Clinical trial NCT06152224: Use of the LEVA® Pelvic Health System for Fecal Incontinence
Official title: Comparison of the Duration of Use of the Leva® Pelvic Health System in Women With Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Fecal Incontinence
Keywords: anal incontinence
accidental bowel leakage
pelvic health system
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Change in Fecal Incontinence Severity
timeFrame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
measure: Cumulative Adherence Correlation With Change in St. Mark's Score
timeFrame: Baseline to 24 weeks, long term follow up at 1 and 2 years
measure: Patient Satisfaction and Usability of the Smartphone Application Component of the Leva Pelvic Health System
timeFrame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
measure: Change in Fecal Incontinence From Baseline to 24 Weeks After 8 or 16 Weeks of Treatment
timeFrame: Baseline to 24 weeks, long term follow up at 1 and 2 years
measure: Change in Pelvic Organ Prolapse Quantification System (POP-Q)
timeFrame: Baseline to 16 weeks
measure: Change in Brink Scale Score: Pressure
timeFrame: Baseline to 16 weeks
measure: Change in Brink Scale Score: Vertical Displacement
timeFrame: Baseline to 16 weeks
measure: Change in Brink Scale Score: Duration Contraction
timeFrame: Baseline to 16 weeks
measure: Change in Stool Consistency
timeFrame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
measure: Change in Fecal Incontinence Quality of Life (FIQoL)
timeFrame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
measure: Change in Sexual Function (PISQ-IR)
timeFrame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 16 and 24 weeks, long term follow up at 1 and 2 years
measure: Patient Satisfaction (PGI-I)
timeFrame: 16 and 24 weeks, long term follow up at 1 and 2 years
measure: Estimated Percentage of Change
timeFrame: 16 and 24 weeks, long term follow up at 1 and 2 years
measure: Change in Global Pelvic Floor Symptoms
timeFrame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
measure: Evaluate Self-continuation of Pelvic Floor Muscle Exercises
timeFrame: Baseline and 24 weeks, long term follow up at 1 and 2 years
measure: Number of Cumulative Adverse Events
timeFrame: Baseline and 24 weeks, long term follow up at 1 and 2 years
measure: mHealth App Usability Questionnaire (MAUQ)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Dobie Giles, MD
role: PRINCIPAL_INVESTIGATOR
References: