Status:
ACTIVE_NOT_RECRUITING
Use of the LEVA® Pelvic Health System for Fecal Incontinence
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Fecal Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
This study will assess whether 8 weeks of use of the Leva Pelvic Health System (Leva) is non-inferior to 16 weeks of use for the treatment of chronic fecal incontinence (symptoms \>/= 3 months) in adu...
Eligibility Criteria
Inclusion
- Adult, age ≥ 18years, assigned female at birth
- Fecal incontinence, defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
- Able to stand to perform daily training for at least 3 minutes
- Able to speak and read English due to Leva smartphone application availability in only English at this time
- Have an email address, owns a smartphone, and can download an app
Exclusion
- Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum)
- Current diagnosis of colorectal or anal malignancy
- Diagnosis of uncontrolled inflammatory bowel disease
- Current rectovaginal fistula or cloacal defect
- Rectal prolapse (mucosal or full thickness)
- Inability to utilize smart phone technology ("app" use)
- Chronic Stool Types 6 or 7
- Fecal impaction by exam
- Stage 4 pelvic organ prolapse
- Concurrent supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback
- Presence of sacral neuromodulator
- Pelvic floor surgery (including anal sphincteroplasty) within the past 3 months
- Currently pregnant
Key Trial Info
Start Date :
January 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06152224
Start Date
January 17 2024
End Date
September 1 2026
Last Update
October 30 2025
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53705