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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
Pelvalon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring fecal incontinence, bowel control

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
July 24, 2012
Last Updated
May 22, 2015
Sponsor
Pelvalon, Inc.
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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

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

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