Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women

Abstract

Background: Pelvic floor muscle training (PFMT) is a recommended treatment for female stress, urgency, and mixed urinary incontinence. Training varies in exercise type (pelvic floor muscles contracting with and without other muscles), dose, and delivery (e.g. amount and type of supervision).

Objectives: To assess the effects of alternative approaches (exercise type, dose, and delivery) to pelvic floor muscle training (PFMT) in the management of urinary incontinence (stress, urgency, and mixed) in women.

Search methods: We searched the Cochrane Incontinence Specialised Register (searched 27 September 2023; which contains CENTRAL, MEDLINE, ClinicalTrials.gov, and World Health Organization ICTRP), handsearched journals and conference proceedings, and reviewed reference lists of relevant articles.

Selection criteria: Randomised, quasi-randomised, or cluster-randomised trials in female stress, urge, or mixed urinary incontinence where one trial arm included PFMT and another was an alternative approach to PFMT type, dose, or intervention delivery. We excluded studies with participants with neurological conditions or pregnant or recently postpartum.

Data collection and analysis: Two review authors independently assessed trials for eligibility and methodological quality using the Cochrane RoB 1 tool. We extracted and cross-checked data and resolved disagreements by discussion. Data processing was as described in the Cochrane Handbook for Systematic Reviews of Interventions (Version 6). Synthesis was completed in intervention subgroups.

Main results: This is a review update. The analysis included 63 trials with 4920 women; the previous version included 21 trials with 1490 women. Samples sizes ranged from 11 to 362. Overall, study participants were mid-age (45 to 65 years) parous women with stress or stress-predominant mixed urinary incontinence (46 trials), who had no prior incontinence treatment or pelvic surgery, or appreciable pelvic floor dysfunction. Trials were conducted in countries around the world, mostly in middle- or high-income settings (53 trials). All trials had one or more arms using 'direct' PFMT, defined as repeated, isolated, voluntary pelvic floor muscle contractions. Trials were categorised as comparisons of exercise type (27 trials, 3 subgroups), dose (11 trials, 5 subgroups, 1 with no data), and delivery (25 trials, 5 subgroups). Incontinence quality of life data are reported here as the primary outcome. Adverse event data were summarised narratively. Comparison 1: exercise type Co-ordinated training (body movements with concurrent pelvic floor muscle contraction) versus direct PFMT Co-ordinated training may slightly improve quality of life (standardised mean difference (SMD) -0.22, 95% confidence interval (CI) -0.44 to -0.01; I² = 81%; 8 trials, 356 women; low-certainty evidence). Indirect training (exercises that are not contractions of the pelvic floor muscles) versus direct PFMT Direct PFMT may moderately improve quality of life (SMD 0.70, 95% CI 0.38 to 1.02; I² = 78%; 4 trials, 170 women; low-certainty evidence). Indirect training combined with direct PFMT versus direct PFMT Combining indirect training with direct PFMT may make little to no difference in quality of life (SMD -0.08, 95% CI -0.26 to 0.10; I² = 33; 7 trials, 482 women; low-certainty evidence). Comparison 2: exercise dose PFMT with resistance device versus PFMT without resistance device PFMT without a resistance device may slightly improve incontinence quality of life, but the evidence is very uncertain (SMD 0.22, 95% CI -0.04 to 0.48; I² = 32%; 3 trials, 227 women; very low-certainty evidence). Maximal pelvic floor muscle contractions versus submaximal pelvic floor muscle contractions No data reported. PFMT more days per week versus PFMT fewer days per week PFMT more days per week may greatly improve incontinence quality of life (SMD -1.60, 95% CI -2.15 to -1.05; 1 trial, 68 women; low-certainty evidence). PFMT in upright body positions versus PFMT when lying down No data reported. Comparison 3: exercise intervention delivery PFMT supervised in clinic versus PFMT at home Clinic supervision may slightly improve incontinence quality of life, but the evidence is very uncertain (SMD -0.30, 95% CI -0.65 to 0.05; I² = 89%; 3 trials, 137 women; very low-certainty evidence). More clinician contact for PFMT supervision versus less clinician contact No usable data reported. Individual supervision of PFMT versus group supervision Individually supervised PFMT probably results in little to no difference in quality of life (SMD -0.18, 95% CI -0.35 to -0.01; I² = 0%; 5 trials, 544 women; moderate-certainty evidence). PFMT supervised in clinic versus supervision using e-health (mobile app communication with clinicians) Clinic supervision may make little to no difference in incontinence quality of life, but the evidence is very uncertain (SMD -0.11, 95% CI -0.41 to 0.19; 1 trial, 173 women; very low-certainty evidence). PFMT instruction delivered via e-health versus written instruction E-health delivery may slightly improve quality of life (SMD -0.21, 95% CI -0.43 to 0.01; I² = 25%; 3 studies, 318 women; low-certainty evidence). Adverse events Nine trials collected adverse event data; 66/1083 (6%) women had an adverse event. Almost all events were associated with use of an intravaginal or intrarectal training device. The adverse events were vaginal discharge, spotting, or discomfort. Limitations in the evidence Four main factors influenced our certainty in the evidence: 44 trials were at unclear or high risk of selection bias; data were sparse in some subgroups with few trials, trials that did not measure outcomes of interest, or did not report usable data; results were inconsistent; and many trials were small (imprecise).

Authors' conclusions: Although there is low- to moderate-certainty evidence that some approaches to PFMT are better than others, for some there was little or no difference. The 7th International Consultation on Incontinence recommends PFMT as first-line therapy for women with urinary incontinence. Direct PFMT (sets of repeated, isolated, voluntary pelvic floor muscle contractions) may result in a small improvement in incontinence quality of life compared to indirect training. In terms of improved quality of life, PFMT can be supervised individually or in a group because it probably makes little to no difference in achieving this outcome. Many comparisons had low- or very low-certainty evidence, often because there was only one trial or several small trials with methodological limitations. More, better designed and reported trials, directly comparing PFMT approaches are needed, especially trials investigating exercise dose.

Trial registration: ClinicalTrials.gov NCT03862326 NCT02039830 NCT03500185 NCT02664714 NCT04484753 NCT03058042 NCT04340323 NCT03203798 NCT02510131 NCT03401983 NCT04351750 NCT00197314 NCT02318251 NCT01948713 NCT02924740 NCT01245153 NCT01032265 NCT04991675 CTRI/2021/09/036247 NCT03166150 NCT03514147 NCT04390204 NCT04587895 NCT05154760 NCT05193435 NCT05253898 NCT05293886 NCT05390008 NCT05446792 NCT05463172 NCT03296462 NCT03727269 NCT03911362 NCT04237753 NCT04994041 NCT05443074 NCT05610761 NCT05618886 NCT05635175 NCT05666427 NCT05751213 NCT05916820 NCT05970796.