerball (first generation), Outcome 8 Postoperative complication rate.

Analysis 7.9.

Comparison 7 Electrode ablation (second generation) versus TCRE + rollerball (first generation), Outcome 9 Requirement for further surgery at 2 years (hysterectomy).

Comparison 8. Microwave ablation (second generation) versus TCRE + rollerball (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhea rate2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 1 year follow up2562Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.93, 1.36]
1.2 At 2 years follow up1249Risk Ratio (M-H, Fixed, 95% CI)1.16 [0.87, 1.53]
1.3 At 2 to 5 years follow up1236Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.78, 1.12]
1.4 > 5 years follow up1189Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.83, 1.05]
2 Success of treatment (PBAC<75 or acceptable improvement)2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 At 1 year follow up2562Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.96, 1.13]
2.2 At 2 to 5 years follow up1236Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.97, 1.28]
2.3 > 5 years follow up1263Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.87, 1.34]
3 Satisfaction rate2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 At 1 year follow up2533Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.95, 1.07]
3.2 At 2 years follow up1249Risk Ratio (M-H, Fixed, 95% CI)1.19 [1.02, 1.38]
3.3 At 2 to 5 years follow up1236Risk Ratio (M-H, Fixed, 95% CI)1.19 [1.04, 1.36]
3.4 > 5 years follow up1263Risk Ratio (M-H, Fixed, 95% CI)1.14 [0.92, 1.42]
4 Duration of operation (mins)  Other dataNo numeric data
5 Operative difficulties1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
5.1 Equipment failure1263Risk Ratio (M-H, Fixed, 95% CI)3.81 [1.09, 13.34]
5.2 Procedure abandoned1263Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.31, 3.50]
6 Proportion having local anaesthesia1315Risk Ratio (M-H, Fixed, 95% CI)2.54 [1.73, 3.72]
7 Duration of hospital stay (hours)  Other dataNo numeric data
8 Inability to work (proportion of women)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 At 12 months follow up1240Risk Ratio (M-H, Fixed, 95% CI)0.53 [0.17, 1.73]
8.2 > 5 years follow up1189Risk Ratio (M-H, Fixed, 95% CI)1.52 [0.26, 8.87]
9 Change in SF36 score after treatment  Other dataNo numeric data
9.1 Physical functioning  Other dataNo numeric data
9.2 Social functioning  Other dataNo numeric data
9.3 Physical role  Other dataNo numeric data
9.4 Emotional role  Other dataNo numeric data
9.5 Mental health  Other dataNo numeric data
9.6 Energy/fatigue  Other dataNo numeric data
9.7 Pain  Other dataNo numeric data
9.8 General health  Other dataNo numeric data
10 Improvement in symptoms1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
10.1 At 1 year follow up1240Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.90, 1.19]
10.2 At 2 to 5 years follow up1236Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.97, 1.28]
11 Improvement in dysmenorrhoea2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
11.1 At 1 year follow up2533Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.89, 1.09]
11.2 At 2 years follow up1249Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.93, 1.19]
12 Reduction in pain score (points)1189Mean Difference (IV, Fixed, 95% CI)-0.80 [-4.32, 2.72]
12.1 >5 years follow up1189Mean Difference (IV, Fixed, 95% CI)-0.80 [-4.32, 2.72]
13 Postoperative analgesia rate1263Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.81, 1.10]
14 Intraoperative complication rate2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
14.1 Perforation2585Risk Ratio (M-H, Fixed, 95% CI)1.63 [0.22, 12.12]
14.2 Haemorrhage1263Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.01, 1.69]
14.3 Cervical laceration1322Risk Ratio (M-H, Fixed, 95% CI)0.50 [0.07, 3.48]
14.4 Cervical stenosis1322Risk Ratio (M-H, Fixed, 95% CI)1.5 [0.06, 36.52]
15 Postoperative complication rate (wihin 24 hours)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
15.1 Chills1322Risk Ratio (M-H, Fixed, 95% CI)1.35 [0.59, 3.11]
15.2 Bloating1322Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.38, 1.83]
15.3 Dysuria1322Risk Ratio (M-H, Fixed, 95% CI)0.77 [0.37, 1.58]
15.4 Fever1322Risk Ratio (M-H, Fixed, 95% CI)2.5 [0.12, 51.62]
15.5 Headache1322Risk Ratio (M-H, Fixed, 95% CI)0.75 [0.22, 2.59]
15.6 Nausea1322Risk Ratio (M-H, Fixed, 95% CI)1.35 [0.83, 2.21]
15.7 Vomiting1322Risk Ratio (M-H, Fixed, 95% CI)3.61 [1.30, 10.00]
15.8 UTI1322Risk Ratio (M-H, Fixed, 95% CI)0.50 [0.03, 7.88]
15.9 Vaginal infection1322Risk Ratio (M-H, Fixed, 95% CI)1.5 [0.06, 36.52]
15.10 Uterine cramping1322Risk Ratio (M-H, Fixed, 95% CI)1.21 [1.01, 1.44]
15.11 Abdominal tenderness1322Risk Ratio (M-H, Fixed, 95% CI)0.61 [0.26, 1.42]
15.12 Endometritis1322Risk Ratio (M-H, Fixed, 95% CI)6.5 [0.37, 114.31]
16 Requirement for further surgery (any surgery)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
16.1 At 1 year follow up1240Risk Ratio (M-H, Fixed, 95% CI)0.82 [0.38, 1.80]
16.2 At 2 years follow up1249Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.55, 1.72]
16.3 At 2 to 5 years follow up1263Risk Ratio (M-H, Fixed, 95% CI)0.85 [0.56, 1.27]
16.4 > 5 years follow up1263Risk Ratio (M-H, Fixed, 95% CI)0.69 [0.48, 0.99]
17 Requirement for further surgery rate (hyst only)2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
17.1 At 1 year follow up2562Risk Ratio (M-H, Fixed, 95% CI)0.77 [0.35, 1.70]
17.2 At 2 years follow up1249Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.50, 1.81]
17.3 At 2 to 5 years follow up1263Risk Ratio (M-H, Fixed, 95% CI)0.63 [0.38, 1.04]
17.4 > 5 years follow up1263Risk Ratio (M-H, Fixed, 95% CI)0.60 [0.38, 0.96]
Analysis 8.1.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 1 Amenorrhea rate.

Analysis 8.2.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 2 Success of treatment (PBAC<75 or acceptable improvement).

Analysis 8.3.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 3 Satisfaction rate.

Analysis 8.4.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 4 Duration of operation (mins).

Duration of operation (mins)
StudyMicrowaveTCREResults
Cooper 1999N=129
Mean duration of procedure (SD):
11.4 (10.5) mins
N=134
Mean duration of procedure (SD):
15.0 (7.2) mins
Mann Whitney U test
Mean difference:
3.6 (-5.7, -1.4); P=0.001
Analysis 8.5.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 5 Operative difficulties.

Analysis 8.6.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 6 Proportion having local anaesthesia.

Analysis 8.7.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 7 Duration of hospital stay (hours).

Duration of hospital stay (hours)
StudyMicrowaveTCREResults
Cooper 1999N=129
Mean duration of hospital stay (SD):
13.4 (17.6) hours
N=134
Mean duration of hospital stay (SD):
16.7 (21.2) hours
Mann Whitney U test
No differences between groups; P=0.17
Analysis 8.8.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 8 Inability to work (proportion of women).

Analysis 8.9.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 9 Change in SF36 score after treatment.

Change in SF36 score after treatment
StudyMEATCREResults
Physical functioning
Cooper 1999

AT 1 YEAR:
N=116
Mean change (SD):
0.7 (18.9)

AT 2 YEARS:
N=120
Mean change (SD):
2.3 (21.3)

AT 5 YEARS:
N=116
Mean change (SD): 0.2 (24)

At 10 YEARS:

N=94

Mean change (SD): -4.4 (27)

AT 1 YEAR:
N=124
Mean change (SD):
2.4 (16.8)

AT 2 YEARS:
N=129
Mean change (SD):
0.9 (20.4)

AT 5 YEARS:
N=120
Mean change (SD): -1.2 (21)

At 10 YEARS:

N=95

Mean change (SD): -3.0 (25)

AT 1 YEAR:
t test:
CI (-6.4, 2.9); P=0.45
Ancova: P=0.58

AT 2 YEARS:
t test:
P=0.28 (95% CI -3.8, 6.6)

AT 5 YEARS:
t test:
NS (95% CI -4.5 to 7.3)

At 10 YEARS:

t test:

NS (95% CI -8.9 to 6.1)

Social functioning
Cooper 1999

AT 1 YEAR:
N=116
Mean change (SD): 20.6 (26.5)

AT 2 YEARS:
N=120
Mean change (SD): 10.1 (27.5)

AT 5 YEARS:
N=116
Mean change (SD): 7.7 (30)

At 10 YEARS:

N=94

Mean change (SD): 10.1 (30)

At 1 YEAR:

N=124
Mean change (SD): 16.2 (24.4)

AT 2 YEARS:
N=129
Mean change (SD): 6.2 (23.7)

AT 5 YEARS:
Mean change (SD):
9.7 (25)

At 10 YEARS:

N=95

Mean change (SD): 9.9 (26)

AT 1 YEAR:
t test:
CI (-2.1, 10.90): P=0.18
Ancova:
P=0.12

AT 2 YEARS:
t test:
P=0.33 (95% CI -2.5, 10.3)

AT 5 YEARS:
t test:
NS (95% CI -9.0 to 5.0)

At 10 YEARS:

t test:

NS (95% CI -7.9 to 8.3)

Physical role
Cooper 1999

AT 1 YEAR:
N=116
Mean change (SD): 23.9 (49.4)

AT 2 YEARS:
N=120
Mean change (SD): 18.5 (53.7)

AT 5 YEARS:
N=116
Mean change (SD): 17 (54)

At 10 YEARS:

N=94

Mean change (SD): 15.0 (53)

AT 1 YEAR:
N=124
Mean change (SD): 11.3 (41.7)

AT 2 YEARS:
N=129
Mean change (SD): 6.1 (43.8)

AT 5 YEARS:
N=120
Mean change (SD): 11 (43)

At 10 YEARS:

N=95

Mean change (SD): 10.9 (47)

AT 1 YEAR:
t test:
CI (1.0 to 24.3);
P=0.03
Ancova:
P=0.03

AT 2 YEARS:
t test:
P=0.06 (95% CI -0.2, 24.6)

AT 5 YEARS:
t test:
NS, 95% CI -5.8 to 19

At 10 YEARS:

t test:

NS, 95% CI -10.3 to 18.5

Emotional role
Cooper 1999

AT ONE YEAR:
N=116
Mean change (SD): 17.0 (48.5)

AT 2 YEARS:
N=120
Mean change (SD): 17.8 (47.5)

AT 5 YEARS:
N=116
Mean change (SD): 19 (48)

At 10 YEARS:

N=94

Mean change (SD): 21.1 (50)

AT 1 YEAR:
N=124
Mean change (SD): 13.7 (47.9)

AT 2 YEARS:
N=129
Mean change (SD): 4.2 (40.1)

AT 5 YEARS:

N=120
Mean change (SD): 20 (41)

At 10 YEARS:

N=95

Mean change (SD): 13.5 (47)

AT 1 YEAR:
t test:
CI (-9.1 to 15.6);
P=0.59
Ancova:
P=0.38

AT 2 YEARS:
t test
P=0.17 (95% CI -3.6, 23.5)

AT 5 YEARS:
t test:
NS, 95% CI -13 to 10

At 10 YEARS:

t test:

NS, 95% CI 6.3 to 21.5

Mental health
Cooper 1999

AT 1 YEAR:
N=116
Mean change (SD): 6.3 (19.5)

AT 2 YEARS:
N=120
Mean change (SD): 6.0 (21.6)

AT 5 YEARS:
N=116
Mean change (SD): 1.4 (21)

At 10 YEARS:

N=94

Mean change (SD): 7.2 (21)

AT 1 YEAR:
N=124
Mean change (SD): 6.0 (22.2)

AT 2 YEARS:
N=129
Mean change (SD): 4.1 (19.8)

AT 5 YEARS

N=120
Mean change (SD): 1.2 (21)

At 10 YEARS:

N=95

Mean change (SD): 7.9 (25)

AT 1 YEAR:
t test:
CI (-4.9 to 5.7);
P=0.89
Ancova:
P=0.83

AT 2 YEARS:
t test:
P=0.44 (95% CI -3.3, 6.9)

AT 5 YEARS:
t test:
NS, 95% CI -5.2 to 5.6

At 10 YEARS:

t test:

NS, 95% CI -7.3 to 5.9

Energy/fatigue
Cooper 1999

AT 1 YEAR:
N=116
Mean change (SD): 12.8 (21.7)

AT 2 YEARS:
N=120
Mean change (SD): 11.4 (25.1)

AT 5 YEARS:

N=116
Mean change (SD): 9.3 (25)

At 10 YEARS:

N=94

Mean change (SD): 12.9 (29)

AT 1 YEAR:
N=124
Mean change (SD): 12.1 (23.0)

AT 2 YEARS:
N=129
Mean change (SD): 11.8 (22.6)

AT 5 YEARS:

N=120
Mean change (SD): 12 (26)

At 10 YEARS:

N=95

Mean change (SD): 15.3 (27)

AT 1 YEAR:
t test:
CI (-4.9 to 6.5);
p=0.80
Ancova:
p=0.58

AT 2 YEARS:
t test:
P=0.90 (95% CI -6.4, 5.5)

AT 5 YEARS:
t test:
NS, 95% CI -9.1 to 4.2

At 10 YEARS:

t test:

NS, 95% CI -10.4 to 5.6

Pain
Cooper 1999

AT 1 YEAR:
N=116
Mean change (SD): 14.8 (31.0)

AT 2 YEARS:
N=120
Mean change (SD): 13.5 (31.7)

AT 5 YEARS:

N=116
Mean change (SD): 9.3 (35)

At 10 YEARS:

N=94

Mean change (SD): 11.6 (37)

AT 1 YEAR:
N=124
Mean change (SD): 7.2 (31.1)

AT 2 YEARS:
N=129
Mean change (SD): 3.0 (29.8)

AT 5 YEARS:

N=120
Mean change (SD): 6.4 (31)

At 10 YEARS:

N=95

Mean change (SD): 12.3 (35)

AT 1 YEAR:
t test:
CI (-0.2 to 15.5);
P=0.06
Ancova:
P=0.54

AT 2 YEARS:
t test:
P=0.02 (95% CI 2.9, 18.2)

AT 5 YEARS:
t test:
NS, 95% CI -5.7 to 12

At 10 YEARS:

t test:

NS, 95% CI -11.0 to 9.6

General health
Cooper 1999

AT 1 YEAR:
N=116
Mean change (SD): 2.4 (20.3)

AT 2 YEARS:
N=120
Mean change (SD): 0.0 (24.4)

AT 5 YEARS:

N=116
Mean change (SD): -3.3 (26)

At 10 YEARS:

N=94

Mean change (SD): 0.94 (23)

AT 1 YEAR:
N=124
Mean change (SD): -2.9 (20.0)

AT 2 YEARS:
N=129
Mean change (SD): -2.9 (19.0)

AT 5 YEARS:

N=120
Mean change (SD): -2.4 (19)

At 10 YEARS:

N=95

Mean change (SD): 2.8 (22)

AT 1 YEAR:
t test:
CI (0.2 to 10.5);
P=0.04
Ancova:
P=0.06

AT 2 YEARS:
t test:
P=0.29 (95% CI -2.5, 8.4)

AT 5 YEARS:
t test:
NS, 95% CI -6.5 to 4.9

At 10 YEARS:

t test:

NS, 95% CI -8.3 to 4.6

Analysis 8.10.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 10 Improvement in symptoms.

