Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction in Women Unable to Perform It A Non-inferiority Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating two methods to help women who cannot correctly contract their pelvic floor muscles, a common problem linked to urinary incontinence and other pelvic floor issues. This study compares biofeedback using an electromyographic sensor with the usual practice of vaginal palpation to teach voluntary pelvic floor muscle contractions. The goal is to see if biofeedback is as effective as vaginal palpation in improving muscle contraction ability in women with poor pelvic floor muscle function. Participants are randomly assigned to one of two groups. Both groups follow the same pelvic floor muscle training protocol tailored to their muscle function, assessed at multiple timepoints over 12 weeks. The control group uses vaginal palpation by a physiotherapist to guide contractions, while the experimental group uses biofeedback displayed on a screen. Training sessions occur weekly with exercises both in the clinic and at home, and participants track their adherence in a diary. Throughout the study, women undergo evaluations of their pelvic floor muscle contraction ability at baseline and several intervals up to 12 weeks. Researchers also assess urinary incontinence symptoms, participants' self-perception of muscle contraction, treatment adherence, satisfaction, and any adverse effects. The study includes educational materials and ongoing support, with safety monitoring and progress assessments conducted regularly during the 12-week period.

Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction