LEVA® Device for Bowel Incontinence
Trial Summary
What is the purpose of this trial?
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.
Research Team
Dobie Giles, MD
Principal Investigator
University of Wisconsin, Madison
Eligibility Criteria
This trial is for adult women over 18 with fecal incontinence, occurring at least monthly and seeking treatment. Participants must be able to stand for daily training, speak/read English (as the app is English-only), have an email, own a smartphone, and can use apps. Exclusions include intolerance to vaginal devices, certain medical conditions like colorectal malignancy or inflammatory bowel disease, recent pelvic surgeries or pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Leva Pelvic Health System for either 8 or 16 weeks to treat fecal incontinence
Follow-up
Participants are monitored for safety and effectiveness after treatment, with surveys conducted at 1 and 2 years
Treatment Details
Interventions
- The Leva Pelvic Health System
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor