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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 35
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Kwong Wah Hospital
RECRUITING
Kowloon
Contact Information
Primary
PRIYA KANNAN, PhD
priya.kannan@polyu.edu.hk
3400
Backup
Brigitte Kim Yook Fung, MSc
fungky3@ha.org.hk
9836
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-10-26
Participants
Target number of participants: 142
Treatments
Experimental: PelviSense-assisted pelvic floor muscle training group
Women allocated to the PelviSense-assisted pelvic floor muscle training (PFMT) group will perform PFMT to contract their urethras while the wearable sensors are positioned close to the vagina (to measure pubococcygeus muscle activation). Exercises will be performed in antigravity (supine or side-lying) positions and will progress to against-gravity positions (sitting/ standing).
Active_comparator: Pelvic floor muscle training (PFMT) alone group
Pelvic floor muscle training (PFMT) alone group: Women allocated to the PFMT alone group will perform unassisted PFMT. Exercise parameters, technique, and progression will be similar to those for the PelviSense-assisted PFMT group, but exercises will be performed without the PelviSense.
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov