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

  • Major change
  • Protocol
  • Intervention

Authors


Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

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 (ES) with non-implanted devices versus no treatment.

2. ES with non-implanted devices versus placebo treatments.

3. ES 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. ES with non-implanted devices in combination with another therapy versus the other therapy alone (e.g. pelvic floor muscle training (PFMT)).

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

Background

Description of the condition

World wide, urinary incontinence in men is a common problem. In western countries, estimates of prevalence rates in men 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 and aimed 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 a 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 μsec (Smith 2009), 300 μsec (Yamanishi 2010), 400 to 600 μsec (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 the duration depends 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), 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 is 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 ES would 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 those 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. These 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).  

ES may be used as stand-alone therapy or in combination with pelvic floor muscle training (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 is to assess the effects of ES in adult men with stress, urgency, 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 will only deal with non-implanted electrodes in this review, there will be no overlap with that review.

Definitions and classifications used in this review will be 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 (ES) with non-implanted devices versus no treatment.

2. ES with non-implanted devices versus placebo treatments.

3. ES 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. ES with non-implanted devices in combination with another therapy versus the other therapy alone (e.g. pelvic floor muscle training (PFMT)).

5. One method of providing ES 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 ES for the management of urinary incontinence will be included. Other forms of clinical trials will be excluded. As well as trials reported as full-text, we will include trials for which only abstracts are 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 use 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 will be 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 will be taken into account.

Comparator interventions to include:

  • PFMT,

  • bladder training,

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

  • surgery,

  • implantable ES 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 will not impose any language or other limits on the searches described below.

Electronic searches

Relevant trials will be 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 we use 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 will be 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 to be used are: 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 will also be 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 will be 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 will be contacted to ask for possible relevant trials, published or unpublished. Additional trials will be sought from the reference lists of included studies.

Data collection and analysis

Selection of studies

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

Data extraction and management

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

Data will be grouped by type of incontinence.

Assessment of risk of bias in included studies

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

  • 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) will independently assess these domains. Any differences of opinion will be resolved by consensus or by consulting a third party (MO).

Measures of treatment effect

Analyses will be 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 will be included. Meta-analysis will be undertaken where data are available from more than one study assessing the same outcome. A fixed-effect model will be used for calculations of pooled estimates and their 95% confidence intervals. For categorical outcomes we will relate 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 will use means and standard deviations to calculate a mean difference (MD) with 95% CI. If similar outcomes are reported on different scales, we will calculate the standardised mean difference (SMD). We will reverse the direction of effect, if necessary, to ensure consistency across trials. If data to calculate RRs or MDs are not given, we will utilise 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 will be per man randomized.

Dealing with missing data

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

Assessment of heterogeneity

Trials will only be combined if they are thought to be clinically similar. Heterogeneity between studies will be assessed by visual inspection of plots of the data, the χ2 test for heterogeneity and the I2statistic (Higgins 2003; Higgins 2011). We will define 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 will aim to minimise their potential impact by ensuring a comprehensive search for eligible studies and by being alert for duplication of data.

Data synthesis

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

Subgroup analysis and investigation of heterogeneity

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

Sensitivity analysis

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

Acknowledgements

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

What's new

DateEventDescription
1 May 2013New citation required and major changesNew protocol

Contributions of authors

All review authors contributed in the writing of the protocol. B Berghmans, Erik Hendriks and Rob de Bie will independently assess the pertinence and quality of eligible studies to be included in the review. The first two review authors will independently extract data from trial reports of identified studies and will interpret the results. M Omar will re-check the extracted data and risk of bias assessments, and will offer methodological advice and help. In the case of  disagreement Rob de Bie and M Omar will act as consultants and will help to make final decisions.

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. 

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