Vaginal electrical stimulation as physical therapy intervention in women who do not voluntarily contract their pelvic floor muscles: a randomized controlled trial

Abstract

It is estimated that about 30% of women cannot voluntarily contract the pelvic floor muscles (PFM). PFM training represents the first therapeutic option for the treatment of female urinary incontinence (UI), however the inability to contract this muscle prevents its use. The primary objective of this project is to evaluate clinically the efficacy of transvaginal electrical stimulation to provide the correct voluntary contraction of PFM in women. The secondary objective is to evaluate the UI reports. This is a randomized controlled trial. The study will include women above 40 years of age, with PFM function level 0 (zero) or 1 evaluated by vaginal palpation, and who agree to participate. The primary outcome of the study will be measured using the Modified Oxford Grading Scale. The secondary outcome will be measured using the ICIQ-SF questionnaire. The sample size planning was based on a pilot sample. Adopting a 5% significance level and a power test of 90% estimated the need for up to 25 participants per group. Considering possible sample loss will be included 30 women per group. For analysis between groups will be used a linear mixed effect model. In all analyzes, the level of significance will be p <0.05. (AU)