Phase 3
Completed N=80
Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
Source: ClinicalTrials.gov NCT00727649 ↗Enrolled (actual)
80
Serious AEs
0.7%
Results posted
Apr 2015
Primary outcomePrimary: 7-day Bowel Diary, Number of Fecal Incontinence Episodes — 7.3; 7.9; 4.8; 4.1 Fecal incontinence episodes
Summary
The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.
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 | — |
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
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. Informational only — not medical advice.