Pelvic Floor Muscle Training With Leva System for Urge Incontinence

Status Terminated

Clinical Trial Summary

This is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (UUI) episode frequency based on voiding diaries in women at 8 weeks.

Clinical Trial Description

Our study aims to investigate a new alternative to formal pelvic floor physical therapy that may provide subjects with a more accessible, private method of undergoing pelvic floor muscle training (PFMT) with real-time biofeedback on performance. The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes. We hypothesize that women using the leva® System will experience significant improvements in subjective urge-related incontinence symptoms. In addition, changes in incontinence-related quality of life and UUI episode frequency will be determined. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03923348
Study type	Interventional
Source	The Christ Hospital
Contact
Status	Terminated
Phase	N/A
Start date	June 6, 2019
Completion date	May 4, 2020

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