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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Drug: Psyllium powder; Drug: Loperamide

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • VA Medical Center, Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Metamucil
Active Comparator: Arm 2; Loperamide	Drug: Loperamide; 1 capsule daily for 28 days (weekly adjusted dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Alayne D Markland, DO MSc, VA Medical Center, Birmingham

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 29, 2008
• First Submitted That Met QC Criteria: August 1, 2008
• First Posted (Estimate): August 4, 2008

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: diarrhea; adults; fecal incontinence
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence; Gastrointestinal Agents; Cathartics; Psyllium; Loperamide; Antidiarrheals
• Other Study ID Numbers: B6126-W