Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

Not Applicable

Completed

• Conditions: Fecal Incontinence
• Interventions: Behavioral: Biofeedback; Other: Combination of biofeedback and medical treatment; Drug: Loperamide; Drug: Stool bulking agent (stericulia or isphagula husk)

• Registration Number: NCT02165475
• Lead Sponsor: University Hospital, Linkoeping

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2005-03
• Status Verified: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Patients older than 18 years of age
• Patients with at least one or more episodes of FI during a period of 2 weeks as recorded by bowel function diary
• Patients from whom written consent was obtained

Exclusion Criteria

• Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
• Presence of neurological diseases or peripheral vascular disease
• Uncontrolled diabetes mellitus
• Congenital anorectal malformations
• Recent colorectal or gastrointestinal surgery
• Presence of external full-thickness rectal prolapse
• Inflammatory bowel disease
• Chronic diarrhoea
• Use of tibial nerve or sacral nerve stimulations
• Ongoing pregnancy
• Any malignant disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biofeedback	Biofeedback	-
medical treatment	Stool bulking agent (stericulia or isphagula husk)	-
combination of the two treatments	Combination of biofeedback and medical treatment	-
medical treatment	Loperamide	-

Primary Outcome Measures

Name	Time	Method
symptom diary	Up to eight months

Trial Locations

Locations (1)

Pelvic floor unit, University hospital of Linköping; 🇸🇪 Linköping, Sweden