A Clinical Evaluation of a New Device 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: August 21, 2014
Last verified: August 2014
  Purpose

The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure device in women with fecal incontinence.


Condition Intervention
Fecal Incontinence
Device: vaginal bowel control device (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) Device for the Treatment of Fecal Incontinence in Women.

Resource links provided by NLM:


Further study details as provided by Pelvalon, Inc.:

Primary Outcome Measures:
  • Change in subject reported episodes of fecal incontinence [ Time Frame: 2 week end of wearing period ] [ Designated as safety issue: No ]
    The number of episodes of fecal incontinence will be compared from a 2 week pre-device use baseline period to a 2 week on device use period.


Secondary Outcome Measures:
  • Number of participants with device related serious adverse events [ Time Frame: Participants will be using the study device for up to 3 months ] [ Designated as safety issue: Yes ]
    The number of participants with device related serious adverse events will be tracked for the duration of their study participation. Subjects may use the study device for up to 3 months.


Enrollment: 61
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginal Bowel Control
A vaginal bowel control device intended to manage fecal incontinence.
Device: vaginal bowel control device (LivSure)
Other Name: LivSure

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female gender
  • History of FI

Exclusion Criteria:

  • 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
  • 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
  • Subject is currently pregnant or planning pregnancy in next 5 months
  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

Responsible Party: Pelvalon, Inc.
ClinicalTrials.gov Identifier: NCT01655498     History of Changes
Other Study ID Numbers: CA003
Study First Received: July 24, 2012
Last Updated: August 21, 2014
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 October 30, 2014