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

Launched by THE HONG KONG POLYTECHNIC UNIVERSITY · Nov 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new device called PelviSense, which is designed to help women with stress urinary incontinence (SUI). SUI is a condition where women accidentally leak urine when they cough, laugh, or exercise. The trial aims to see if using PelviSense along with pelvic floor muscle training (PFMT) can improve symptoms more effectively than just doing PFMT alone. Additionally, the study will look at whether using this device is cost-effective and gather feedback from women about their experiences with it.

To be eligible for the trial, participants should be non-pregnant women aged 35 to 65 who experience mild to moderate stress urinary incontinence. Women who have recently given birth, severe pelvic organ issues, or certain psychological conditions will not be included. If you participate, you will be randomly assigned to either use the PelviSense device with PFMT or do PFMT without the device. The study will track your progress and compare the outcomes between the two groups, helping to determine if PelviSense makes a real difference in managing SUI.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • non-pregnant women with stress urinary incontinence (SUI),
• • aged 35 to 65 years,
• • women who experience mild to moderate SUI, as indicated by a pad weight gain of 1-50 g during the 1-hour pad test with stress test,
• • women with a score ≥24 on the Mini-Mental State Examination.
• Exclusion Criteria:
• • women \<6 months postpartum,
• • women with severe pelvic organ prolapse,
• • women with complicated SUI due to pelvic region radiation,
• • women with a body mass index (BMI) ≥30,
• • women with severe psychological problems impairing study participation,
• • women with mixed urinary incontinence (MUI) or urge urinary incontinence (UUI)