A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE) (LIFE)
Primary Purpose
Fecal Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vaginal bowel control system (LivSure)
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence focused on measuring fecal incontinence, bowel control
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaginal Bowel Control
Arm Description
A vaginal bowel control system intended to manage fecal incontinence.
Outcomes
Primary Outcome Measures
Frequency of FI Episodes
Subjects with at least a 50% reduction in FI episodes (major or minor soiling)
Secondary Outcome Measures
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
Device-related Adverse Events
The number of overall adverse events rated as probably or definitely related to the study device.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01655498
Brief Title
A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)
Acronym
LIFE
Official Title
A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pelvalon, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
fecal incontinence, bowel control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaginal Bowel Control
Arm Type
Experimental
Arm Description
A vaginal bowel control system intended to manage fecal incontinence.
Intervention Type
Device
Intervention Name(s)
vaginal bowel control system (LivSure)
Other Intervention Name(s)
LivSure System, Eclipse™ System
Primary Outcome Measure Information:
Title
Frequency of FI Episodes
Description
Subjects with at least a 50% reduction in FI episodes (major or minor soiling)
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Number of Incontinent Days
Description
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
Time Frame
1 Month
Title
Device-related Adverse Events
Description
The number of overall adverse events rated as probably or definitely related to the study device.
Time Frame
1month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Richter, PhD, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27564386
Citation
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.
Results Reference
derived
PubMed Identifier
25730213
Citation
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):540-547. doi: 10.1097/AOG.0000000000000639.
Results Reference
derived
Learn more about this trial
A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)
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