Status:
ACTIVE_NOT_RECRUITING
PelviSense, an Innovative, Non-invasive, Biofeedback Device for the Treatment of Stress Urinary Incontinence in Women
Lead Sponsor:
The Hong Kong Polytechnic University
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief 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) investi...
Detailed Description
Background and purpose: Stress urinary incontinence (SUI) is a common condition among women, resulting in urine leakage during physical exertion, sneezing, or coughing. Due to the risks associated wit...
Eligibility Criteria
Inclusion
- non-pregnant women with SUI and
- aged 18-60 years; and (2) women who experience mild-to-moderate SUI, as indicated by a pad weight gain of 1-50 g during the 1-h pad test and stress test (referred to as the 1-h pad test)
Exclusion
- non-pregnant women with SUI and
- aged 18-60 years; and (2) women who experience mild-to-moderate SUI, as indicated by a pad weight gain of 1-50 g during the 1-h pad test and stress test (referred to as the 1-h pad test)
- women with severe pelvic organ prolapse (stages 3 and 4 according to the Baden-Walker Halfway Scoring System)
- women with complicated urinary incontinence due to pelvic radiation; (3) women with severe psychological problems that would impair study participation; and
- women with urge-predominant mixed urinary incontinence or urge incontinence.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06126757
Start Date
September 1 2024
End Date
December 31 2025
Last Update
December 3 2025
Active Locations (1)
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1
The Hong Kong Polytechnic University
Kowloon, Hung Hom, Hong Kong, 999077