Use of the LEVA® Pelvic Health System for Fecal Incontinence

Comparison of the Duration of Use of the Leva® Pelvic Health System in Women With Fecal Incontinence

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.

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.

The hypothesis is that 8 weeks of use of Leva is non-inferior to 16 weeks of use, assessed by a validated FI symptom severity survey. Surveys will be completed at 0 weeks, 16 weeks, and 24 weeks. Long-term surveys will be completed at 1 year and 2 years from enrollment.

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