Analysis 8.11.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 11 Improvement in dysmenorrhoea.

Analysis 8.12.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 12 Reduction in pain score (points).

Analysis 8.13.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 13 Postoperative analgesia rate.

Analysis 8.14.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 14 Intraoperative complication rate.

Analysis 8.15.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 15 Postoperative complication rate (wihin 24 hours).

Analysis 8.16.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 16 Requirement for further surgery (any surgery).

Analysis 8.17.

Comparison 8 Microwave ablation (second generation) versus TCRE + rollerball (first generation), Outcome 17 Requirement for further surgery rate (hyst only).

Comparison 9. Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhea rate3 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 1 year follow up3352Risk Ratio (M-H, Fixed, 95% CI)0.63 [0.41, 0.97]
1.2 At 2 years follow up1227Risk Ratio (M-H, Fixed, 95% CI)0.60 [0.33, 1.07]
1.3 At 2 to 5 years follow up1122Risk Ratio (M-H, Fixed, 95% CI)0.7 [0.39, 1.25]
2 Amenorrhoea/eumenorrhoea rate2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 At 1 year follow up2259Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.86, 1.06]
2.2 At 2 years follow up1227Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.91, 1.08]
2.3 At 2 to 5 years follow up1122Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.91, 1.06]
3 PBAC score after treatment  Other dataNo numeric data
3.1 At 1 year follow up  Other dataNo numeric data
3.2 At 2 years follow up  Other dataNo numeric data
4 Success of treatment (lighter periods and no further surgery)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
4.1 At 2 to 5 years follow up1170Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.80, 1.20]
5 Success of treatment (PBAC<75)193Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.77, 1.19]
5.1 At 1 year follow up193Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.77, 1.19]
6 Success of treatment (menstrual score <185)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
6.1 At 1 year follow up1129Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.83, 1.20]
6.2 At 2 years follow up1121Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.83, 1.23]
7 Satisfaction rate4 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
7.1 At 1 year follow up3352Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.93, 1.06]
7.2 At 2 years follow up2348Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.93, 1.12]
7.3 At 2 to 5 years follow up1122Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.87, 1.01]
8 Duration of operation (mins)3471Mean Difference (IV, Fixed, 95% CI)-20.87 [-22.47, -19.28]
9 Operative difficulties1139Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.49, 2.22]
9.1 Technical complication rate1139Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.49, 2.22]
10 Inability to work (proportion of women)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
10.1 At 1 year follow up1239Risk Ratio (M-H, Fixed, 95% CI)1.52 [0.37, 6.22]
10.2 At 2 years follow up1227Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.03, 2.72]
10.3 At 2 to 5 years follow up1210Risk Ratio (M-H, Fixed, 95% CI)0.87 [0.26, 2.93]
11 Improvement in dysmenorrhea at 12 months1239Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.80, 1.09]
12 Improvement in premenstrual symptoms (from moderate/severe)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
12.1 At 1 year follow up1185Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.74, 1.19]
12.2 At 2 years follow up1177Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.82, 1.29]
12.3 At 2 to 5 years follow up1166Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.75, 1.30]
13 Complication rate (proportion of women)3 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
13.1 Fluid overload2332Risk Ratio (M-H, Fixed, 95% CI)0.20 [0.02, 1.66]
13.2 Perforation2378Risk Ratio (M-H, Fixed, 95% CI)0.17 [0.02, 1.42]
13.3 Cervical lacerations3471Risk Ratio (M-H, Fixed, 95% CI)0.21 [0.04, 1.19]
13.4 Endometritis2332Risk Ratio (M-H, Fixed, 95% CI)2.45 [0.48, 12.47]
13.5 UTI1239Risk Ratio (M-H, Fixed, 95% CI)2.74 [0.11, 66.54]
13.6 Hematometra2332Risk Ratio (M-H, Fixed, 95% CI)0.43 [0.07, 2.84]
13.7 Hydrosalpinx1239Risk Ratio (M-H, Fixed, 95% CI)0.30 [0.01, 7.39]
13.8 Bleeding193Risk Ratio (M-H, Fixed, 95% CI)0.21 [0.01, 4.32]
13.9 Pain1139Risk Ratio (M-H, Fixed, 95% CI)5.65 [0.30, 107.43]
13.10 Nausea1139Risk Ratio (M-H, Fixed, 95% CI)0.27 [0.01, 6.50]
13.11 Infection1139Risk Ratio (M-H, Fixed, 95% CI)0.27 [0.01, 6.50]
14 Requirement for further surgery (any surgery)3 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
14.1 At 1 year follow up2332Risk Ratio (M-H, Fixed, 95% CI)0.86 [0.30, 2.47]
14.2 At 2 years follow up2392Risk Ratio (M-H, Fixed, 95% CI)0.67 [0.35, 1.28]
14.3 At 2 to 5 years follow up1122Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.64, 1.55]
15 Requirement for further surgery (hyst only)2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
15.1 At 1 year follow up00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
15.2 At 2 years follow up1137Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.38, 2.83]
15.3 At 2 to 5 years follow up1122Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.61, 1.63]
Analysis 9.1.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 1 Amenorrhea rate.

Analysis 9.2.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 2 Amenorrhoea/eumenorrhoea rate.

Analysis 9.3.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 3 PBAC score after treatment.

PBAC score after treatment
StudyBalloonRollerballResults
At 1 year follow up
Meyer 1998N=125
Mean PBAC (SD): 52.2 (85.2)
N=114
Mean PBAC (SD): 39.6 (86.4)
No statistical test performed of these outcomes
Soysal 2001N=41
Mean PBAC (SD): 41.1 (29)
N=44
Mean PBAC (SD): 40.2 (45)
Significance not reported
van Zon-Rabelink 2003N=74
Median PBAC (range): 70 (0, 2265)
N=55
Median PBAC (range): 73 (0, 535)
Wilcoxon test:
P=0.90
At 2 years follow up
van Zon-Rabelink 2003N=66
Median PBAC (range): 33.5 (0, 905)
N=55
Median PBAC (range): 73 (0, 585)
Wilcoxon test: P=0.01
Analysis 9.4.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 4 Success of treatment (lighter periods and no further surgery).

Analysis 9.5.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 5 Success of treatment (PBAC<75).

Analysis 9.6.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 6 Success of treatment (menstrual score <185).

Analysis 9.7.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 7 Satisfaction rate.

Analysis 9.8.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 8 Duration of operation (mins).

Analysis 9.9.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 9 Operative difficulties.

Analysis 9.10.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 10 Inability to work (proportion of women).

Analysis 9.11.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 11 Improvement in dysmenorrhea at 12 months.

Analysis 9.12.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 12 Improvement in premenstrual symptoms (from moderate/severe).

Analysis 9.13.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 13 Complication rate (proportion of women).

Analysis 9.14.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 14 Requirement for further surgery (any surgery).

Analysis 9.15.

Comparison 9 Balloon endometrial ablation (second generation) versus rollerball endometrial ablation (first generation), Outcome 15 Requirement for further surgery (hyst only).

Comparison 10. Balloon (second generation) versus laser (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 6 months follow up170Risk Ratio (M-H, Fixed, 95% CI)1.11 [0.61, 2.02]
1.2 At 12 months follow up167Risk Ratio (M-H, Fixed, 95% CI)0.75 [0.38, 1.46]
2 PBAC score after treatment  Other dataNo numeric data
2.1 At 6 months follow up  Other dataNo numeric data
3 Satisfaction rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 At 6 months follow up169Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.91, 1.20]
3.2 At 12 months follow up157Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.86, 1.09]
4 Operative difficulties170Risk Ratio (M-H, Fixed, 95% CI)4.47 [0.22, 89.94]
4.1 Failure of equipment170Risk Ratio (M-H, Fixed, 95% CI)4.47 [0.22, 89.94]
5 Euroquol 5D1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
5.1 At 6 months follow up170Mean Difference (IV, Fixed, 95% CI)0.01 [-0.11, 0.13]
5.2 At 12 months follow up167Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.13, 0.11]
6 Euroquol 5D VAS1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
6.1 At 6 months follow up170Mean Difference (IV, Fixed, 95% CI)1.20 [-5.95, 8.35]
6.2 At 12 months follow up167Mean Difference (IV, Fixed, 95% CI)10.10 [2.43, 17.77]
7 SF12 Physical Scale1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
7.1 At 6 months follow up170Mean Difference (IV, Fixed, 95% CI)1.70 [-2.18, 5.58]
7.2 At 12 months follow up167Mean Difference (IV, Fixed, 95% CI)-0.20 [-3.89, 3.49]
8 SF12 Mental Scale1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
8.1 At 6 months follow up170Mean Difference (IV, Fixed, 95% CI)3.40 [-0.42, 7.22]
8.2 At 12 months follow up167Mean Difference (IV, Fixed, 95% CI)2.10 [-2.04, 6.24]
9 SAQ pleasure scale1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
9.1 At 6 months follow up170Mean Difference (IV, Fixed, 95% CI)0.5 [-1.30, 2.30]
9.2 At 12 months follow up167Mean Difference (IV, Fixed, 95% CI)-0.60 [-2.68, 1.48]
10 SAQ habit scale1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
10.1 At 6 months follow up170Mean Difference (IV, Fixed, 95% CI)-0.16 [-0.42, 0.10]
10.2 At 12 months follow up167Mean Difference (IV, Fixed, 95% CI)-0.09 [-0.27, 0.09]
11 SAQ discomfort scale1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
11.1 At 6 months follow up170Mean Difference (IV, Fixed, 95% CI)-0.14 [-0.98, 0.70]
11.2 At 12 months follow up167Mean Difference (IV, Fixed, 95% CI)0.10 [-0.67, 0.87]
12 PMS (visual analogue)  Other dataNo numeric data
12.1 At 6 months follow up  Other dataNo numeric data
12.2 At 12 months follow up  Other dataNo numeric data
13 Dysmenorrhoea (visual analogue)  Other dataNo numeric data
13.1 At 6 months follow up  Other dataNo numeric data
13.2 At 12 months follow up  Other dataNo numeric data
14 Pain score170Mean Difference (IV, Fixed, 95% CI)32.7 [23.72, 41.68]
15 Requirement for further surgery1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
15.1 At 6 months follow up00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
15.2 At 12 months follow up167Risk Ratio (M-H, Fixed, 95% CI)0.78 [0.23, 2.64]
Analysis 10.1.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 1 Amenorrhoea rate.

Analysis 10.2.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 2 PBAC score after treatment.

PBAC score after treatment
StudyBalloonLaserStatistical test
At 6 months follow up
Hawe 2003N=37
Mean PBAC (SD): 28.8 (59.6)
N=33
Mean PBAC (SD): 27.4 (57.6)
Significance not reported
Analysis 10.3.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 3 Satisfaction rate.

Analysis 10.4.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 4 Operative difficulties.

Analysis 10.5.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 5 Euroquol 5D.

Analysis 10.6.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 6 Euroquol 5D VAS.

Analysis 10.7.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 7 SF12 Physical Scale.

Analysis 10.8.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 8 SF12 Mental Scale.

Analysis 10.9.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 9 SAQ pleasure scale.

Analysis 10.10.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 10 SAQ habit scale.

Analysis 10.11.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 11 SAQ discomfort scale.

Analysis 10.12.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 12 PMS (visual analogue).

PMS (visual analogue)
StudyBalloonLaserStatistical test
At 6 months follow up
Hawe 2003N=37
Mean score (SD): 24.6 (33)
N=33
Mean score (SD): 34.8 (36)
Not reported
At 12 months follow up
Hawe 2003N=34
Mean score (SD): 21.9 (26.9)
N=33
Mean score (SD): 30.5 (34.7)
Not reported

Analysis 10.13.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 13 Dysmenorrhoea (visual analogue).

Dysmenorrhoea (visual analogue)
StudyBalloonLaserStatistical test
At 6 months follow up
Hawe 2003N=37
Mean score (SD): 24 (30.9)
N=33
Mean score (SD): 23 (33.9)
Not reported
At 12 months follow up
Hawe 2003N=34
Mean score (SD): 25.2 (31.5)
N=33
Mean score (SD): 16.5 (22.3)
Not reported
Analysis 10.14.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 14 Pain score.

Analysis 10.15.

Comparison 10 Balloon (second generation) versus laser (first generation), Outcome 15 Requirement for further surgery.

Comparison 11. Balloon (second generation) versus TCRE (first generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 6 months follow up149Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.31, 2.93]
1.2 At 12 months follow up145Risk Ratio (M-H, Fixed, 95% CI)1.21 [0.50, 2.95]
2 Satisfaction rate2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 At 6 months follow up150Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.93, 1.20]
2.2 At 12 months follow up2122Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.96, 1.18]
2.3 At 2 years follow up168Risk Ratio (M-H, Fixed, 95% CI)1.35 [1.06, 1.72]
3 Duration of operation (mins)182Mean Difference (IV, Fixed, 95% CI)-13.0 [-15.20, -10.80]
4 Duration of operation (mins)  Other dataNo numeric data
5 Operative difficulties151Risk Ratio (M-H, Fixed, 95% CI)7.22 [0.42, 123.83]
5.1 Equipment failure151Risk Ratio (M-H, Fixed, 95% CI)7.22 [0.42, 123.83]
6 Hospital stay (days)182Mean Difference (IV, Fixed, 95% CI)-0.30 [-0.52, -0.08]
7 Duration of hospital stay (hours)  Other dataNo numeric data
8 Return to normal activities (days)182Mean Difference (IV, Fixed, 95% CI)-2.10 [-3.38, -0.82]
9 Return to normal activities (days)  Other dataNo numeric data
10 Intraoperative complications (continuous data)182Mean Difference (IV, Fixed, 95% CI)-81.8 [-93.33, -70.27]
10.1 Blood loss182Mean Difference (IV, Fixed, 95% CI)-81.8 [-93.33, -70.27]
11 Intraoperative complications (dichotomous data)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
11.1 Fluid overload182Risk Ratio (M-H, Fixed, 95% CI)0.10 [0.01, 1.67]
11.2 Cervical tear182Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.01, 8.34]
11.3 Conversion to hysterectomy188Risk Ratio (M-H, Fixed, 95% CI)0.24 [0.01, 4.84]
12 Postoperative pain (continuous data)182Mean Difference (IV, Fixed, 95% CI)-0.60 [-0.88, -0.32]
13 Postoperative pain (descriptive data)  Other dataNo numeric data
14 Postoperative complications1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
14.1 Fever182Risk Ratio (M-H, Fixed, 95% CI)0.53 [0.05, 5.57]
14.2 Urinary infection or retention182Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.01, 8.34]
14.3 Hemorrhage182Risk Ratio (M-H, Fixed, 95% CI)1.31 [0.38, 4.54]
14.4 Blood transfusion182Risk Ratio (M-H, Fixed, 95% CI)5.24 [0.26, 105.97]
15 Requirement for further surgery1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
15.1 At 12 months follow up175Risk Ratio (M-H, Fixed, 95% CI)0.51 [0.10, 2.64]
15.2 At 2 years follow up168Risk Ratio (M-H, Fixed, 95% CI)0.38 [0.08, 1.81]
16 Requirement for further surgery (hyst only)145Risk Ratio (M-H, Fixed, 95% CI)0.12 [0.01, 2.44]
16.1 At 12 months follow up145Risk Ratio (M-H, Fixed, 95% CI)0.12 [0.01, 2.44]
Analysis 11.1.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 1 Amenorrhoea rate.

