NCT05627726 Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device for Stress Urinary Incontinence in Women
| NCT ID | NCT05627726 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Stress Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-10-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2024-04-01 with a primary completion date of 2025-10-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 PelviSense device, and the control group will perform PFMT without biofeedback (i.e., PFMT alone). Outcome measures: International Consultation on Incontinence Questionnaire-Short Form, one-hour pad test, Modified Oxford Scale, EQ-5D-5L, and electronic cost diary. Data analysis and expected results: Statistical analysis will be conducted using analysis of covariance. The PelviSense group is expected to report significant improvements in primary and secondary outcomes compared with the PFMT alone group. The PelviSense group will yield cost savings and result in lower health care utility compared with the PFMT alone group.
Eligibility 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)
Contact & Investigator
PRIYA KANNAN, PhD
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT05627726 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 65 Years, studying Stress Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05627726 currently recruiting?
Yes, NCT05627726 is actively recruiting participants. Contact the research team at priya.kannan@polyu.edu.hk for enrollment information.
Where is the NCT05627726 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Kowloon, Hong Kong.
Who is sponsoring the NCT05627726 clinical trial?
NCT05627726 is sponsored by The Hong Kong Polytechnic University. The principal investigator is PRIYA KANNAN, PhD at The Hong Kong Polytechnic University. The trial plans to enroll 142 participants.