Use of the LEVA® Pelvic Health System for Fecal Incontinence

Phase 4Active Not RecruitingNCT06152224

University of Wisconsin, Madison38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Fecal Incontinence

Interventions

The Leva Pelvic Health SystemDEVICE

The Leva Pelvic Health System includes an intra-vaginal device that pairs with a smartphone application to provide real-time visual feedback about pelvic floor muscle performance during usage.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use

Treatment response as length of use on symptom improvement at 16 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by Vaizey Score, score ranges from 0-24, higher scores indicate more severe symptoms. A difference of -4.3 ± 3 is expected at 8 weeks and 16 weeks (compared to baseline), with an allowable difference of 1.

Time frame: Baseline to 16 weeks

Secondary Outcomes

Change in Fecal Incontinence Severity

Using St. Mark's Incontinence score, score ranges from 0-24, higher scores indicate more severe symptoms.

Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Cumulative Adherence Correlation With Change in St. Mark's Score

Adherence as a percentage of all expected exercise sessions correlated with change in St Mark's Incontinence Score (1-24)

Time frame: Baseline to 24 weeks, long term follow up at 1 and 2 years

Patient Satisfaction and Usability of the Smartphone Application Component of the Leva Pelvic Health System

Measured through the mHealth App Usability Questionnaire. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree. To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.

Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Change in Fecal Incontinence From Baseline to 24 Weeks After 8 or 16 Weeks of Treatment

Treatment response as length of use on symptom improvement at 24 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by St Mark's (Vaizey) scores.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Baseline to 24 weeks, long term follow up at 1 and 2 years

Change in Pelvic Organ Prolapse Quantification System (POP-Q)

The POP-Q system is an objective, site-specific system used to describe, quantify, and stage pelvic support. Measurements are rated as Stage 0-Stage 4, with Stage 4 being complete prolapse.

Time frame: Baseline to 16 weeks

Change in Brink Scale Score: Pressure

The Brink scale evaluates 3 PFM contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner's fingers, and duration of contraction. Each muscle contraction variable is rated on a 4-point ordinal scale (1-4). Higher scores indicating greater strength.

Time frame: Baseline to 16 weeks

Change in Brink Scale Score: Vertical Displacement

Time frame: Baseline to 16 weeks

Change in Brink Scale Score: Duration Contraction

Time frame: Baseline to 16 weeks

Change in Stool Consistency

Use the Bristol Stool Scale to evaluate stool consistency. Ranges from Type 1 to Type 7, where Type 1 is hardest consistency and Type 7 is entirely liquid.

Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Change in Fecal Incontinence Quality of Life (FIQoL)

Use FIQoL scale, in which participants rate questions about how often an issue is a concern, and how much they agree with statements on a scale of 1-5. Higher scores indicate lower quality of life.

Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Change in Sexual Function (PISQ-IR)

PISQ-IR is a 20 item survey, where higher scores indicate lower sexual function.

Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Patient Global Impression of Improvement (PGI-I)

PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.

Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years

Patient Satisfaction (PGI-I)

PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.

Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years

Estimated Percentage of Change

Qualitative question in which participants state their estimate of how much better they are, on a scale from 0% (no better) to 100% (completely better).

Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years

Change in Global Pelvic Floor Symptoms

Use the Pelvic Floor Distress Inventory (PFDI-20) to evaluate change in pelvic floor symptoms. It is a 20 item survey with a range from 0-100 where higher scores indicate greater symptoms.

Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Evaluate Self-continuation of Pelvic Floor Muscle Exercises

Participant self-report on whether and how often they continued the pelvic floor muscle exercises.

Time frame: Baseline and 24 weeks, long term follow up at 1 and 2 years

Number of Cumulative Adverse Events

Systematic assessment of all adverse events over the course of the study, reported as a number of total AEs.

Time frame: Baseline and 24 weeks, long term follow up at 1 and 2 years

mHealth App Usability Questionnaire (MAUQ)

MAUQ is an 18-item survey scored on a 7 point likert scale from 1 (disagree) to 7 (agree) with higher scores indicative of higher usability.

Time frame: 16 weeks