Electrical stimulation with non-implanted electrodes for urinary incontinence in men

  • Review
  • Intervention

Authors


Abstract

Background

Electrical stimulation with non-implanted devices is used for patients with different types of urinary incontinence and symptoms of urgency, frequency and nocturia. The current review focused on electrical stimulation with non-implanted devices for the treatment of urinary incontinence in men.

Objectives

To determine the effectiveness of electrical stimulation with non-implanted devices for men with stress, urgency or mixed urinary incontinence in comparison with no treatment, placebo treatment, or any other 'single' treatment. Additionally, the effectiveness of electrical stimulation with non-implanted devices in combination with another intervention was compared with the other intervention alone. Finally, the effectiveness of one method of electrical stimulation with non-implanted devices was compared with another method.

Search methods

We searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, and handsearching of journals and conference proceedings (searched 21 January 2012). We also searched other electronic and non-electronic bibliographic databases and the reference lists of the included studies as well as contacting researchers in the field to identify other relevant trials.

Selection criteria

Randomized and quasi-randomized controlled trials.

Data collection and analysis

Two review authors independently assessed all the identified trials for eligibility. Risk of bias was assessed using the Cochrane tool for determining bias. Disagreements were resolved by discussion, and a third review author was involved in the case of no consensus. Data were analysed using Cochrane methods.

Main results

Six randomized controlled trials (five full papers and one abstract) were included. There was considerable variation in the interventions used, study protocols, types of electrical stimulation parameters and devices, study populations and outcome measures. In total 544 men were included, of whom 305 received some form of electrical stimulation, and 239 a control or comparator treatment. The trials were mostly small and generally there was not sufficient information to assess risk of bias; only two trials used secure methods of randomization.

There was some evidence that electrical stimulation (ES) had a short-term effect in reducing incontinence compared with sham treatment (for example risk ratio (RR) at six months 0.38, 95% CI 0.16 to 0.87) but not at 12 months. Four trials evaluated the effect of adding PFMT to ES versus pelvic floor muscle training (PFMT) alone or with biofeedback. There was no evidence of a statistically significant difference in the number of men with urinary incontinence at three months (146/239, 61% for combined treatment versus 98/156, 63% with PFMT alone; RR 0.93, 95% CI 0.82 to 1.06). However, there were more adverse effects with combined treatment (23/139, 17% versus 2/99, 2% with PFMT alone; RR 7.04, 95% CI 1.51 to 32.94) and quality of life also seemed better with PFMT alone. One small trial did not detect statistically significant differences between two methods of administration of transcutaneous electrical stimulation (anal versus perineal) but the quality of life score was lower (better) in the anal stimulation group.

Authors' conclusions

There was some evidence that electrical stimulation enhanced the effect of PFMT in the short term but not after six months. There were, however, more adverse effects (pain or discomfort) with electrical stimulation.

Résumé scientifique

Stimulation électrique avec électrodes non implantées pour l'incontinence urinaire chez l'homme

Contexte

La stimulation électrique avec des dispositifs non implantés est utilisée pour les patients présentant différents types d'incontinence urinaire et des symptômes d'urgence, de fréquence et de nycturie. La revue actuelle se concentrait sur la stimulation électrique avec des dispositifs non implantés pour traiter l'incontinence urinaire chez l'homme.

Objectifs

Déterminer l'efficacité de la stimulation électrique avec des dispositifs non implantés pour les hommes souffrant d'incontinence urinaire de l'effort, d'urgence ou mixte par rapport à aucun traitement, un traitement placebo ou un autre traitement 'unique'. De plus, l'efficacité de la stimulation électrique avec des dispositifs non implantés en association à une autre intervention a été comparée à l'autre intervention seule. Pour terminer, l'efficacité d'une méthode de stimulation électrique avec des dispositifs non implantés a été comparée aux autres méthodes.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre spécialisé du groupe Cochrane sur l'incontinence, qui contient des essais issus du registre Cochrane des essais contrôlés (CENTRAL), MEDLINE et PreMEDLINE, ainsi que des recherches manuelles dans les journaux et actes de congrès (recherches effectuées le 21 janvier 2012). Nous avons également effectué des recherches dans des bases de données bibliographiques électroniques et non électroniques et dans les bibliographies des études incluses, et contacté les chercheurs dans le domaine afin d'identifier d'autres essais pertinents.

Critères de sélection

Essais contrôlés randomisés ou quasi randomisés.

Recueil et analyse des données

Deux auteurs ont indépendamment évalué l'ensemble des essais identifiés pour déterminer leur éligibilité. Le risque de biais a été évalué à l'aide de l'outil Cochrane pour déterminer les biais. Les désaccords ont été résolus après discussion et un troisième auteur a été inclus en cas de non consensus. Les données ont été analysées à l'aide des méthodes Cochrane.

Résultats principaux

Six essais contrôlés randomisés (cinq essais complets et un résumé) ont été inclus. Il a été constaté une variation énorme dans les interventions utilisées, les protocoles d'étude, les types de paramètres et de dispositifs de stimulation électrique, les populations d'étude et les critères de jugement. Au total, 544 hommes ont été inclus, dont 305 ont reçu une forme de stimulation électrique et 239 un traitement témoin ou comparateur. Les essais étaient principalement de petite taille et généralement, les informations étaient insuffisantes pour évaluer le risque de biais ; seuls deux essais utilisaient des méthodes sécurisées de randomisation.

Nous avons trouvé des données indiquant que la stimulation électrique (SE) avait un effet à court terme sur la diminution de l'incontinence par rapport à un traitement factice (par exemple, rapport de risque (RR) à six mois 0,38, IC à 95 % 0,16 à 0,87) mais pas à 12 mois. Quatre essais ont évalué l'effet de l'ajout de la formation aux exercices de renforcement des muscles pelviens (PFMT pour Pelvic Floor Muscle Training) à la SE par rapport à la PFMT seule ou avec biofeedback. Il n'a été constaté aucune donnée concernant une différence statistiquement significative dans le nombre d'hommes présentant une incontinence urinaire à trois mois (146/239, 61 % pour le traitement combiné par rapport à 98/156, 63 % avec la PFMT seule ; RR 0,93, IC à 95 % 0,82 à 1,06). Toutefois, il y avait plus d'effets indésirables avec un traitement combiné (23/139, 17 % versus 2/99, 2 % avec la PFMT seule ; RR 7.04, IC à 95 % 1,51 à 32,94) et la qualité de vie semblait meilleure avec la PFMT seule. Un essai de petite taille n'a pas détecté de différences statistiquement significatives entre les deux méthodes d'administration de la stimulation électrique transcutanée (anale versus périnéale) mais le score de qualité de vie était plus faible (meilleur) dans le groupe avec stimulation anale.

Conclusions des auteurs

Nous avons trouvé des données indiquant que la stimulation électrique renforçait l'effet de la PFMT sur le court terme mais pas après six mois. Il a cependant été constaté plus d'effets indésirables (douleur ou inconfort) avec la stimulation électrique.

アブストラクト

尿失禁のある男性に対する、非埋込み型電極を用いた電気刺激

背景

非埋め込み型装置による電気刺激は、異なる種類の尿失禁や、切迫性尿失禁、頻尿、夜間頻尿の症状を呈する患者に用いられる。本レビューは、尿失禁のある男性に対する、非埋込み型電極を用いた電気刺激に焦点を当てた。

目的

腹圧性、切迫性、または混合型尿失禁を呈する男性を対象に、無治療、プラセボ治療、あるいは他の単独治療と比較した場合の非埋め込み型装置を用いた電気刺激の効果を検討する。さらに、非埋め込み型装置を用いた電気刺激と他の介入との併用を、その介入単独と比較した場合の効果を検討する。最後に、非埋め込み型装置を用いた電気刺激による効果と、別の方法による効果を比較する。

検索戦略

Cochrane Central Register of Controlled Trials (CENTRAL)から同定された試験を内容とするCochrane Incontinence Group Specialised Trials Register、MEDLINE、PreMEDLINEの検索、および定期刊行物と学会予稿集のハンドサーチを実施した(検索日:2012年1月21日)。他の電子的および非電子的書誌目録データベースと選択した研究の参考文献リストをも検索し、関連する試験が他にないか同定するため本領域の研究者にも連絡を取った。

選択基準

ランダム化および準ランダム化比較試験。

データ収集と分析

2名のレビュー著者が独立して、同定した試験すべてに対して適格性審査を行った。バイアス検討用コクランツールを用いて、バイアスのリスクを評価した。不一致は討議により解決し、意見が一致しない場合は第三のレビューアを入れて協議した。コクランメソッドを用いて、データ解析を行った。

主な結果

6件のランダム化比較試験(5件は論文全文、1件は抄録)を選択した。用いた介入、研究プロトコル、電気刺激パラメーターの種類と装置、研究対象集団、およびアウトカム指標は大きく異なっていた。組み入れた合計544名の男性のうち、305名はなんらかの形式による電気刺激を、残る239名は対照治療または比較治療を受けた。試験は、ほとんどが小規模で、総じてバイアスのリスクを評価するに十分な情報がなかった。2件の試験のみランダム化を保証する方法を用いていた。

