Treatment of recurrent stress urinary incontinence after failed minimally invasive synthetic suburethral tape surgery in women

  • Review
  • Intervention

Authors

  • Evangelia Bakali,

    1. Leicester General Hospital, Obstetrics and Gynaecology, Leicester, UK
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  • Brian S Buckley,

    1. National University of Ireland, Department of General Practice, Galway, Ireland
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  • Paul Hilton,

    1. Newcastle upon Tyne Hospitals NHS Foundation Trust, Directorate of Women's Services, Newcastle upon Tyne, UK
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  • Douglas G Tincello

    Corresponding author
    1. University of Leicester, Reproductive Sciences Sections, Cancer Studies & Molecular Medicine, Leicester, Leicestershire, UK
    • Douglas G Tincello, Reproductive Sciences Sections, Cancer Studies & Molecular Medicine, University of Leicester, RKB, Leicester Royal Infirmary, Leicester, Leicestershire, LE2 7LX, UK. dgt4@le.ac.uk.

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Abstract

Background

Surgery is a common treatment modality for stress urinary incontinence (SUI), usually offered for women who fail conservative treatments. Suburethral tapes have superseded colposuspension because cure rates are comparable and recovery time reduced. However, some women will not be cured after suburethral tape surgery, and currently there is no consensus on how to manage these women.

Objectives

To obtain and examine evidence supporting different management strategies for recurrent/persistent stress urinary incontinence (SUI) in women after failed suburethral tape surgery.

Search methods

We searched the Cochrane Incontinence Group Specialised Register of controlled trials (searched 18 December 2012), which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and PreMEDLINE; and handsearched journals and conference proceedings, and the reference lists of included studies and previous Cochrane reviews for randomised or quasi-randomised studies treating patients with recurrent incontinence, either as the sole population or a subset. Conservative, medical and surgical treatments were included.

Selection criteria

We included randomised and quasi-randomised controlled trials in women who had recurrent urinary incontinence after previous minimally invasive suburethral tape surgery.

Data collection and analysis

Abstracts of identified studies were checked by two authors to confirm eligibility. Full text reports of relevant studies were obtained, and authors were contacted directly where necessary. Outcome data were extracted onto a standard proforma and processed according to the methods in the Cochrane Handbook for Systematic Reviews of Interventions.

Main results

Twelve studies were identified, but all were excluded because they did not meet the eligibility criteria. Six were randomised controlled trials (RCTs) but were not eligible because the previous incontinence surgery was not a suburethral tape. A subset of one RCT may have been eligible for inclusion because some of the women were having repeat surgery, but we were unable to obtain from the authors the data according to primary surgery for this cohort.

Authors' conclusions

There were no data to recommend or refute any of the different management strategies for recurrent or persistent stress incontinence after failed suburethral tape surgery. Evidence is urgently required to address this deficiency, ideally from RCTs.

Résumé scientifique

Traitement de l'incontinence urinaire à l'effort récurrente après l'échec d'une chirurgie mini-invasive avec mise en place d'une bandelette sous-urétrale synthétique chez les femmes

Contexte

La chirurgie est une modalité de traitement courante pour l'incontinence urinaire à l'effort (IUA), proposée en général aux femmes ayant eu un échec avec les traitements conservateurs. Les bandelettes sous-urétrales ont supplanté la colposuspension parce que les taux de guérison sont comparables et le temps de récupération est réduit. Toutefois, certaines femmes ne sont pas guéries après une intervention chirurgicale pour la mise en place d'une bandelette sous-urétrale, et, actuellement, il n'existe pas de consensus sur la manière de prendre en charge ces femmes.

Objectifs

Obtenir et examiner les preuves soutenant différentes stratégies de prise en charge de l'incontinence urinaire à l'effort (IUA) récurrente/persistante chez les femmes après l'échec d'une intervention chirurgicale pour la mise en place d'une bandelette sous-urétrale.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre d'essais spécialisés du groupe Cochrane sur l'incontinence (recherche datant du 18.12.2012), qui contient les essais identifiés dans le registre Cochrane des essais contrôlés (CENTRAL), MEDLINE et PreMEDLINE ; et nous avons effectué des recherches manuelles de revues et d'actes de conférences, et dans les listes bibliographiques des études incluses et des précédentes revues Cochrane pour trouver des études randomisées ou quasi-randomisées portant sur le traitement de patients présentant une incontinence récurrente, soit en tant que population unique soit en tant que sous-ensemble. Les traitements conservateurs, médicaux et chirurgicaux ont été inclus.

Critères de sélection

Nous avons inclus les essais contrôlés randomisés et quasi-randomisés menés chez des femmes ayant eu une incontinence urinaire récurrente après une précédente chirurgie mini-invasive avec mise en place d'une bandelette sous-urétrale.