Analysis 11.2.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 2 Satisfaction rate.

Analysis 11.3.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 3 Duration of operation (mins).

Analysis 11.4.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 4 Duration of operation (mins).

Duration of operation (mins)
StudyCavaterm balloonTCREComments
Brun 2006

n=31

Median (range): 48 (24-150)

n=20

Median (range): 45 (23-105)

No statistical test reported - unlikely to be a difference
Analysis 11.5.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 5 Operative difficulties.

Analysis 11.6.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 6 Hospital stay (days).

Analysis 11.7.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 7 Duration of hospital stay (hours).

Duration of hospital stay (hours)
StudyCavaterm balloonTCREComments
Brun 2006

n=31

Median (range): 21 (0-36)

n=20

Median (range): 30 (6-72)

Mann Whitney rank sum test

P=0.012

Analysis 11.8.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 8 Return to normal activities (days).

Analysis 11.9.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 9 Return to normal activities (days).

Return to normal activities (days)
StudyCavaterm balloonTCREComments
Brun 2006

n=31

Median (range): 4 (1-20)

n=20

Median (range): 2 (1-30)

Mann Whitney rank test - not significantly different
Analysis 11.10.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 10 Intraoperative complications (continuous data).

Analysis 11.11.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 11 Intraoperative complications (dichotomous data).

Analysis 11.12.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 12 Postoperative pain (continuous data).

Analysis 11.13.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 13 Postoperative pain (descriptive data).

Postoperative pain (descriptive data)
StudyCavaterm balloonTCREComments
Brun 2006

n=31

Pain score (VAS scale 0-100): median (range): 45 (1-100)

n=20

Pain score (VAS scale 0-100): median (range): 10 (0-90)

Mann Whitney rank sum test:

P=0.012

Analysis 11.14.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 14 Postoperative complications.

Analysis 11.15.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 15 Requirement for further surgery.

Analysis 11.16.

Comparison 11 Balloon (second generation) versus TCRE (first generation), Outcome 16 Requirement for further surgery (hyst only).

Comparison 12. Bipolar radiofrequency (second generation) versus balloon ablation (second generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate3 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 6 months follow up2179Risk Ratio (M-H, Fixed, 95% CI)4.39 [2.00, 9.66]
1.2 At 12 months follow up3231Risk Ratio (M-H, Fixed, 95% CI)3.78 [2.07, 6.91]
1.3 At 2 to 5 years follow up1120Risk Ratio (M-H, Fixed, 95% CI)1.56 [0.93, 2.64]
2 PBAC score after treatment  Other dataNo numeric data
2.1 At 12 months follow up  Other dataNo numeric data
3 Satisfaction rate3 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 At 6 months follow up2181Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.94, 1.24]
3.2 At 12 months follow up3230Risk Ratio (M-H, Fixed, 95% CI)1.10 [0.99, 1.22]
4 Duration of operation  Other dataNo numeric data
5 Operative difficulties1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
5.1 Technical complication rate155Risk Ratio (M-H, Fixed, 95% CI)0.73 [0.13, 3.99]
6 Completion of procedure181Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.97, 1.15]
7 SF12 physical score155Mean Difference (IV, Fixed, 95% CI)1.60 [-4.27, 7.47]
7.1 At 12 months follow up155Mean Difference (IV, Fixed, 95% CI)1.60 [-4.27, 7.47]
8 SF12 mental score155Mean Difference (IV, Fixed, 95% CI)7.5 [-0.52, 15.52]
8.1 At 12 months follow up155Mean Difference (IV, Fixed, 95% CI)7.5 [-0.52, 15.52]
9 SF-36 Physical function score1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
9.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)2.0 [-6.55, 10.55]
9.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)3.0 [-6.44, 12.44]
9.3 At 2 to 5 years follow up198Mean Difference (IV, Fixed, 95% CI)2.0 [-8.26, 12.26]
10 SF-36 Role physical1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
10.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)5.0 [-7.67, 17.67]
10.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)5.0 [-6.96, 16.96]
10.3 At 2 to 5 years follow up198Mean Difference (IV, Fixed, 95% CI)8.0 [-2.66, 18.66]
11 SF-36 Role emotional1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
11.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)-6.0 [-18.64, 6.64]
11.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)4.0 [-1.92, 9.92]
11.3 At 2 to 5 years follow up198Mean Difference (IV, Fixed, 95% CI)-9.0 [-14.45, -3.55]
12 SF-36 Social functioning1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
12.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)-1.0 [-9.98, 7.98]
12.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)3.0 [-6.17, 12.17]
12.3 At 2 to 5 years follow up198Mean Difference (IV, Fixed, 95% CI)4.0 [-5.60, 13.60]
13 SF-36 Mental health1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
13.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)-3.0 [-10.84, 4.84]
13.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)0.0 [-8.03, 8.03]
13.3 At 2 to 5 years follow up198Mean Difference (IV, Fixed, 95% CI)-5.0 [-11.39, 1.39]
14 SF-36 Energy/vitality1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
14.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)-6.0 [-13.54, 1.54]
14.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)9.0 [-0.44, 18.44]
14.3 At 2 to 5 years follow up198Mean Difference (IV, Fixed, 95% CI)-3.0 [-10.39, 4.39]
15 SF-36 Pain1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
15.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)2.0 [-6.00, 12.00]
15.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)-1.0 [-12.61, 10.61]
15.3 At 2 to 5 years follow up198Mean Difference (IV, Fixed, 95% CI)-5.0 [-14.79, 4.79]
16 SF-36 General health1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
16.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)-5.0 [-13.30, 3.30]
16.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)6.0 [-4.10, 16.10]
16.3 At 2 to 5 years follow up198Mean Difference (IV, Fixed, 95% CI)6.0 [-5.72, 17.72]
17 RSCL Physical symptoms1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
17.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)1.0 [-3.94, 5.94]
17.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)-4.0 [-8.56, 0.56]
18 RSCL Psychological distress1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
18.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)-1.0 [-10.14, 8.14]
18.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)-1.0 [-7.92, 5.92]
19 RSCL Activity level1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
19.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)-1.0 [-3.35, 1.35]
19.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)-2.0 [-4.32, 0.32]
20 RSCL Overall quality of life1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
20.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)-2.0 [-12.29, 8.29]
20.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)-9.0 [-18.77, 0.77]
21 SDS Depression1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
21.1 At 6 months follow up190Mean Difference (IV, Fixed, 95% CI)2.0 [-1.55, 5.55]
21.2 At 12 months follow up178Mean Difference (IV, Fixed, 95% CI)-1.0 [-5.24, 3.24]
22 Multi-attribute utility tool151Mean Difference (IV, Fixed, 95% CI)8.80 [-6.08, 23.68]
22.1 At 12 months follow up151Mean Difference (IV, Fixed, 95% CI)8.80 [-6.08, 23.68]
23 Menorrhagia Outcome Questionnaire151Mean Difference (IV, Fixed, 95% CI)-0.60 [-3.87, 2.67]
23.1 At 12 months follow up151Mean Difference (IV, Fixed, 95% CI)-0.60 [-3.87, 2.67]
24 EQ 5-D utility149Mean Difference (IV, Fixed, 95% CI)0.03 [-0.16, 0.22]
24.1 At 12 months follow up149Mean Difference (IV, Fixed, 95% CI)0.03 [-0.16, 0.22]
25 Eq 5-D health thermometer143Mean Difference (IV, Fixed, 95% CI)4.8 [-10.07, 19.67]
25.1 At 12 months follow up143Mean Difference (IV, Fixed, 95% CI)4.8 [-10.07, 19.67]
26 Dysmenorrhoea rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
26.1 At 6 months follow up1126Risk Ratio (M-H, Fixed, 95% CI)0.69 [0.26, 1.86]
26.2 At 12 months follow up1126Risk Ratio (M-H, Fixed, 95% CI)0.52 [0.18, 1.51]
26.3 At 2 to 5 years follow up197Risk Ratio (M-H, Fixed, 95% CI)0.61 [0.26, 1.44]
27 Dysmenorrhoea rate (VAS score)  Other dataNo numeric data
27.1 At 12 months follow up  Other dataNo numeric data
28 Improvement in dysmenorrhoea144Risk Ratio (M-H, Fixed, 95% CI)1.37 [0.89, 2.10]
28.1 At 12 months follow up144Risk Ratio (M-H, Fixed, 95% CI)1.37 [0.89, 2.10]
29 PMS rate (VAS score)  Other dataNo numeric data
29.1 At 12 months follow up  Other dataNo numeric data
30 Improvement in PMS (emotional)136Risk Ratio (M-H, Fixed, 95% CI)0.8 [0.45, 1.43]
30.1 At 12 months follow up136Risk Ratio (M-H, Fixed, 95% CI)0.8 [0.45, 1.43]
31 Improvement in PMS (physical)136Risk Ratio (M-H, Fixed, 95% CI)1.3 [0.72, 2.34]
31.1 At 12 months follow up136Risk Ratio (M-H, Fixed, 95% CI)1.3 [0.72, 2.34]
32 Time taken off work (days)  Other dataNo numeric data
33 Time to resume normal activities (days)  Other dataNo numeric data
34 Postoperative complication rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
34.1 Infection (endometritis)173Risk Ratio (M-H, Fixed, 95% CI)0.30 [0.06, 1.42]
35 Requirement for further surgery (ablation or hyst)3 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
35.1 At 6 months follow up153Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
35.2 At 12 months follow up2135Risk Ratio (M-H, Fixed, 95% CI)1.36 [0.34, 5.42]
35.3 At 2 to 5 years follow up1120Risk Ratio (M-H, Fixed, 95% CI)0.72 [0.28, 1.89]
36 Requirement for further surgery (hyst only)2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
36.1 At 12 months follow up2207Risk Ratio (M-H, Fixed, 95% CI)0.59 [0.18, 1.93]
36.2 At 2 to 5 years follow up1120Risk Ratio (M-H, Fixed, 95% CI)0.77 [0.27, 2.20]
Analysis 12.1.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 1 Amenorrhoea rate.

Analysis 12.2.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 2 PBAC score after treatment.

PBAC score after treatment
StudyElectrodeBalloonStatistical test
At 12 months follow up
Abbott 2003N=37
Median PBAC (range): 3 (0, 720)
N=18
Median PBAC (range): 21 (0, 157)
Mann Whitney
P=0.2
Analysis 12.3.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 3 Satisfaction rate.

Analysis 12.4.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 4 Duration of operation.

Duration of operation
StudyElectrodeBalloonStatistical test
Abbott 2003N=37
Mean time in mins (range): 4 (2, 8)
N=18
Mean time in mins (range): 23 (19, 29)
t test
P=0.0001
Bongers 2004N=82
Mean time in mins (range): 9 (5, 32)
N=43
Mean time in mins (range): 14 (9, 40)
Not reported
Clark 2011

N=42

Mean time in mins (SD): 5.7 (2.1)

N=39

Mean time in mins (SD): 12.5 (2.3)

MD=6.7 mins (95% CI 5.8 to 7.7); p<0.001

Note: this is an office procedure in both arms)

Analysis 12.5.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 5 Operative difficulties.

Analysis 12.6.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 6 Completion of procedure.

Analysis 12.7.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 7 SF12 physical score.

Analysis 12.8.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 8 SF12 mental score.

Analysis 12.9.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 9 SF-36 Physical function score.

Analysis 12.10.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 10 SF-36 Role physical.

Analysis 12.11.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 11 SF-36 Role emotional.

Analysis 12.12.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 12 SF-36 Social functioning.

Analysis 12.13.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 13 SF-36 Mental health.

Analysis 12.14.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 14 SF-36 Energy/vitality.

Analysis 12.15.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 15 SF-36 Pain.

Analysis 12.16.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 16 SF-36 General health.

Analysis 12.17.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 17 RSCL Physical symptoms.

Analysis 12.18.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 18 RSCL Psychological distress.

Analysis 12.19.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 19 RSCL Activity level.

Analysis 12.20.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 20 RSCL Overall quality of life.

Analysis 12.21.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 21 SDS Depression.

Analysis 12.22.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 22 Multi-attribute utility tool.

Analysis 12.23.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 23 Menorrhagia Outcome Questionnaire.

Analysis 12.24.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 24 EQ 5-D utility.

Analysis 12.25.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 25 Eq 5-D health thermometer.

Analysis 12.26.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 26 Dysmenorrhoea rate.

Analysis 12.27.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 27 Dysmenorrhoea rate (VAS score).

Dysmenorrhoea rate (VAS score)
StudyElectrodeBalloonStatistical test
At 12 months follow up
Abbott 2003N=37
Median score (range): 0 (0, 96)
N=18
Median score (range): 29 (0, 77)
Mann Whitney
P=0.008
Analysis 12.28.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 28 Improvement in dysmenorrhoea.

Analysis 12.29.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 29 PMS rate (VAS score).

PMS rate (VAS score)
StudyElectrodeBalloonStatistical test
At 12 months follow up
Abbott 2003N=37
Median score (range): 0 (0, 100)
N=18
Median score (range): 32 (0, 100)
Mann Whitney
P=0.007
Analysis 12.30.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 30 Improvement in PMS (emotional).

Analysis 12.31.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 31 Improvement in PMS (physical).

Analysis 12.32.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 32 Time taken off work (days).

Time taken off work (days)
StudyBipolar RF ablationThermal ablationResults
Clark 2011

N=42

Mean: 6.4 days

N=39

Mean: 6.6 days

No significant difference between groups: 0.2 days difference (95% CI -5.9 to 6.2)

Analysis 12.33.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 33 Time to resume normal activities (days).

Time to resume normal activities (days)
StudyBipolar RF ablationBalloon ablationResults
Clark 2011

N=42

Mean (days): 4.9

N=39

Mean (days): 8.1

No significant difference between groups: 3.2 days difference (95% CI -1.6 to 8.1)
Analysis 12.34.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 34 Postoperative complication rate.

Analysis 12.35.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 35 Requirement for further surgery (ablation or hyst).

Analysis 12.36.

Comparison 12 Bipolar radiofrequency (second generation) versus balloon ablation (second generation), Outcome 36 Requirement for further surgery (hyst only).

Comparison 13. Microwave ablation (second generation) versus balloon ablation (second generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 6 months follow up1277Risk Ratio (M-H, Fixed, 95% CI)1.50 [1.07, 2.12]
1.2 At 12 months follow up1282Risk Ratio (M-H, Fixed, 95% CI)1.10 [0.82, 1.47]
2 PBAC score at 12 months follow up  Other dataNo numeric data
3 Satisfaction at 12 months follow up1278Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.88, 1.14]
4 Operative difficulties causing failure1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
4.1 Failure of device1314Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.01, 0.70]
4.2 Unsuitable cavity1314Risk Ratio (M-H, Fixed, 95% CI)0.75 [0.17, 3.30]
4.3 Device not sterile1314Risk Ratio (M-H, Fixed, 95% CI)5.0 [0.24, 103.32]
5 Operation time (mins)1314Mean Difference (IV, Fixed, 95% CI)-6.60 [-7.36, -5.84]
6 Proportion choosing local anaesthesia1314Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.79, 1.31]
7 Proportion requiring opiate analgesia1314Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.83, 1.01]
8 Proportion requiring overnight stay1314Risk Ratio (M-H, Fixed, 95% CI)0.66 [0.42, 1.04]
9 Quality of life scores: EQ5D1285Mean Difference (IV, Fixed, 95% CI)0.02 [-0.04, 0.08]
10 Quality of life scores: SF121 Mean Difference (IV, Fixed, 95% CI)Subtotals only
10.1 Physical score1285Mean Difference (IV, Fixed, 95% CI)-0.70 [-2.64, 1.24]
10.2 Mental score1285Mean Difference (IV, Fixed, 95% CI)-1.20 [-3.67, 1.27]
11 Requirement for further surgery at 12 months follow up (hyst only)1285Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.31, 2.84]
12 Pain score at 12 months follow up  Other dataNo numeric data
Analysis 13.1.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 1 Amenorrhoea rate.

