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Use of the LEVA® Pelvic Health System for Fecal Incontinence

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study completion pushed from Sep 2026 to Dec 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 11 of 18 entries
    • Study description revised
  2. 4 versions Re-verified since Jul 28, 2025, no change to tracked fieldsv11-v14
  3. Results first posted: May 30, 2025v10 Show 5 more changesShow less
    • Primary endpoint revised
    • Trial status: Completed to Active, Not Recruiting
    • Enrollment target: 39 to 38
    • Study completion date: Apr 11, 2025 to Sep 2026
    • Secondary endpoints: 16 to 18
  4. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Mar 20, 2025 to Apr 11, 2025
    v9
  5. Primary completion date changed from estimate of Feb 2025 to Dec 17, 2024
    • Study completion date: Sep 2026 to Mar 20, 2025
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study completion date: Apr 2025 to Sep 2026
    • Secondary endpoints: 15 to 16
    • Study description expanded, about 50 words
    v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 38 to confirmed 39
    • Site details revised
    v6
  3. Primary completion date: Oct 2024 to Feb 2025
    • Study completion date: Oct 2024 to Apr 2025
    • Site contact updated
    v5
  4. Start date changed from estimate of Jan 2024 to Jan 17, 2024v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2023 to Jan 2024
    • Site details revised
    v3
  6. Secondary endpoints revised (15)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06152224
Lead Sponsor University of Wisconsin, Madison
Conditions
(from sponsor)		 Fecal Incontinence
Related terms Encopresis, Fecal Incontinence
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov