Use of the LEVA® Pelvic Health System for Fecal Incontinence

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to learn about how the duration of use of The Leva Pelvic Health System® affects treatment of fecal incontinence in women. The main question it aims to answer is to test whether use of the The Leva Pelvic Health System® for 8 weeks is as good as using it for 16 weeks. Participants will complete surveys, and use the Leva device.

Clinical Trial Description

This study will assess whether 8 weeks of use of the Leva Pelvic Health System (Leva) is non-inferior to 16 weeks of use for the treatment of chronic fecal incontinence (symptoms >/= 3 months) in adults with a vagina. Participants will be instructed to complete pelvic floor muscle training using the Leva for 8 or 16 weeks. ;

Study Design

Related Conditions & MeSH terms

Fecal Incontinence

Clinical Trial Details

NCT number	NCT06152224
Study type	Interventional
Source	University of Wisconsin, Madison
Contact	Ushma Patel, MD
Phone	608-720-5212
Email	UPatel@uwhealth.org
Status	Recruiting
Phase	Phase 4
Start date	January 17, 2024
Completion date	October 2024

View Details

See also
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