Recueil et analyse des données

Les résumés des études identifiées ont été vérifiés par deux auteurs afin de confirmer leur éligibilité. Le compte-rendu avec le texte complet des études pertinentes a été obtenu, et les auteurs ont été contactés directement lorsque cela s'est avéré nécessaire. Les données relatives aux critères de jugement ont été extraites selon un schéma standard prédéfini et traitées conformément aux méthodes indiquées dans le Manuel Cochrane pour les revues systématiques d'interventions (Cochrane Handbook for Systematic Reviews of Interventions).

Résultats principaux

Douze études ont été identifiées, mais ont toutes été exclues parce qu'elles ne répondaient pas aux critères d'éligibilité. Six étaient des essais contrôlés randomisés (ECR), mais n'étaient pas éligibles parce que la précédente chirurgie pour l'incontinence ne comportait pas la mise en place d'une bandelette sous-urétrale. Un sous-ensemble d'un ECR pouvait être éligible à l'inclusion parce que certaines femmes avaient eu des interventions chirurgicales répétées, mais nous n'avons pas pu obtenir de la part des auteurs les données relatives à la chirurgie primaire pour cette cohorte.

Conclusions des auteurs

Aucune donnée n'était disponible pour recommander ou réfuter une ou plusieurs des différentes stratégies de prise en charge de l'incontinence urinaire à l'effort récurrente ou persistante après l'échec d'une intervention chirurgicale pour la mise en place d'une bandelette sous-urétrale. Il est urgent de rassembler des données afin de combler ce vide, idéalement par des ECR.

Resumo

Tratamento da incontinência urinária de esforço recorrente após cirurgia minimamente invasiva de fita suburetral sintética em mulheres

Introdução

Cirurgia é a modalidade de tratamento comum para incontinência urinária de esforço (IUE), geralmente oferecida para mulheres nas quais os tratamentos conservadores falharam. Fitas suburetral têm substituído a colposuspenão porque as taxas de cura são comparáveis e o tempo de recuperação reduzido. No entanto, algumas mulheres não serão curadas após cirurgia de fita suburetral, e atualmente não há consenso sobre como gerenciar essas mulheres

Objetivos

Obter e examinar as evidências que sustentem diferentes estratégias de tratamento para a recorrente/persistente incontinência urinária de esforço (IUE) em mulheres após falha da cirurgia de fita suburetral.

Métodos de busca

Buscamos no Cochrane Incontinence Group Specialised Register of controlled trials (buscado em 18 de Dezembro de 2012), a qual contém ensaios clínicos identificados da Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE e PreMEDLINE; realizamos busca manual em revistas e conferências proferidas, e a lista de referências dos estudos incluídos e revisões anteriores da Cochrane para estudos randomizados e parcialmente randomizados tratando pacientes com incontinência recorrente como população ou subgrupo. Tratamentos conservador, medicamentoso e cirúrgico foram incluídos.

Critério de seleção

Foram incluidos ensaios clínicos randomizados e parcialmente randomizados com mulheres que tinham incontinência urinaria recorrente após cirurgia minimamente invasiva com fita suburetral.

Coleta dos dados e análises

Resumos dos estudos identificados foram avaliados por dois autores para confirmar a elegibilidade. Textos completos de estudos relevantes foram obtidos e os autores foram contactados diretamente, sempre que necessário. . Dados de resultados foram extraídos dentro de um padrão proforma e processados de acordo com os métodos do Cochrane Handbook for Systematic Reviews of Interventions.

Principais resultados

Doze estudos foram identificados, mas todos foram excluídos porque não reuniam os critérios de elegibilidade Seis eram ensaios clínicos controlados randomizados (ECR), mas não eram elegíveis, porque a cirurgia de incontinência anterior não foi uma fita suburetral Um subconjunto de um ECR pode ter sido elegível para inclusão porque algumas mulheres foram submetidas a uma cirurgia de repetição, mas fomos incapazes de obter dos autores os dados da cirurgia primária para esta coorte

Conclusão dos autores

Não houve dados para recomendar ou refutar qualquer uma das diferentes estratégias de manejo para a incontinência recorrente ou persistente após a falha da cirurgia de fita suburetral. Evidências são urgentemente necessárias para resolver essa deficiência, idealmente de ECR.

Notas de tradução

Notas de tradução CD009407.pub2

Plain language summary

Treatment of recurrent stress urinary incontinence in women after a failed suburethral tape operation

Stress urinary incontinence (SUI) is loss of urine when a person coughs or exercises. Damage to the pelvic floor muscles and injuries to the nerves during childbirth may lead to SUI. Simple treatments, such as exercising the muscles in the pelvic floor or drugs (medication), may be tried at first. If these methods have not worked, surgery is often performed. This usually involves placing a tape made from polypropylene (a synthetic material, like nylon, that is used in some surgical stitches and other medical devices) underneath the neck of the bladder. This operation is very successful but not all women will be cured after a first tape surgery, and there is currently no agreement among experts on how to treat women with persistent or recurrent problems. This review set out to find evidence for different treatments, but it did not identify any studies which provided answers. High quality randomised clinical trials are urgently needed to answer this question.

