drugset / Trial / NCT02165475

Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

NCT02165475

Treatment

Summary

Background: Biofeedback and medical treatments have been extensively used for moderate fecal incontinence. There is limited data comparing and combining these two treatments. Aim: To evaluate the effect of biofeedback and medical treatments, separately and in combination. Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal incontinence were included. The patients were randomized to start with either biofeedback (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both groups continued with a combination treatments, i.e. medical treatment was added to biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments.

Timeline

Start
2002-05
Primary completion
2005-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Loperamide Small molecule
Subject isphagula husk Unknown
Subject stericulia Unknown

Indications

No indication recorded.