PelviSense, an Innovative, Non-invasive, Biofeedback Device for the Treatment of Stress Urinary Incontinence in Women

NACompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

April 30, 2025

Study Completion Date

May 31, 2025

Conditions
Stress Urinary Incontinence
Interventions
DEVICE

PelviSense-assisted pelvic floor muscle training

The PelviSense consists of a high-precision, oval-shaped, wearable EMG sensor that displays the electrical activity of the PFMs on the user's mobile device. The re-usable sensor can be attached to the user's perineal region, and when positioned correctly, the width of the sensor is oriented along the medial-lateral axis, and the length is oriented along the anterior-posterior axis of the perineal region. The sensor detects PFM activity as the voltage between the two surface electrodes and transmits this activity to the data acquisition unit, which processes the signal and conveys it to a smartphone via a Wi-Fi connection. The mobile app provides real-time muscular feedback, displayed as EMG waveforms in microvolts.

OTHER

Active Comparator

Pelvic Floor Muscle Training Exercise will be performed without the assistance of the PelviSense Device.

Trial Locations (1)

999077

The Hong Kong Polytechnic University, Kowloon

All Listed Sponsors
lead

The Hong Kong Polytechnic University

OTHER

NCT06126757 - PelviSense, an Innovative, Non-invasive, Biofeedback Device for the Treatment of Stress Urinary Incontinence in Women | Biotech Hunter | Biotech Hunter