Résumé simplifié

Traitement de l'incontinence urinaire à l'effort récurrente après l'échec d'une intervention chirurgicale pour la mise en place d'une bandelette sous-urétrale chez les femmes

L'incontinence urinaire à l'effort (IUA) est la perte d'urine lorsqu'une personne tousse ou fait un effort physique. Les traumatismes des muscles du plancher pelvien et les lésions des nerfs au cours de l'accouchement peuvent conduire à une IUA. Les traitements simples, tels que la pratique d'exercices des muscles du plancher pelvien ou les médicaments (traitement), peuvent d'abord être tentés. Si ces méthodes ne donnent aucun résultat, la chirurgie est souvent pratiquée. La procédure implique en général la mise en place d'une bandelette fabriquée en polypropylène (une matière synthétique, comme le nylon, qui est utilisée dans certaines sutures chirurgicales et d'autres dispositifs médicaux) sous le col de la vessie. Cette opération est très efficace mais les femmes ne sont pas toutes guéries après une première intervention chirurgicale pour la mise en place d'une bandelette, et il n'existe, à l'heure actuelle, aucun accord parmi les experts sur la manière de traiter les femmes souffrant de problèmes persistants ou récurrents. Cette revue avait pour objet de trouver les preuves en faveur des différents traitements, mais elle n'a pas identifié d'étude qui apportait des réponses. Il est donc urgent de réaliser des essais cliniques randomisés de haute qualité afin de répondre à cette question.

Notes de traduction

Traduit par: French Cochrane Centre 1st March, 2013
Traduction financée par: Pour la France : Ministère de la Santé. Pour le Canada : Instituts de recherche en santé du Canada, ministère de la Santé du Québec, Fonds de recherche de Québec-Santé et Institut national d'excellence en santé et en services sociaux.

Resumo para leigos

Tratamento da incontinência urinária de esforço recorrente em mulheres após falha de uma operação de fita suburetral.

Incontinência urinária de esforço (IUE) é a perda de urina quando a pessoa tosse ou se exercita. Danos aos músculos do assoalho pélvico e lesões dos nervos durante o parto podem levar a IUE. Tratamentos simples, como exercitar os músculos do assoalho pélvico, ou medicamentos, podem ser tentados primariamente. Se esses métodos não funcionarem, a cirurgia é freqüentemente realizada. Isso normalmente envolve a colocação de uma fita de polipropileno (um material sintético, como o nylon, que é usado em alguns pontos cirúrgicos e outros dispositivos médicos) sob o colo da bexiga. Esta operação é muito bem sucedida, mas nem todas as mulheres serão curadas após uma primeira cirurgia de fita, e atualmente, não existe acordo entre os especialistas sobre como tratar as mulheres com problemas persistentes ou recorrentes. Esta revisão procurou evidências para diferentes tratamentos, mas não identificou quaisquer estudos que fornecesse respostas. Ensaios clínicos randomizados de alta qualidade são urgentemente necessários para responder estas questões.

Notas de tradução

Notas de tradução CD009407.pub2

Background

Description of the condition

Stress urinary incontinence (SUI) is defined as a complaint of involuntary loss of urine on effort or physical exertion (for example sporting activities), or on sneezing or coughing (Haylen 2010). It can be a debilitating condition for women, severely affecting their quality of life (Margalith 2004). Surgery is a common treatment modality that is usually offered for women who fail conservative treatments.

Description of the intervention

Currently the most common surgical option for SUI is the tension free vaginal tape (TVT) (Hilton 2008). This has superseded colposuspension as the 'gold standard' treatment in recent years due to comparable cure rates and more rapid return to normal activity. Cure rates for incontinence after TVT are comparable to colposuspension (Ward 2008). More recently, alternative suburethral tapes have been developed, including the trans-obturator tapes (inserted via the 'inside out' or 'outside in' routes) and various single incision tapes. Cure rates for these other tapes appear comparable although robust comparative studies for the newer devices are lacking (Novara 2010).

However, some patients will not be cured after suburethral tape surgery, and currently there is no consensus on how to manage these patients. This constitutes a major problem not only for the patient but also for the clinician who is faced with choosing a second surgical procedure with the best possible long term success rate. Furthermore, there is no consensus about whether the previously inserted tape should be excised or if a second tape should simply be placed over the existing tape. The decision whether to use a tape inserted via a different route (retropubic versus trans-obturator versus single incision) also has not been addressed.                                                                      

Recurrent SUI after a TVT procedure is reported to be from 2% to 16% (Merlin 2001). Comparably, recurrence after two years following the Burch colposuspension has been reported as about 10% (Alcalay 1995; Auwad 2006; Monga 1994; Ward 2008). Despite the recurrence of urinary incontinence, sling procedures seem to be the treatment of choice for managing recurrent SUI (McGuire 1992). A preliminary study using a pubofascial anchor sling procedure for recurrent SUI conducted by Kane et al (Kane 1999) found that all 13 patients claimed subjective cure of urinary continence and 12 of the 13 were objectively cured. Similar results were also published by Barrington 1998 using a modified rectus fascial sling. Breen 1997, in a study of 60 participants, reported the use of a suburethral fascia lata sling as an effective method of treatment of recurrent SUI with a 90% cure rate. A small randomised controlled study by Enzelsberger 1996 comparing the Lyodura sling and Burch colposuspension at 32 to 48 months follow up for repair of unsuccessful incontinence surgery found a cure rate of 86% for the Burch and 92% for the sling. They suggested that sling surgery should be used only in certain cases due to the higher rate of complications, and a posterior vaginal repair should be performed after the modified Burch colposuspension.

