The effects of individual pelvic floor muscle training versus individual treatment with progression to group versus group training for women with stress urinary incontinence: protocol for a randomized controlled trial
Background: Pelvic floor muscle training can be practiced in an individual format or in a group. The research question for this randomised, controlled trial will be: pelvic floor muscle training format including individualized and group training, would be more effective than an individualized training only or groups only? Additionally, it will be evaluated the adherence and follow up (results after 3 and 6 months of the end of training).
Methods: This is a randomized clinical trial. Data collection will be performed at the Women's Health Research Laboratory, allocated in the Department of Physical Therapy of Federal University of São Carlos, from January 2016 to December 2016. It will be included, women with stress urinary incontinence, older than 18 years old. The participants will be will be allocated into three groups. In Group 1 sessions will be only individualized and Group 2 will perform individualized treatment and then the volunteer will be referred to join the group training sessions. Group 3 only group treatment. Later, all volunteers will be reassessed after 12 sessions, three months and six months from the discharge date. The primary outcome is the severity measures of the King's Health Questionnaire. The secondary outcomes are miccional diary, PERFECT scheme, perineometry, self-efficacy scale for pelvic floor exercises practice, exercise diary and presence of the participants in the surpevisioned sessions. Data normality will be tested by the Shapiro-Wilk test. The comparison between the evaluations will be performed by ANOVA, and the comparison between groups will be performed by Student t-test (independent Measures). In order to measure the practical significance of the date, the size effect and the confidence interval will be calculated. A 5% significance level will be assumed. The data are presented as mean ± standard deviation.
Conclusions: A combined treatment format including individualized and group training, would be more effective than an individualized training only or groups only.
Trial registration: The study was approved by the Research Ethics Committee of Federal University of São Carlos (UFSCar) (Number 1207393) and Clinical Trials (NCT02664714).
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