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

NARecruitingINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

October 26, 2025

Study Completion Date

October 26, 2026

Conditions
Stress Urinary Incontinence
Interventions
DEVICE

PelviSense-assisted pelvic floor muscle training group

The PelviSense consists of a high-precision, oval-shaped, wearable EMG sensor that displays electrical activity measured in PFMs on the user's mobile device. The reusable, wearable EMG sensor is non-invasive and can be attached to the user's perineal region. The mobile app provides real-time muscular feedback, displayed as EMG waveforms in microvolts. The mobile app can store data for up to 7 days, allowing participants to monitor their progress over the last 7 days in a graphical format.

OTHER

Active comparator

Pelvic floor muscle training (PFMT) alone group: Women allocated to the PFMT alone group will perform unassisted PFMT. Exercise parameters, technique, and progression will be similar to those for the PelviSense-assisted PFMT group, but exercises will be performed without the PelviSense.

Trial Locations (2)

999077

RECRUITING

The Hong Kong Polytechnic University, Hong Kong

Unknown

RECRUITING

Kwong Wah Hospital, Kowloon

All Listed Sponsors
lead

The Hong Kong Polytechnic University

OTHER