Training for Urinary Leakage Improvement After Pregnancy: A Randomized Trial Comparing Pelvic Floor Muscle Training, Leva4 Biofeedback Device, and Education

What this Trial Is About

Researchers are studying urinary incontinence in first-time mothers who are at high risk for prolonged pelvic floor problems after giving birth. This trial evaluates different nonsurgical treatments to improve bothersome urinary leakage following pregnancy. The study is randomized and single-blind, involving around 216 women, and focuses on changes in urinary incontinence from baseline to 6 months postpartum, with follow-up continuing to 12 months postpartum. The trial has three groups: one receives pelvic floor muscle training guided by a skilled therapist starting around 8 weeks postpartum, continuing with home exercises supported by a smartphone app until 12 months postpartum. The second group uses a home biofeedback device called leva4 to guide pelvic floor exercises, also supported by an app, carried out from about 8 weeks to 12 months postpartum. The third group receives basic education on pelvic floor health and urinary control without specific exercise instructions. Participants will complete monthly questionnaires on urinary incontinence from baseline through 12 months postpartum. Researchers will assess symptoms using the ICIQ-SF score at 6 months as the primary outcome and continue evaluating other measures like urinary symptoms, sexual function, and patient impressions up to 12 months. The study also monitors exercise adherence through app prompts and involves regular follow-ups to capture changes in pelvic floor function and urinary leakage.

Training for Urinary Leakage Improvement After Pregnancy