Actively Recruiting
Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device With Wearable Sensors for Stress Urinary Incontinence in Women: a Randomised Controlled Trial Alongside Economic Evaluation
Led by The Hong Kong Polytechnic University · Updated on 2025-03-17
142
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 women's 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 device's 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.
CONDITIONS
Brief Title
Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device for Stress Urinary Incontinence in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-pregnant women with stress urinary incontinence (SUI)
- Aged 35 to 65 years
- Mild to moderate SUI indicated by 1-50 g pad weight gain during 1-hour pad test with stress
- Mini-Mental State Examination score 24 or higher
You will not qualify if you...
- Women less than 6 months postpartum
- Severe pelvic organ prolapse
- Complicated SUI due to pelvic radiation
- Body mass index (BMI) 30 or higher
- Severe psychological problems impairing participation
- Mixed or urge urinary incontinence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants perform pelvic floor muscle training (PFMT) either with the PelviSense biofeedback device or unassisted. This includes a 1-month supervised training period followed by 5 months of unsupervised home exercises.
1 baseline visit and regular supervised training during first month followed by unsupervised exercises
Duration - Up to 8 months post-randomisation
Participants attend follow-up visits to assess treatment effectiveness and participate in optional focus groups to discuss their experience with the PelviSense device.
Follow-up assessments at 1 month and 6 months; focus groups at 8 months for selected participants
Trial Site Locations
Total: 2 locations
1
The Hong Kong Polytechnic University
Hong Kong, Hong Kong, 999077
Actively Recruiting
2
Kwong Wah Hospital
Kowloon, Hong Kong
Actively Recruiting
Research Team
P
PRIYA KANNAN, PhD
B
Brigitte Kim Yook Fung, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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