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Active Not Recruiting NCT06152224

Use of the LEVA® Pelvic Health System for Fecal Incontinence

Conditions: Fecal Incontinence

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 38
Sponsor: University of Wisconsin, Madison

Location: University of Wisconsin Madison Wisconsin

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.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06152224). StuddyBuddy aggregates publicly available trial information.