How the intervention might work

Further surgery following failed continence surgery of any tape has a short term subjective cure rate of 80% and an objective cure rate of about 75% (Cardozo 1999; Maher 1999). Various factors have been associated with failure of surgery for SUI, such as a pre-operative weight of greater than 80 kg (Alcalay 1995), low pre-operative urethral pressure, pre-operative detrusor overactivity or its development post-operatively (Stanton 1978) and intra-operative blood loss of over one litre (Alcalay 1995). Success rates vary depending on the different sling types but Jarvis 1994 suggested that long term success may be higher with the repeat Burch colposuspension. A prospective cross-sectional observational study by Thakar (Thakar 2002), evaluating secondary colposuspension for recurrent SUI, reported a 71% subjective and 80% objective cure rate with a median follow up of four years. Twenty-six patients had a colposuspension as a primary procedure and one had a sling procedure.

In 2008 the James Lind Alliance, a partnership of patient and clinician groups, identified and prioritised through consensus 10 unanswered research questions thought to be of pressing clinical importance relating to the treatment of urinary incontinence (Buckley 2010). One of these treatment uncertainties was the treatment of stress urinary incontinence after failed suburethral tape surgery. The purpose of this review was to identify the existing evidence addressing this uncertainty, and identify research evidence supporting best practice for the management of recurrent urinary stress incontinence following failed suburethral tape surgery.

Why it is important to do this review

This review addresses a separate question to other existing reviews, although the question may be related to the existing reviews of minimally invasive slings (Ogah 2009) and single incision slings (Jeffery 2010), from which data may be extracted and analysed; data may also be extracted and analysed from other existing reviews including, for example, open retropubic colposuspension (Lapitan 2012), pelvic floor muscle training (Dumoulin 2010), periurethral injection (Kirchin 2012) and traditional sling operations (Rehman 2011).

Objectives

To obtain and examine evidence supporting different management strategies for recurrent and persistent stress urinary incontinence (SUI) in women after failed suburethral tape surgery.

Methods

Criteria for considering studies for this review

Types of studies

Randomised or quasi-randomised controlled studies comparing conservative treatment and medical or further surgical treatments, or comparing two different surgical treatments, after failed suburethral tape surgery were included.

Types of participants

Women of any age with persistent or recurrent SUI after any suburethral tape surgery (failed surgery). Diagnosis of SUI should normally have been confirmed by urodynamics. Women with de novo detrusor overactivity or overactive bladder (OAB) were not excluded from this review but were to be subjected to subgroup analysis if large enough numbers of patients had been identified from included studies. Recurrent incontinence after any of the suburethral tapes was included. Subgroup analyses of the outcome after specific routes of insertion would have been considered if sufficient data had been identified from the literature review (for example recurrence after retropubic versus transobturator, retropubic after single incision).

Types of interventions

The interventions that were compared were further surgery (including injectables), administration of medication or conservative treatment (for example pelvic floor muscle training) in patients who had failed suburethral tape surgery. Any form of previous suburethral tape was included (retropubic, transobturator (either direction), and minimally invasive). Comparisons were planned to include the following.

  • Conservative treatment (e.g. pelvic floor muscle training or bladder retraining) versus surgical treatment (any route).

  • Conservative treatment versus medical treatment (e.g. duloxetine or anticholinergic medication, or both).

  • Medical treatment versus surgical treatment (any route).

  • Repeat suburethral sling (any type) versus any other (non-tape) surgical treatment (e.g. traditional sling, colposuspension, injectables, other).

  • One type of repeat suburethral sling versus another type of repeat suburethral sling.

  • Repeat suburethral sling versus single incision sling.

  • Surgery with excision of (failed) tape versus surgery without excision of tape.

Where sufficient data were obtained, comparisons between pelvic floor muscle training or bladder retraining (for conservative treatment) and duloxetine or anticholinergics (for medical treatments) were undertaken.

Types of outcome measures

Primary outcomes

The primary outcome measure was the proportion of women who had subjective (woman reported) urinary continence after intervention assessed by subjective report, urinary diary or validated incontinence questionnaires in the short term (less than 12 months) and longer term (more than 12 months).

Secondary outcomes

These included the following.

1. Woman’s observations

     Women with stress incontinence not improved in the short term (less than 12 months) and longer term (more than 12 months).

2. Quantification of symptoms
  • Incontinence episodes (from self-completed bladder chart)

  • Pad changes (from self-reported number of pads used)

  • Pad tests of quantified leakage (mean volume or weight of urine loss)

3. Clinician’s observations

Objective cure rates in the short term (less than 12 months) and longer term (more than 12 months) (observed leakage during repeat urodynamics).

4. Quality of life
  • General health status measures (e.g. Short-Form 36) (Ware 1993)

  • Condition-specific instruments designed to assess incontinence (e.g. Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS) (Jackson 1996)

5. Surgical outcome measures

Surgical outcomes collected included the following.

  •      Duration of operation.

  •      Length of hospital stay.

  •      Operative blood loss.

  •      Major vascular and visceral injury.

  •      Bladder, urethral and bowel perforation.

  •      Nerve damage.

  •      Peri-operative surgical complications (e.g. infection, bacteriuria, haemorrhage).

6. Adverse events

Data on the following adverse events were collected, where recorded.

  •      De novo (new) urgency symptoms or urgency incontinence.

  •      De novo (new) detrusor overactivity (urodynamic diagnosis).

  •      Voiding dysfunction or difficulty passing urine after three months (with or without urodynamic confirmation).

  •      Pelvic organ prolapse (e.g. cystocele, rectocele, enterocele).

  •      Infection related to the use of synthetic mesh.

  •      Erosion to vagina.

  •      Erosion to bladder or urethra.

7. Economic measures

We sought to collect any health economic data where presented.

  •      Costs of interventions.

  •      Cost effectiveness of repeat treatment.

  •      Resource implications.

Search methods for identification of studies

We did not impose any restrictions, for example language or publication status, on the searches detailed below.

Electronic searches

Search strategies were designed in accordance with the Cochrane Incontinence Review Group methods and guidance. Relevant trials were identified by searching the Cochrane Incontinence Review Group Specialised Register of controlled trials, which is described in the Incontinence Group's module in The Cochrane Library. The register contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, and handsearching of journals and conference proceedings. The terms that were used to search the Specialised Register are given in Appendix 1. The date of the last search was 18 December 2012.

Searching other resources

Reference lists from other completed reviews and the identified papers were also checked.

Studies treating patients with recurrent stress urinary incontinence were included; both those studies solely recruiting recurrent cases and those where a subset of patients with recurrent stress urinary incontinence were included. Data from the recurrent cases were extracted and included in the review.

Data collection and analysis

Selection of studies

The initial search results were scanned by two review authors to identify trials which appeared to meet the inclusion criteria. The full text reports of potentially eligible studies were accessed and read by two review authors and inclusion criteria were applied independently. Another review author acted as the arbiter and resolved any difference of opinion. Papers in languages other than English would have been assessed by native speakers for eligibility and subsequently for data extraction. Excluded studies and reasons for exclusion are detailed in the 'Characteristics of excluded studies' table. 

Data extraction and management

Data would have been extracted by two review authors independently using a standard form containing pre-specified outcomes. Where data from the study were not provided, the author(s) was contacted requesting further information. Included trial data were to be processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Differences were resolved by discussion between the two review authors and if necessary referred to a third review author for arbitration.

Assessment of risk of bias in included studies

The risk of bias in eligible trials would have been assessed independently by two review authors using the Cochrane risk of bias tool. Factors that would have been considered included: quality of random sequence generation and concealment of allocation; description of drop-outs, withdrawals and missing data; blinding during intervention and at outcome assessment (where appropriate); and description of and protection against possible other sources of bias (where appropriate).

Measures of treatment effect

Risk ratios for dichotomous data and mean differences with 95% confidence intervals for continuous data would have been reported where relevant.

Dealing with missing data

Where possible, if insufficient data were included in trial reports, authors were contacted to request missing data.

Assessment of heterogeneity

Trial data were only to be combined if there was no clinical heterogeneity. Differences between trials would have been investigated if significant heterogeneity was found from the Chi2 test or the I2 statistic (Higgins 2003) or had appeared obvious from visual inspection of the results. Statistical heterogeneity would have been regarded as substantial if either the I2 was greater than 30% or there was a low P value (less than 0.10) in the Chi2 test for heterogeneity.

Assessment of reporting biases

Where appropriate, funnel plots would have been generated to assess reporting bias if enough studies were identified to allow this.

Data synthesis

Included data were to be processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

A fixed-effect model would have been used in data analysis unless there was evidence of marked heterogeneity, in which case a random-effects model could be used. Where quantitative data synthesis and meta-analysis were not appropriate, because of the nature of reported data or because of evident heterogeneity, a narrative review of the evidence could have been presented.

Subgroup analysis and investigation of heterogeneity

Where adequate data were reported, subgroup analysis would have been used to consider differences in outcomes between subgroups defined by criteria such as type of urinary incontinence (stress or urgency), race, co-morbidity, concurrent treatment for co-morbidities, different types of surgical operations and different types of anaesthetic procedures.

