CI

At a glance

ClinicalIndex Comparison Record
Phase 4Active· 38 enrolled
Drug / intervention
The Leva Pelvic Health Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06152224
NCT06152224Phase 4Active
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Comparison of the Duration of Use of the Leva® Pelvic Health System in Women With Fecal Incontinence

University of Wisconsin, Madison·interventional·Posted Nov 30, 2023·Updated Oct 30, 2025

In Brief

A Phase 4 clinical trial evaluating The Leva Pelvic Health System for Fecal Incontinence. Active but no longer recruiting, targeting 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence
CountriesUnited States
Collaborators--

Timeline

Phase 4Active
202420252026
First PostedNov 30, 2023
Enrollment StartJan 17, 2024
Primary CompletionDec 17, 2024
Study CompletionSep 1, 2026
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.6 years ago

Interventions

The Leva Pelvic Health Systemdevice

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.