This review drew on the search strategy developed by Cochrane Incontinence. We identified relevant trials from the Cochrane Incontinence Specialized Register. The date of the last search was February 12, 2018.

We included randomized and quasi-randomized controlled trials of PFMT for the treatment of UI. Two review authors (CD with LPC or JHS) independently screened the list of titles and abstracts generated by our search and further independently assessed the full-text articles or abstracts for eligibility. Any differences of opinion were resolved by discussion or involvement of a third party.

All included trial data were processed as described in the Cochrane Handbook for Systematic Reviews of Interventions.15 Data extraction was undertaken independently by two review authors (CD and LPC) and cross-checked by JHS. Any differences of opinion related to the data extraction were resolved by discussion. Where study data were possibly collected but not reported, or data were reported in a form that could not be used in the formal comparisons, further clarification was sought from the trialists.

We assessed the risk of bias using Cochrane's ‘Risk of bias’ assessment tool.15 Two review authors (CD with LPC) independently assessed these domains and they were cross-checked by JHS. Any differences of opinion were resolved by consensus.

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. 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% CI.

Analysis within subgroups was used to address the effect of the type of incontinence on outcome. Because the rationale for PFMT is different for the two main types of UI (stress and urgency), it is plausible to expect a difference in the outcome of PFMT on the basis of the type of incontinence. The four pre-specified diagnostic subgroups were trials that recruited women with: SUI, UI, MUI, and UI all types (women could have stress, urgency or MUI, but data were not reported separately according to these subgroups). If heterogeneity between trials was sufficiently large, an investigation to identify its causes was conducted. If heterogeneity remained after appropriate investigation, and possible removal of outlying trials, a random-effects model rather than a fixed-effect model was used in the meta-analysis.

The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach was employed to interpret findings16 and the GRADE profiler (GRADEPRO) allowed us to import data from Review Manager 5.2 (Review Manager) to create ‘Summary of findings’ tables. These tables provide outcome-specific information concerning the overall quality of evidence from studies included in the comparison, the magnitude of effect of the interventions examined, and the sum of available data on the outcomes we considered. The following outcomes were included in the ‘Summary of findings’ tables: participant perceived cure; participant perceived cure or improvement; number of leakage episodes in 24h; short (up to one hour) pad test measured as grams of urine, and GRADE A UI-specific symptom measures; GRADE A UI-specific QoL measures.

A Brief Economic Commentary was developed to summarize the availability and principal findings of the economic evaluations captured as part of this review. This included evaluations alongside trials and model based evaluations. This was carried out in accordance with current guidance. This commentary focused on the extent to which principal findings of eligible economic evaluations indicate that an intervention might be judged favourably (or unfavourably) from an economic perspective, when implemented in different settings. A supplementary search to identify economic studies was carried out according to the guidelines in Cochrane Economics Methods.17

The search produced 1299 records, from which 94 potentially relevant full-text articles were retrieved. Fifty-two reports of 31 trials met the inclusion criteria. See Fig. 1.

Figure 1.

PRISMA study flow diagram.

(0.37MB).

Ten new trials were added in the update. In total, thirty-one trials involving 1817 women (933 PFMT, 884 controls) were included18–48; 27 trials contributed data to the meta-analysis (1570 women) with four trials containing no usable data.22,35,40,43 Twenty-one trials contributed to the analysis of primary outcomes.19–21,23,26–34,36,38,39,41,44,46–48 Further details on the characteristics of the included and excluded trials are provided in the full version of the Cochrane review.14

All the women had UI. Based on diagnosis, the subgroups were: SUI (21 trials),18,19,22–30,32,34–36,41,43,45–48 MUI (one trial),38 UUI (one trial)23 and a combination of UI diagnoses, grouped together here as UI all types (ten trials).20,21,29,31,33,37,39,40,42,44

Three trials gave no details of the PFMT programme used.25,26,43 Of the 28 remaining trials, 21 stated that a correct voluntary PFM maximal contraction was confirmed prior to training using either vaginal, rectal or physical examination.18,20,21,23,24,30,32–40,42,44–48 Five trials reported that participants were taught a voluntary PFM maximal contraction but did not say how.22,27–29,31 One trial reported that participants were instructed by a smartphone app to identify the correct voluntary PFM contraction, but without face-to-face interaction with health professionals.19

The individual characteristics of each exercise programme including the number of voluntary PFM contractions; duration of hold; duration of rest; number of sets per day; types of contraction (e.g., maximal, sustained, fast); body position; and adherence strategies are detailed in Appendix A (PFMT protocols).

Control interventions included no treatment,18–21,23–25,27,30,34–38,41–43,45,47 placebo drug44 and sham electrical stimulation.26 Inactive control treatments comprised use of an anti-incontinence device,46 advice on incontinence pads,32 motivational phone calls once per month,48 advice on simple lifestyle alterations,31,40 general education class (cognitive function, osteoporosis and oral hygiene),29,39 refraining from special exercises aiming to increase muscle strength, to reduce body mass index or to improve dietary habits28 and access to an educational pamphlet or advices on UI.22,33

Overall there was no consistency in the choice of outcome measures, by trialists. This limited the possibilities for considering together the results from individual trials. Four eligible trials did not contribute any data to the main analyses because they did not report any pre-specified outcome of interest or they did not report their outcome data in a usable way (e.g., mean without a measure of dispersion, p values without raw data or only post-intervention minus pre-intervention data available).22,35,40,43 Communication with the authors was attempted but no responses were received.

