Use of the LEVA® Pelvic Health System for Fecal Incontinence

University of Wisconsin (UW)

Status and phase

Completed

Phase 4

Conditions

Fecal Incontinence

Treatments

Device: The Leva Pelvic Health System

Study type

Interventional

Funder types

Other

Identifiers

NCT06152224

SMPH/OBGYN BENIGN GYN (Other Identifier)

2023-1304

Protocol Version 10/1/2024 (Other Identifier)

A532810 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment

39 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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