Using a new biofeedback device to help women with stress urinary incontinence
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
This study tests whether a new biofeedback device can help women with stress urinary incontinence improve their pelvic floor muscle training and overall symptoms compared to doing it on their own.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | Female |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT05627726 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the PelviSense device in assisting pelvic floor muscle training (PFMT) for women suffering from stress urinary incontinence (SUI). It compares the outcomes of women using PelviSense with those performing PFMT alone, focusing on symptom severity and cost-effectiveness. The study employs a randomized controlled trial design and includes semi-structured focus groups to gather qualitative insights from participants about their experiences. A total of 142 women aged 35 to 65 with mild to moderate SUI will be enrolled to assess the device's impact on their lives and well-being.
Who should consider this trial
Good fit: Ideal candidates for this study are non-pregnant women aged 35 to 65 with mild to moderate stress urinary incontinence.
Not a fit: Patients who may not benefit include those with severe pelvic organ prolapse, severe psychological issues, or those who are postpartum within the last six months.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive and effective treatment option for women suffering from stress urinary incontinence.
How similar studies have performed: While there have been studies on various adjunctive therapies for PFMT, the PelviSense device represents a novel, non-invasive approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hong Kong and 1 other locations
- The Hong Kong Polytechnic University — Hong Kong, Hong Kong (Recruiting)
- Kwong Wah Hospital — Kowloon, Hong Kong (Recruiting)
Study contacts
- Principal investigator: PRIYA KANNAN, PhD — The Hong Kong Polytechnic University
- Study coordinator: PRIYA KANNAN, PhD
- Email: priya.kannan@polyu.edu.hk
- Phone: 3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.