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

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Fecal Incontinence

Treatments: Drug: Loperamide; Drug: Psyllium powder

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00727649

B6126-W

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

Fiber (psyllium) powder

Treatment:

Drug: Psyllium powder

Arm 2

Active Comparator group

Description:

Loperamide

Treatment:

Drug: Loperamide