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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01655498
First Posted: August 2, 2012
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pelvalon, Inc.
  Purpose
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 Intervention
Fecal Incontinence Device: vaginal bowel control system (LivSure)

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Pelvalon, Inc.:

Primary Outcome Measures:
  • 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:
  • 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

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


Enrollment: 61
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655498


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pelvalon, Inc.
ClinicalTrials.gov Identifier: NCT01655498     History of Changes
Other Study ID Numbers: CA003
First Submitted: July 24, 2012
First Posted: August 2, 2012
Results First Submitted: April 1, 2015
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