Analysis 13.2.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 2 PBAC score at 12 months follow up.

PBAC score at 12 months follow up
StudyFollow upMicrowave ablationBalloon ablationResults
Sambrook 2009b12 months

N=143

Mean PBAC score (interquartile range): 3.0 (0.0 to 14.0)

N=135

Mean PBAC score (interquartile range): 4.0 (0.0 to 14.0)

Incidence rate ratio (95% CI):

0.91 (0.6 to 1.5)

Analysis 13.3.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 3 Satisfaction at 12 months follow up.

Analysis 13.4.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 4 Operative difficulties causing failure.

Analysis 13.5.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 5 Operation time (mins).

Analysis 13.6.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 6 Proportion choosing local anaesthesia.

Analysis 13.7.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 7 Proportion requiring opiate analgesia.

Analysis 13.8.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 8 Proportion requiring overnight stay.

Analysis 13.9.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 9 Quality of life scores: EQ5D.

Analysis 13.10.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 10 Quality of life scores: SF12.

Analysis 13.11.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 11 Requirement for further surgery at 12 months follow up (hyst only).

Analysis 13.12.

Comparison 13 Microwave ablation (second generation) versus balloon ablation (second generation), Outcome 12 Pain score at 12 months follow up.

Pain score at 12 months follow up
StudyMicrowave ablationBalloon ablationResults
Sambrook 2009bN=  
Comparison 14. Bipolar radiofrequency (second generation) versus hydrothermal ablation (second generation)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rates1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 6 months follow up1150Risk Ratio (M-H, Fixed, 95% CI)2.27 [1.25, 4.12]
1.2 At 12 months follow up1146Risk Ratio (M-H, Fixed, 95% CI)1.95 [1.21, 3.15]
1.3 2 to 5 years follow up1139Risk Ratio (M-H, Fixed, 95% CI)1.57 [1.06, 2.31]
2 Satisfaction1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 At 6 months follow up1150Risk Ratio (M-H, Fixed, 95% CI)1.44 [1.17, 1.77]
2.2 At 12 months follow up1146Risk Ratio (M-H, Fixed, 95% CI)1.11 [1.02, 1.21]
2.3 2 to 5 years follow up1139Risk Ratio (M-H, Fixed, 95% CI)1.62 [1.23, 2.13]
3 Absence of dysmenorrhoea1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 At 12 months follow up1146Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.79, 1.06]
3.2 2 to 5 years follow up1139Risk Ratio (M-H, Fixed, 95% CI)1.32 [1.00, 1.74]
4 Duration of procedure (mins)  Other dataNo numeric data
5 Postoperative complications1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
5.1 Uterine perforation1156Risk Ratio (M-H, Fixed, 95% CI)2.71 [0.11, 65.54]
5.2 Saline leakage1156Risk Ratio (M-H, Fixed, 95% CI)0.13 [0.01, 2.46]
6 Requirement for further surgery (any)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
6.1 At 12 months follow up1160Risk Ratio (M-H, Fixed, 95% CI)0.28 [0.11, 0.72]
6.2 2 to 5 years follow up1136Risk Ratio (M-H, Fixed, 95% CI)0.44 [0.23, 0.83]
7 Requirement for further surgery (hyst only)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
7.1 At 12 months follow up1160Risk Ratio (M-H, Fixed, 95% CI)0.42 [0.14, 1.32]
7.2 2 to 5 years follow up1136Risk Ratio (M-H, Fixed, 95% CI)0.63 [0.29, 1.38]
Analysis 14.1.

Comparison 14 Bipolar radiofrequency (second generation) versus hydrothermal ablation (second generation), Outcome 1 Amenorrhoea rates.

Analysis 14.2.

Comparison 14 Bipolar radiofrequency (second generation) versus hydrothermal ablation (second generation), Outcome 2 Satisfaction.

Analysis 14.3.

Comparison 14 Bipolar radiofrequency (second generation) versus hydrothermal ablation (second generation), Outcome 3 Absence of dysmenorrhoea.

Analysis 14.4.

Comparison 14 Bipolar radiofrequency (second generation) versus hydrothermal ablation (second generation), Outcome 4 Duration of procedure (mins).

Duration of procedure (mins)
StudyBipolar RFHydrotherm ablationResults
Penninx 2010

N=82

Median (range): 11.8 (5 to 40)

N=74

Median (range): 27.8 (14 to 55)

Test used not stated

p<0.001

Analysis 14.5.

Comparison 14 Bipolar radiofrequency (second generation) versus hydrothermal ablation (second generation), Outcome 5 Postoperative complications.

Analysis 14.6.

Comparison 14 Bipolar radiofrequency (second generation) versus hydrothermal ablation (second generation), Outcome 6 Requirement for further surgery (any).

Analysis 14.7.

Comparison 14 Bipolar radiofrequency (second generation) versus hydrothermal ablation (second generation), Outcome 7 Requirement for further surgery (hyst only).

Comparison 15. Ablative curettage versus overcurettage
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate1100Risk Ratio (M-H, Fixed, 95% CI)4.5 [2.33, 8.69]
1.1 At 3 years follow up1100Risk Ratio (M-H, Fixed, 95% CI)4.5 [2.33, 8.69]
2 Amenorrhoea and normal menses rate1100Risk Ratio (M-H, Fixed, 95% CI)1.86 [1.30, 2.66]
2.1 At 3 years follow up1100Risk Ratio (M-H, Fixed, 95% CI)1.86 [1.30, 2.66]
3 Postoperative complications1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 Bleeding1100Risk Ratio (M-H, Fixed, 95% CI)0.21 [0.07, 0.70]
3.2 Infection/leukorrhea1100Risk Ratio (M-H, Fixed, 95% CI)0.8 [0.23, 2.81]
3.3 Uterine perforation1100Risk Ratio (M-H, Fixed, 95% CI)0.14 [0.01, 2.70]
4 Hospital stay (days)1100Mean Difference (IV, Fixed, 95% CI)1.6 [1.18, 2.02]
5 Failure rate of procedure1100Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.12, 0.74]
6 Requirement for further surgery (hyst only)1100Risk Ratio (M-H, Fixed, 95% CI)0.42 [0.16, 1.10]
6.1 Within 3 years1100Risk Ratio (M-H, Fixed, 95% CI)0.42 [0.16, 1.10]
Analysis 15.1.

Comparison 15 Ablative curettage versus overcurettage, Outcome 1 Amenorrhoea rate.

Analysis 15.2.

Comparison 15 Ablative curettage versus overcurettage, Outcome 2 Amenorrhoea and normal menses rate.

Analysis 15.3.

Comparison 15 Ablative curettage versus overcurettage, Outcome 3 Postoperative complications.

Analysis 15.4.

Comparison 15 Ablative curettage versus overcurettage, Outcome 4 Hospital stay (days).

Analysis 15.5.

Comparison 15 Ablative curettage versus overcurettage, Outcome 5 Failure rate of procedure.

Analysis 15.6.

Comparison 15 Ablative curettage versus overcurettage, Outcome 6 Requirement for further surgery (hyst only).

Comparison 16. Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Amenorrhoea rate12 Risk Ratio (M-H, Random, 95% CI)Subtotals only
1.1 At 6 months follow up149Risk Ratio (M-H, Random, 95% CI)1.27 [0.91, 1.77]
1.2 At 1 year follow up122085Risk Ratio (M-H, Random, 95% CI)0.94 [0.74, 1.20]
1.3 At 2 years follow up3701Risk Ratio (M-H, Random, 95% CI)0.97 [0.72, 1.30]
1.4 At 2 to 5 years follow up4672Risk Ratio (M-H, Random, 95% CI)1.16 [0.78, 1.72]
1.5 > 5 years follow up1189Risk Ratio (M-H, Random, 95% CI)0.94 [0.83, 1.05]
2 Satisfaction rate13 Risk Ratio (M-H, Random, 95% CI)Subtotals only
2.1 At 1 year follow up111690Risk Ratio (M-H, Random, 95% CI)1.00 [0.97, 1.02]
2.2 At 6 months follow up150Risk Ratio (M-H, Random, 95% CI)1.06 [0.93, 1.20]
2.3 At 2 years follow up5802Risk Ratio (M-H, Random, 95% CI)1.09 [0.99, 1.21]
2.4 At 2 to 5 years follow up4672Risk Ratio (M-H, Random, 95% CI)1.02 [0.93, 1.13]
2.5 > 5 years follow up1263Risk Ratio (M-H, Random, 95% CI)1.14 [0.92, 1.42]
3 Success of treatment (PBAC<75 or acceptable improvement)6 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 At 12 months follow up61375Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.97, 1.08]
3.2 At 2 to 5 years follow up1236Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.97, 1.28]
3.3 > 5 years follow up1263Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.87, 1.34]
4 Operative difficulties5 Risk Ratio (M-H, Random, 95% CI)Subtotals only
4.1 Equipment failure3384Risk Ratio (M-H, Random, 95% CI)4.26 [1.46, 12.43]
4.2 Procedure abandoned3629Risk Ratio (M-H, Random, 95% CI)1.18 [0.38, 3.67]
5 Duration of operation (mins)91762Mean Difference (IV, Random, 95% CI)-14.86 [-19.68, -10.05]
6 Proportion having local anaesthesia (%)61434Risk Ratio (M-H, Random, 95% CI)2.78 [1.76, 4.40]
7 Inability to work2479Risk Ratio (M-H, Random, 95% CI)0.84 [0.30, 2.30]
8 Operative or postoperative complication rate11 Risk Ratio (M-H, Random, 95% CI)Subtotals only
8.1 Fluid overload4681Risk Ratio (M-H, Random, 95% CI)0.18 [0.04, 0.79]
8.2 Perforation81885Risk Ratio (M-H, Random, 95% CI)0.32 [0.10, 1.01]
8.3 Cervical lacerations81676Risk Ratio (M-H, Random, 95% CI)0.22 [0.08, 0.61]
8.4 Endometritis51188Risk Ratio (M-H, Random, 95% CI)1.25 [0.45, 3.49]
8.5 UTI81834Risk Ratio (M-H, Random, 95% CI)0.89 [0.44, 1.80]
8.6 Hematometra51133Risk Ratio (M-H, Random, 95% CI)0.32 [0.12, 0.85]
8.7 Hydrosalpinx1239Risk Ratio (M-H, Random, 95% CI)0.30 [0.01, 7.39]
8.8 Haemorrhage5982Risk Ratio (M-H, Random, 95% CI)0.74 [0.29, 1.91]
8.9 Muscle fasciculation1267Risk Ratio (M-H, Random, 95% CI)2.57 [0.11, 62.41]
8.10 Fever3671Risk Ratio (M-H, Random, 95% CI)0.92 [0.20, 4.29]
8.11 Nausea/vomiting4997Risk Ratio (M-H, Random, 95% CI)1.98 [1.30, 3.02]
8.12 Myometritis1267Risk Ratio (M-H, Random, 95% CI)0.29 [0.01, 6.93]
8.13 Pelvic inflammatory disease1265Risk Ratio (M-H, Random, 95% CI)1.03 [0.09, 11.19]
8.14 Pelvic abscess1265Risk Ratio (M-H, Random, 95% CI)0.17 [0.01, 4.19]
8.15 Cervical stenosis1322Risk Ratio (M-H, Random, 95% CI)1.5 [0.06, 36.52]
8.16 Uterine cramping2601Risk Ratio (M-H, Random, 95% CI)1.21 [1.01, 1.44]
8.17 Severe pelvic pain3683Risk Ratio (M-H, Random, 95% CI)0.87 [0.19, 3.98]
8.18 External burns1269Risk Ratio (M-H, Random, 95% CI)2.32 [0.11, 47.89]
8.19 Blood transfusion182Risk Ratio (M-H, Random, 95% CI)5.24 [0.26, 105.97]
9 Requirement for any additional surgery9 Risk Ratio (M-H, Random, 95% CI)Subtotals only
9.1 In 1 year follow up71028Risk Ratio (M-H, Random, 95% CI)0.77 [0.46, 1.28]
9.2 In 2 years follow up5988Risk Ratio (M-H, Random, 95% CI)0.83 [0.52, 1.32]
9.3 In 2 to 5 years follow up3647Risk Ratio (M-H, Random, 95% CI)0.95 [0.72, 1.26]
9.4 > 5 years follow up1263Risk Ratio (M-H, Random, 95% CI)0.69 [0.48, 0.99]
10 Requirement for further surgery (hyst only)9 Risk Ratio (M-H, Random, 95% CI)Subtotals only
10.1 At 1 year follow up4772Risk Ratio (M-H, Random, 95% CI)0.72 [0.37, 1.39]
10.2 At 2 years follow up4920Risk Ratio (M-H, Random, 95% CI)0.86 [0.52, 1.42]
10.3 At 2 to 5 years follow up4758Risk Ratio (M-H, Random, 95% CI)0.85 [0.59, 1.22]
10.4 > 5 years follow up1263Risk Ratio (M-H, Random, 95% CI)0.60 [0.38, 0.96]
Analysis 16.1.

Comparison 16 Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation, Outcome 1 Amenorrhoea rate.

Analysis 16.2.

Comparison 16 Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation, Outcome 2 Satisfaction rate.

Analysis 16.3.

Comparison 16 Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation, Outcome 3 Success of treatment (PBAC<75 or acceptable improvement).

Analysis 16.4.

Comparison 16 Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation, Outcome 4 Operative difficulties.

Analysis 16.5.

Comparison 16 Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation, Outcome 5 Duration of operation (mins).

Analysis 16.6.

Comparison 16 Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation, Outcome 6 Proportion having local anaesthesia (%).

Analysis 16.7.

Comparison 16 Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation, Outcome 7 Inability to work.

Analysis 16.8.

Comparison 16 Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation, Outcome 8 Operative or postoperative complication rate.

Analysis 16.9.

Comparison 16 Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation, Outcome 9 Requirement for any additional surgery.

Analysis 16.10.

Comparison 16 Overall analyses: second-generation endometrial ablation versus first-generation endometrial ablation, Outcome 10 Requirement for further surgery (hyst only).