偽治療と比較すると、電気刺激(ES)には失禁を低減する短期的効果があることを示すある程度のエビデンスが存在した(例えば、6カ月時点におけるリスク比 [RR]:0.38、95%信頼区間[CI]:0.16~0.87)が、12カ月時点では存在しなかった。4件の試験では、骨盤底筋トレーニング(PFMT)およびESの併用による効果と、PFMT単独または生体自己制御法の併用による効果との比較を検討していた。3カ月時点における尿失禁を呈する男性の数に統計学的な有意差を示すエビデンスは存在しなかった(併用療法群は146/239[61%]、PFMT単独群は98/156[63%]、RR:0.93、CI:0.82~1.06)。しかし、有害事象は併用療法群でより多く報告されており(23/139[17%]に対しPFMT単独群は2/99[2%]、RR:7.04、95%CI:1.51~32.94)、QOLもPFMT単独群の方が良好であることが認められた。1件の小規模試験では、2つの経皮的電気刺激(肛門部と会陰部との比較)の間に統計学的な有意差は検出されなかったが、QOLスコアは肛門部刺激群で低かった(より良好)。

著者の結論

短期的には電気刺激がPFMTの効果を高めることを示すある程度のエビデンスは存在したが、6カ月以降については存在しなかった。しかし、有害事象(痛みあるいは不快感)は電気刺激群でより多く認められた。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2015.12.25] 《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Plain language summary

Electrical stimulation with non-implanted electrodes for urinary incontinence in men

Some men leak urine (urinary incontinence) when they cough or exercise (stress urinary incontinence) or when they have a sudden, compelling urge to pass urine (urgency urinary incontinence). Men may also need to pass urine more often than usual (frequency) or get up more than once at night to pass urine (nocturia). In men this may be due to an enlarged prostate gland or develop after surgery to removal the prostate. Men can contract their pelvic floor muscles to reduce or stop these symptoms. Electrical stimulation with non-implanted devices involves stimulation of these muscles with a painless electric current using surface electrodes on the skin or a probe placed into the anus. The aim is to make the pelvic floor muscles contract so that they become stronger and so better able to prevent leakage, or to make the muscle at the base of the bladder (the sphincter) contract more strongly to stop urine escaping. Electrical stimulation might also lessen the contractions of the bladder muscle to ease the sense of urgency and allow the bladder to hold more urine.

In this review, electrical stimulation was compared with no treatment, placebo treatment (dummy medical treatment) or any other single treatment. There was some evidence that electrical stimulation increased the effect of pelvic floor muscle training (exercises to strengthen the pelvic floor muscles) in the short term but not after six months. It was not possible to identify whether one treatment was more successful than another. There was, however, more discomfort or pain (adverse effects) with electrical stimulation than with pelvic floor muscle exercises alone. There was not enough information about whether and how electrical stimulation should be used, which type of person or problem it would be best for, and how much it would cost.

Résumé simplifié

Stimulation électrique avec électrodes non implantées pour l'incontinence urinaire chez l'homme

Certains hommes souffrent de fuites urinaires (incontinence urinaire) lorsqu'ils toussent ou pratiquent une activité physique (incontinence urinaire à l'effort) ou lorsqu'ils ont une envie subite et pressante d'uriner (incontinence urinaire d'urgence). Les hommes peuvent également avoir envie d'uriner plus que d'habitude (fréquence) ou de se lever la nuit pour aller uriner (nycturie). Chez l'homme, cela peut être dû à une hypertrophie de la prostate ou se développer après une ablation chirurgicale de la prostate. Les hommes peuvent contracter les muscles de leur plancher pelvien pour atténuer ou stopper ces symptômes. La stimulation électrique avec des électrodes non implantées induit la stimulation de ces muscles à l'aide d'un courant électrique sans douleur via des électrodes de surface posées sur la peau ou une sonde placée dans l'anus. L'objectif est de faire contracter les muscles du plancher pelvien de sorte qu'ils se renforcent et ainsi mieux prévenir les fuites, ou de faire que le muscle situé à la base de la vessie (le sphincter) se contracte plus vigoureusement pour empêcher l'urine de s'écouler. La stimulation électrique peut également atténuer les contractions du muscle vésical afin de soulager la sensation d'urgence et de permettre à la vessie de contenir plus d'urine.

Dans cette revue, la stimulation électrique était comparée à l'absence de traitement, un traitement placebo (traitement médical factice) ou tout autre traitement unique. Il existait des données indiquant que la stimulation électrique augmentait l'effet de la formation aux exercices de renforcement des muscles du plancher pelvien (exercices destinés à renforcer les muscles du plancher pelvien) sur le court terme mais pas au-delà de six mois. Il n'a pas été possible d'identifier si un traitement était plus efficace qu'un autre. Il a toutefois été constaté plus d'inconfort et de douleur (effets indésirables) avec la stimulation électrique qu'avec les exercices de renforcement des muscles du plancher pelvien seuls. Il n'y avait pas suffisamment d'informations permettant d'indiquer si et comment la stimulation électrique devrait être utilisée, pour quel type de personne ou pour problème elle serait la plus appropriée, et combien cela coûterait.

Notes de traduction

Traduit par: French Cochrane Centre 16th July, 2013
Traduction financée par: Pour la France : Minist�re de la Sant�. Pour le Canada : Instituts de recherche en sant� du Canada, minist�re de la Sant� du Qu�bec, Fonds de recherche de Qu�bec-Sant� et Institut national d'excellence en sant� et en services sociaux.

平易な要約

尿失禁のある男性に対する、非埋込み型電極を用いた電気刺激

男性における尿漏れ(尿失禁)の症状として、咳や運動をする際の尿漏れ(腹圧性尿失禁)や、急な抑えがたい尿意による尿漏れ(切迫性尿失禁)などが認められる。通常よりも頻回の排尿が必要(頻尿)であることや、排尿のため夜間何度も起きなければならない(夜間頻尿)ことがある。これは男性における前立腺肥大が原因であったり、あるいは前立腺切除術後に発症することがある。男性は骨盤底筋を収縮することにより、こうした症状を軽減または予防することができる。非埋め込み型装置を用いた電気刺激は、皮膚表面に表面電極を当てて、またはプローブを肛門に挿し込んで無痛電流を流し、これらの筋肉を刺激する。骨盤底筋を強化し、より効果的に尿漏れ予防ができるよう骨盤底筋を収縮させる、あるいは尿漏れ予防のため膀胱基底部の筋肉(括約筋)をより強力に収縮させることが目的である。電気刺激により、膀胱筋の収縮を軽減させ切迫感を和らげたり、より多量の尿を膀胱内に保持できるようになる場合もある。

本レビューでは、電気刺激と無治療、プラセボ治療(偽治療)または他の単独治療とを比較した。電気刺激により、骨盤底筋トレーニング(骨盤底筋を強化する運動)の効果が短期的に増大することを示すある程度のエビデンスが得られたが、6カ月以降はなかった。ある治療が他の治療よりも成功したか否か同定することはできなかった。しかし、電気刺激に伴う不快感または痛み(有害事象)は、骨盤底筋運動単独よりも多かった。電気刺激使用の是非や使用法、電気刺激が最も適する患者または障害の種類、および費用に関する十分な情報はなかった。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2015.12.25] 《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Background

Description of the condition

World wide, urinary incontinence in men is a common problem. In western countries, estimates of prevalence rates up to 65 years of age are between 0.9% and 5% (Campbell 2012). In men over 50 years of age, after radical prostatectomy the prevalence of urinary incontinence varies between 5% and 60% (van Kampen 2000; Wolin 2009).

Male stress urinary incontinence is rare except after radical prostatectomy and transurethral resection of the prostate (TURP), which may cause both sphincter and local nerve injury leading to intrinsic sphincter deficiency or weakness of the urethra with stress urinary incontinence as a consequence (Gacci 2003; Groutz 2000; Hu 2003; Moore 1999; Palmer 2003). As well as intrinsic sphincter deficiency, detrusor overactivity and poor compliance of the bladder neck may be factors related to urinary incontinence (Carlson 2001; Groutz 2000; Gudziak 1996; Moore 1999). In general, persistent stress urinary incontinence tends to occur only in a minority of men, mostly because of surgery of the prostate (Buckley 2008). In the case of (persistent) urinary incontinence, this health problem has a major impact on their daily life activities and quality of life (Coyne 2012).

Male detrusor overactivity, including urgency urinary incontinence, may be due to bladder outlet obstruction such as with benign prostatic hyperplasia (De Nunzio 2003; Dmochowski 2002) or neurogenic disease (Steers 2002). Urgency urinary incontinence might also be a symptom related to many different health problems of the lower urinary tract, such as inflammation, infections, kidney stones and tumours.  

For urinary incontinence, detrusor overactivity or symptoms of urgency and frequency, treatment options vary between several surgical and conservative or non-surgical interventions, pharmaceuticals and non-pharmaceuticals (Abrams 2009). In the algorithms of the International Consultation of Incontinence, electrical stimulation has been suggested as one of the first-line treatment options (Abrams 2009).   

Description of the intervention

In the context of conservative therapy, electrical stimulation can be applied using surface electrodes (Appell 1998; Brubaker 2000; Goldberg 2000; Govier 2001; Hasan 1998; Jabs 2001; Siegel 1992; van Kerrebroeck 1998). Surface electrodes include:

(1) transcutaneous electrical stimulation (Berghmans 2002; Brubaker 2000; Jabs 2001) or transcutaneous electrical nerve stimulation (TENS) via suprapubic, sacral or penile attachment of electrodes, anal plug electrodes, plantar or thigh and similar stimulation, and other placement of surface electrodes such as for interferential or maximum electrical stimulation;
(2) percutaneous electrical stimulation (Govier 2001; Janknegt 1997; van Balken 2001), e.g. posterior tibial nerve stimulation, electro-acupuncture, in general via insertion of a percutaneous needle electrode with another stick-on surface electrode placed near to the needle as the reference electrode.

