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Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women

Abstract

Background

Pelvic floor muscle training (PFMT) is the most commonly used physical therapy treatment for women with stress urinary incontinence (SUI). It is sometimes also recommended for mixed urinary incontinence (MUI) and, less commonly, urgency urinary incontinence (UUI).

This is an update of a Cochrane Review first published in 2001 and last updated in 2014.

Objectives

To assess the effects of PFMT for women with urinary incontinence (UI) in comparison to no treatment, placebo or sham treatments, or other inactive control treatments; and summarise the findings of relevant economic evaluations.

Search methods

We searched the Cochrane Incontinence Specialised Register (searched 12 February 2018), which contains trials identified from CENTRAL, MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP, handsearching of journals and conference proceedings, and the reference lists of relevant articles.

Selection criteria

Randomised or quasi‐randomised controlled trials in women with SUI, UUI or MUI (based on symptoms, signs or urodynamics). One arm of the trial included PFMT. Another arm was a no treatment, placebo, sham or other inactive control treatment arm.

Data collection and analysis

At least two review authors independently assessed trials for eligibility and risk of bias. We extracted and cross‐checked data. A third review author resolved disagreements. We processed data as described in the Cochrane Handbook for Systematic Reviews of Interventions. We subgrouped trials by diagnosis of UI. We undertook formal meta‐analysis when appropriate.

Main results

The review included 31 trials (10 of which were new for this update) involving 1817 women from 14 countries. Overall, trials were of small‐to‐moderate size, with follow‐ups generally less than 12 months and many were at moderate risk of bias. There was considerable variation in the intervention’s content and duration, study populations and outcome measures. There was only one study of women with MUI and only one study with UUI alone, with no data on cure, cure or improvement, or number of episodes of UI for these subgroups.

Symptomatic cure of UI at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT groups were eight times more likely to report cure (56% versus 6%; risk ratio (RR) 8.38, 95% confidence interval (CI) 3.68 to 19.07; 4 trials, 165 women; high‐quality evidence). For women with any type of UI, PFMT groups were five times more likely to report cure (35% versus 6%; RR 5.34, 95% CI 2.78 to 10.26; 3 trials, 290 women; moderate‐quality evidence).

Symptomatic cure or improvement of UI at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT groups were six times more likely to report cure or improvement (74% versus 11%; RR 6.33, 95% CI 3.88 to 10.33; 3 trials, 242 women; moderate‐quality evidence). For women with any type of UI, PFMT groups were two times more likely to report cure or improvement than women in the control groups (67% versus 29%; RR 2.39, 95% CI 1.64 to 3.47; 2 trials, 166 women; moderate‐quality evidence).

UI‐specific symptoms and quality of life (QoL) at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT group were more likely to report significant improvement in UI symptoms (7 trials, 376 women; moderate‐quality evidence), and to report significant improvement in UI QoL (6 trials, 348 women; low‐quality evidence). For any type of UI, women in the PFMT group were more likely to report significant improvement in UI symptoms (1 trial, 121 women; moderate‐quality evidence) and to report significant improvement in UI QoL (4 trials, 258 women; moderate‐quality evidence). Finally, for women with mixed UI treated with PFMT, there was one small trial (12 women) reporting better QoL.

Leakage episodes in 24 hours at the end of treatment: PFMT reduced leakage episodes by one in women with SUI (mean difference (MD) 1.23 lower, 95% CI 1.78 lower to 0.68 lower; 7 trials, 432 women; moderate‐quality evidence) and in women with all types of UI (MD 1.00 lower, 95% CI 1.37 lower to 0.64 lower; 4 trials, 349 women; moderate‐quality evidence).

Leakage on short clinic‐based pad tests at the end of treatment: women with SUI in the PFMT groups lost significantly less urine in short (up to one hour) pad tests. The comparison showed considerable heterogeneity but the findings still favoured PFMT when using a random‐effects model (MD 9.71 g lower, 95% CI 18.92 lower to 0.50 lower; 4 trials, 185 women; moderate‐quality evidence). For women with all types of UI, PFMT groups also reported less urine loss on short pad tests than controls (MD 3.72 g lower, 95% CI 5.46 lower to 1.98 lower; 2 trials, 146 women; moderate‐quality evidence).

Women in the PFMT group were also more satisfied with treatment and their sexual outcomes were better. Adverse events were rare and, in the two trials that did report any, they were minor. The findings of the review were largely supported by the ‘Summary of findings’ tables, but most of the evidence was downgraded to moderate on methodological grounds. The exception was ‘participant‐perceived cure’ in women with SUI, which was rated as high quality.

Authors’ conclusions

Based on the data available, we can be confident that PFMT can cure or improve symptoms of SUI and all other types of UI. It may reduce the number of leakage episodes, the quantity of leakage on the short pad tests in the clinic and symptoms on UI‐specific symptom questionnaires. The authors of the one economic evaluation identified for the Brief Economic Commentary reported that the cost‐effectiveness of PFMT looks promising. The findings of the review suggest that PFMT could be included in first‐line conservative management programmes for women with UI. The long‐term effectiveness and cost‐effectiveness of PFMT needs to be further researched.

