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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pelvalon, Inc.
ClinicalTrials.gov Identifier:
NCT01655498
First received: July 24, 2012
Last updated: May 22, 2015
Last verified: May 2015
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   19 Years to 75 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Pelvalon, Inc.

Additional 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
Study First Received: July 24, 2012
Results First Received: April 1, 2015
Last Updated: May 22, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pelvalon, Inc.:
fecal incontinence
bowel control

Additional relevant MeSH terms:
Fecal Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 27, 2015