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ACTIVE NOT RECRUITING
NCT06152224
PHASE4

Use of the LEVA® Pelvic Health System for Fecal Incontinence

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

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.

Official title: Comparison of the Duration of Use of the Leva® Pelvic Health System in Women With Fecal Incontinence

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2024-01-17

Completion Date

2026-09

Last Updated

2025-10-30

Healthy Volunteers

No

Interventions

DEVICE

The Leva Pelvic Health System

The Leva Pelvic Health System includes an intra-vaginal device that pairs with a smartphone application to provide real-time visual feedback about pelvic floor muscle performance during usage.

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States