Plain language summary

Pelvic floor muscle training for urinary incontinence in women

Review question

We wanted to find out if pelvic floor muscle training (PFMT) helps women with urinary incontinence problems. We did this by comparing the effects of this training with no treatment, or with any inactive treatment (for example, advice on management with pads). We also summarised findings on costs and cost‐effectiveness.

We searched for clinical trials up to 12 February 2018.

Why is this question important?

Stress incontinence is leaking of urine which cannot be easily controlled (if at all) when performing a physical activity. Physical activities could include coughing, sneezing, sporting activities or suddenly changing position. Urgency incontinence happens with a sudden, strong need to urinate. This can often lead to not making it to the toilet in time to urinate, resulting in leakage. Mixed incontinence is where someone has both stress and urgency incontinence.

PFMT is a programme of exercise to improve pelvic floor muscle strength, endurance, power, relaxation or a combination of these. It is a widely used treatment for women with stress, urgency and mixed incontinence.

How did we carry out the review of the evidence?

The 31 included trials involved 1817 women from 14 countries. The studies included women with stress, urgency or mixed urinary incontinence. The women were allocated randomly to either receive or not receive PFMT and the effects were compared. We looked at whether the condition was ‘cured,’ or ‘cured or improved.’ We also looked at symptoms, the effect on quality of life (QoL) and the frequency and amount of urine lost.

Study funding sources

Eight studies were publicly funded. Three received grants from public and private sources. Two received grants from private sources, while two studies received no funding. Sixteen studies did not declare their funding sources.

What we found

The quality of the evidence we looked at was mostly moderate, which means we can have some confidence in the results.

Cure of urinary incontinence after PFMT: women with stress urinary incontinence in the PFMT group were, on average, eight times more likely to report being cured. Women with any type of urinary incontinence in the PFMT group were, on average, five times more likely to report being cured.

Cure or improvement of urinary incontinence after PFMT: women with stress urinary incontinence in PFMT groups were, on average, six times more likely to report they were cured or improved. Women with all type of urinary incontinence in the PFMT group were roughly twice as likely to report they were cured or improved.

Leakage episodes after PFMT: women with stress urinary incontinence and women with all types of urinary incontinence in the PFMT group had one fewer leakage episode in 24 hours. PFMT appeared to reduce leakage episodes in women with urgency urinary incontinence alone.

For women with stress and all types of urinary incontinence, their incontinence symptoms and QoL were improved in the PFMT groups. Women were more satisfied with the PFMT treatment, while those in the control groups were more likely to seek further treatment.

Negative side effects of performing PFMT were rare and, in the two trials that did report them, the side effects were minor.

The authors of the one economic evaluation identified for the Brief Economic Commentary reported that the cost‐effectiveness of PFMT looks promising.

Authors’ conclusions

Implications for practice

Based on the data available, pelvic floor muscle training (PFMT) is better than no treatment, placebo or inactive control treatments for women with stress urinary incontinence (SUI) or urinary incontinence (UI) (all types). We can be confident that PFMT can cure or improve symptoms of SUI and all other types of UI.

PFMT may reduce the number of leakage episodes in women with SUI and in women with all types of UI.

There was new information from two small trials about women with urgency urinary incontinence (UUI) alone or mixed urinary incontinence (MUI) also supporting PFMT. From this new addition, there is now low‐quality evidence that PFMT reduces leakage episodes in women with UUI. For women with MUI treated with PFMT, there is now one report of better quality of life.

Overall, women with SUI or all types of UI treated with PFMT were more likely to report better quality of life and have less urine leakage on short clinic‐based pad tests than controls. Women were also more satisfied with the active treatment, and their sexual outcomes were better. Finally, the findings of the review suggest that PFMT could be included in first‐line conservative management programmes for women with UI.

The limited nature of follow‐up beyond the end of treatment in the majority of the trials means that the long‐term outcomes of the use of PFMT remain uncertain. At this time, we are only starting to gather data on whether PFMT is cost‐effective in the long‐term.

Implications for research

There is a need for a pragmatic, well‐conducted and explicitly reported trial comparing PFMT with control to investigate the longer‐term clinical effectiveness and cost‐effectiveness of PFMT for women with symptoms of SUI, UUI or MUI. Although the quality of recent trials has improved (choice of outcome, duration of follow‐up, reporting method and data), most of the data in this review comes from small‐ to moderate‐size trials of moderate methodological quality. In planning future research, trialists are encouraged to consider the following.

  • The choice of primary outcomes important to women (urinary outcomes and quality of life), the size of a clinically important effect, and subsequent estimation of sample size.
  • Choice and reporting of PFMT exercise programmes, including details of the number of voluntary pelvic floor muscle contraction per set, duration of hold, duration of rest, number of sets per day, body position, types of contractions and other recommended exercises.
  • The reporting on adherence outcomes and adherence strategies, including practice of pelvic floor muscle exercises in both the intervention and control groups.
  • The need for further treatment, such as with pessaries, surgery or drugs.
  • The choice and reporting of secondary outcome measures, such as sexual function.
  • The duration of follow‐up, especially long‐term follow‐up.
  • The reporting of formal economic analysis, such as cost‐effectiveness and cost utility.
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