A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)

Study Overview
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Brief Summary
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The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the Eclipse™ System) in women with fecal incontinence.

Official Title
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A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women.

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: vaginal bowel control system (LivSure)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of FI for at least 6 months Baseline diary requirement for min # of FI episodes in a two-week period Ability to manage investigational device insertion and removal Successful fitting of study device Willing and able to give written informed consent to participate in the study Exclusion Criteria: Chronic rectal, anal or pelvic pain Any vaginal prolapse that extends beyond the plane of the hymen. Previous rectal or pelvic floor surgery within the last 12 months (24 months in the case of cancer) Congenital anorectal malformation Chronic watery diarrhea unmanageable by drugs or diet as primary cause of FI Inflammatory bowel disease Presence of a vaginal, anal, rectal or urethral fistula or anastomosis Presence of a vaginal, rectal or bladder tumor Presence of an open wound or tear in the vagina or anus by exam Presence or history of rectovaginal fistula Atrophic vaginal tissue as determined by symptoms or visualization Current vaginal or urinary infection requiring treatment History of recurrent urinary or vaginal infections Subject is currently pregnant or planning pregnancy in next 5 months Concurrent use of any intra-vaginal device that would interfere with LivSure (now called Eclipse) placement or wearing Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.) or other factor that the investigator believes would interfere with study participation and/or increase subject risk

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Bowel Control<br>A vaginal bowel control system intended to manage fecal incontinence. | Device: vaginal bowel control system (LivSure)<br> <br> * Other names: Eclipse™ System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of FI Episodes | Subjects with at least a 50% reduction in FI episodes (major or minor soiling) | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Incontinent Days | Change in number of incontinent days while wearing the device during the 2-week assessment period as compared to the baseline 2-week assessment period | 1 Month | 
| Device-related Adverse Events | The number of overall adverse events rated as probably or definitely related to the study device. | 1month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal incontinence, bowel control