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Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device for Stress Urinary Incontinence in Women

RecruitingNAAges 35 Years - 65 YearsFemaleThe Hong Kong Polytechnic University
NCT05627726 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Aims: (1) Investigate the efficacy of PelviSense-assisted PFMT compared with PFMT alone for improving SUI symptom severity in women; (2) Compare the cost-effectiveness of the PelviSense device against PFMT alone for treating SUI in women; (3) Explore the views of women regarding the use of the PelviSense device as an adjunct to PFMT and the impacts of the PelviSense device on their lives and well-being. Design and subjects: A sequential, embedded, experimental mixed-methods design, including a randomised controlled trial (RCT) and semi-structured focus groups, will be conducted alongside an economic evaluation. The proposed study will include 142 women with SUI or stress-predominant mixed urinary incontinence. Interventions: Women will be randomly allocated to one of two groups (PelviSense or PFMT alone \[control\]). The PelviSense group will perform PFMT with assistance from the Pelvi

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📋 Eligibility rules (as published)
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)
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What it tests

  • PelviSense-assisted pelvic floor muscle training group
  • Active comparator
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Where

2 sites
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Kwong Wah Hospital
Kowloon, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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