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

NCT05627726 | Recruiting

• 1 other identifier: HMRF PolyU
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (3)

• Stress urinary incontinence (SUI) symptom severity

  (ICIQ-SF) will be used to measure SUI symptom severity.

  Baseline (0 month)

• Stress urinary incontinence (SUI) symptom severity

  The disease-specific International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) will be used to measure SUI symptom severity.

  1-month

• Stress urinary incontinence (SUI) symptom severity

  (ICIQ-SF) will be used to measure SUI symptom severity.

  6 months

Secondary Outcomes (10)

• The severity of urine leakage

  Baseline (0 month)

• The severity of urine leakage

  1-month

• The severity of urine leakage

  6 months

• Pelvic floor muscle strength

  Baseline (0 month)

• Pelvic floor muscle strength

  1-month

Study Arms (2)

PelviSense-assisted pelvic floor muscle training group

EXPERIMENTAL

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).

Device: PelviSense-assisted pelvic floor muscle training group

Pelvic floor muscle training (PFMT) alone group

ACTIVE COMPARATOR

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.

Other: Active comparator

Interventions

PelviSense-assisted pelvic floor muscle training group DEVICE

The PelviSense consists of a high-precision, oval-shaped, wearable EMG sensor that displays electrical activity measured in PFMs on the user's mobile device. The reusable, wearable EMG sensor is non-invasive and can be attached to the user's perineal region. The mobile app provides real-time muscular feedback, displayed as EMG waveforms in microvolts. The mobile app can store data for up to 7 days, allowing participants to monitor their progress over the last 7 days in a graphical format.

Also known as: Non-invasive novel biofeedback

PelviSense-assisted pelvic floor muscle training group

Active comparator OTHER

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.

Also known as: Pelvic floor muscle training (PFMT) alone group

Pelvic floor muscle training (PFMT) alone group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

The Hong Kong Polytechnic University

Hong Kong, 999077, Hong Kong

RECRUITING

Kwong Wah Hospital

Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• PRIYA KANNAN, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PRIYA KANNAN, PhD

CONTACT

3400; priya.kannan@polyu.edu.hk

Brigitte Kim Yook Fung, MSc

CONTACT

9836; fungky3@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 28, 2022
• Study Start: April 1, 2024
• Primary Completion: October 26, 2025
• Study Completion (Estimated): October 26, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)