Clinical Trial: Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

Brief Summary: The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.

Detailed Summary: 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.
Sponsor: VA Office of Research and Development

Current Primary Outcome:

  • 7-day Bowel Diary, Number of Fecal Incontinence Episodes [ Time Frame: 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.
  • Percentage of Bowel Movements With Incontinence [ Time Frame: 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.


Original Primary Outcome: 7-day bowel diary, proportion of incontinent bowel movements [ Time Frame: 4 weeks ]

Current Secondary Outcome: Fecal Incontinence Severity Index Score, FISI [ Time Frame: 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.


Original Secondary Outcome:

Information By: VA Office of Research and Development

Dates:
Date Received: July 29, 2008
Date Started: July 2008
Date Completion:
Last Updated: March 18, 2015
Last Verified: March 2015