Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence (FIRM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00727649
First received: July 29, 2008
Last updated: March 18, 2015
Last verified: March 2015
  Purpose

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


Condition Intervention Phase
Fecal Incontinence
Drug: Psyllium powder
Drug: Loperamide
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 80
Study Start Date: July 2008
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Loperamide
Drug: Loperamide
1 capsule daily for 28 days (weekly adjusted dose)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727649

Locations
United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
Investigators
Principal Investigator: Alayne D Markland, DO MSc VA Medical Center, Birmingham
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00727649     History of Changes
Other Study ID Numbers: B6126-W
Study First Received: July 29, 2008
Results First Received: January 23, 2015
Last Updated: March 18, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
fecal incontinence
adults
diarrhea

Additional relevant MeSH terms:
Fecal Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antidiarrheals
Loperamide
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2015