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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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Brief Summary:
The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Drug: Psyllium powder Drug: Loperamide Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
Study Start Date : July 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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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 Name: Metamucil
Active Comparator: Arm 2
Loperamide
 Drug: Loperamide
1 capsule daily for 28 days (weekly adjusted dose)


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Alayne D Markland, DO MSc VA Medical Center, Birmingham
More Information
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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00727649    
Other Study ID Numbers: B6126-W
First Posted: August 4, 2008    Key Record Dates
Results First Posted: April 1, 2015
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
fecal incontinence
adults
diarrhea
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Loperamide
Antidiarrheals
Psyllium
Gastrointestinal Agents
Cathartics