Using a new biofeedback device to help women with stress urinary incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.