Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

University Hospital, Linkoeping

Status: Completed

Conditions: Fecal Incontinence

Treatments: Drug: Loperamide; Drug: Stool bulking agent (stericulia or isphagula husk); Other: Combination of biofeedback and medical treatment; Behavioral: Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT02165475

Dnr 02-220

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

Biofeedback

Experimental group

Treatment:

Behavioral: Biofeedback

medical treatment

Experimental group

Treatment:

Drug: Stool bulking agent (stericulia or isphagula husk)

Drug: Loperamide

combination of the two treatments

Experimental group

Treatment:

Other: Combination of biofeedback and medical treatment