Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Linkoeping
• Treatments: Antidiarrheals; Loperamide

Criteria

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