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

Not Applicable

Completed

• Conditions: Fecal Incontinence
• Interventions: Device: vaginal bowel control system (LivSure)

• Registration Number: NCT01655498
• Lead Sponsor: Pelvalon, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-24
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-02
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Results First Submitted: 2015-04-01
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-22
• Last Update Submitted: 2015-05-22
• Results First Posted: 2015-05-27
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaginal Bowel Control	vaginal bowel control system (LivSure)	A vaginal bowel control system intended to manage fecal incontinence.

Primary Outcome Measures

Name	Time	Method
Frequency of FI Episodes	1 Month	Subjects with at least a 50% reduction in FI episodes (major or minor soiling)

Secondary Outcome Measures

Name	Time	Method
Number of Incontinent Days	1 Month	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
Device-related Adverse Events	1month	The number of overall adverse events rated as probably or definitely related to the study device.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States