Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

Fecal Incontinence Clinical Trial

— FIRM  

Official title:

Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727649
• Other study ID #: B6126-W
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 29, 2008
• Last updated: March 18, 2015
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Drug:
• Psyllium powder
2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)
• Loperamide
1 capsule daily for 28 days (weekly adjusted dose)

Locations

Country	Name	City	State
United States	VA Medical Center, Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day Bowel Diary, Number of Fecal Incontinence Episodes	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.	6 weeks and 12 weeks	No
Primary	Percentage of Bowel Movements With Incontinence	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.	4 weeks	No
Secondary	Fecal Incontinence Severity Index Score, FISI	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.	baseline, 4 week and 12 weeks	No