Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence (FIRM)
The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.
Drug: Psyllium powder
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence|
- 7-day Bowel Diary, Number of Fecal Incontinence Episodes [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
- Fecal Incontinence Severity Index Score, FISI [ Time Frame: baseline, 4 week and 12 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2008|
|Study Completion Date:||December 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1
Fiber (psyllium) powder
Drug: Psyllium powder
2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)
Other Name: Metamucil
Active Comparator: Arm 2
1 capsule daily for 28 days (weekly adjusted dose)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727649
|United States, Alabama|
|VA Medical Center, Birmingham|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Alayne D Markland, DO MSc||VA Medical Center, Birmingham|