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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Fecal Incontinence	Device: vaginal bowel control system (LivSure)	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	61 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women.
Study Start Date :	August 2012
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	March 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Vaginal Bowel Control; A vaginal bowel control system intended to manage fecal incontinence.	Device: vaginal bowel control system (LivSure); Other Names: LivSure System; Eclipse™ System

Outcome Measures

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Primary Outcome Measures :

1. Frequency of FI Episodes [ Time Frame: 1 Month ]
   Subjects with at least a 50% reduction in FI episodes (major or minor soiling)

Secondary Outcome Measures :

1. Number of Incontinent Days [ Time Frame: 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
2. Device-related Adverse Events [ Time Frame: 1month ]
   The number of overall adverse events rated as probably or definitely related to the study device.

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249

Sponsors and Collaborators

Pelvalon, Inc.

Investigators

Principal Investigator:	Holly Richter, PhD, MD	University of Alabama at Birmingham

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Matthews CA, Varma MG, Takase-Sanchez MM, Hale DS, Van Drie D, Muir T, Wells E, Jannelli M, Richter HE. Characteristics Associated With Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence. Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):359-63. doi: 10.1097/SPV.0000000000000290.

Richter HE, Matthews CA, Muir T, Takase-Sanchez MM, Hale DS, Van Drie D, Varma MG. A vaginal bowel-control system for the treatment of fecal incontinence. Obstet Gynecol. 2015 Mar;125(3):540-7. doi: 10.1097/AOG.0000000000000639.

Responsible Party:	Pelvalon, Inc.
ClinicalTrials.gov Identifier:	NCT01655498 History of Changes
Other Study ID Numbers:	CA003
First Posted:	August 2, 2012
Results First Posted:	May 27, 2015
Last Update Posted:	May 27, 2015
Last Verified:	May 2015

Keywords provided by Pelvalon, Inc.:

fecal incontinence; bowel control

Additional relevant MeSH terms:

Fecal Incontinence; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases