drugset / Trial / NCT01717456
Educational-Medical-Behavioral Treatment of Fecal Incontinence
Terminated
31 enrolled
University of North Carolina, Chapel Hill
Agency for Healthcare Research and Quality (AHRQ) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. The purpose of this study is to determine whether this treatment is effective when delivered by home health care nurses to frail elderly patients.
Timeline
- Start
- 2013-01
- Primary completion
- 2015-03
- Completion
- 2015-03
Outcome
Missed primary endpoint
Stopped (Enrollment): “Low enrollment led sponsor to terminate study early.”
registry analysis (superiority or other test); Educational-Medical-Behavioral vs Standard Care; p = .05; Mean Difference (Final Values) 4.0; t-test, 2 sided; NCT01717456 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Loperamide | Small molecule | 2 mg | — |
| Subject | Polyethylene Glycol 3350 | Other / unclassified | 17 g | — |
Indications
No indication recorded.