Many different scales were used to measure a participant's response to treatment, including Likert scales, visual analogue scales, and percent reduction in symptoms. Whatever the scale, data were included in the formal comparisons when the trialists stated the number of women who perceived they were cured or improved (as defined by the trialists) after treatment. Where more than one level of improvement was reported (e.g., much better and somewhat better), data for the greater degree of improvement was entered in the comparison. It was thought this was more likely to capture those who had improvement that was clinically important. As some trial reports did not differentiate cure from improvement, two measures (cure only, and cure or improvement) were used so that important data were not lost. The following definitions were used by the trialists.

Participant reported cure comprised:

• •

  no urine loss or ‘dry’29,44;

• •

  ‘incontinence is now unproblematic’,46 and

• •

  no leakage in a urinary diary.26,28,31

• •

  Participant reported cure or improvement was defined as:

• •

  much better and somewhat better19,21;

• •

  ‘75% or more perceived improvement’44;

• •

  ‘dry’ or ‘improved’,32 and

• •

  ‘continent’ or ‘almost continent’.46

Thirteen trials used GRADE A psychometrically robust questionnaires for assessment of incontinence symptoms (ICIQ-UI and UDI),19,20,27,30,34,38 the impact of these symptoms on QoL (ICIQ-LUTSqol, IIQ and I-QOL),19,20,33,34,37,39,48 or both (King's Health Questionnaire).36,41,47

• •

  Longer-term symptomatic cure and improvement after stopping treatment (six months to one year after end of treatment; more than one year after end of treatment)24,31,39;

• •

  Satisfaction44,46,48;

• •

  Need for further treatment44,46;

• •

  Self-efficacy39

• •

  Number of urinary leakage episodes (per 24h)19,20,23,32–34,39,44–46,48;

• •

  Number of micturitions during the day (frequency) or night (nocturia)20,21,23,42;

• •

  Pad and paper towel testing short (up to one hour) or long (24h) urine loss (grams of urine lost) at the end of treatment20,21,34,36,39,42,46,48;

• •

  Number cured or improved based on pad weights in short office-based pad test at the end of treatment18,24,25,46,48;

• •

  Other pad or paper towel tests (e.g.: those not reported as cure, cure and improvement or grams, those reported at other time points after treatment)18,21,35,39,43;

• •

  QoL (not condition specific)27,44,46;

• •

  Sexual function or problems46;

• •

  Adverse effects32,33,38,39,44,46,48;

• •

  Socioeconomic measures19,49;

• •

  Measures of PFM function,18,20,21,23,30,34–36,40–42,45–48 and

• •

  Measures of adherence.19,28,31–33,38–40,43,45,46,48

Due to brevity of reporting, it was difficult to assess the two trials that were published as conference abstracts.25,43 Fifteen of the trials were small, with fewer than 25 women per comparison group.18,21–23,25–27,30,34–39,42 Ten were of moderate size, with around 25–50 per group.24,28,31–33,41,45–48 The other five allocated more than 50 women per group.19,20,31,40,44 Bidmead et al.43 randomized participants in a 2:1 ratio, with 40 in the PFMT group and 20 as controls.43 Eleven trials, including five recent ones, reported on a priori power calculation.19,20,23,28,31,33,34,37,39,46,48 Risk of bias assessment is illustrated in Fig. 2 and fully described in the complete Cochrane review.

Figure 2.

Summary of risk of bias analysis. Low risk in green (+), unclear risk in yellow (?), high risk in red (−).

(0.58MB).

The following factors were considered to downgrade the evidence: limitations in the study design; inconsistency of results; indirectness of evidence; imprecision, and publication bias.

The main secondary outcomes are presented below. More details and forest plots (when applicable) are presented in the complete Cochrane review.14

The addition of ten new trials did not change the essential findings of the prior review. The wider range of populations, countries and secondary outcomes within these new trials emphasized the strength of recommendation of PFMT for women with UI. For women with UUI treated with PFMT there is now one report of reduction of urinary leakage episodes, and for women with MUI treated with PFMT, there is now one report of better QoL. Of note, in almost all new included trials, the PFMT protocols were described in more details, with progressive training based on exercise physiology. Moreover, Grade A patient reported symptoms and QoL outcomes, were used more often in line with recent recommendations.52 Finally, we are starting to gather data supporting PFMT cost-effectiveness. However, the limited nature of follow-up beyond the end of treatment in the majority of the trials means that the long-term outcomes and cost-effectivess of use of PFMT remain uncertain.

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 stress, urgency, 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 sized 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 QoL), 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 PFM contractions 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 PFM 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, e.g. sexual function.

• •

  The duration of follow-up, especially long-term.

• •

  The reporting of formal economic analysis (for example cost-effectiveness, cost utility).