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Clinical Trial 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.


Clinical Trial 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 adults with a vagina. Participants will be instructed to complete pelvic floor muscle training using the Leva for 8 or 16 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06152224
Study type Interventional
Source University of Wisconsin, Madison
Contact Ushma Patel, MD
Phone 608-720-5212
Email UPatel@uwhealth.org
Status Recruiting
Phase Phase 4
Start date January 17, 2024
Completion date October 2024

See also
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