Sensitivity analysis

If the data allowed, sensitivity analysis could have been performed to assess the effect of possible bias associated with individual trials on the outcome of the meta-analysis.

Results

Description of studies

See: Characteristics of excluded studies.

We did not identify any relevant trial to be included in this systematic review.

Results of the search

In total 14 records were identified by the literature search. Twelve potentially eligible full text studies were considered, which were all excluded. Six randomised controlled trials (RCTS) (Cardozo 2002; Enzelsberger 1993; Enzelsberger 1996; Hilton 2002; Maher 2004; Wallwiener 1995) were identified but were ineligible for inclusion because the previous incontinence surgery was not a suburethral tape. One RCT (Abdel-Fattah 2011) included a subset of women having repeat suburethral tape surgery; however the authors were unwilling to share data for this subset in a manner that was appropriate for inclusion in a Cochrane review. The flow of literature through the assessment process is shown in Figure 1.

Figure 1.

PRISMA study flow diagram.

Included studies

No studies were included in the review.

Excluded studies

Twelve studies were excluded for reasons listed in the table Characteristics of excluded studies.

In one excluded trial, Abdel-Fattah 2010 reported a large RCT comparing two different trans-obturator tape devices. The study included a group undergoing secondary surgery and reported a higher failure rate, overall, of 31.8% for secondary surgery compared to 18.5% for primary cases (odds ratio (OR) 1.41, 95% confidence interval (CI) 1.18 to 1.91) using the patient global impression of improvement (Yalcin 2003) as the primary outcome. The 46 patients having secondary surgery were discussed in detail in one paper identified in the review search (Abdel-Fattah 2011): 28 women were randomised to receive an 'inside-out' trans-obturator tape (TOT), and 18 women to receive an 'outside-in' TOT. The previous surgeries included colposuspension in 15 women, retropubic TVT in 15 women, trans-obturator tape in 11, and more than one previous surgery in five women. Success rates after the alternative routes of TOT insertion were different but a trend towards greater efficacy of the 'inside out' route of insertion was not statistically significant (Table 2 in the paper). The authors did not provide data on the nature of the previous surgery in the 'inside-out' and 'outside-in' TOT groups included in their analysis. Thus the effectiveness of the two approaches could be compared in women who had only had previous suburethral tape surgery.

Risk of bias in included studies

We did not identify any relevant trial to be included in this systematic review.

Effects of interventions

We did not identify any relevant trial to be included in this systematic review.

Discussion

This review is the first looking at the management of recurrent stress urinary incontinence after failed suburethral tape surgery for urodynamic stress incontinence.

Summary of main results

This review focused only on randomised or quasi-randomised trials because evidence from uncontrolled series, cohorts or registry data is known to be liable to bias. No studies were identified that were eligible for inclusion in the review, and therefore no trial-based conclusions could be drawn on the best management strategy for recurrent or persistent stress urinary incontinence after a failed suburethral tape. None of the excluded RCTs considered conservative treatment.

The randomised trials of surgery that were identified mostly included women whose previous surgery had been with procedures other than suburethral tapes. Authors rarely described the exact nature of previous surgeries. Although several studies have considered the efficacy of secondary suburethral tape surgery, the overwhelming majority of women in many of the studies had underdone non-tape surgery as the primary procedure. One RCT with potentially relevant data had to be excluded because the authors were not able to provide separate data for the women whose previous surgery had been a suburethral tape (Abdel-Fattah 2011).

Agreements and disagreements with other studies or reviews

Information from non-randomised studies

Non-randomised studies are open to bias and their findings must be interpreted with caution. Yet in the absence of randomised trials they provide the only evidence available to inform clinical decisions. Thus, in order to consider what is known about the management of failed tape surgery it is worth considering the literature relating to non-randomised studies.

Alternative management strategies

A number of studies have considered specific methods for the management of failed suburethral tape insertion.

  • Periurethral bulking agents achieved subjective cure in 8 of 23 patients (35%) with persistent or recurrent incontinence after suburethral tape insertion, which is in keeping with the primary success rates for bulking agents (Lee 2010).

  • Several authors have reported methods of tightening the unsuccessful primary tape by means of sutures to overlap the loose tape. This technique was first described on four patients (Neuman 2004), three of whom became continent in the short term. Lo 2006 reported on 14 patients, with a short term success rate of 71%; and de Landsheere 2010 reported a cure rate from three of seven women, and improvement in a further three. However, long term data have not been published, and there are theoretical risks of mesh extrusion or exposure due to folding of the tape.

  • Han 2012 recently reported a retrospective comparison of 36 women having secondary suburethral tape surgery with 30 women having the original tape shortened. The cure rates (unspecified time frame) were 72% for repeat surgery and 47% for tape shortening.

  • Colposuspension was reported to be a successful option for secondary surgery in two small series, with subjective cure rates of 93% and 85% after laparoscopic or open surgery (de Cuyper 2008; Giarenis 2012).

