Status:
COMPLETED
Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.
Detailed Description
Fecal incontinence (FI) affects 4-24% adults in the community and greatly impacts quality of life. Both fiber and loperamide are common, first-line treatments for diarrhea-associated FI in primary car...
Eligibility Criteria
Inclusion
- weekly fecal incontinence
Exclusion
- fecal impaction
- inability to complete a baseline 1-week bowel diary
- rectal prolapse
- any prior radiation to the pelvis
- colo-rectal cancer
- rectal fistula
- inflammatory bowel disease
- neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)
- constipation (\<2 bowel movements/week) or total colectomy
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00727649
Start Date
July 1 2008
End Date
December 1 2013
Last Update
April 1 2015
Active Locations (1)
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1
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233