Status:
TERMINATED
Treatment of Patients With Fecal Incontinence
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if a behavioral treatment method called biofeedback will reduce the frequency of episodes of leakage of fecal material in patient suffering from fecal inconti...
Detailed Description
Fecal incontinence (FI) is a devastating condition that causes psychological stress, shame, embarrassment, and social isolation. It has a major impact on quality of life of patients and their families...
Eligibility Criteria
Inclusion
- Male or female patient with inadequate relief of fecal incontinence symptoms after documented management in the primary care setting. They must have:
- a mini-mental status score of \> 18
- an "up and go" test score of \< 30 seconds
- bowel habit diary showing \> one episode of fecal incontinence episode per week
Exclusion
- patients who previously underwent a course of biofeedback for fecal incontinence
- age \< 18 years
- major neurological disease
- significant cognitive impairment (mini mental status examination score \< 18), functional impairment (up and go score of \> 30 seconds)
- active inflammatory bowel disease
- history of spinal cord injury
- rectal resection
- ileal pouch procedures
- latex allergy
- significantly distressed and unable to consider informed consent issues adequately
- needing urgent medical referral
- insufficient written English skills to complete the questionnaires
- require surgery
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00292318
Start Date
January 1 2008
End Date
September 1 2014
Last Update
August 19 2015
Active Locations (1)
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1
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States, 91343