Appendices

Appendix 1. MEDLINE search strategy

1 (menstrua$ adj5 disorder$).tw. (2227)
2 (heavy adj5 menstrua$).ti,ab,hw,tn,mf. (491)
3 (iron adj5 anaem$).ti,ab,hw,tn,mf. (2708)
4 menorrhag$.ti,ab,hw,tn,mf. (4543)
5 hypermenorr$.ti,ab,hw,tn,mf. (241)
6 exp menorrhagia/ (3404)
7 (dysfunction$ adj2 uter$).tw. (1006)
8 (excessive$ adj2 menstru$).tw. (172)
9 (heavy adj2 menses).tw. (38)
10 (abnormal$ adj2 uterine).tw. (1950)
11 (excessive$ adj2 uter$).tw. (152)
12 (heavy adj2 period$).tw. (343)
13 or/1-12 (12460)
14 (endometr$ adj2 ablat$).tw. (1025)
15 TCRE.tw. (72)
16 (transcerv$ adj3 resect$).tw. (288)
17 (laser$ adj3 ablat$).tw. (5551)
18 rollerball$.tw. (132)
19 (balloon adj ablat$).tw. (109)
20 (microwav$ adj3 ablat$).tw. (656)
21 electrosurg$.tw. (2588)
22 hypertherm$.tw. (26557)
23 photodynam$.tw. (13874)
24 thermotherap$.tw. (1839)
25 phototherap$.tw. (5668)
26 cryoablat$.tw. (1961)
27 radiofreq$.tw. (19983)
28 (laser adj3 interstit$).tw. (591)
29 Thermachoice.tw. (40)
30 Cavaterm.tw. (17)
31 Elitt.tw. (5)
32 Vesta.tw. (49)
33 Novasure.tw. (38)
34 Microsoulis.tw. (0)
35 Cryogen.tw. (296)
36 (endometr$ adj2 destr$).tw. (107)
37 (electrode$ adj2 ablat$).tw. (250)
38 (endometr$ adj2 resection$).tw. (482)
39 (saline adj2 irrigat$).tw. (844)
40 (heat$ adj2 balloon).tw. (20)
41 ablat$.tw. (65942)
42 or/14-41 (124143)
43 13 and 42 (1050)
44 randomized controlled trial.pt. (366782)
45 controlled clinical trial.pt. (87663)
46 randomized.ab. (282296)
47 placebo.tw. (155172)
48 clinical trials as topic.sh. (169792)
49 randomly.ab. (202465)
50 trial.ti. (121377)
51 (crossover or cross-over or cross over).tw. (59024)
52 or/44-51 (896557)
53 exp animals/ not humans.sh. (3905619)
54 52 not 53 (827176)
55 43 and 54 (184)

Appendix 2. EMBASE search strategy

1 (menstrua$ adj5 disorder$).tw. (2378)
2 (heavy adj5 menstrua$).ti,ab,hw,tn,mf. (555)
3 (iron adj5 anaem$).ti,ab,hw,tn,mf. (3049)
4 menorrhag$.ti,ab,hw,tn,mf. (6318)
5 hypermenorr$.ti,ab,hw,tn,mf. (519)
6 menstruation disorder/ or exp "menorrhagia and metrorrhagia"/ or exp hypermenorrhea/ or exp menorrhagia/ or exp metrorrhagia/ (17031)
7 (dysfunction$ adj2 uter$).tw. (1162)
8 (excessive$ adj2 menstru$).tw. (170)
9 (heavy adj2 menses).tw. (40)
10 (abnormal$ adj2 uterine).tw. (2348)
11 (excessive$ adj2 uter$).tw. (165)
12 (heavy adj2 period$).tw. (393)
13 or/1-12 (24778)
14 exp endometrium ablation/ (1493)
15 (endometr$ adj2 ablat$).tw. (1373)
16 TCRE.tw. (103)
17 (transcerv$ adj3 resect$).tw. (384)
18 (laser$ adj3 ablat$).tw. (5601)
19 rollerball$.tw. (167)
20 (balloon adj ablat$).tw. (169)
21 (microwav$ adj3 ablat$).tw. (782)
22 electrosurg$.tw. (2838)
23 hypertherm$.tw. (28222)
24 photodynam$.tw. (15092)
25 thermotherap$.tw. (2214)
26 phototherap$.tw. (6670)
27 cryoablat$.tw. (2524)
28 radiofreq$.tw. (23732)
29 (laser adj3 interstit$).tw. (733)
30 Thermachoice.tw. (73)
31 Cavaterm.tw. (25)
32 Elitt.tw. (8)
33 Vesta.tw. (50)
34 Novasure.tw. (76)
35 Microsoulis.tw. (0)
36 Cryogen.tw. (318)
37 (endometr$ adj2 destr$).tw. (138)
38 (electrode$ adj2 ablat$).tw. (318)
39 (endometr$ adj2 resection$).tw. (668)
40 (saline adj2 irrigat$).tw. (954)
41 (heat$ adj2 balloon).tw. (22)
42 ablat$.tw. (75045)
43 or/14-42 (138894)
44 43 and 13 (1648)
45 Clinical Trial/ (867728)
46 Randomized Controlled Trial/ (324293)
47 exp randomization/ (58661)
48 Single Blind Procedure/ (16047)
49 Double Blind Procedure/ (109462)
50 Crossover Procedure/ (34246)
51 Placebo/ (200426)
52 Randomi?ed controlled trial$.tw. (76061)
53 Rct.tw. (9482)
54 random allocation.tw. (1151)
55 randomly allocated.tw. (17271)
56 allocated randomly.tw. (1811)
57 (allocated adj2 random).tw. (708)
58 Single blind$.tw. (12263)
59 Double blind$.tw. (128449)
60 ((treble or triple) adj blind$).tw. (270)
61 placebo$.tw. (175748)
62 prospective study/ (206989)
63 or/45-62 (1255203)
64 case study/ (16016)
65 case report.tw. (226142)
66 abstract report/ or letter/ (835489)
67 or/64-66 (1073067)
68 63 not 67 (1220198)
69 68 and 44 (459)
70 (2010$ or 2011$ or 2012$).em. (2623648)
71 69 and 70 (74)

Appendix 3. CINAHL search strategy

1     (menstrua$ adj5 disorder$).tw. (222)

2     (heavy adj5 menstrua$).ti,ab,hw,tn,mf. (64)

3     (iron adj5 anaem$).ti,ab,hw,tn,mf. (141)

4     menorrhag$.ti,ab,hw,tn,mf. (357)

5     hypermenorr$.ti,ab,hw,tn,mf. (6)

6     menstruation disorder/ or exp "menorrhagia and metrorrhagia"/ or exp hypermenorrhea/ or exp menorrhagia/ or exp metrorrhagia/ (815)

7     (dysfunction$ adj2 uter$).tw. (73)

8     (excessive$ adj2 menstru$).tw. (11)

9     (heavy adj2 menses).tw. (1)

10     (abnormal$ adj2 uterine).tw. (118)

11     (excessive$ adj2 uter$).tw. (11)

12     (heavy adj2 period$).tw. (40)

13     or/1-12 (1308)

14     exp endometrium ablation/ (0)

15     (endometr$ adj2 ablat$).tw. (110)

16     TCRE.tw. (4)

17     (transcerv$ adj3 resect$).tw. (18)

18     (laser$ adj3 ablat$).tw. (109)

19     rollerball$.tw. (7)

20     (balloon adj ablat$).tw. (12)

21     (microwav$ adj3 ablat$).tw. (21)

22     electrosurg$.tw. (202)

23     hypertherm$.tw. (546)

24     photodynam$.tw. (239)

25     thermotherap$.tw. (59)

26     phototherap$.tw. (262)

27     cryoablat$.tw. (89)

28     radiofreq$.tw. (1054)

29     (laser adj3 interstit$).tw. (13)

30     Thermachoice.tw. (4)

31     Cavaterm.tw. (2)

32     Elitt.tw. (0)

33     Vesta.tw. (2)

34     Novasure.tw. (5)

35     Microsoulis.tw. (0)

36     Cryogen.tw. (2)

37     (endometr$ adj2 destr$).tw. (8)

38     (electrode$ adj2 ablat$).tw. (13)

39     (endometr$ adj2 resection$).tw. (26)

40     (saline adj2 irrigat$).tw. (41)

41     (heat$ adj2 balloon).tw. (0)

42     ablat$.tw. (2303)

43     or/14-42 (4003)

44     43 and 13 (113)

45     limit 44 to yr="2004 - 2008" (50)

46     exp clinical trials/ (67630)

47     Clinical trial.pt. (35888)

48     (clinic$ adj trial$1).tw. (15438)

49     ((singl$ or doubl$ or trebl$ or tripl$) adj (blind$3 or mask$3)).tw. (9068)

50     Randomi?ed control$ trial$.tw. (13156)

51     Random assignment/ (19843)

52     Random$ allocat$.tw. (1383)

53     Placebo$.tw. (12496)

54     Placebos/ (4821)

55     Quantitative studies/ (4427)

56     Allocat$ random$.tw. (78)

57     or/46-56 (93074)

58     57 and 45 (19)

59     from 58 keep 1-19 (19)   

Appendix 4. PsycInfo search strategy

--------------------------------------------------------------------------------
1 exp Menstrual Disorders/ (931)
2 menorrhag$.tw. (67)
3 (menstrua$ adj5 disorder$).tw. (297)
4 (heavy adj5 menstrua$).tw. (15)
5 (iron adj5 anaem$).tw. (33)
6 hypermenorr$.tw. (2)
7 (dysfunction$ adj2 uter$).tw. (20)
8 (excessive$ adj2 menstru$).tw. (7)
9 (heavy adj2 menses).tw. (0)
10 (abnormal$ adj2 uterine).tw. (10)
11 (excessive$ adj2 uter$).tw. (3)
12 (heavy adj2 period$).tw. (57)
13 or/1-12 (1278)
14 TCRE.tw. (1)
15 (transcerv$ adj3 resect$).tw. (1)
16 rollerball$.tw. (1)
17 electrosurg$.tw. (9)
18 hypertherm$.tw. (1136)
19 photodynam$.tw. (27)
20 thermotherap$.tw. (7)
21 phototherap$.tw. (269)
22 cryoablat$.tw. (4)
23 radiofreq$.tw. (265)
24 (laser adj3 interstit$).tw. (1)
25 Thermachoice.tw. (0)
26 Cavaterm.tw. (0)
27 Elitt.tw. (0)
28 Vesta.tw. (9)
29 Novasure.tw. (0)
30 Microsoulis.tw. (0)
31 Cryogen.tw. (0)
32 (endometr$ adj2 destr$).tw. (0)
33 (endometr$ adj2 resection$).tw. (4)
34 (saline adj2 irrigat$).tw. (9)
35 (heat$ adj2 balloon).tw. (0)
36 ablat$.tw. (3631)
37 or/14-36 (5321)
38 13 and 37 (8)
39 random.tw. (35618)
40 control.tw. (276867)
41 double-blind.tw. (16080)
42 clinical trials/ (6164)
43 placebo/ (3235)
44 exp Treatment/ (520230)
45 or/39-44 (788734)
46 38 and 45 (7)

Appendix 5. CENTRAL search strategy

1 (menstrua$ adj5 disorder$).tw. (60)
2 (heavy adj5 menstrua$).ti,ab,hw,tn,mf. (51)
3 (iron adj5 anaem$).ti,ab,hw,tn,mf. (287)
4 menorrhag$.ti,ab,hw,tn,mf. (380)
5 hypermenorr$.ti,ab,hw,tn,mf. (16)
6 exp menorrhagia/ (219)
7 (dysfunction$ adj2 uter$).tw. (97)
8 (excessive$ adj2 menstru$).tw. (16)
9 (heavy adj2 menses).tw. (2)
10 (abnormal$ adj2 uterine).tw. (143)
11 (excessive$ adj2 uter$).tw. (16)
12 (heavy adj2 period$).tw. (23)
13 or/1-12 (986)
14 (endometr$ adj2 ablat$).tw. (170)
15 TCRE.tw. (21)
16 (transcerv$ adj3 resect$).tw. (55)
17 (laser$ adj3 ablat$).tw. (284)
18 rollerball$.tw. (28)
19 (balloon adj ablat$).tw. (26)
20 (microwav$ adj3 ablat$).tw. (38)
21 electrosurg$.tw. (144)
22 hypertherm$.tw. (579)
23 photodynam$.tw. (602)
24 thermotherap$.tw. (148)
25 phototherap$.tw. (738)
26 cryoablat$.tw. (38)
27 radiofreq$.tw. (685)
28 (laser adj3 interstit$).tw. (27)
29 Thermachoice.tw. (18)
30 Cavaterm.tw. (13)
31 Elitt.tw. (1)
32 Vesta.tw. (7)
33 Novasure.tw. (9)
34 Microsoulis.tw. (0)
35 Cryogen.tw. (22)
36 (endometr$ adj2 destr$).tw. (8)
37 (electrode$ adj2 ablat$).tw. (10)
38 (endometr$ adj2 resection$).tw. (110)
39 (saline adj2 irrigat$).tw. (195)
40 (heat$ adj2 balloon).tw. (0)
41 ablat$.tw. (1932)
42 or/14-41 (4652)
43 13 and 42 (194)
44 limit 43 to yr="2008 -Current" (20)

Appendix 6. MDSG trial register search strategy

Keywords CONTAINS "heavy bleeding"or"heavy menstrual bleeding"or "heavy menstrual loss"or "menometrorrhagia"or "menorrhagia"or "menorrhagia-outcome"or "Menorrhagia-Symptoms"or "abnormal bleeding"or "abnormal uterine bleeding"or "abnormal vaginal bleeding"or"excessive menstrual bleeding"or "excessive menstrual loss"or "dysfunctional bleeding"or "dysfunctional uterine bleeding" or Title CONTAINS "heavy bleeding"or"heavy menstrual bleeding"or "heavy menstrual loss"or "menometrorrhagia"or "menorrhagia"or "menorrhagia-outcome"or "Menorrhagia-Symptoms"or "abnormal bleeding"or "abnormal uterine bleeding"or "abnormal vaginal bleeding"or"excessive menstrual bleeding"or "excessive menstrual loss"or "dysfunctional bleeding"or "dysfunctional uterine bleeding"

AND

Keywords CONTAINS "endometrial ablation" or "endometrial ablation, bipolar radiofrequency" or "Endometrial ablation, chemical" or "endometrial ablation, laser" or "endometrial ablation, microwave" or "endometrial ablation, Novasure" or "endometrial ablation, rollerball" or "endometrial ablation, thermal balloon" or "transcervical endometrial resection" or "transcervical hysteroresection" or "transcervical hysteroscopic endometrial coagulation" or "Laser Ablation" or "rollerball" or "rollerball electroablation" or "balloon endometrial ablation" or "microwave endometrial ablation" or "microwave" or "photoablation" or "cryoblation therapy" or "NovaSure" or "endometrial cryoblation" or "endometrial resection" or "endometrial resection, transcervical" or "ablation"

What's new

Last assessed as up-to-date: 12 June 2013.

DateEventDescription
31 July 2013New citation required but conclusions have not changedSix new publications added but no change to conclusions.
31 July 2013New search has been performedReview updated. Six new publications added: one was longer follow up of a study already included, four were new trials, and one additional publication was longer follow up of one of the four new trials. Summary measure for dichotomous data changed from odds ratios to relative risks because for some outcomes the event rates were large (satisfaction, amenorrhoea rates).

History

Protocol first published: Issue 2, 1999
Review first published: Issue 2, 2002

DateEventDescription
6 August 2009New citation required but conclusions have not changedUpdate with 2 new citations but unchanged conclusions. New author added.
17 December 2008AmendedTitle changed from Endometrial destruction techniques for heavy menstrual bleeding to Endometrial resection / ablation techniques for heavy menstrual bleeding
10 December 2008AmendedConverted to new review format.
23 August 2005New citation required and conclusions have changedSubstantive amendment

Contributions of authors

Ray Garry commented on the final draft of an earlier version of the review.

Martha Hickey commented on the final list of included trials, extracted data from the included trials for earlier versions of the review, wrote the discussion and conclusion, and commented on the draft of the protocol and an earlier version of the full review.

Anne Lethaby wrote the protocol, searched for relevant trials, assessed trials for eligibility for inclusion, extracted data from the included trials, assessed trials for risk of bias, compared the independent data extraction and clarified points of disagreement, entered the data and wrote and commented on the final review (excluding the discussion and conclusion).