There are two main types of electrical stimulation:

  1. long-term or chronic electrical stimulation delivered below the sensory threshold aiming at detrusor inhibition by afferent pudendal nerve stimulation. The electrically evoked activity is suggested to result in reflex activation of hypogastric efferents and central inhibition of pelvic efferent mechanisms sensitive to low-frequency stimulation (Fall 1994). The device is used six to 12 hours a day for several months (Eriksen 1989);

  2. maximal electrical stimulation using a high-intensity stimulus (just below the pain threshold). It aims to improve urethral closure. Fall (Fall 1991) suggested a direct and reflexogenic contraction of striated peri-urethral musculature. Detrusor inhibition by afferent pudendal nerve stimulation has also been suggested (Berghmans 2002). Maximal electrical stimulation is applied with short duration (15 to 30 minutes) several times a week (or one to two times daily using portable devices at home) (Yamanishi 1997; Yamanishi 1998; Yamanishi 2000a).

Parameters used in previous studies, that is current source, pulse width and duration, current intensity (range), stimulus frequency, pulse shape, time and total number of sessions and rest to work ratio, vary according to type of urinary incontinence and type of electrical stimulation. Berghmans (Berghmans 2002) reported that frequencies of 5 to 20 Hz are usually used for urgency urinary incontinence, 20 to 50 Hz for stress (post-prostatectomy) incontinence, and for mixed urinary incontinence around 20 Hz or high and low frequency alternately (Smith 2009). Pulse durations of 200 (Smith 2009), 300 (Yamanishi 2010), 400 to 600 (Everaert 1999) and 1000 μsec (Moore 1999) have been reported for stress urinary incontinence, for detrusor overactivity 200 to 500 μsec, and for mixed urinary incontinence depending on the dominant factor of the urinary incontinence (Berghmans 2002; Smith 2009). The pulse shape is generally rectangular, and biphasic pulses are preferred (Smith 2009). 

In the literature, authors suggest that intermittent, short-term stimulation (maximal electrical stimulation) using a portable stimulation device for home-use should usually be used. In men, rectal or anal or surface electrodes can be used to apply electrical stimulation (ES). Surface electrodes can be positioned:

For the treatment of post-prostatectomy incontinence, ES has been used in combination with pelvic floor muscle training (PFMT) but also on its own (Yokoyama 2004). Normally, an anal or rectal electrode is used and the stimulation artificially stimulates the pudendal nerve and its branches to cause direct reflex responses of the urethral and peri-urethral striated muscles (Moore 1999). Frequencies of 5 to 20 Hz are recommended for urgency urinary incontinence, for example Yamanishi (Yamanishi 2000a) used 10 Hz. For stress (post-prostatectomy) urinary incontinence (Moore 1999; Wille 2003; Yamanishi 1998a; Yokoyama 2004) 20 to 50 Hz is used.

Although a wide range of parameters has been claimed to be successful, the optimal set of parameters for each type of urinary incontinence has not been determined (Smith 2009). Duration of the stimulation varies according to the investigators, from 15 minutes/day (Amarenco 2003) to 15 minutes/twice daily (Wille 2003; Yokoyama 2004), to 20 minutes three times/week (Hoffmann 2005) to twice weekly (Moore 1999). As for the number of sessions needed, some authors have recommended at least 10 treatment sessions before the clinical effect was assessed (Fall 1998; Primus 1996). Others used a treatment episode of one month (electrical stimulator also used at home) (Yokoyama 2004), four to six weeks (Amarenco 2003; Bent 1993; Plevnik 1986), 12 weeks (Moore 1999; Soomro 2001) or three months (Wille 2003).

So far, no studies reporting on a comparison of ES protocols or the parameters specified above have been identified, so up to now it is completely unclear what the most appropriate ES protocol and parameters might be, and for which type of urinary incontinence they might be most suitable.

How the intervention might work

ES of the pelvic floor aims at stimulating motor fibres of the pudendal nerve, which may elicit a direct contraction of the pelvic floor muscles or the striated peri-urethral musculature to support the intrinsic part of the urethral sphincter closing mechanism (Fall 1991; Scheepens 2003). As such, ES might contribute to compensation of a weak intrinsic sphincter but it is questionable whether or not ESwould be the first choice treatment option in such cases or would have any additional value to functional training (Berghmans 1998b; Smith 2009).    

ES might also be used as a kind of biofeedback. As such, by stimulating awareness, it might help male patients with stress urinary incontinence and who lack conscious control how and where exactly to contract and relax the pelvic floor muscles to regain this control (Berghmans 1998a). Although it is suggested that ES might be useful to train or strengthen the pelvic floor muscles (Sand 1995), or to strengthen the structural support of the urethra and the bladder neck (Plevnik 1991), these hypotheses are not well supported by scientific evidence so far.   

In patients with detrusor overactivity or symptoms of urgency and urgency urinary incontinence, ES can elicit direct contractions of the pelvic floor muscles. The contractions stimulate afferent fibres of the pudendal nerve going to the sacral spinal cord, which reflexively decrease the feeling or sensation of urgency and inhibit parasympathetic activity at the level of the sacral micturition centre in the sacral cord in order to reduce involuntary detrusor contractions and reflexively activate the striated peri-urethral musculature. Several authors have suggested that ES of these afferent nerve fibres influences remodelling of neuronal reflex loops, such as the detrusor inhibition reflex (Berghmans 2002; Fall 1994; Vodusek 1986; Weil 2000).  

Electrical stimulation may be used as stand-alone therapy or in combination with PFMT (Meaglia 1990; Moore 1999; Wille 2003).

Why it is important to do this review

It has been postulated that by using ES in combination with PFMT, continence is regained more rapidly (Hirakawa 1993; Salinas 1993) and the duration of the application of ES is reduced when PFMT is augmented with ES (Campbell 2012). 

The aim of this systematic review was to assess the effects of ES in adult men with stress, urgency and mixed urinary incontinence, and combinations of types of urinary incontinence.

ES for urinary incontinence is the subject of more than one Cochrane review. In men, a Cochrane review (Campbell 2012) reviewed a combination of PFMT and rectal ES for urinary incontinence after radical prostatectomy. ES with the use of implanted stimulation is the subject of a further Cochrane review (Herbison 2009). Because we only deal with non-implanted electrodes in this review, there is no overlap with that review.

Definitions and classifications used in this review are according to the Standardization Committees of the International Continence Society (ICS) and the International Urogynecological Association (Abrams 2002; Haylen 2010; Messelink 2005).

Objectives

The following comparisons will be considered, in men with stress urinary incontinence; detrusor overactivity with urgency urinary incontinence or men with symptoms of urgency, frequency and urgency urinary incontinence; or mixed urinary incontinence.

1. Electrical stimulation with non-implanted devices versus no treatment.

2. Electrical stimulation with non-implanted devices versus placebo treatments.

3. Electrical stimulation with non-implanted devices versus other 'single' treatments (e.g. a physical therapy such as pelvic floor exercises, a pharmaceutical such as an anticholinergic, or a type of surgery).

4. Electrical stimulation with non-implanted devices in combination with another therapy versus the other therapy alone (e.g. pelvic floor muscle training).

5. One method of providing electrical stimulation with non-implanted devices (e.g. anal plug electrodes) versus another method (e.g. transcutaneous electrical nerve stimulation (TENS).

Methods

Criteria for considering studies for this review

Types of studies

Randomized and quasi-randomized controlled trials of surface electrical stimulation (ES) for the management of urinary incontinence were included. Other forms of clinical trials were excluded. As well as trials reported as full-text, we also included trials of which only abstracts were available.   

Types of participants

Adult men with: stress urinary incontinence; detrusor overactivity with urgency urinary incontinence or symptoms of urgency, frequency and urgency urinary incontinence; or mixed urinary incontinence.

Types of interventions

One arm of the study must have used ES with non-implanted devices to provide stimulation to the nerves or muscles of the pelvic floor or the bladder, or both, according to a standardised protocol. Any type of non-implanted device was included.

Setting (hospital, office, at home), intensity (both level of electrical current and duration and frequency of stimulation) and method (surface, anal, percutaneous) of stimulation were taken into account.

Comparator interventions included:

  • pelvic floor muscle training (PFMT),

  • bladder training,

  • drugs such as serotonin-noradrenaline reuptake inhibitors (SNRIs), anticholinergics,

  • surgery,

  • implantable electrical stimulation systems.

Types of outcome measures

Primary outcomes
Men’s observations

- self report of urinary incontinence

Secondary outcomes
Quantification of symptoms

- pad changes (voiding diary)

- frequency symptoms (voiding diary)

- urgency symptoms (voiding diary)

- incontinent episodes (voiding diary)

- standardised pad tests (24-hr, 1-hr, 20-min) measuring grams of involuntary loss of urine (continuous)

Health status measures

- condition-specific quality of life (QOL) e.g. Incontinence Quality of Life (IQOL) Questionnaire

Clinician’s observations

- observation of urinary incontinence

- urodynamic measurements and studies

- pelvic floor muscle function and strength

Health status measures

- general health status e.g. Short Form 36 (Ware 1993)

Adverse effects

- tissue damage

- exhaustion of stimulated muscle fibres

- pain, discomfort

- infection of the lower urinary tract

Health economics

- cost of interventions

- resource implications of differences in outcome

- formal economic analysis (e.g. cost-effectiveness and cost utility)

Search methods for identification of studies

We did not impose any language or other limits on the searches described below.

