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

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Psyllium powder
Loperamide
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring fecal incontinence, adults, diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Medical Center, Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Fiber (psyllium) powder

Loperamide

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 29, 2008
Last Updated
March 18, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00727649
Brief Title
Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
Acronym
FIRM
Official Title
Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
fecal incontinence, adults, diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Fiber (psyllium) powder
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Loperamide
Intervention Type
Drug
Intervention Name(s)
Psyllium powder
Other Intervention Name(s)
Metamucil
Intervention Description
2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)
Intervention Type
Drug
Intervention Name(s)
Loperamide
Intervention Description
1 capsule daily for 28 days (weekly adjusted dose)
Primary Outcome Measure Information:
Title
7-day Bowel Diary, Number of Fecal Incontinence Episodes
Description
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.
Time Frame
6 weeks and 12 weeks
Title
Percentage of Bowel Movements With Incontinence
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Fecal Incontinence Severity Index Score, FISI
Description
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.
Time Frame
baseline, 4 week and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alayne D Markland, DO MSc
Organizational Affiliation
VA Medical Center, Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

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