Different tape insertion routes

Few studies have reported comparative data on different tape insertion routes following failed suburethral tape surgery patients exclusively.

  • Lee 2007 reported a retrospective analysis of 29 patients who underwent secondary surgery after a failed primary surgery (17 women had received a retropubic tape, and 12 a trans-obturator tape). Overall cure rate for the secondary procedure was 76% (22 of 29), with a trend for retropubic tapes performing better as a secondary procedure (cure rate 92% (12 of 13) versus 63% (10 of 16), P = 0.089). In this series, the previous tape was left in position.

  • Stav 2010 reported data from a large cohort of 1225 patients comparing outcomes between primary and secondary suburethral slings. At mean follow up of 50 months, the subjective cure rate was 62% for the 77 women having repeat surgery compared to 86% for the primary surgery patients (1035). In this non-randomised comparison, repeat retropubic surgery was more successful than repeat trans-obturator surgery (71% versus 48%, P = 0.04). Urgency and urge incontinence were both more common after secondary surgery (30% versus 14%, and 22% versus 5% respectively, P < 0.001 for both).

Single cohort studies

A number of single cohort studies have reported surgical outcomes after exclusively primary suburethral tape surgery.

  • Tsivian 2007 reported a subjective cure rate at 23 months of 92%, from 12 patients, with a lower cure rate after trans-obturator tapes (one of three, compared to all of five after retropubic tapes). 

  • van Baelen 2009 reported subjective cure rates from 21 women having trans-obturator tape surgery as a secondary procedure after failed primary tape surgery. Cure rate, defined by the ICIQ-short form questionnaire (Avery 2004), was 53% at 17 months.

  • Liapis 2009 reported outcomes from 31 women after retropubic suburethral tape insertion as secondary surgery; 15 women had received trans-obturator tapes, 6 patients a retropubic tape and 10 patients a single incision tape. No mention was made about whether the previous tape was removed or not. Objective cure based on a 1-hour pad test at 12 months was 74%, and a negative cough stress test during cystometry was seen in 77% of patients. The number of women with each individual primary procedure was 10 or fewer, and no difference in secondary cure rate was seen by primary procedure.

  • Palva 2009 reported on 26 women who had a secondary retropubic tape insertion after failed primary retropubic surgery with a range of different primary tapes including multifilament tapes. Nine women had excision of the primary tape for infection or erosion before secondary surgery. The cure rate after secondary surgery in this cohort was 77%.

  • Sabadell 2011 reported a cure rate of 59% at 24 months after secondary retropubic suburethral sling following unsuccessful primary trans-obturator tape surgery.

Systematic review

A recent systematic review of the literature on suburethral tapes for recurrent incontinence excluded some of the above studies on methodological grounds. However, the review’s conclusions based upon one randomised trial and 11 other papers were similar: suburethral tape surgery appears less effective as a secondary procedure than a primary procedure; and retropubic tapes appear to be more effective than trans-obturator tapes (Pradhan 2012). The authors highlighted the lack of prospective randomised studies.

Authors' conclusions

Implications for practice

To date there is no high-quality, trial-based evidence that can inform treatment decisions on the management of recurrent SUI after a failed suburethral tape. No randomised comparison studies exist. Conservative treatment options include lifestyle advice, pelvic floor muscle training, bladder training and drugs (medication). Surgical treatment options may include retropubic colposuspension, urethral bulking agents, a fascial sling procedure, artificial urethral sphincter or repeat suburethral tape.

Among the literature of non-randomised studies, the data suggest that repeat suburethral tape surgery is less effective than for primary surgery, and there is some evidence that retropubic suburethral tapes are superior to trans-obturator tapes as secondary procedures. In view of the absence of any evidence comparing the alternative management options for failed primary suburethral tape surgery, clinicians must rely largely on expert opinion or personal experience when advising patients about treatment options.

Implications for research

None of the objectives pre-stated in the protocol have been satisfactorily addressed in published trials. The absence of evidence in the management of recurrent or persistent stress incontinence after a failed suburethral tape indicates the need for well-designed randomised controlled clinical trials comparing interventions to answer this question. It is not entirely clear what proportion of women having failed suburethral surgery require a secondary procedure, nor what the management options currently offered by specialists include. However, given the number of suburethral tapes inserted globally each year, it is likely that the numbers involved are significant and that research is warranted. Such surgical trials will necessitate multicentre collaboration. They should include careful pre- and post-surgical assessment to allow evaluation of factors which may influence cure, such as positioning of the original tape, the presence of detrusor overactivity or significant symptoms of urgency, voiding function and the presence or recurrence of co-existing urogenital prolapse. Suggested recommendations have been published recently (Smith 2011).

Acknowledgements

The review authors would like to acknowledge the support and help of the Cochrane Incontinence Review Group staff.

Data and analyses

Download statistical data

This review has no analyses.