Julie Brown performed independent selection of trials for the 2009 update.

Josien Penninx performed independent data extraction and assessment of risk of bias for the 2009 and 2013 updates and commented on the final version of the review.

Jane Marjoribanks helped update the search for the 2013 update.

Declarations of interest

The review authors did not report any conflict of interest.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • UK NHS, Not specified.

    The update in 2009 was funded by Dept of Health (England) Incentive Scheme 2008

Differences between protocol and review

Title changed from 'Endometrial destruction techniques for heavy menstrual bleeding' to 'Endometrial resection / ablation techniques for heavy menstrual bleeding' in December 2008.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Abbott 2003

MethodsRandomisation: computer-generated sequences in balanced blocks of 5, imbalanced randomization 2:1 and opaque envelope
Study was a randomised controlled trial, with use of double blinding (women and assessor) and the authors did not report the number of centres involved in the study
Number of women randomised: 57
Number of women analysed: 55 evaluated at 6 months follow up
Power calculation performed and the authors reported the use of intention-to-treat analysis
Source of funding: Novacept
Participants57 women with unstated ages (mean Novasure 40.5(6.0), mean Cavaterm 40.5(8.1) recruited from James Cook University Hospital in the UK
Inclusion criteria: abnormal uterine bleeding - pictorial blood loss assessment chart score > 150; no intrauterine pathology demonstrated by in- or outpatient hysterectomy; normal endometrial biopsy; a uterine length < 12 cm; premenstrual gonatrophin levels; normal pap smear; had completed their family
Exclusion criteria: none reported
Interventions(1) Novasure (TM) endometrial ablation
(2) Cavaterm (TM) endometrial ablation
Duration: 6-month follow up and 12-month follow up
OutcomesPrimary: amenorrhoea; menstrual change, QOL, sexual activity, patient satisfaction, procedure acceptability
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated sequences in balanced blocks of five
Allocation concealment (selection bias)Low riskOpaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants, nursing staff and GP all blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessors blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskOne participant in each group withdrew after randomisation and prior to surgery
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported.
Other biasUnclear riskGroups appeared balanced at baseline but medical equipment company provided funding

Bhattacharya 1997

MethodsRandomisation: random number sequence computer generated + numbered concealed opaque envelopes
Single centre, parallel groups with no blinding
Number of women randomised: 372
Number of women analysed: 366 had treatments, 332 were evaluated at 6 months follow up, 321 evaluated at 12 months follow up
Power calculation performed for sample size and authors reported intention to treat analysis (although because of dropouts, this was impossible)
Source of funding: Chief Scientist Office of the Scottish Dept of Health
Participants372 women with mean age 41 years, recruited from gynaecology clinics at Aberdeen Royal Infirmary, Scotland
Inclusion criteria: ≤ 50 years of age; <100 kg in weight; clinical diagnosis of dysfunctional uterine bleeding (uterus < size of a pregnancy of 10 weeks and normal endometrial histology)
Exclusion criteria: not reported
InterventionsAll women had clinical assessment and endometrial biopsy prior to treatment, and also endometrial preparation with a single injection of goserelin 3.6 mg subcutaneously 5 weeks prior to surgery
(1) Laser ablation
(2) TCRE with rollerball
Duration: 12 months
OutcomesOperative complications; post-operative recovery; relief of menstrual and other symptoms; need for further surgical treatment; satisfaction with treatment; differential resource use
NotesRecruitment of participants took place over 2 different time periods. 105 women were randomised to ELA or TCRE for an earlier study. After a gap of 8 months, an additional 267 women were recruited
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated
Allocation concealment (selection bias)Low riskNumbered sealed opaque envelopes stratified per consultant
Blinding of participants and personnel (performance bias)
All outcomes
High riskOpen study
Blinding of outcome assessment (detection bias)
All outcomes
High riskOpen study
Incomplete outcome data (attrition bias)
All outcomes
High riskDifferent numbers of participants provided data for different outcomes; 366/372 for operative details, 321/372 for satisfaction; 306/372 for menstrual loss
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskRecruitment of participants over 2 different time period and the 2 groups differed in baseline characteristics. 15% of one group crossed over to the other treatment but analyses were undertaken according to randomised group

Bongers 2004

MethodsRandomisation: computer generated at a 2:1 ratio with opaque sealed envelopes
Single centre, parallel group design and double blind (participants and investigators)
No of women randomised: 126
Number of women analysed: 126 (1 woman in bipolar group did not receive any treatment but was included in the analyses) (at 5-year follow up, 6 participants were lost to follow up and not included in the analyses)
Power calculation for sample size performed and authors claimed analysis by intention to treat
Source of funding: Novasure devices provided by Novacept; Thermachoice devices discounted
Participants126 women with mean age 43 years, recruited from a large teaching hospital (500 beds) in the Netherlands
Inclusion:
Menorrhagia (PBAC≥150); normal uterus with benign histology and uterine length 6-11 cm; normal PAP smear; negative Chlamydia test, FSH<40 iu/L
Exclusion:
Coagulopathies; treatment with anticoagulation; desire to preserve fertility; prior uterine surgery (except low segment caesarean section)
Interventions(1) Novasure endometrial ablation
(2) Thermachoice endometrial ablation
Follow up at 3, 6 and 12 months
OutcomesPrimary:
Amenorrhoea at 3, 6, 12 months and later follow up at 5 years
Secondary:
Duration of surgery; satisfaction; re-intervention rates (hysterectomy); dysmenorrhoea rates; proportion with blood clots; health-related quality of life
NotesA technical failure with the Novasure generator part way during the trial. As a result, 2 analyses were performed:
A: analysis of all women
B: analysis of only those women included after the technical failure
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated
Allocation concealment (selection bias)Low riskOpaque sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants and co-ordinator of follow up blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessment by either patients or doctors, so blinding was followed
Incomplete outcome data (attrition bias)
All outcomes
Low riskMinimal loss to follow up over 5 years (6/126)
Selective reporting (reporting bias)Unclear riskAdverse events not prespecified or reported
Other biasUnclear riskSupport to trial by medical equipment company. At baseline, more women (16%) in the bipolar group had a retroverted uterus when compared with women (9%) in the balloon group

Boujida 2002

MethodsRandomisation: Geigy random numbers in sealed envelopes (even=coagulation, uneven=resection)
The study was a randomised controlled trial, the use of blinding is unclear and the authors did not report the number of centres involved
Number of women randomised: 120
Number of women analysed: 109 evaluated at 2 years for bleeding outcomes, 113 at 5 and 10 years for bleeding outcomes (reasons given)
A power calculation was performed; the authors did not report Intention-to-treat analysis but no dropouts reported for primary outcomes
Source of funding: Research Foundation of the County of West Zealand
Participants120 women aged >35 years (mean coagulation 42.6, mean resection 44.8) recruited from an unreported location
Inclusion criteria: bleeding abnormalities so severe that hysterectomy would have been performed if ablation not possible
Exclusion criteria: uterus more than twice normal size as evaluated by exploration; uterine cavity depth of >12 cm; pelvic pain a major problem; if in doubt about future pregnancy
Interventions(1) Transcervical hysteroscopic endometrial coagulation (n=61)
(2) Endometrial resection (n=59)
Duration: clinical exam 2 years post-questionnaire and 5-year follow up
OutcomesPrimary: rate of hysterectomy 5 and 10 years later; days with bleeding; would they recommend treatment
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskDocumenta Geigy random numbers; even numbers rollerball, odd numbers TCRE
Allocation concealment (selection bias)Low riskNumbered sealed envelopes opened just prior to surgery
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Low riskTrue intention-to-treat analysis. No dropouts for assessment of primary outcomes
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasLow riskGroups balanced at baseline

Brun 2006

Methods

Randomisation: computer generated telephone number sequence in a 1:1 allocation ratio

Parallel group randomised trial in 6 centres in France, blinding unlikely

Number of women randomised: 62

Number of women analysed: 45 at 12 months (1 in Cavaterm group and 8 in TCRE group were excluded prior to treatment mostly because of non-eligibility; 1 in each group decided to withdraw before treatment; of the remaining 51 treated women, 2 in TCRE group withdrawn because of menopause and pulmonary embolism and 2 in Cavaterm group because of loss to follow up)

Power calculation for sample size (26 participants in each arm for 80% power to detect 42% difference in amenorrhoea rate between groups). Analysis not by intention to treat and randomisation unbalanced after withdrawals

Source of funding: Wallsten (a medical equipment company in Switzerland) acknowledged for technical assistance - unknown whether funding provided

Participants

62 women with a median age of 45 years (Cavaterm) and 46 years (TCRE) recruited between Feb 2000 and Dec 2001 from departments of obstetrics and gynaecology in university hospitals in France (6 centres)

Inclusion: women with menorrhagia unresponsive to medical treatment requesting conservative surgical management; no longer wishing to become pregnant; Higham blood loss score >100; internal uterine cavity length 4-12cm; normal endometrial biopsy; normal cervical cytology; completed family; using a reliable method of contraception

Exclusion: endometrial malignancy; active pelvic infection; submucous fibroids; polyps; uterine malformation; history of endometrial ablation; hormone treatment (GnRHa or danazol) in previous 6 months

Interventions

(1) Cavaterm thermal balloon ablation

(2) Transcervical resection of the endometrium (TCRE)

Duration: 6 and 12-month follow up

Outcomes

Primary: amenorrhoea rates; PBAC scores

Secondary: satisfaction; safety (technical complication rate, duration of surgery; clinical complications (intra and post-operative); pain scores; hospital stay' resumption of normal or work activities; additional surgery

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated telephone number sequence in 1:1 allocation ratio
Allocation concealment (selection bias)Low riskCentralised system
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
High riskWithdrawals unbalanced between groups - created unbalanced randomisation
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported.
Other biasHigh riskMenstrual blood loss higher in the Cavaterm group at baseline. Medical equipment company acknowledged - not sure if they provided funding

Clark 2011

Methods

Randomisation: Computer generated stratified block randomisation with variable block size

Single centre, parallel group, single blinded (not clear if this is patients)

No of women randomised: 81

No of dropouts:

RFA group: n=17 at 12 months, no outcome data available

TBA group: n=13 at 12 months, no outcome data available

Power calculation for sample size, allowing for dropouts

Intention-to-treat analysis for feasibility, pain and acceptability. Not for amenorrhoea and menstrual data

Source of funding: First author received funding from Cytyc which manufactures the Novasure ablation system

Participants

81 women with heavy menstrual bleeding, mean age 42 and 44 years, recruited from gynaecology outpatients clinic, Birmingham Women's Hospital, Birmingham, UK

Inclusion criteria:

Women presenting to gynaecology outpatient clinic with HMB without organic pathology; no response to previous medical therapy; no desire to preserve their fertility; no contraindications to endometrial ablation (uterine cavity length >11cm, previous open myomectomy, end ablation or resection and classical CS)

Exclusion criteria:

<25 years; perimenopausal (FSH ≥40 IU/L); suspected of having genital tract infection; significant uterine pathology (from preop end biopsy and imaging either by transvaginal US or diagnostic hysteroscopy) – included submucuous fibroids and extracavity fibroids >3cm in diameter.

Duration of follow up: 3, 6 and 12 months

Interventions

All women had pre-operative endometrial biopsy and imaging of the uterine cavity either by transvaginal US or office diagnostic hysteroscopy prior to randomisation. Surgery performed in an office setting and local anaesthetics used

(1) Bipolar radiofrequency ablation (Novasure)

(2) Thermal balloon ablation (Thermachoice III)

Outcomes

Primary:

Amenorrhoea rate at 6 months

Secondary:

Satisfaction, QOL, technical feasibility (failed procedure, operative complications, duration of Rx), acceptability, improvement in dysmenorrhoea, improvement in premenstrual syndrome

NotesPrespecified subgroups: age (<40 years, ≥40 years) and uterine cavity length (8cm or less, >8 cm)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated stratified block randomisation with variable block size
Allocation concealment (selection bias)Low riskTelephone randomisation with variable block size
Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk

Women not told of allocation - no details on how blinding maintained and authors acknowledged that women could have guessed their allocation

Surgeons not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskAssessment by patient questionnaire, so unclear if blinding broken
Incomplete outcome data (attrition bias)
All outcomes
High riskFor primary outcome, significant dropout
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasLow riskNo significant differences at baseline, except for women in TEA group being slightly older and more likely to be sexually active

Cooper 1999

Methods

Randomisation:
Allocation obtained by phone after consent given. Sequence by computer generated random number tables in balanced blocks of 20

Sealed opaque envelopes opened by an independent person. 1:1 ratio
Single centre, parallel group design with no blinding
Number of women randomised = 263
Number of dropouts/lost to follow up = 23
Power calculation for sample size (230 women required to have a power of 80% to detect a minimum 15% difference in satisfaction, significant at 0.5 level)
Analysis by intention to treat but loss to follow up of 23 women not included
Support received from Microsulis (microwave equipment and salary support)

Participants263 women with mean age 41 years, recruited from gynaecology outpatient department of Aberdeen Royal Infirmary (referred for surgery) between Sept 1996 and February 1998
Inclusion criteria: premenopausal, completed their families, dysfunctional uterine bleeding (uterine size equivalent to 10 weeks pregnancy or less), informed consent
Exclusion criteria: histopathological abnormalities of the endometrium
InterventionsEndometrial thinning with goserelin 3.6 mg 5 weeks prior to surgery for all women
(1) TCRE with rollerball
(2) Microwave endometrial ablation after USS for measurement of endometrial thickness
(2) Microwave endometrial ablation
Duration: 12 months initially; extended to 5 years
OutcomesPrimary:
Participant satisfaction with and acceptability of treatment
Secondary: Menstrual status, quality of life, morbidity, duration of surgery, intraoperative complications, post-operative pain relief, post-operative stay, absence from work
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated random number tables in balanced blocks of 20
Allocation concealment (selection bias)Low riskSealed opaque envelopes opened by an independent person
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Low riskTotal dropouts 23/263 for menstrual and satisfaction outcomes - balanced between groups and unlikely to affect estimates
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskFunding by medical equipment company

Cooper 2002

MethodsRandomisation: list of random numbers for each site (separate for <40 and >40)
Multicentre (9), randomised multicentre double-arm study with no blinding
Number of women randomised: 265 (using ratio of 2:1 Novasure: Rollerball)
Number of women analysed: 259 received treatment, 235 left after others discontinued trial
No power calculation performed and the authors did not report Intention to treat analysis (except for safety results)
Source of funding: in part by unrestricted grant from Novacept Inc (Dr Cooper is a stockholder and Dr Laberge a consultant)
Participants265 women aged 25 - 50 recruited from centres in the USA
Inclusion criteria: menorrhagia verified by validated PBLAC = 150 for 3 consecutive months; history of failed medical therapy
Exclusion criteria: bacteraemia sepsis or other active systemic infection; active or recurrent chronic pelvis inflammatory disease; symptomatic endometriosis; history of uterine surgery that would have interrupted integrity of uterine wall; previous endometrial ablation; abnormal pap smear and/or endometrial biopsy; taking anticoagulants, hormone contraceptives or drugs that could thin myometrial muscle like long-term steroids; desire future childbearing/preservation of fertility; abnormal or obstructed uterine cavity
Interventions(1) Novasure Impedance - controlled endometrial oblation
(2) Hysteroscopic wire loop resection and rollerball ablation
Duration: follow up at 3, 6, and 12 months
OutcomesPictorial blood loss assessment chart; procedure time; sedation; intra-operative adverse events and post-operative adverse effects
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskList of random numbers
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAll participants contributed data for safety outcomes but for other outcomes there was a 13% lost to follow up with no details reported
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskGroups appeared balanced at baseline but funding by medical equipment company

