Use of the LEVA® Pelvic Health System for Fecal Incontinence (NCT06152224) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Use of the LEVA® Pelvic Health System for Fecal Incontinence
United States38 participantsStarted 2024-01-17
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use