Electronic searches

Relevant trials have been identified from the Specialised Register of controlled trials of the Cochrane Incontinence Group. This Register includes trials identified from searches in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, CINAHL, and by handsearching of journals and conference proceedings. The methods used to derive the Register, including the search strategy, are described under the Group's module in The Cochrane Library. Date of last search: 21 January 2012.

Additional trials have been sought by the authors from a broader search of computerized bibliographic databases (EMBASE, the Excerpta Medica website, the Dutch National Institute of Allied Health Professions, and the database of the Cochrane Rehabilitation and Related Therapies Field at Maastricht University), from 1980 to 21 January 2012. The keywords used were: incontinence, urinary incontinence, detrusor instability, detrusor overactivity, bladder, overactive bladder, stress incontinence, urge incontinence, mixed incontinence, urgency, frequency, nocturia, physiotherapy, physical therapy, conservative management, conservative therapy, non-surgical stimulation, electrostimulation, neuromuscular stimulation, electrical stimulation, electrotherapy, RCTs, controlled trials, evaluation, effectiveness, efficacy and outcomes.

Searching other resources

One non-electronic bibliographic database was also searched: Physiotherapy Index (up to September 2011), using the search terms given above. In addition, published abstracts presented at the International Continence Society, the European Association of Urology, the American Urogynaecology Society, and the American Urological Association have been reviewed (from 2000 to 2012) and cross-referenced to find if a full-length report has been published. Known trialists and other experts in the field have been contacted to ask for possible relevant trials, published or unpublished. Additional trials have been sought from the reference lists of included studies.

Data collection and analysis

Selection of studies

Only randomized and quasi-randomized controlled trials were included. Two review authors independently screened the list of titles and abstracts generated by our search. Full-text articles of potentially relevant studies were retrieved. Two review authors independently assessed the full-text articles for eligibility. We contacted study investigators as required. Any differences of opinion were resolved by discussion or involvement of a third party. Studies formally considered for the review but excluded were listed with reasons given for their exclusion.

Data extraction and management

Data extraction of the included studies was performed independently by two of the review authors (BB and EH) using a standardised form. Any disagreement was resolved by discussion or by consulting a third party (RdB or MO). Where there was insufficient information regarding the primary outcome in the published reports, study authors were contacted. For data entry, performed by BB and EH, Review Manager software (RevMan 5.2) was used. Processing of the included data of trials was according to the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Data were grouped by type of incontinence.

Assessment of risk of bias in included studies

The risk of bias in the included studies was assessed using the Cochrane risk of bias assessment tool (Higgins 2011). This included:

  • sequence generation,

  • allocation concealment,

  • blinding of participants or therapists,

  • blinding of outcome assessors,

  • completeness of outcome data,

  • selective outcome reporting, and

  • other potential sources of bias. 

Two of the review authors (BB and EH) independently assessed these domains. Any differences of opinion were resolved by consensus or by consulting a third party (MO).

Measures of treatment effect

Analyses were based on available data from all included trials relevant to the comparisons and outcomes of interest. For trials with multiple publications, only the most up-to-date or complete data for each outcome were included. Meta-analysis was undertaken where data were available from more than one study assessing the same outcome. A fixed-effect model was used for calculations of pooled estimates and their 95% confidence intervals. For categorical outcomes we related the numbers reporting an outcome to the numbers at risk in each group to calculate a risk ratio (RR) with 95% confidence interval (CI). For continuous variables we used means and standard deviations to calculate a mean difference (MD) with 95% confidence interval. If similar outcomes were reported on different scales, we calculated the standardised mean difference (SMD). We reversed the direction of effect, if necessary, to ensure consistency across trials. If data to calculate RRs or MDs were not given, we utilised the most detailed numerical data available to calculate the actual numbers or means and standard deviations (for example test statistics, P values).

Unit of analysis issues

The primary analysis was per man randomised.

Dealing with missing data

The data were analysed on an intention-to-treat basis, as far as possible, meaning that all participants must be analysed in the groups to which they were randomised. If this was not the case, we considered whether the trial should be excluded. Attempts were made to obtain missing data from the original trialists. However, if this was not possible, data were reported as given in the studies, except if there was evidence of differential loss to follow up from the randomised groups. In that case, the use of imputation of missing data was considered. If trials reported sufficient detail to calculate mean differences but gave no information on associated standard deviations (SD), the outcome was assumed to have a standard deviation (SD) equal to the highest SD from other trials within the same analysis.  

Assessment of heterogeneity

Trials were only combined if they were thought to be clinically similar. Heterogeneity between studies was assessed by visual inspection of plots of the data, the χ2 test for heterogeneity and the I2statistic (Higgins 2003; Higgins 2011). We defined the thresholds for interpretation of the I2 statistic according to the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Assessment of reporting biases

In view of the difficulty of detecting and correcting for publication bias and other reporting biases, the authors aimed to minimise their potential impact by ensuring a comprehensive search for eligible studies and by being alert for duplication of data.

Data synthesis

Trials were combined if interventions were similar, based on clinical criteria. To combine trial data, a meta-analysis was conducted and a fixed effect model approach to the analysis was used unless there was evidence of heterogeneity across studies.

Subgroup analysis and investigation of heterogeneity

Data were subgrouped, if possible, by the type of underlying urinary incontinence or lower urinary tract symptoms:

  • stress urinary incontinence;

  • detrusor overactivity with urgency urinary incontinence or symptoms of urgency, frequency and urgency urinary incontinence; or

  • mixed urinary incontinence (both stress and urgency urinary incontinence).

If heterogeneity between trials was sufficiently large, an investigation to identify its causes was conducted. The investigation of heterogeneity addressed populations and interventions in the individual trials. The investigation could also include subgroup analyses, meta-regression and sensitivity analyses. If heterogeneity remained after appropriate investigation and possible removal of outlying trials, a random-effects model was used in the meta analysis.

Sensitivity analysis

The effects of including or excluding trials at high risk of bias were investigated by means of sensitivity analyses.

Results

Description of studies

Results of the search

Our search strategy yielded 20 potentially eligible studies. All 20 studies were deemed to study ES protocols. For assessment of ES effect only six trials (five full publications: Hoffmann 2005; Moore 1999; Wille 2003; Yamanishi 2010; Yokoyama 2004; 1 abstract: Ceresoli 2002) could be included, whereas 14 studies were excluded. Closer investigation demonstrated that the abstract of Yamanishi 2006 and the full publication of Yamanishi 2010 were the same trial. The randomized clinical trial (RCT) of Yokoyama (Yokoyama 2004) was included but data were not usable as they were not presented in a format usable in the tables of comparison. The literature assessment process is documented with a PRISMA flow chart (Figure 1).

Figure 1.

PRISMA study flow diagram.

Included studies

Trial populations

All six included trials involved patients after radical prostatectomy. In total, 544 men were included of whom 305 received some form of ES and 239 a control or comparator treatment.

The trials were conducted at different time points:

This means that the study population of Wille 2003 might have consisted of men with and without urinary incontinence after radical prostatectomy, while in the other studies only patients with urinary incontinence after radical prostatectomy were included. So, based upon status of incontinence, study populations might already have been heterogeneous.

Trial interventions

The following interventions or management strategies were included:

The specific study characteristics (participants, interventions, etc.) of the six included RCTs are presented in the table Characteristics of included studies.

Electrical stimulation (ES) protocols

As in all other ES trials, the included trials showed considerable variation in design, parameters used and intensity of ES: 

As described above, the variety in the duration of each session of stimulation and the number of sessions was considerable. Frequencies used in the different studies varied between:

Also, intensity differed between trials:

  • in the Wille study patients could control intensity, from 10% to 100% of maximal intensity (Wille 2003);

  • whereas patients in the Moore study used ‘comfortable’ intensity (Moore 1999);

  • Yokoyama (Yokoyama 2004) reported a maximal output current of 24 mA;

  • in two studies an intensity of maximal output of 70 mA (Hoffmann 2005; Yamanishi 2010) was reported;

  • Ceresoli (Ceresoli 2002) used daily TENS, with intensity below the sensory threshold.  

In four trials a biphasic pulse shape was used, only Ceresoli (Ceresoli 2002) and Yokoyama (Yokoyama 2004) did not specify this. Pulse width was between 1 sec (Moore 1999; Wille 2003) and 250 msec (Hoffmann 2005). Yamanishi (Yamanishi 2010) and Yokoyama (Yokoyama 2004) reported a pulse duration of 300 μsec.

Excluded studies

Fourteen studies needed to be excluded, mainly because in these trials both men and women were included without separate reporting of results according to gender. Reasons for exclusion can be found in the table Characteristics of excluded studies.

Risk of bias in included studies

Specific characteristics, details of assessment, methodological quality and risk of bias of the included studies are presented in the table Characteristics of included studies and in Figure 2 and Figure 3.

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias 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

Random sequence generation (selection bias)

The method used for random sequence generation was unclear in 3/6 trials (Ceresoli 2002; Wille 2003; Yokoyama 2004). Three trials were judged to be at low risk of bias: Hoffmann 2005 and Yamanishi 2010 used computer-generated randomization; whereas Moore 1999 used a computer-generated random-number list.