Cooper 2004

MethodsRandomisation: computer generated random numbers in a 2:1 ratio
8 centres, parallel group design and blinding not reported (unlikely)
Number of women randomised: 322
Number of women analysed: 322 for primary outcomes
Power calculation for sample size and intention-to-treat analysis (evaluable patient analysis also performed)
Source of funding: all authors are associated with the company that produces the microwave device
Participants322 women with mean age 41 years recruited from 5 centres in the USA, 2 centres in Canada and 1 centre in the UK (academic medical centres and private medical practices)
Inclusion:
Non pregnant women >30 years; no desire for future pregnancy; failed, refused or not tolerated medical treatment; PBAC≥185 (previous 1 or 3 months); FSH≤30 iu/L; uterine cavity 6-14 cm
Exclusion:
Myometrial wall thickness <8 mm; active endometriosis; endometrial hyperplasia; endometrial cancer; active PID; previous endometrial ablation; previous caesarean section (classical scar); history of gynaecological malignancy in past 5 years; untreated or unevaluable cervical dysplasia; known clotting defects or bleeding disorders; IUD
Interventions

(1) Microwave ablation
(2) Rollerball

All women had prior investigations with ultrasound, endometrial biopsy and pap smear

All women had pre treatment with GnRHa for 1 month

Duration: 12 months

OutcomesPrimary:
PBAC<75
Secondary:
amenorrhoea; duration of surgery; anaesthesia; complications; adverse events; dysmenorrhoea; quality of life (SF-36); satisfaction; acceptability
NotesWomen were stratified into 2 groups: <40 years and ≥40 years
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated random numbers
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Low riskTrue intention-to-treat analysis for primary outcomes; dropouts regarded as failures
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskAuthors were either employees, consultants/speakers for or owned stock in a medical equipment company that produced one of the interventions

Corson 2000

MethodsRandomisation: Allocation computerised using sealed individual envelopes
Multicentre study (n=8), parallel group design with no blinding
Number of women randomised = 276
Number of dropouts/lost to follow up = 21/276 lost before surgery; 42/276 lost at 12 months follow up
No power calculation for sample size reported
Analysis was not by intention to treat.
Supported by Vesta Medical, Colorado
Participants276 women aged from 30 to 49 years recruited from 8 centres (7 in the USA, 1 in Australia)
Inclusion criteria: Score of 150 or more on the PBAC (pictorial blood loss assessment chart); no plan for more children; either using contraception or one of either partner sterilised; failed progestin therapy or refused medical therapy or shown intolerance to these agents
Exclusion criteria: FSH (follicle-stimulating hormone) levels >40mIU/ml (suggestive of impending menopause); distorted uterine cavities; myomas or polyps; cavity in excess of 9.75 cm; significant systemic medical diseases; pregnancy; pelvic inflammatory disease; carcinoma; clotting defects; previous unsuccessful endometrial ablation; myomectomy; uterine reconstruction; long acting hormone therapy within 3 months of enrolment; hyperplasia of the endometrium
InterventionsAll participants were initially treated with 2 weeks of oral contraceptive pills and their randomised treatment followed immediately after withdrawal bleeding
Rx 1: TCRE + rollerball
Rx 2: Vesta device (inflatable balloon with electrodes)
Duration: 12 months (follow up at 2 weeks, 3, 6 and 12 months)
OutcomesPBAC scores post Rx
Proportion with amenorrhoea
Proportion with successful Rx (defined as PBAC<76)
Adverse events
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputerised random number sequence
Allocation concealment (selection bias)Low riskSealed individual envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk42/276 (15%) participants lost at assessment of outcomes at 12 months follow up - no reasons given. For assessment of operative outcomes 21/276 participants lost
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskFunding by medical equipment company that produces one of the interventions and some of the authors received stocks in the company

Corson 2001

MethodsRandomisation: In blocks of 12 stratified by site with a 2:1 ratio, and stratified into 2 groups by age. Allocation concealment unclear
Multicentre study (n=9), parallel group design with no blinding
Number of women randomised: 276
Number of exclusions prior to treatment: 3 (HTA), 4 (balloon)
Number of dropouts/lost to follow up after treatment by 1 year: 17 (HTA) - 7 of these for equipment failure; 2 (balloon)
Power calculation for sample size (276 required, assuming success in rollerball arm 80% and rates not differing by more than 20%, a=0.05, b=0.10, dropout rate=12%
Analyses both intention to treat and per protocol
Support received from BEI Medical Systems
Participants276 women aged 30-50 years recruited from 9 private practice and university centres in the USA
Inclusion criteria: 30-50 years; family planning complete; documentation of excessive bleeding; uterine cavity measuring ≤10.5 cm; history of ineffective, not tolerated or refused medical therapy
Exclusion criteria: active or symptomatic pelvic inflammatory disease; intramural myomas >4 cm; submucous myomas or polyps
InterventionsAll participants had endometrial biopsy and cervical cytology to exclude pathology and endometrial preparation (single injection of depot leuprolide acetate 7.5 mg on day 21 of cycle) and a pregnancy test
(1) HTA (Hydro Thermablator)
(2) Rollerball ablation
Duration: 1 year
OutcomesReduction in menstrual diary blood loss scores; success of treatment (PBAC score <75); amenorrhoea rates; quality of life scores; adverse events; need for further surgery; operative complications; need for analgesia
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBlock randomisation stratified by site
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk26/276 (9%) lost at 12 months - unbalanced between groups and no reasons given. Authors claimed intention-to-treat analyses but not for all randomised participants. Dropouts regarded as failures
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskGroups appeared balanced at baseline but funding provided by medical equipment company that produced one of the interventions

Duleba 2003

MethodsRandomisation: sealed envelopes stratified for age at a ratio of 2:1
Multicentre (10), parallel prospective randomised design with the use of blinding unclear
Number of women randomised: 279
Number of women analysed: 228 were evaluated at 12 mos follow up
Power calculation performed and authors did not state intention-to-treat analysis
Source of funding: Cryogen Inc (Duleba, Soderstrom and Townsend all consultants)
Participants279 women aged 30-50 years (mean EC 41.2(5.1) and RBE 41.1(4.8)) recruited from university and private medical centres in the USA.
Inclusion criteria: menorrhagia due to benign causes, good general health, documented history of excessive uterine bleeding for at least 3 months, failed traditional therapy, did not desire future fertility, PBAC>150
Exclusion criteria: uterine volume greater than 300 ml, uterine cavity sounding more than 10 cm, clotting deficit or bleeding disorders, active pelvic inflammatory disease, abnormal cervical cytology within 1 year; history of gynaecologic malignancy within 5 years, intramural myomas>2 cm, submucous myomas or endometrial polyps; septate uterus; previous endometrial ablation or other surgery in which thinning of uterine wall may occur; malignant pathology or hyperplasia; pregnancy
Interventions(1) Endometrial cryoablation (n=193)
(2) Rollerball electroablation (n=86)
OutcomesMenstrual diaries 1 cycle before and 12 months after; PBAC, bleeding, pain, mood, PMS; QOL - Dartmouth COOP assessment questionnaire, anaesthesia, adverse outcomes, satisfaction; those randomised to cryoablation had significantly worse menorrhagia
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod not reported
Allocation concealment (selection bias)Unclear riskSealed envelopes but no other details of how allocation concealed
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk51/279 (18%) dropouts for outcomes measured at 12 months - no reasons given or details on distribution per group
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskParticipants receiving cryoablation had higher PBAC scores at baseline. Authors consultants for the medical equipment company that provided funding for cryoablation

Hawe 2003

MethodsRandomisation: random permutated blocks predetermined by computer generated random number tables (blocks of four sequentially numbered envelopes)
Single centre study, randomised controlled trial with double blinding
Number of women randomised: 72
Number of women analysed: 71 underwent surgery, 70 were evaluated at 6 mos and 67 were evaluated at 12 months
Power calculation performed and the authors didn't report intention-to-treat analysis
Source of funding: not reported but Wallsten Medical supplied the Cavaterm equipment
Participants72 women aged 29-51 years (mean cav 41.4, mean laser 41.1) recruited from a minimal access gynae surgery unit in a district general hospital
Inclusion criteria: normal endometrial biopsy, no intrauterine pathology; normal uterine cavity (uterine length <12 cm); high on blood loss score (>100); normal cervical cytology; completed family and using contraception
Exclusion criteria: endometrial hyperplasia and malignancy; active pelvic infection and intrauterine pathology
Interventions(1) Cavatern thermal balloon endometrial ablation (n=37)
(2) Nd :YAG laser (n=35)
Duration: pre-op 6 and 12 months for questionnaire; pictorial blood loss assessment 6 months
OutcomesPrimary: amenorrhoea rate then effect on menstrual status; questionnaire assessing menstrual symptoms, QOL, sexual activity; procedure satisfaction and acceptability- included questionnaire EQ-51, SF-12, SAQ; VAS; pain VAS; operative details and morbidity
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom permutated blocks predetermined by computer generated random number tables (blocks of four sequentially numbered envelopes)
Allocation concealment (selection bias)Low riskSequentially numbered envelopes
Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants, nursing staff and GP blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessor of outcomes blinded
Incomplete outcome data (attrition bias)
All outcomes
Low risk1 participant excluded after randomisation because she didn't meet the inclusion criteria; 4 other participants lost by 12 months - unlikely to affect assessment of outcomes
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskGroups appeared balanced at baseline except for cavity length but difference unlikely to be clinically significant. A medical equipment company provided one of the interventions

McClure 1992

MethodsRandomisation: method not stated and allocation concealment not reported
Single centre study, parallel group design with unclear blinding
Number of women randomised: 22
No dropouts reported
No power calculation for sample size
Analysis by intention to treat except for duration of surgery (malfunction of laser in 2 cases)
Source of funding not stated
Participants38 women initially recruited for trial, mean age 42 years, from tertiary referral centre at University Department, Monash University
12 excluded prior to randomisation because prior MBL measurements <70ml and 4 dropped out because of dissatisfaction with operative delay
Inclusion criteria: subjective diagnosis of menorrhagia unresponsive to medical therapy; normal cervical cytology; MBL>/=70ml (alkaline hematin method)
Exclusion criteria: fibroid enlargement; other intrauterine pathology
InterventionsAll participants had pelvic examination and transvaginal ultrasonography. Those randomised also had pre-operative treatment with 10 mg MPA 3 times/day for 3 months to thin the endometrium
(1) Laser (argon) ablation
(2) TCRE + rollerball
Duration: 6 months
OutcomesReduction in MBL; duration of surgery; post-operative complications and requirement for analgesia; need for further surgery; amenorrhoea rate
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod not stated
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo dropouts reported but very small study
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasLow riskNo evidence of other biases. Source of funding not reported and groups appeared balanced at baseline

Meyer 1998

MethodsRandomisation: random numbers table in a 1:1 allocation ratio
Multicentre (n=14), parallel group, blinding not reported
Number of women randomised = 275
Number of women treated =255. Withdrawals/exclusions prior to treatment, n = 20 (15 withdrew before treatment, 4 had exclusion criteria and 1 had a uterine perforation). 239/275 had data at 12 months follow up
Power calculation for sample size performed (108 participants required per group (assuming response rate of 85% for those treated with rollerball) to detect if balloon therapy more than 20% less effective at a 5% level of significance with 90% power)
Analysis not by intention to treat
Source of funding: Gynecare Ltd, USA
Participants275 women aged 29 to 50 years recruited from 12 investigative centres in USA and 2 in Canada
Inclusion criteria: 30 years or more and premenopausal; normal Pap smears; normal endometrial biopsies within last 6 months; history of 3 months of excessive uterine bleeding (PBAC score >/= 150); ineffective medical therapy; uterine cavity normal (by either hysterosalpingography, hysteroscopy or TSS) and with a range between 4 and 10 cm; no desire for future fertility; willing to continue current contraception
Exclusion criteria: submucous fibroids; suspected genital tract infection or malignancy; previous endometrial ablation
InterventionsRx 1: Rollerball ablation
Rx 2: Balloon ablation (Thermachoice)
Duration: 12 months follow up
OutcomesSatisfaction rate
Improvement in dysmenorrhoea symptoms
Proportion with PMS after treatment
Inability to work
PBAC score
Complication rate
Duration of surgery
Requirement for additional surgery
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom numbers table
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Low risk20/275 (7%) withdrew prior to surgery. 239/275 (87%) provided data at 12 months follow up. Authors compared characteristics of original randomised group with the group that provided 6 and 12 month data and found no differences Reasons not provided for loss to follow up
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskFunding provided by medical equipment company

Onoglu 2007

Methods

Randomisation: order in which seen in the clinic

Single-centre study, parallel group, with unclear blinding (except for histopathologist who assessed outcomes not extracted for this review)

Number of women randomised: n=48

Number of women analysed: n=45 (reasons not given for dropouts)

No power calculation for sample size and intention-to-treat analysis not reported

Source of funding: Akdeniz University

Participants

48 women with average age 48yrs and 47 yrs recruited from hospital clinic in Turkey

Inclusion criteria: women with heavy menstrual bleeding in the absence of physical abnormality

Exclusion criteria: intrauterine disease diagnosed at hysteroscopy (polyps, myomata, adenomyosis)

Interventions

Rx 1: Rollerball

Rx 2: TCRE

Duration: not reported

Outcomes

Duration of surgery

Menstrual blood loss

NotesQuasi-randomised trial
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskParticipants randomised in order at which seen in the clinic - this has the potential for significant bias
Allocation concealment (selection bias)High riskNot reported but very likely allocation known to investigators
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Low risk3 dropouts - unlikely to affect calculation of estimates
Selective reporting (reporting bias)High riskBleeding patterns prespecified but figures not reported
Other biasLow riskNo evidence of other significant bias - groups appeared balanced at baseline and funding not reported

Pellicano 2002

MethodsRandomisation: computer generated randomisation sequence
Single centre, parallel group, blinding not reported
Number of women randomised: 82
Number of women analysed: 82 for some outcomes such as satisfaction and additional surgery rates (75 at 1yr, 68 at 2 yrs)
Power calculation not reported.
Analysis was not intention to treat
Source of funding: surgical equipment provided by medical equipment company
Participants82 women with mean age 43 yrs recruited from University of Naples Obs and Gyn Department (Italy)
Inclusion criteria:
Aged <50 yrs; weighed <100 kg; not desiring pregnancy; history of ≥3 months failed medical Rx; evidence of normal endometrial histology/Pap smear within previous 12 months
Exclusion criteria:
Uterine size >12 weeks pregnancy; submucosal fibroids, adnexal masses or endometriosis; uterovaginal prolapse and severe urinary symptoms; severe intercurrent illness
Interventions(1) Cavaterm balloon ablation
(2) Transcervical endometrial resection (after pre Rx with 2 months of GnRHa)
Duration: 3 months, 1-year and 2-year follow-up
OutcomesPrimary: satisfaction rate at 3 months, 1 yr and 2 yrs
Secondary:
Duration of surgery; intra-operative blood loss; requirement for further surgery; post-operative pain; hospital stay; complications; resumption of normal activity
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAssessment of some outcomes such as requirement for further surgery and satisfaction included all randomised participants. 8.5% had dropped out for assessment of year 1 outcomes; 17% had dropped out for assessment of year 2 outcomes. No reasons given
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskGroups appeared balanced at baseline; funding by medical equipment company

