Phase 3 N=80 Randomized Quadruple-blind Treatment

Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

Fecal Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT00727649 ↗

Enrolled (actual)

Serious AEs

0.7%

Results posted

Apr 2015

Primary outcome: Primary: 7-day Bowel Diary, Number of Fecal Incontinence Episodes — 7.3; 7.9; 4.8; 4.1 Fecal incontinence episodes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Psyllium powder (Drug); Loperamide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY 7-day Bowel Diary, Number of Fecal Incontinence Episodes	7.3; 7.9; 4.8; 4.1; 4.3; 5.0	—
PRIMARY Percentage of Bowel Movements With Incontinence	30.5; 32.3; 23.4; 21.3; 23.0; 18.8	—
SECONDARY Fecal Incontinence Severity Index Score, FISI	29.1; 31.9; 24.9; 24.9; 22.0; 23.2	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00727649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.