Allocation concealment (selection bias)

Security of allocation concealment was unclear in 4/6 trials (Ceresoli 2002; Hoffmann 2005; Wille 2003; Yokoyama 2004). It was considered adequate in two trials: Moore 1999 reported that the "participants were assigned using a computer-generated random-number list placed in sealed envelopes at the end of the assessment visit, with patient and researcher opening the sealed envelope" whereas Yamanishi 2010 reported that "none of the patients, doctors or medical staff knew which type of stimulation had been assigned until the key code was opened".

Blinding

The doctors, nurses and medical staff were blinded in the trial conducted by Yamansihi and colleagues (Yamanishi 2010). Moore 1999 reported that the physiotherapists and the outcome assessors were blinded. Blinding of participants, personnel and outcome assessors was unclear in the other four trials (Ceresoli 2002; Hoffmann 2005; Wille 2003; Yokoyama 2004).

Incomplete outcome data

There were no missing data in one trial (Yokoyama 2004). Three trials reported dropouts resulting in incomplete outcome data, but these were evenly distributed across the groups (Moore 1999; Yamanishi 2010) or the information about the group distribution was not supplied (Wille 2003). In one trial we assumed that there were no missing data but the information was not provided (Ceresoli 2002). One trial was judged to be at high risk of bias because there was differential dropout (Hoffmann 2005).

Selective reporting

It was unclear if there was selective reporting of the outcomes in all six trials because the protocols were not available (Ceresoli 2002; Hoffmann 2005; Moore 1999; Wille 2003; Yamanishi 2010; Yokoyama 2004).

Other potential sources of bias

Information about other potential sources of bias was unclear in 3/6 trials (Ceresoli 2002; Moore 1999; Wille 2003). No other potential source of bias was found in 1/6 trials (Yokoyama 2004), whereas 2/6 trials were judged to be at high risk of bias (Hoffmann 2005; Yamanishi 2010). Support for these judgements are detailed under Characteristics of included studies and summarised in Figure 2 and Figure 3.

Outcome measures

Outcome measures in the included studies showed a lack of consistency. With regard to the primary outcomes of the included studies, objective measures were reported by Moore (Moore 1999), Ceresoli (Ceresoli 2002), Yokoyama (Yokoyama 2004) and Yamanishi (Yamanishi 2010) using a 24-hr pad test; Wille (Wille 2003) used a 20-min provocative pad test and Hoffmann (Hoffmann 2005) a 1-hr standardised pad test. Self report of cure or improvement using a visual analogue scale (VAS) was done only by Ceresoli (Ceresoli 2002) and Hoffmann (Hoffmann 2005). Micturition charts were used in the Wille (Wille 2003), Ceresoli (Ceresoli 2002) and Moore (Moore 1999) trials.  

Quality of life (QOL) as a secondary outcome measure, using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ), was measured by Hoffmann (Hoffmann 2005) and Moore (Moore 1999) while the latter also used the Incontinence Impact Questionaire (IIQ-7). In the study of Yokoyama (Yokoyama 2004) the Incontinence Quality of Life (I-QOL) was scored. The Incontinence Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and King's Health Questionnaire (KHQ) were secondary endpoints in Yamanishi (Yamanishi 2010).

Adherence to the protocol was measured by Moore (Moore 1999) and compliance was measured by Wille (Wille 2003) and Hoffmann (Hoffmann 2005).

There was no reporting of economic measures in any of the included studies. 

Effects of interventions

The specific characteristics and outcomes of the included studies are in the table 'Characteristics of included studies'. Data, when available, are summarised in the paragraph 'Comparisons and data'.

1. Electrical stimulation (ES) with non-implanted devices versus no active treatment

One trial addressed this comparison (Moore 1999). All the men had stress urinary incontinence at baseline. Moore compared anal electrical nerve stimulation with PFMT. The trial was too small to reliably detect differences between the groups (Analysis 1.1; Analysis 1.2).

2. Electrical stimulation (ES) with non-implanted devices versus placebo treatments

One RCT compared ES against placebo treatment (sham stimulation) (Yamanishi 2010). All the men had stress urinary incontinence.

Urinary incontinence

ES resulted in statistically significantly fewer incontinent men at 3 and 6 months (for example RR at 6 months 0.38, 95% CI 0.16 to 0.87, Analysis 2.1), but not at 12 months. Pad tests also showed less urine loss at 3, but not at 6 or 12 months (Analysis 2.2). These findings were reflected in the ICI-Questionaire (Short Form) data: the total score (range 0 to 21) was significantly less (better) at 3 and 6 months (MD -3.9, 95% CI -7.15 to -0.65, Analysis 2.3.2) although the QOL score (range 0 to 10) was only better at 3 months (MD -1.5, 95% CI -2.9 to -0.1, Analysis 2.4.1).

Adverse effects in the active ES group occurred in 2 of 26 men, and in 4 out of 30 men in the sham ES group (discomfort or anal pain) (Analysis 2.5).

3. Electrical stimulation with non-implanted devices versus other 'single' treatments

One small trial addressed this comparison (Yokoyama 2004) but it provided no useable data. There were no statistically significant differences between the groups but the trial was too small to detect them.

4. Electrical stimulation with non-implanted devices in combination with another therapy versus the other therapy alone

Four small trials addressed this comparison (Ceresoli 2002; Hoffmann 2005; Moore 1999; Wille 2003). All the men had stress urinary incontinence at baseline. The following interventions were compared:

Transcutaneous (anal) ES plus PFMT versus PFMT alone

All four trials provided information about the number of men with urinary incontinence at three months after treatment. There was no evidence of a difference in the number of men with urinary incontinence (RR 0.98, 95% CI 0.84 to 1.15, Analysis 4.1.1), nor in the pad test data (Analysis 4.7). However, one small trial suggested that men reported better QOL scores with PFMT alone (MD 2.34, 95% CI 0.07 to 4.61, Analysis 4.4.1). Overall, men reported more adverse effects with anal ES (20/79, 25% versus 2/99, 2% with PFMT alone; RR 9.77, 95% CI 2.42 to 39.44, Analysis 4.8.1).

Transcutaneous (perineal) ES plus PFMT versus PFMT alone

One trial used perineal ES (Hoffmann 2005). There was no statistically significant difference in the incontinence rate (Analysis 4.12). However, men reported better quality of life with PFMT (MD 6.51, 95% CI 4.70 to 8.32, Analysis 4.4.2) (Hoffmann 2005). There were too few adverse effects for meaningful analysis (Analysis 4.8.2).

Transcutaneous (any) ES plus PFMT versus PFMT alone

Ceresoli 2002 did not specify the method of transcutaneous ES. There was no statistically significant difference in the incontinence rate (Analysis 4.13). Men used fewer pads per day in the PFMT group (MD 1, 95% CI 0.53 to 1.47, Analysis 4.6,1) (Ceresoli 2002).

Transcutaneous (anal or perineal) ES plus PFMT versus PFMT alone

Overall, there was no evidence of a statistically significant difference in the number of men with urinary incontinence at 3 months (146/239, 61% for combined treatment versus 98/156, 63% with PFMT alone; RR 0.93, 95% CI 0.82 to 1.06, Analysis 4.1.3). However, there were more adverse effects (23/139, 17% versus 2/99, 2% with PFMT alone; RR 7.04, 95% CI 1.51 to 32.94, Analysis 4.8.3) and QOL also seemed better with PFMT alone (Analysis 4.4).

Based on these six trials there seems to be no additional value of the addition of ES to PFMT in men with stress urinary incontinence after a radical prostatectomy.

5. One method of providing electrical stimulation (ES) with non-implanted devices versus another method

One trial compared transcutaneous (anal) ES with PFMT versus transcutaneous (perineal) ES with PFMT (Hoffmann 2005). All the men had stress urinary incontinence at baseline.

This small trial did not detect statistically significant differences between the two methods of administration of transcutaneous ES (anal versus perineal) (Analysis 5.1; Analysis 5.2) but the QOL score was lower (better) in the anal stimulation group (Analysis 5.3).

Discussion

Value and benefits of electrical stimulation

Today, it is still very difficult to clarify the real value, potentials and benefits of electrical stimulation (ES) in the treatment of male urinary incontinence (Smith 2009). There are several reasons for this. First, the nomenclature used to describe electrical stimulation has been inconsistent, leading to confusion how to categorize ES. Stimulation has sometimes been described on the basis of the type of current being used (for example faradic stimulation, interferential therapy) but is also described on the basis of the structures being targeted (for example neuromuscular electrical stimulation), the current intensity (for example low-intensity stimulation, or maximal stimulation) and the proposed mechanism of action (for example neuromodulation). Second, in electrical stimulation studies many combinations of current types, amplitudes, types of waveforms, frequencies, intensities, electrode placements etc. are reported (Smith 2009). Third, although it has been suggested that ES as an intervention for urinary incontinence is using the natural neural pathways and micturition reflexes (Fall 1998; Yamanishi 1998a), and the understanding of both the neuro-anatomy and neurophysiology of the central and peripheral nervous systems is increasing, there is still lack of a well-substantiated biological rationale supporting the use of ES (Smith 2009).