Penninx 2010

Methods

Randomisation: computer generated in 1:1 ratio

Single centre, parallel group design, double blinding

No of women randomised: 160

No of women who dropped out: 7 in each group lost to follow up

Power calculation for sample size

Stated as intention-to-treat analysis but no imputation for dropouts

Source of funding: not stated

Participants

160 women with menorrhagia,heavy menstrual bleeding, mean age 45 years, recruited from Maxima Medical Centre, Veldhoven, the Netherlands between March 2005 and August 2007

Inclusion criteria:

Women with menorrhagia (defined by Higham – minimum score of 150 points); normal uterine cavity (length 6-12cm and histologically benign endometrium); normal pap smear; negative chlamydia test; premenopausal (FSH<40 IU/L); desire for ablation after looking at other options for Rx

Exclusion criteria:

Presence of coagulopathies; use of anticoagulants; desire to preserve fertility; prior uterine surgery (except low segment CS); suspected or confirmed uterine malignancy

Interventions

Saline infusion sonography or diagnostic hysteroscopy required to confirm normal uterine cavity (6-12cm)

Surgery in day 3-8 of the menstrual cycle, no endometrial pretreatment

(1) Bipolar radiofrequency endometrial ablation (Novasure)

(2) Hydrothermablation

Duration of follow up: 1 month, 6 months, 12 months, 5 years

Outcomes

Primary:

Amenorrhoea at 12 months after surgery

Secondary:

Reduction in bleeding, patient satisfaction, complications and re-intervention for hysterectomy

NotesWomen who chose to have a hysterectomy after ablation were considered amenorrhoeic. This may have inflated the rates of amenorrhoea in women who felt their ablation had not been successful
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"computer generated"
Allocation concealment (selection bias)Low riskDoctors were masked
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskParticipants unaware of their treatment but doctors performing the surgery not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessors blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskMinimal dropouts (7 lost in each group)
Selective reporting (reporting bias)Unclear riskComplications not reported
Other biasLow riskGroups comparable at baseline; no other potential bias

Perino 2004

MethodsRandomisation: computer generated list
Single centre, parallel group design, blinding not reported but unlikely
No randomised: 116
No analysed: 111
Power calculation for sample size
No intention to treat analysis performed
Source of funding not mentioned
Participants116 women with age range 36 to 48 years (mean, 41-42) recruited from university clinic in Italy
Inclusion criteria:
dysfunctional uterine bleeding not associated with organic pathology and not responding to medical treatment
Exclusion criteria: not reported
Interventions(1) ELITT (endometrial laser intrauterine thermal therapy)
(2) TCRE
All women had investigations prior to treatment: ultrasound, hysteroscopy with endometrial biopsy, blood tests for clotting defects, FSH/E2 serum sampling. All had pre-treatment with 1 dose of GnRHa
OutcomesPrimary:
Amenorrhoea and other menstrual status; satisfaction rates
Secondary:
Intraoperative complication rate, operation time, pain; further treatment with hysterectomy
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Low risk5/116 (4%) dropped out and no reasons given, but proportion was balanced between randomised groups
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasLow riskGroups appeared balanced at baseline but characteristics only reported for 96% of those randomised (minimal dropout). No source of funding reported. No evidence of significant other bias

Romer 1998

MethodsRandomisation: method not stated
Single-centre, parallel group, blinding not reported
Number of women randomised = 20
Number of dropouts/lost to follow up: none reported
No power calculation for sample size reported
Analysis by intention to treat (no dropouts)
Source of funding not reported
Participants20 women aged 35 to 52 recruited
Inclusion criteria: recurrent menorrhagia not responsive to medical therapy; no desire for future fertility
Exclusion criteria: intrauterine abnormality; fibroids; hyperplasia
InterventionsAll women were pretreated with 2 injections (4 weeks apart) of leuprorelin acetate depot. Treatment followed 2 weeks after the last injection
Rx 1: Rollerball ablation
Rx 2: Cavaterm balloon ablation
Duration: Follow up of 9-15 months
OutcomesSatisfaction rate
Amenorrhoea or hypomenorrhoea rate
NotesPaper in German language. Author contacted for clarification but no reply received.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo dropouts reported but very small study
Selective reporting (reporting bias)Unclear riskComplications of procedures not reported
Other biasLow riskGroups appear balanced at baseline. No source of funding reported. No evidence of other significant bias

Sambrook 2009b

Methods

Randomisation: computer generated blocks

Single centre, parallel group design, blinding of assessors but not patients or investigators

No of women randomised: 320

No of women analysed: operative outcomes n=314 (4 withdrew consent, 2 unsuitable for Rx – post randomisation exclusions), 2 week questionnaire: n=288, 12 months questionnaire: n=285, 12 months PBLAC: n=178

Power calculation for sample size

Stated as intention-to-treat analysis but no imputation made for dropouts

Source of funding by Chief Scientists Office, Scottish Government Health Directorates

Participants

320 women requesting endometrial ablation with mean age 43 years. Recruited from the Gynaecology Department of Aberdeen Royal Infirmary in the UK from January 2003 to January 2005

Inclusion criteria:

Women complaining of heavy menstrual loss and requesting endometrial ablation; premenopausal; completed their families; uterine size equivalent to a 12 week pregnancy or less; no histopathological abnormalities; no fibroids obstructing the uterine cavity; lower segment caesarean section if scar thickness >10mm on transvaginal US

Exclusion criteria not reported

Interventions

Patients did not routinely undergo hysteroscopy. Treatment undertaken in the postmenstrual phase, either under general or local anaesthetic, according to patient preference

(1) microwave endometrial ablation

(2) thermal balloon endometrial ablation

Follow up at 2 weeks, 6 months and 1 year following surgery

Outcomes

Primary:

Satisfaction (6 point scale) and menstrual scores at 1 year (PBAC)

Secondary:

Operative differences, acceptability of treatment and health-related quality of life

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Computer generated random blocks"
Allocation concealment (selection bias)Low risk"Telephone randomisation service based on a separate site"
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskBlinding for patients but not investigators
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBlinding for assessors
Incomplete outcome data (attrition bias)
All outcomes
Low riskReasons for dropouts given – similar for 2 groups and not likely to cause major bias
Selective reporting (reporting bias)Low riskAll likely outcomes reported
Other biasLow riskGroups similar at baseline. No evidence of any other potential bias

Soysal 2001

MethodsRandomisation: computer generated, numbered opaque sealed envelopes
Single centre, prospective randomised design, unclear if blinding used
Number of women randomised: 96
Number of women analysed: 93 had treatments, 3 lost to follow up (no reason given)
No power calculation was mentioned and authors did not report intention-to-treat analysis
Source of funding: not reported
Participants96 women aged 40-49 years (mean TBA 43.6, mean RBA 44.3) recruited from the Teaching Dept of University Medical Centre
Inclusion criteria: myoma-induced menorrhagia; completion of childbearing; =40 years; menorrhagia documented by PBAC>150; myomatous uterus ding by high resolution ultrasound, a volume of =12-week; pregnancy at clinical evaluation and/or =380 ml at ultrasonography or a myoma <5 cm diameter
Exclusion criteria: active pelvic inflammatory disease; submucous myoma = 3 cm diameter or with <50% intramural extension
Interventions(1) Rollerball ablation (n=48)
(2) Thermal balloon ablation (n=45, 3 lost post-randomisation)
Duration: PBAC pre-op 3, 6, 12 months, haemoglobin pre-op and 12 months
OutcomesOperating time; intraoperative complications; post-op pain; eumenorrhea and PBAC = 75 / satisfaction / hysterectomy
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated
Allocation concealment (selection bias)Low riskNumbered opaque sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Low risk3/96 (3%) lost prior to surgery but no further loss to follow up - unlikely to affect the assessment of estimates
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskNo source of funding identified. Groups appeared balanced at baseline but denominators for some outcomes in the publication did not correspond to the numbers of participants allocated to treatment

Thabet 2010

Methods

Randomisation: described as "true random bases"

Single centre, unclear if blinding used

No of women randomised: 100

No of women analysed: 100 (authors replaced dropouts by other cases)

No power calculation reported and intention to treat analysis not reported

Source of funding: not reported

Participants

100 women with premenopausal uterine bleeding - no other inclusion criteria or descriptive characteristics reported. Recruited from oupatient clinic at Kasr El-Aini School of Medicine, Cairo University, Egypt

Exclusion criteria: patients suspected or confirmed having malignancy, endometriosis or coagulation defects

Interventions

(1) Dilatation and ablative curettage using the Thabet curette

(2) Overcurettage - using a Sim's curette but continuing beyond the gritty sensation felt with routine D and C until the disappearance of the sensation

Duration of follow up: Not clear, although the authors report a follow-up time of 3 years

Outcomes

Intra-operative complications

Amenorrhoea

Normal menstruation

Sexual function

NotesFollow up in the trial unclear. Potential bias from the replacing of dropouts with new cases
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"true random bases"
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
High riskReplacement of dropouts with new cases likely to cause bias in the results
Selective reporting (reporting bias)Low riskNo evidence of selective reporting
Other biasUnclear riskBaseline comparability not reported

van Zon-Rabelink 2003

MethodsRandomisation: allocated to treatment at random by blind envelope
Single centre, randomized controlled trial, use of blinding is unclear
Number of women randomized: 139
Number of women analysed: 139 (none lost to follow up)
Power calculation was performed and authors did not state intention-to-treat analysis
Source of funding: not reported
Participants139 women with unreported ages recruited from a teaching hospital, in the Netherlands
Inclusion criteria: menorrhagia without sufficient relief from medical therapy by GP; menstrual blood loss score = 185 pt in 2 periods due to dysfunctional uterine bleeding according to ultrasound and diagnostic hysteroscopy
Exclusion criteria: not reported
Interventions(1) RBE hysteroscopic rollerball electrocoagulation (n=62)
(2) UBT non-hysteroscopic uterine balloon thermal ablation ThermachoiceTM (n=77)
OutcomesTechnical safety aspects; reduction in menstrual bleeding; success rate (PBAC<185); satisfaction
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod not reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnlikely
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo dropouts reported
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported
Other biasUnclear riskGroups appeared balanced at baseline but only for age and cavity length; other characteristics not reported. No source of funding identified. Numbers in the randomised groups differed substantially

Vercellini 1999

MethodsR: Computer generated randomisation sequence using serially numbered opaque sealed envelopes kept by an independent source
Single-centre, parallel group, no blinding
Number of women randomised = 91
Number of dropouts/lost to follow up = 1
Power calculation for sample size performed (40 women per treatment arm required to find a difference of 200 mL in fluid absorption with 80% power and 5% significance level)
Intention-to-treat analysis for satisfaction rate and menstrual pattern
Source of funding = Circum Acmi (supply of vaporising electrodes)
Participants91 women with mean age 46 years recruited from outpatient clinic in Milan, Italy
Inclusion criteria: >35 years; referred for hysterectomy; uterine volume < 12 week pregnancy; normal uterine cavity at hysteroscopy; no evidence of atypical hyperplasia; no adnexal tumours on clinical and ultrasonographic examination
Exclusion criteria: women uncertain about future children; recent use of hormonal agents or drugs that might affect menstrual blood loss; intramural or subserous fibroids of >/= 3 cm; "unstable" general conditions
InterventionsAll participants had complete clinical examination, transvaginal ultrasonography, diagnostic hysteroscopy and endometrial biopsy prior to treatment. They also had preoperative treatment with depot GnRH agonist triptorelin for 2 months
Rx 1: vaporising electrode
Rx 2: TCRE
Duration: 12 months
OutcomesAmount of absorption of distension fluid
Duration of surgery
Difficulty of surgery
Satisfaction rate
Proportion with amenorrhoea
Proportion with amenorrhoea and hypomenorrhoea
PBAC score
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated
Allocation concealment (selection bias)Low riskSerially numbered opaque sealed envelopes kept secure in another location
Blinding of participants and personnel (performance bias)
All outcomes
High riskOpen study
Blinding of outcome assessment (detection bias)
All outcomes
High riskOpen study
Incomplete outcome data (attrition bias)
All outcomes
Low riskImmediate postoperative outcomes included all randomised participants; for outcomes assessed at 1 year, one woman was lost to follow up and did not contribute data to the PBAC
Selective reporting (reporting bias)Low riskAll prespecifed outcomes reported
Other biasUnclear riskGroups were balanced at baseline but a medical equipment company provided funding

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Abd Ek Hameed 2012RCT of endometrial thermal balloon ablation with or without a co-intervention (pre-ablation curettage)
Cash 2012RCT of third generation thermal uterine balloon therapy with or without a co-intervention (post-ablation curettage). Includes non-randomised comparison with first-generation balloon ablation
Chang 2009A comparison of different wave forms for rollerball ablation, not different ablation methods
El-Nashar 2009Cohort study - not randomised
Feng 2006Not a randomsied study
Shokeir 2013RCT of hysteroscopic endometrial resection with or without a co-intervention (long-acting gestagen)
Vihko 2003Was excluded as it compared two types of balloon ablation, Menotreat and Cavaterm

Characteristics of studies awaiting assessment [ordered by study ID]

Bongers 2011

MethodsLong-term follow up of RCT already included in the review (Bongers 2004)
ParticipantsFollow-up rate for participants was 85.9% of those in the bipolar group and 79.5% of those in the balloon group from original trial. Contacted by letter and questionnaire
Interventions1) Novasure bipolar ablation, 2) Thermachoice I balloon ablation
OutcomesAmenorrhoea rate, re-intervention rate, satisfaction rate
NotesAttempting to contact authors for data

Hamza 2005

MethodsNot clear whether randomised
ParticipantsParticipants had dysfunctional uterine bleeding
Interventions1) rollerball ablation, 2) TCRE
OutcomesComplications, menstrual blood loss
NotesAttempt being made to contact authors

Pados 2011

MethodsRandomised, parallel group open label trial
ParticipantsWomen with dysfunctional uterine bleeding
InterventionsNovasure (bipolar impedance control system) versus microwave endometrial ablation
OutcomesPrimary: amenorrhoea rates one year after intervention
NotesTrial completed; results not published. Attempt being made to contact authors

Penninx 2012

MethodsMulticentre double blind randomised controlled trial
ParticipantsWomen with menorrhagia
InterventionsBipolar impedance controlled endometrial ablation (NovaSure) versus balloon ablation (Thermablate)
OutcomesPrimary: amenorrhoea
NotesResults published in abstract form. Attempt being made to contact authors

Yu 2009

MethodsRandomised, parallel group, single blind (subject)
ParticipantsWomen with dysfunctional uterine bleeding
InterventionsCavaterm TM thermal balloon endometrial ablation versus transcervical resection of the endometrium (TCRE)
OutcomesPrimary: reduction of uterine bleeding
NotesUnclear whether trial completed; results not published. Attempt being made to contact authors

Characteristics of ongoing studies [ordered by study ID]

Cooper 2012

Trial name or titleBlind versus visual endometrial ablation: A randomised controlled trial
MethodsDouble blind randomised active controlled parallel group trial
ParticipantsWomen eligible for endometrial ablation and be willing to be randomised to either treatment
InterventionsEither blind or visual endometrial ablation performed under local or general anaesthesia in the immediate postmenstrual phase
OutcomesPrimary: Patient satisfaction with each technique. Measured using a six point Likert scale, post-operatively and at 6 and 12 months
Starting dateJan 2012
Contact informationJan 2017
Notes