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PelviSense, an Innovative, Non-invasive, Biofeedback Device for the Treatment of Stress Urinary Incontinence in Women
Sponsor: The Hong Kong Polytechnic University
Summary
Background and purpose: The research team developed the PelviSense, a non-invasive biofeedback device paired with wearable EMG sensors for use as a PFMT adjunct. The proposed study aims to (1) investigate the efficacy of PelviSense-assisted PFMT compared with unassisted PFMT on SUI in women, and (2) identify the mechanisms underlying the beneficial effects of PFMT for the treatment of SUI. Methods: A two-arm, parallel-group RCT will be conducted using 132 non-pregnant women with SUI, aged 18-60 years. The study participants will be randomised into two study groups: PelviSense-assisted PFMT or unassisted PFMT. Women will be supervised in the performance of PelviSense-assisted and unassisted PFMT on a 1:1 basis for 4 weeks and instructed to perform unsupervised home exercises for 24 weeks after the completion of supervised training. The primary outcome will be the severity of urine loss, as measured using the one-hour pad test. Secondary outcomes will include quality of life, SUI symptoms severity, and PFM strength, as measured using the incontinence impact questionnaire, short-form, international consultation on incontinence questionnaire, short-form, and modified Oxford scale, respectively. Mediator variables will include the following: bladder neck elevation and levator hiatus area. Outcomes and mediator variables will be assessed at baseline, 4, and 28 weeks. Statistical analysis: Treatment and mediation effects will be evaluated using analysis of covariance and the Hayes' PROCESS macro, respectively.
Official title: An Innovative, Non-invasive, Biofeedback Device for the Treatment of Stress Urinary Incontinence in Women: Evaluation and Mechanism Testing
Key Details
Gender
FEMALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2024-09-01
Completion Date
2025-12-31
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
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.
Active Comparator
Pelvic Floor Muscle Training Exercise will be performed without the assistance of the PelviSense Device.
Locations (1)
The Hong Kong Polytechnic University
Kowloon, Hung Hom, Hong Kong