A Multi-center, Randomized, Double-blind Study Comparing a Neuromuscular Electrical Stimulation Device and Sham Device for Treating Stress Urinary Incontinence in Women

What this Trial Is About

Researchers are conducting a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial focused on female patients with stress urinary incontinence. The study aims to evaluate and compare the effectiveness of a non-implantable neuromuscular electrical stimulation NMES device against a sham control device in reducing urine leakage. Participants will use either the investigational NMES device or a sham device at home for 12 weeks. The treatment involves at least 5 days per week of use, with sessions twice daily morning and evening, each lasting 15 minutes. Two study groups are involved one receiving the NMES treatment and the other using the sham device without electrical stimulation. During the study, participants will be monitored for changes in urine leakage using standardized pad tests at weeks 4, 8, and 12. Additional assessments include urinary incontinence episode counts, pelvic floor muscle and intravaginal pressure measurements, and patient-reported outcomes such as the Patient Global Impression of Improvement and urgency intensity scales. The primary outcome is the proportion of patients achieving less than 1 gram of urine leakage by week 12 compared to baseline.

Stress Urinary Incontinence for Female Patients (CGM MUIT-2301)