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OpenTrials
Completed

NCT Number: NCT00727649

Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

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

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Key information

Conditions

Fecal Incontinence Diarrhea Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psyllium powder

Drug

2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)

Other names: Metamucil

Loperamide

Drug

1 capsule daily for 28 days (weekly adjusted dose)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Acronym: FIRM

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2008
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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