Appendices

Appendix 1. Search terms for location of randomised studies

Cochrane Incontinence Group Specialised Register – search terms

({design.cct*} OR {design.rct*})

AND

{topic.urine.incon.recurrent.} OR {topic.urine.incon.stress.recurrent.}

(All searches were of the keyword field of Reference Manager 12, Thomson Reuters).

Appendix 2. Search methods for location of non-randomised studies

One of the review authors performed the following searches for non-randomised studies:

  • MEDLINE using the terms: (previous surgery OR repeat surgery) AND (mid-urethral tape OR sub-urethral tape);

  • Web of knowledge using Science Citation Index was 'forward' searched for papers which had cited some of the papers.

What's new

DateEventDescription
19 December 2012New citation required and conclusions have changedNew review about the treatment of recurrent stress urinary incontinence after failed minimally invasive synthetic suburethral tape surgery in women

Contributions of authors

Evangelia Bakali contributed to the design of the protocol, wrote the preliminary draft and made changes based on the feedback from the review authors. She was an independent reviewer of eligible studies and wrote the preliminary draft of the review. Brian Buckley contributed to the design of the protocol and critically appraised the protocol. He was an independent reviewer for the eligible studies and contributed in writing the review. Paul Hilton contributed to the design of the protocol and critically appraised the protocol. He contributed in writing the review. Douglas Tincello contributed to the design of the protocol and helped write the preliminary draft. He was the arbitrator for reviewing eligible studies. He helped write the preliminary draft of the review. All authors approved the final version of the review.

Declarations of interest

Douglas Tincello has been a participant in advisory boards for clinical trial design (TVT-World Registry) for Ethicon and was the UK Chief Investigator for this study. He has received honoraria for teaching the Pelvic Organ Prolapse Quantification System (POP-Q) to investigators on studies funded by Ethicon, and has received Investigator Initiated Grant research awards from Ethicon. He jointly supervises a Female Urology Clinical Fellowship which is part funded by American Medical Systems.

Brian Buckley has received honoraria, consultancy fees and educational funding from Pfizer, Astellas, Medtronic, Roche, Novo Nordisk and SCA Hygiene. Educational funding has involved the reimbursement of expenses by Pfizer, Astellas, Medtronic, Roche and SCA Hygiene for attending symposia, conferences and educational events. Consultancy fees have been received from Astellas for writing a report on a television awareness campaign on overactive bladder. An honorarium and expenses were received from Novo Nordisk for presenting and participation at meetings aimed at the development of a quality of life instrument. All these were prior to 2009 and the author does not believe that any of these interests has in any way affected this review or any other research.

Paul Hilton has no current financial interests to declare. Within the last 10 years he has received commercial research funding for trials of surgery for SUI from Gynecare (1998 to 2003) and Gynae Ideas (2001 to 2003), and received reimbursement of travel expenses to attend meetings in connection with these studies. He was chair of the NICE guideline development group on urinary incontinence in women (2004 to 2007), and received an honorarium and travel expenses in association with this role. He has previously been a member of the NICE Interventional Procedures Advisory Committee, NCC-HTA Therapeutic Procedures Panel (2007 to 2008) and Clinical Evaluations and Trials Prioritisation Group (2008 to 2010), and the International Consultation on Incontinence section on surgery in women (2007 to 2009). Reimbursement of, or contribution to, travel expenses was received in respect of these activities.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • NIHR, UK.

    The Cochrane Incontinence Review Group is supported by NIHR, UK

Differences between protocol and review

There were no eligible studies identified and therefore no data extraction could be performed. Primary and secondary outcomes could not be measured and no data analysis was performed.

Characteristics of studies

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Abdel-Fattah 2011RCT comparing ‘inside-out’ TVT-O or ‘outside-in’ trans-obturator tape (TOT). This study contains a subgroup of 46 women from that RCT who had previous incontinence surgery; 31 of the 46 women had previous transobturator tapes, TVT or colposuspension plus suburethral tapes of some kind, but 15 of the women involved had only had a colposuspension. The authors were contacted but we were unable to obtain usable data from their results, as the type of previous surgery was not specified.
Ashok 2010Not RCT. This is a review.
Barber 2008Not RCT. This is a secondary analysis using logistic regression to determine risk factors for recurrent UI. The treatment of recurrent UI is not addressed.
Cardozo 2002RCT. Authors were contacted but the patients had a previous colposuspension and not a tape procedure.
Courtney-Watson 2002Paper could not be found or accessed.
Enzelsberger 1993RCT but women had hysterectomies with an anterior repair. There was no mention of previous tape surgery.
Enzelsberger 1996This is an RCT but women had hysterectomies with an anterior repair. There was no mention of previous tape surgery.
Hilton 2002RCT. Author was contacted but data were not available as trial was closed prematurely in view of slow recruitment; few of the included participants had previous suburethral tapes.
Lovatsis 2010Not RCT. This is a clinical guideline.
Maher 2004RCT. Author was contacted but data were not complete.
Schraffordt 2006Not RCT. This is a prospective cohort.
Wallwiener 1995RCT but previous incontinence surgery was not tape.

Ancillary