Comparing ES in combination with another treatment modality with that treatment modality alone, there seems to be little to no additional value of the addition of ES to PFMT in men with stress urinary incontinence after a radical prostatectomy. However, this conclusion should be taken with caution because in all four included RCTs the number of included participants was relatively small. There were too few data to draw final conclusions about the effects of ES with non-implantable devices.

Summary of main results

One small trial showed that ES was more effective than sham treatment in the first few months in both urinary outcomes and quality of life (QOL), but this did not persist after six months (Yamanishi 2010).

There was not enough evidence from four small trials to suggest that supplementing ES with PFMT resulted in better urinary outcomes than with PFMT alone (Analysis 4.1), but there were more adverse effects (Analysis 4.4). However, the QOL score was lower (better) in the anal stimulation group than in the perineal group (Analysis 5.3).

Of the included trials, Ceresoli (Ceresoli 2002) and Wille (Wille 2003) did not report any adverse event or side effect. It remains unclear whether these were not reported or that there were no adverse events or side effects in these trials. The other four trials reported that a minority of ES patients suffered from discomfort from the electrode, pain or an increase in incontinence symptoms in such way that they dropped out. Most reported side effects were pain, soreness or local irritation and psychological distress.

Therefore there was not enough evidence for or against ES, partly due to the variability in the interventions of the included trials and their small size.

Overall completeness and applicability of evidence

Patient selection and electrical stimulation protocols

There were many differences in the populations, the intervention protocols and the timing of the outcome measures in the included trials, as summarised above. As all the trials included men with stress urinary incontinence, it was not possible to determine the effect of ES on other types of incontinence such as urgency. The trials were also confined to men who had undergone a prostatectomy.

Five of the six included studies used surface anal electrodes, Hoffmann et al (Hoffmann 2005) also used transcutaneous (anal and perineal) ES. Ceresoli (Ceresoli 2002) used  a transcutaneous electrode. Although both anal and surface electrodes have been reported to be safe (Yamanishi 2000a), sometimes patients do not tolerate anal plug electrode because of pain, discomfort, mucosal injury or exacerbation of haemorrhoids (Moore 1999).

Most often intensity of stimulation is used up to the maximum tolerable level, because many authors report that the stronger the intensity the better the outcome (Geirsson 1997; Sand 1995; Yamanishi 1997a; Yamanishi 1998a; Yamanishi 2000a; Yashuda 1999). In the included studies frequencies and duration of the stimulation and the number of sessions varied depending on the investigators. Hoffmann (Hoffmann 2005) and Yamanishi (Yamanishi 2010) used a maximal amplitude of 70 mA, Moore (Moore 1999) reported the use of intensities "adequate to induce a visual lifting of the levator ani and pubococcygeus muscle, considering the level of comfort of the patients", Wille (Wille 2003) instructed patients to control intensity of current ‘from 10% to 100%’. Although it is not clear yet whether or not maximal tolerable intensity of current really is necessary to get an optimal result of ES therapy, it might be that in the included studies intensity of current was not adequate or sufficient to reach an optimal result.

All six trials reported some of the primary outcome measures of interest, that is patient perceived urinary incontinence, pad tests and condition specific QOL. However, none of the trials used the same subjective outcome measures. Regarding pad tests, Moore (Moore 1999), Ceresoli (Ceresoli 2002), Yamanishi (Yamanishi 2010) and Yokoyama (Yokoyama 2004) used a 24-hr pad test, while Hoffmann (Hoffmann 2005) used a 1-hr pad test and Wille (Wille 2003) a 20-min pad test. As a result, the amount of data available for meta-analysis was very limited, making interpretation of results difficult.

In all but one (Yokoyama 2004) of the six RCTs, ES was combined with PFMT. Because of this, it is difficult to assess any specific effect of ES (as could have been the case if ES was provided as a stand-alone therapy). Especially when ES is combined with PFMT, any effect may be partly due to the attention and support given to patients during their clinic sessions (Moore 1999). Both Moore et al (Moore 1999) and Hoffman et al (Hoffmann 2005) discussed that these non-specific effects might have contributed to the effect of ES.

Quality of the evidence

Study quality and methodological assessment

Various conservative treatment modalities for the management of stress, mixed, and urgency urinary incontinence are available. ES is used alone or as an adjunct to one of other eligible physiotherapeutic treatment modalities such as PFMT. All but one of the included trials in this review used ES as an adjunct to PFMT.

Only a small number of RCTs investigating the effect of ES could be identified.
When assessing methodological quality, the primary goal is to assess the reported effects of interventions and the influence, risk and direction of bias on the results of these treatments as methodological quality plays an important role in weighing the conclusions of different trials. In order to explore the possibility that an increasing likelihood of bias was reflected in the results of the trials (through an increasing number of methodological shortcomings), the 'Risk of bias' criteria presented in The Cochrane Handbook for Systematic Reviews of Intervention, were assessed.

The risk of bias in the six included studies appeared to range from low to high risk of bias. Allocation concealment and blinding were unclear in more than half of the studies while incomplete outcome reporting and selective reporting were identified in about 40% and 14% respectively, and other potential bias in 40% of the studies. So, bias with respect to measurement, intervention or allocation might have been introduced. None of the studies reported whether or not they had performed an intention-to-treat analysis. A power calculation was only performed by Moore et al (Moore 1999) and Yamanishi et al (Yamanishi 2010). It might be that studies were underpowered to find any statistical differences between study groups.

Because of small numbers per group in the included RCTs, occurrence of type II-errors was more likely than would have been the case in RCTs with larger groups.

Apart from Ceresoli et al (Ceresoli 2002), all included RCTs had sufficient descriptions of the content, the duration and the intensity of the interventions.

Potential biases in the review process

None known

Authors' conclusions

Implications for practice

The six small included trials were of disparate populations and interventions, limiting our ability to combine the data. There was some evidence that electrical stimulation (ES) enhanced the effect of PFMT in the short term but not after six months. There were, however, more adverse effects with ES.

There was a marked lack of consistency in the ES protocols, which implies a lack of consensus about the physiological principles of rehabilitating urinary incontinence in men through ES in clinical practice.

Since no RCTs on ES were available for any type of urinary incontinence other than post-prostatectomy stress urinary incontinence, at the moment it is not possible to reach any conclusion on effects, side effects or adverse events of ES as a-stand alone therapy or in combination with other treatments on men with other types of urinary incontinence. 

In men with stress urinary incontinence after radical prostatectomy, up till now there is no convincing evidence from RCTs that ES is a useful treatment. So far, it is impossible to recommend the optimal ES regimen and protocol.

Implications for research

Because of the scanty evidence of an effect of ES on incontinence in men, and the lack of agreement about the correct mode of administration, duration and frequency of treatment, there is a need to design rigorous trials to determine whether there is a place for ES in the management of men with stress urinary incontinence. Any trialists should use the recommendations and principles set out in the CONSORT statement when designing and reporting their trials.

There is a need for more research to determine the best ES protocol(s) and important standardised outcome measures for these men. Future trials should follow the recommendations and principles of the CONSORT statement and should include primary and secondary outcomes which are most suitable (with respect to sensitivity, responsiveness, validity, and reliability).

Acknowledgements

The authors would like to acknowledge the team of the Cochrane Incontinence Review Group for their help.

Data and analyses

Download statistical data

Comparison 1. ES with non-implanted devices versus no active treatment
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of men with urinary incontinence1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 3 months: Anal ES + PFMT vs standard treatment1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 6 months: Anal ES + PFMT vs standard treatment0 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.3 12 months: Anal ES + PFMT vs standard treatment0 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 24-hr pad test (grams of urine lost)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
2.1 <3 months: Anal ES + PFMT vs standard treatment1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
2.2 3 months: Anal ES + PFMT vs standard treatment1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
2.3 6 months: Anal ES + PFMT vs standard treatment1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 1.1.

Comparison 1 ES with non-implanted devices versus no active treatment, Outcome 1 Number of men with urinary incontinence.

Analysis 1.2.

Comparison 1 ES with non-implanted devices versus no active treatment, Outcome 2 24-hr pad test (grams of urine lost).

Comparison 2. ES with non-implanted devices versus placebo
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of men with urinary incontinence1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 Urinary incontinence at 3 months1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Urinary incontinence at 6 months1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.3 Urinary incontinence at 12 months1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 24-hr Pad test (grams loss of urine)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
2.1 Urine loss at 3 months1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
2.2 Urine loss at 6 months1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
2.3 Urine loss at 12 months1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
3 Urinary incontinence score (Short Form International Consultation of Incontinence Score1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
3.1 Score at 3 months1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
3.2 Score at 6 months1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
3.3 Score at 12 months1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
4 Quality of life score: International Consultation of Incontinence Questionnaire1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
4.1 Score at 3 months1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
4.2 Score at 6 months1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
4.3 Score at 12 months1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
5 Adverse events1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
5.1 During treatment1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 2.1.

Comparison 2 ES with non-implanted devices versus placebo, Outcome 1 Number of men with urinary incontinence.

Analysis 2.2.

Comparison 2 ES with non-implanted devices versus placebo, Outcome 2 24-hr Pad test (grams loss of urine).

Analysis 2.3.

Comparison 2 ES with non-implanted devices versus placebo, Outcome 3 Urinary incontinence score (Short Form International Consultation of Incontinence Score.

Analysis 2.4.

Comparison 2 ES with non-implanted devices versus placebo, Outcome 4 Quality of life score: International Consultation of Incontinence Questionnaire.

