Non-invasive biofeedback device for treating stress urinary incontinence in women

An Innovative, Non-invasive, Biofeedback Device for the Treatment of Stress Urinary Incontinence in Women: Evaluation and Mechanism Testing

This study is testing if a new non-invasive device can help women with stress urinary incontinence strengthen their pelvic floor muscles and reduce urine loss.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: The Hong Kong Polytechnic University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Kowloon, Hung Hom)
• Trial ID: NCT06126757 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of PelviSense, a non-invasive biofeedback device, in assisting pelvic floor muscle training (PFMT) for women suffering from stress urinary incontinence (SUI). The trial involves 132 non-pregnant women aged 18-60, who will be randomly assigned to either PelviSense-assisted PFMT or unassisted PFMT for four weeks, followed by 24 weeks of unsupervised home exercises. The primary outcome measured will be the severity of urine loss, assessed through a one-hour pad test, while secondary outcomes will include quality of life and SUI symptoms. The study aims to uncover the mechanisms behind the benefits of PFMT in treating SUI.

Who should consider this trial

Good fit: Ideal candidates are non-pregnant women aged 18-60 experiencing mild-to-moderate stress urinary incontinence.

Not a fit: Patients with severe pelvic organ prolapse or those with urge-predominant mixed urinary incontinence may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more comfortable and effective treatment option for women with stress urinary incontinence.

How similar studies have performed: While conventional biofeedback methods have shown efficacy, this non-invasive approach is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Kowloon, Hung Hom

• The Hong Kong Polytechnic University — Kowloon, Hung Hom, Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Priya Kannan, PhD — The Hong Kong Polytechnic University
• Study coordinator: Gladys Cheing, PhD

Conditions: Stress Urinary Incontinence