Treatment of Patients With Fecal Incontinence

Stopped early · Not applicable

Conditions studied: Fecal Incontinence

In brief

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 incontinence.

Key facts

Study ID

NCT00292318

Run by

US Department of Veterans Affairs

People needed

7

Starts

2008-01-01

Expected to finish

2014-09-01

Last updated by the study team

2015-08-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Greater Los Angeles Healthcare System, Sepulveda, CA — Sepulveda, California, United States

Full record on ClinicalTrials.gov

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