Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence (FIRM)
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|ClinicalTrials.gov Identifier: NCT00727649|
Recruitment Status : Completed
First Posted : August 4, 2008
Results First Posted : April 1, 2015
Last Update Posted : April 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Drug: Psyllium powder Drug: Loperamide||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence|
|Study Start Date :||July 2008|
|Primary Completion Date :||October 2013|
|Study Completion Date :||December 2013|
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)
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727649
|United States, Alabama|
|VA Medical Center, Birmingham|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Alayne D Markland, DO MSc||VA Medical Center, Birmingham|