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NCT06152224 · ClinicalTrials.gov registry record · Phase 4
Use of the LEVA® Pelvic Health System for Fecal Incontinence
A Phase 4 study of Fecal Incontinence, sponsored by University of Wisconsin, Madison.
- Active
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT06152224: Active Phase 4 study of Fecal Incontinence, sponsored by University of Wisconsin, Madison.
NCT06152224 is a Phase 4 study of Fecal Incontinence that is active but no longer recruiting, run by University of Wisconsin, Madison. The registered enrollment target is 38 participants, below the 333-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06152224, a Phase 4 study of Fecal Incontinence, is active but no longer recruiting, sponsored by University of Wisconsin, Madison.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Treatment response as length of use on symptom improvement at 16 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by Vaizey Score, score ranges from 0-24, higher scores indicate more severe symptoms. A difference of -4.3 ± 3 is expected at 8 weeks and 16 weeks (compared to baseline), with an allowable difference of 1.
Conditions Studied
Interventions
- DEVICE The Leva Pelvic Health System
Study Locations (1)
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2024-01-17 |
| Est. Completion | 2026-09 |
| Phase | Phase 4 |
What the registry record for NCT06152224 still lists
NCT06152224 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 333-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Fecal Incontinence appearing as the primary indexed condition, and to 1 intervention - of which The Leva Pelvic Health System is the first listed.
NCT06152224 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06152224 about?
NCT06152224 is a clinical study titled "Use of the LEVA® Pelvic Health System for Fecal Incontinence". 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 wee...
What is the current status of trial NCT06152224?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2024-01-17. Estimated completion is 2026-09.
What conditions does trial NCT06152224 study?
This clinical trial studies the following conditions: Fecal Incontinence.
What interventions are being tested in trial NCT06152224?
The interventions under investigation include: The Leva Pelvic Health System (DEVICE).
Who is sponsoring clinical trial NCT06152224?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06152224 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fecal Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06152224's enrollment target sits among peer trials
38 13th of 22 higher than 10 of 22 other Fecal Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fecal Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Indiana University Gastrointestinal Motility Diagnosis Registry
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
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Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
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