PelviSense, an Innovative, Non-invasive, Biofeedback Device for the Treatment of Stress Urinary Incontinence in Women

NCT06126757 | Active Not Recruiting

• 1 other identifier: GRF RGC 15217822
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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) investigate the efficacy of PelviSense-assisted PFMT compared with unassisted PFMT on SUI in women, and (2) identify the mechanisms underlying the beneficial effects of PFMT for the treatment of SUI. Methods: A two-arm, parallel-group RCT will be conducted using 132 non-pregnant women with SUI, aged 18-60 years. The study participants will be randomised into two study groups: PelviSense-assisted PFMT or unassisted PFMT. Women will be supervised in the performance of PelviSense-assisted and unassisted PFMT on a 1:1 basis for 4 weeks and instructed to perform unsupervised home exercises for 24 weeks after the completion of supervised training. The primary outcome will be the severity of urine loss, as measured using the one-hour pad test. Secondary outcomes will include quality of life, SUI symptoms severity, and PFM strength, as measured using the incontinence impact questionnaire, short-form, international consultation on incontinence questionnaire, short-form, and modified Oxford scale, respectively. Mediator variables will include the following: bladder neck elevation and levator hiatus area. Outcomes and mediator variables will be assessed at baseline, 4, and 28 weeks. Statistical analysis: Treatment and mediation effects will be evaluated using analysis of covariance and the Hayes' PROCESS macro, respectively.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Severity of urine loss

  The one-hour pad test will be used to quantify the severity of urine loss. For the one-hour pad test, all participants will be instructed to empty their bladders before wearing the pre-weighed pads, after which they will be made to drink 500 ml water. The women will then perform a set of activities for 30 minutes: walking, climbing up and down one flight of stairs, standing up from sitting (10 times), coughing vigorously (10 times), bending to pick up an object from the floor (5 times), and washing their hands for one minute under running water. The weight of the pad will then be measured after 1 hour to quantify urine loss in grams.

  Baseline (0 month), 4 and 24 weeks

Secondary Outcomes (5)

• Quality of life of women with stress urinary incontinence

  Baseline (0 month), 4 and 24 weeks

• Stress urinary incontinence symptoms severity

  Baseline (0 month), 4 and 24 weeks

• Pelvic Floor Muscle Strength

  Baseline (0 month), 4 and 24 weeks

• Bladder neck elevation

  Baseline (0 month), 4 and 24 weeks

• Levator Hiatus (LH) area

  Baseline (0 month), 4 and 24 weeks

Study Arms (2)

PelviSense-assisted pelvic floor muscle training group

EXPERIMENTAL

Women assigned to the experimental group will perform pelvic floor muscle training exercises with the wearable PelviSense device sensor to the perineal region.

Device: PelviSense-assisted pelvic floor muscle training

Pelvic floor muscle exercise (training) without the Pelvisense device

ACTIVE COMPARATOR

Women assigned to the unassisted PFMT group will perform the exercise without the PelviSense device.

Other: Active Comparator

Interventions

Active Comparator OTHER

Pelvic Floor Muscle Training Exercise will be performed without the assistance of the PelviSense Device.

Also known as: Pelvic Floor Muscle Exercise (Training) without the PelviSense Device

Pelvic floor muscle exercise (training) without the Pelvisense device

PelviSense-assisted pelvic floor muscle training DEVICE

The PelviSense consists of a high-precision, oval-shaped, wearable EMG sensor that displays the electrical activity of the PFMs on the user's mobile device. The re-usable sensor can be attached to the user's perineal region, and when positioned correctly, the width of the sensor is oriented along the medial-lateral axis, and the length is oriented along the anterior-posterior axis of the perineal region. The sensor detects PFM activity as the voltage between the two surface electrodes and transmits this activity to the data acquisition unit, which processes the signal and conveys it to a smartphone via a Wi-Fi connection. The mobile app provides real-time muscular feedback, displayed as EMG waveforms in microvolts.

PelviSense-assisted pelvic floor muscle training group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hung Hom, 999077, Hong Kong

Location

Related Publications (1)

• Liu SZ, Cheing GL, Kannan P. Clinical effectiveness of biofeedback for treating stress urinary incontinence in women: protocol for a randomised controlled trial. BMJ Open. 2025 Dec 18;15(12):e107751. doi: 10.1136/bmjopen-2025-107751.

  PMID: 41412615 DERIVED

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

Study Design

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

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)