NCT02165475

Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents is Effective for the Treatment of Fecal Incontinence in Women - a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
BEHAVIORAL	Biofeedback
DRUG	Loperamide
DRUG	Stool bulking agent (stericulia or isphagula husk)
OTHER	Combination of biofeedback and medical treatment

Timeline

• Start date: 2002-05-01
• Primary completion: 2005-03-01
• First posted: 2014-06-17
• Last updated: 2014-06-18

Locations

1 site across 1 country: Sweden