Analysis 2.5.

Comparison 2 ES with non-implanted devices versus placebo, Outcome 5 Adverse events.

Comparison 4. ES with non-implanted devices combined with other therapy versus other therapy without ES
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of men with urinary incontinence (subjective): at 3 months4 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 Transcutaneous (Anal) ES + PFMT vs PFMT alone3269Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.84, 1.15]
1.2 Transcutaneous (Perineal) ES + PFMT vs PFMT1111Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.92, 1.04]
1.3 ES (not specified) + PFMT vs PFMT170Risk Ratio (M-H, Fixed, 95% CI)0.49 [0.21, 1.14]
1.4 Transcutaneous ES (any) + PFMT vs PFMT alone4395Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.82, 1.06]
2 Number of men with urinary incontinence (subjective): at 6 months1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2.1 Transcutaneous ES + PFMT vs PFMT1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
3 Number of men with urinary incontinence (subjective): at 12 months1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
3.1 Anal ES + PFMT vs PFMT1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
4 Quality of life (EORTC QLQ 30)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
4.1 Transcutaneous (Anal) ES + PFMT vs PFMT1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
4.2 Transcutaneous (Perineal) ES + PFMT vs PFMT1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
5 Number of men with urinary incontinence (objective): anal ES1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
5.1 Anal ES + PFMT vs PFMT alone1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
6 Mean number of pads/day (from voiding diary)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
6.1 Transcutaneous ES + PFMT vs PFMT1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
7 24-hr pad test (grams of urine lost)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
7.1 <3 months: Anal ES + PFMT vs PFMT alone1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
7.2 3 months: Anal ES + PFMT vs PFMT alone1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
7.3 6 months: Anal ES + PFMT vs PFMT alone1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
8 Adverse effects2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 Transcutaneous (Anal) ES + PFMT vs PFMT alone2178Risk Ratio (M-H, Fixed, 95% CI)9.77 [2.42, 39.44]
8.2 Transcutaneous (Perineal) ES + PFMT vs PFMT1120Risk Ratio (M-H, Fixed, 95% CI)7.0 [0.37, 132.66]
8.3 Transcutaneous (any) ES + PFMT vs PFMT alone2238Risk Ratio (M-H, Fixed, 95% CI)7.04 [1.51, 32.94]
Analysis 4.1.

Comparison 4 ES with non-implanted devices combined with other therapy versus other therapy without ES, Outcome 1 Number of men with urinary incontinence (subjective): at 3 months.

Analysis 4.2.

Comparison 4 ES with non-implanted devices combined with other therapy versus other therapy without ES, Outcome 2 Number of men with urinary incontinence (subjective): at 6 months.

Analysis 4.3.

Comparison 4 ES with non-implanted devices combined with other therapy versus other therapy without ES, Outcome 3 Number of men with urinary incontinence (subjective): at 12 months.

Analysis 4.4.

Comparison 4 ES with non-implanted devices combined with other therapy versus other therapy without ES, Outcome 4 Quality of life (EORTC QLQ 30).

Analysis 4.5.

Comparison 4 ES with non-implanted devices combined with other therapy versus other therapy without ES, Outcome 5 Number of men with urinary incontinence (objective): anal ES.

Analysis 4.6.

Comparison 4 ES with non-implanted devices combined with other therapy versus other therapy without ES, Outcome 6 Mean number of pads/day (from voiding diary).

Analysis 4.7.

Comparison 4 ES with non-implanted devices combined with other therapy versus other therapy without ES, Outcome 7 24-hr pad test (grams of urine lost).

Analysis 4.8.

Comparison 4 ES with non-implanted devices combined with other therapy versus other therapy without ES, Outcome 8 Adverse effects.

Comparison 5. One type of ES with non-implanted devices versus other ES
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Patient perceived recovery (dichotomous scales)1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 Stress urinary incontinence1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Urgency urinary incontinence0 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.3 Mixed urinary incontinence0 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.4 Urinary incontinence: stress, urgency or mixed UI0 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 1-hr PAD test (grams loss of urine)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
2.1 Stress urinary incontinence1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
2.2 Urgency urinary incontinence0 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
2.3 Mixed urinary incontinence0 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
2.4 Urinary incontinence: stress, urgency or mixed UI0 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
3 Quality of life (EORTC QLQ 30)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
3.1 Stress urinary incontinence1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 5.1.

Comparison 5 One type of ES with non-implanted devices versus other ES, Outcome 1 Patient perceived recovery (dichotomous scales).

Analysis 5.2.

Comparison 5 One type of ES with non-implanted devices versus other ES, Outcome 2 1-hr PAD test (grams loss of urine).

Analysis 5.3.

Comparison 5 One type of ES with non-implanted devices versus other ES, Outcome 3 Quality of life (EORTC QLQ 30).

Contributions of authors

All review authors contributed in the writing of the protocol. Authors Bary Berghmans, Erik Hendriks and Rob de Bie independently assessed the pertinence and quality of eligible studies and selected which to include in the review. The first two review authors independently extracted data from trial reports of identified studies and interpreted the results. Muhammad Imran Omar re-checked extracted data and risk of bias assessments and offered methodological advice and help. In the case of  disagreement Rob de Bie and Muhammad Imran Omar acted as consultants and helped to make final decisions. All review authors contributed in the writing of the final version of the review.

Declarations of interest

None known

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • NIHR, UK.

    The National Institute for Health Research (NIHR) is the largest single funder of the Cochrane Incontinence Group. 

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ceresoli 2002

Methods2-arm Randomized Controlled Trial
Participants

Participants underwent post-radical perineal prostatectomy for localized prostate cancer with post-operative (stress) incontinence

Age: not specified

Interventions

A (n=34): Daily Transcutaneous Electrical Nerve Stimulation (DTENS) + PFMT based on Kegel's exercises

B (n=36): PFMT based on Kegel's exercises (control group)

Length of follow-up: not reported

Number of dropouts not reported

Outcomes

Continence described according to Catalona's definition and measured with

- subjective visual analogue scale of improvement

- mean number of pads used daily

- 24-hour pad test: maximal speed of recovery from incontinence, grams/month

Data collected at 1, 4, and 6 months post-operatively

Number of men dry at 4 months: A 82%, B 65% (wet: A 6/34, B 13/36)

Number of men dry at 6 months: A 87%, B 76% (wet: A 4/34, B 9/36)

Number of pads (mean per day): A 1, B 1.5 (no SDs given)

NotesOnly abstract available.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskReported as "randomized trial" but method of sequence generation not specified
Allocation concealment (selection bias)Unclear riskReported as "randomized trial" but method of allocation concealment not specified
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot specified
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot specified
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo information or reporting about attrition and exclusions (we assumed there were no dropouts)
Selective reporting (reporting bias)Unclear riskAssessment is based upon the published abstract. Complete report of the trial and the protocol not available.
Other biasUnclear riskInformation not provided about the method of statistical analysis; lost to follow-up (if any); dropouts (if any), and whether or not intention-to-treat analysis (ITT) performed.

Hoffmann 2005

Methods3-arm Randomized Controlled Trial
Participants

Participants underwent radical retropubic prostatectomy with post-operative grade 3 SUI
Mean age: 65.0 years

Inclusion: between 12 and 35 days post-surgery

Interventions

A (n=60): Transcutaneous (perineal) ES (20 minutes, max amp 70 mA, pulse width 250 ms, frequency 14 Hz, biphasic) + PMFT
B (n=60): Transcutaneous (anal) ES (same parameters as perineal ES) + PMFT
C (n=60): PMFT thrice a week, group training 30 minutes (control group)

Length of follow-up: 3 months after discharge

Outcomes

Incontinence defined as "self reports of incontinence" and measured with:

  • 1-hour ICS pad test

  • VAS-incontinence

  • Uroflowmetry

Quality of life measured with EORTC QLQ C30

Number of men with incontinence at end of treatment: A 54/56, B 37/38, C 54/55

Adverse effects leading to dropout: A 2/60 (discomfort) + 2/60 (pain); B 16/60 (discomfort) + 4/60 (pain); C 0/60

Deterioration in SUI: A 1/60, B 2/60, C 0/60

NotesAuthors state that additional use of ES was only significantly superior to PFMT alone in a highly compliant subgroup. Dropouts: 22 out of 60 in anal ES group, 4 out of 60 in perineal ES group. No reasons for dropouts given. High score on device errors and lack of patient compliance.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomization
Allocation concealment (selection bias)Unclear riskMethod of allocation concealment not specified
Blinding (performance bias and detection bias)
All outcomes
Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information to permit judgement
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes
High riskDropouts: 22 out of 60 in anal ES group, 4 out of 60 in perineal ES group. No reasons for dropouts given.
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasHigh riskNo intention-to-treat analysis; insufficient information on methods of statistical analysis; interventions unclear and insufficiently specified.

