Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

US Department of Veterans Affairs80 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fecal Incontinence

Interventions

Psyllium powderDRUG

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

LoperamideDRUG

1 capsule daily for 28 days (weekly adjusted dose)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

VA Medical Center, Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 4 weeks

Secondary Outcomes

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.

Time frame: baseline, 4 week and 12 weeks

Data from ClinicalTrials.gov

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