Evaluating the Effectiveness and Cost Savings of PelviSense, a New Wearable Biofeedback Device, for Treating Stress Urinary Incontinence in Women Aged 35 to 65

What this Trial Is About

Researchers are evaluating the effectiveness and cost-effectiveness of PelviSense, a new non-invasive biofeedback device, compared with pelvic floor muscle training PFMT alone for treating stress urinary incontinence SUI in women. The study aims to improve symptom severity, assess economic benefits, and explore womens experiences using the PelviSense device alongside PFMT. This trial includes 142 women with SUI or stress-predominant mixed urinary incontinence and uses a randomized controlled design with an economic evaluation and focus groups. Participants are randomly assigned to two groups one using PelviSense-assisted PFMT and another performing unassisted PFMT alone. The PelviSense device is a wearable EMG sensor attached near the vagina that provides real-time muscle activity feedback through a mobile app. Both groups follow the same exercise parameters over six months, starting with one month of supervised training, then five months of home exercises consisting of at least eight contractions, three times per day, five days a week. Focus groups with some PelviSense users will be held eight months post-randomization. During the study, women undergo baseline assessments including questionnaires, pad tests, and muscle strength measurements, with follow-ups at one and six months to measure changes in SUI severity, urine leakage, muscle strength, and quality-adjusted life-years QUALYs. Researchers will analyze collected data, including costs and participant feedback, to compare the PelviSense devices impact and cost-effectiveness against PFMT alone. Outcome assessors are blinded to group assignments to reduce bias, and the total study duration includes assessments at multiple time points.

Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device for Stress Urinary Incontinence in Women