Use of the LEVA® Pelvic Health System for Fecal Incontinence

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: The Leva Pelvic Health System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 8 week use of Leva<br> | Device: The Leva Pelvic Health System<br>* 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.<br>|
| Active Comparator: 16 week use of Leva<br> | Device: The Leva Pelvic Health System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 St Mark's Incontinence score, score ranges from 0-24, higher scores indicate more severe symptoms. A difference of -3 ± 4.37 is expected at 8 weeks and 16 weeks (compared to baseline), with an allowable difference of 1. | Baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fecal incontinence severity | Using St. Mark's Incontinence score, score ranges from 0-24, higher scores indicate more severe symptoms. | Baseline to 16 and 24 weeks | 
| 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) | Baseline to 24 weeks | 
| 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. | Baseline to 16 and 24 weeks | 
| 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. | Baseline to 24 weeks | 
| 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. | Baseline to 16 weeks | 
| Change in Brink Scale Score | 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. Ratings are summed to obtain total scores, with a possible range of scores of 3 to 12 and higher scores indicating greater strength. | 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. | Baseline to 16 and 24 weeks | 
| 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. | Baseline to 16 and 24 weeks | 
| Change in sexual function (PISQ-IR) | PISQ-IR is a 20 item survey, where higher scores indicate lower sexual function. | Baseline to 16 and 24 weeks | 
| 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. | 16 and 24 weeks | 
| Patient Satisfaction (PGI-I) | PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement. | 16 and 24 weeks | 
| 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). | 16 and 24 weeks | 
| 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. | Baseline to 16 and 24 weeks | 
| Evaluate self-continuation of pelvic floor muscle exercises | Participant self-report on whether and how often they continued the pelvic floor muscle exercises. | Baseline and 24 weeks | 
| Number of cumulative adverse events | Systematic assessment of all adverse events over the course of the study, reported as a number of total AEs. | Baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal incontinence, accidental bowel leakage, pelvic health system