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

Launched by THE HONG KONG POLYTECHNIC UNIVERSITY · Nov 6, 2023

Keywords

ClinConnect Summary

The PelviSense trial is studying a new device designed to help women with stress urinary incontinence (SUI), which is the involuntary loss of urine during activities like laughing, sneezing, or exercising. This device works with wearable sensors to support pelvic floor muscle training (PFMT), a common exercise method to strengthen the pelvic area. The trial will compare the effectiveness of training with the PelviSense device to traditional training without it. Researchers are looking for 132 non-pregnant women aged 18 to 60 who experience mild to moderate SUI to participate in the study.

Participants in this trial can expect to receive four weeks of supervised training, either using the PelviSense device or doing the exercises on their own. After this, they will continue with home exercises for another 24 weeks. The main goal is to see how much the training reduces urine leakage, but the study will also look at how the treatment affects quality of life and pelvic muscle strength. If you are a woman within the age range and experience mild to moderate SUI, this trial might be a good fit for you, but women with certain severe conditions will not be eligible.

Gender

FEMALE

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.