Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

Phase 2

Completed

• Conditions: Fecal Incontinence
• Interventions: Drug: Psyllium powder; Drug: Loperamide

• Registration Number: NCT00727649
• Lead Sponsor: US Department of Veterans Affairs

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 care. No known studies exist that compare fiber and loperamide for diarrhea-predominant FI. Further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for FI. This study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-04
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Results First Submitted: 2015-01-23
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-18
• Last Update Submitted: 2015-03-18
• Results First Posted: 2015-04-01
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• weekly fecal incontinence

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Psyllium powder	Fiber (psyllium) powder
Arm 2	Loperamide	Loperamide

Primary Outcome Measures

Name	Time	Method
Percentage of Bowel Movements With Incontinence	4 weeks	After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups.
7-day Bowel Diary, Number of Fecal Incontinence Episodes	6 weeks and 12 weeks	After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups.

Secondary Outcome Measures

Name	Time	Method
Fecal Incontinence Severity Index Score, FISI	baseline, 4 week and 12 weeks	The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms.

Trial Locations

Locations (1)

VA Medical Center, Birmingham; 🇺🇸 Birmingham, Alabama, United States