Clinical Trial

Use of the LEVA® Pelvic Health System for Fecal Incontinence

Active, Not Recruiting Phase 4
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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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2023-11-21; most recent amendment 2025-10-13.
Status change: Completed → Active, Not Recruiting 2025-05-29
Status change: Active, Not Recruiting → Completed 2025-04-14
Status change: Recruiting → Active, Not Recruiting 2024-10-14
Status change: Not Yet Recruiting → Recruiting 2023-12-20
Trial Details
NCT Number NCT06152224
Lead Sponsor University of Wisconsin, Madison
Conditions Fecal Incontinence
Enrollment 38 participants
Start Date 2024-01-17
Primary Completion 2024-12-17 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-10-30