Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery - protocol of a randomized controlled trial.
Study Goal
The researchers aimed to determine whether combining a low-calorie diet with pelvic floor muscle training (PFMT) improves urinary incontinence reports in obese women more effectively than weight loss alone.
Results Summary
The study protocol outlines a randomized controlled trial to compare the effects of a low-calorie diet alone versus a low-calorie diet plus PFMT on urinary incontinence severity, quality of life, and pelvic floor muscle function in obese women. Results are pending as this is a protocol for an upcoming trial.
Population
Obese women reporting urinary incontinence and capable of pelvic floor muscle contraction.
Effective Dosage
12-week low-calorie diet protocol; group II additionally receives 6 supervised PFMT sessions.
Duration
12 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Pelvic floor muscle training (PFMT) | decrease | urinary incontinence | - | - | is the first line of treatment | #1 |
surgical and conservative weight loss | decrease | urinary incontinence reports | obese women | - | results in improvement | #2 |
a low-calorie diet in combination with PFMT | decrease | urinary symptoms | women with UI | - | would result in additional beneficial effects | #3 |
a low-calorie diet plus PFMT protocol | neutral | obese women's urinary incontinence reports | obese women | - | To assess the effect | #4 |
the association of a low-calorie diet and PFMT | decrease | urinary incontinence reports | women with obesity | - | can provide a larger effect in the improvement | #5 |
BACKGROUND: Obesity represents a growing threat to health with multiple negative impacts including urinary incontinence. Pelvic floor muscle training (PFMT) is the first line of treatment for urinary incontinence. Both surgical and conservative weight loss results in improvement of urinary incontinence reports in obese women and we hypothesize that a low-calorie diet in combination with PFMT would result in additional beneficial effects to urinary symptoms in women with UI compared would with weight loss alone. OBJECTIVE: To assess the effect of a low-calorie diet plus PFMT protocol in obese women's urinary incontinence reports. METHODS: This is a protocol for a randomized controlled trial that will include obese women reporting UI and being able to contract their pelvic floor muscles. The participants will be randomly allocated in two groups: group 1 will participate in a 12-week protocol of low-calorie diet delivered by a multi-professional team at a tertiary hospital; group II will receive the same low-calorie diet protocol during 12 weeks and will additionally participate in 6 group sessions of supervised PFMT delivered by a physiotherapist. The primary outcome of the study is self-reported UI, and severity and impact of UI on women's quality of life will be assessed by the ICIQ-SF score. The secondary outcomes will be adherence to the protocols assessed using a home diary, pelvic floor muscle function assessed by bidigital vaginal palpation and the modified Oxford grading scale, and women's self-perception of their PFM contraction using a questionnaire. Satisfaction with treatments will be assessed using a visual analog scale. The statistical analysis will be performed by intention to treat and multivariate analysis of mixed effects will be used to compare outcomes. The complier average causal effects (CACE) method will be used to assess adherence. There is an urgent need for a high-quality RCT to investigate if the association of a low-calorie diet and PFMT can provide a larger effect in the improvement of urinary incontinence reports in women with obesity. TRIAL REGISTRATION: Clinical Trials NCT04159467. Registered on 08/28/2021.