Moore 1999

Methods3-arm Randomized Controlled Trial
ParticipantsParticpants were post-radical prostatectomy patients with incontinence based on 24-hour pad test and questionnaires (Incontinence Impact Questionnaire IIQ7 and EORTC QLQ C30)
Age: mean 67 years (range 49 to 77 years)
Interventions

A (n=21): PFMT in outpatient clinic 2 per week for 12 weeks + home exercises
B (n=21): PFMT in outpatient clinic 2 per week for 12 weeks + ES via surface anal electrode + home exercise

C (n=21): pre and post-operative oral and written information about PFMT

Home exercises: 12-20 contractions of 5-10 seconds, 8-10 contractions of 20-30 seconds and repetitive contractions in 10 seconds 3 per day

Length of follow up was 24 weeks

Outcomes

Reported following outcomes:

  • Continence defined as less than or equal to 2 gm urine per 24 hours

  • Urine loss (measured by 24-hour pad test)

  • Quality of life:

    • Incontinence Impact Questionnaire

    • European Organization for the Research and Treatment of Cancer-EORTC QLQ C-30

    • Physical symptom inventor

Data collection: baseline and at 12 weeks, 16 weeks and 24 weeks

Number of incontinent men at 3 months: A 12/18, B 11/19, C 14/21

Number of incontinent men at 6 months: A 8/18, C 7/21 (B not given)

24 hour pad test (grams urine lost, mean (SD) n):

  • At 3 months: A 87 (123) 18, B 156 (168) 19, C 104 (176) 21

  • At 6 months: A 74 (131) 18, B 202 (242) 19, C 67 (137) 21

  • At 12 months: A 70 (114) 17, B 98 (132) 19, C 54 (103) 21

Adverse effects: A 2/18 (anal pain), B 0/19, C 0/21

NotesPower calculation performed.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Participants were assigned using a computer-generated random-number list placed in sealed envelopes at the end of the assessment visit, with patient and researcher opening the sealed envelope"
Allocation concealment (selection bias)Low risk"participants were assigned using a computer-generated random-number list placed in sealed envelopes at the end of the assessment visit, with patient and researcher opening the sealed envelope"
Blinding (performance bias and detection bias)
All outcomes
Unclear riskBlinding to intervention not possible, however outcome assessor was blinded
Blinding of participants and personnel (performance bias)
All outcomes
Low riskPhysiotherapists were blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessors were blinded
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk"Five dropouts, three with bladder neck contractures requiring dilatation, one with rectal pain when doing the exercise and one unable to complete therapy while on vacation." However, there was no differential dropout from one group.
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasUnclear riskIntention-to-treat-analysis not performed.

Wille 2003

Methods3-arm Randomized Controlled Trial
ParticipantsParticipants undergoing radical prostatectomy with post-operative urinary incontinence
Age: mean 64.6 (in group A and B) and 65.9 (group C)
Interventions

A (n=47): PFMT

B (n=46): PFMT + ES via surface anal electrode with a bio-impulser for 15 minutes

C (n=46): PFMT + ES + biofeedback 15 minutes sessions two times per day for 3 months

All groups received instructions about PFMT by physiotherapist

They were instructed to perform PFMT for 20 to 30 minutes, two times per day for 3 months plus 3 weeks of rehabilitation programme after discharge. There was regular interaction with the healthcare professional and the patient during the first 6 weeks after surgery.

Length of follow up was 12 months

Outcomes

The following outcomes were reported at baseline, 3 months and 12 months post-operatively:

  • Urine loss measure by questionnaire (subjective) and 20 minutes provocative mean pad test (objective)

  • Quality of life EORCT QLQ-C30: scores for physical; role; emotional; social; and global quality of life were not significantly different between the groups at 3 or 12 months (no SDs provided)

Continence defined as reported use of 0 to1 pads by questionnaire (subjective outcome)

Wet at 3 months: A 19/47, B 16/46, C 22/46

Wet at 12 months: A 6/47, B 9/46, C 5/46

Number of participants with loss of <1 gram of urine on pad test (objective outcome)

Wet at 12 months: A 9/47, B 8/46, C 4/46

Willingness to undergo surgery again (satisfaction): A 73%, B 83%, C 73%

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskReported as "prospective randomized trial" but method of sequence generation not specified
Allocation concealment (selection bias)Unclear riskReported as "prospective randomized trial" but method of sequence generation not specified
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot specified
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot specified
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk"Resuts at baseline after catheter removal, at 3 and 12 months postoperatively were available for 139, 120 and 128 (questionnaires at three different time points) and 116, 79 and 124 (pad test at three different time points) patients, respectively". However, no information about individual groups.
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasUnclear riskReasons for dropouts not provided.

Yamanishi 2010

Methods2-arm Randomized Controlled Trial
Participants

Men with severe urinary incontinence (> 200 gram daily) after radical prostatectomy
Mean age: mean (SD) 66.2 (6.2) Range [50 to 76]

Inclusion criteria: UI > 200 gram daily after removal of catheter, no residual cancer after radical prostatectomy on pathological examination

Exclusion criteria: Participants on anticholinergics or tricyclic antidepressants, neurological disorders and urethral strictures

Interventions

Participants were taught by nurses about PFMT before the surgery and continued at the follow-up visits

A (n=26) intervention: PFMT plus anal electrical stimulation for 15 minutes twice daily (50 Hz square waves with 300 μsec pulse duration, maximum output 70mA (5 seconds on, 5 seconds off-duty cycle)

B (n=30) control: PFMT plus sham stimulation (output 3mA, 2 seconds on, 13 seconds off-duty cycle)

Length of follow up: 1 months, 3 months , 6 months and 12 months after treatment

Outcomes

Number of incontinent men

24 hour pad test weights

ICIQ-SF score

ICIQ-QoL score

Time until continent in months

Adverse effects

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Randomisation was done by computer"
Allocation concealment (selection bias)Low risk"None of the patients, doctors or medical staff knew which type of stimulation had been assigned until the key code was opened"
Blinding (performance bias and detection bias)
All outcomes
Low riskSeems to be adequate, but no report when key-code was broken
Blinding of participants and personnel (performance bias)
All outcomes
Low riskBlinding of doctors, nurses and medical staff
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBlinding of assessors, medical staff
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskIt is reported that "In the active ES group 2 patients discontinued after 2 and 3 months, respectively, due to urethral stricture at the bladder neck. In the sham group 1 patient discontinued treatment at 7 months because of an increase in prostate specific antigen and he then underwent radiation therapy." However, there is no evidence that dropout was related to trial interventions.
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasHigh riskNumber of dropouts given, but reasons not specified.

Yokoyama 2004

  1. a

    List of abbreviations

    (D)TENS: (Daily) Transcutaneous electrical nerve stimulation

    ES: Electrical stimulation

    GSI: Genuine stress incontinence

    Hz: Hertz

    ICS: International Continence Society
    IEF: Incontinence episodes frequency
    IFT: Interferential therapy
    Imax: Maximal tolerable intensity

    I-QOL: Incontinence Quality of Life

    MES: Magnetic electrical stimulation

    MUI: Mixed urinary incontinence

    PFM: Pelvic floor muscle(s)

    PFMT: Pelvic floor muscle training
    OAB: Overactive bladder
    QOL: Quality of life
    RCT: Randomized clinical trial
    SUI: Stress urinary incontinence
    USUI: Urodynamic stress urinary incontinence
    UUI: Urgency urinary incontinence

Methods3-arm Randomized Controlled Trial
Participants

Recruitment: Post-operative

Included: 36 men with urinary incontinence after retropubic radical prostatectomy with incontinence defined as >100 gram on 24-hour pad test, one day after catheter removal

Mean age (SD): Group A 67.2 (6.7) years, Group B 68.2 (4.9) years, Group C 66.2 (7.6) years

Interventions

A (n=12) intervention: anal electrode for 15 minutes twice a day for 1 month

B (n=12) intervention: extracorporeal magnetic innervation, neocontrol system, treatment sessions 20 minutes, twice a week for 2 weeks

C (n=12) control: PFMT, digital anal teaching of correct contractions, then verbal and written instructions for home practice

Length of follow up: 6 months

Outcomes

24-hour pad test weight (grams):

3 months: A 34 gram, B 7.3 gram, C 50 gram

6 months: For all groups less than 10 gram

Quality of Life measured by I-QOL: Improvement in all groups over time, no statistically significant difference between the groups

Remaining UI at 6 months: A 2/12, B 1/12, C 2/12

Notes

Dropouts: It appears that there are no drop outs but this was not specifically mentioned.

Side effects: No complaints about discomfort or irritation from the probe.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk".........randomly assigned to three groups....." no further details about sequence generation provided
Allocation concealment (selection bias)Unclear risk".........randomly assigned to three groups....." no further details about allocation concealment provided
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot specified
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot specified
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow riskIt appears that there are no dropouts but this was not specifically mentioned. Study appears to be free of other sources of bias.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Bocker 2002Men (post-prostatectomy) and women (with post-polio syndrome) included, no separate reporting of results
Goode 2009No analysis of separate results of ES possible, because ES always combined with biofeedback
Hasan 1994Both men and women included, without separate reporting of results
Lin 2004Both full-text report and abstract only available in the Chinese language
Mariotti 2009No analysis of separate results of ES possible, because ES always combined with biofeedback
McClurg 2008Both men and women included, without separate reporting of results
Petersen 1994Not an RCT, consecutive patients. Neurogenic urinary incontinence due to neurogenic detrusor overactivity in both men and women without separate reporting
Soomro 2001Both men and women included, without separate reporting of results
Walsh 2001Both men and women included, without separate reporting of results
Webb 1992Both men and women included, without separate reporting of results
Yamanishi 1997aBoth men and women included, without separate reporting of results
Yamanishi 1998aBoth men and women included, without separate reporting of results
Yamanishi 2000aBoth men and women included, without separate reporting of results
Yasuda 1994Both men and women included, without separate reporting of results

Ancillary