Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165475
• Other study ID #: Dnr 02-220
• Status: Completed
• Phase: N/A
• First received: June 11, 2014
• Last updated: June 17, 2014
• Start date: May 2002

Study information

• Verified date: June 2014
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Behavioral:
• Biofeedback

Drug:
• Loperamide

• Stool bulking agent (stericulia or isphagula husk)

Other:
• Combination of biofeedback and medical treatment

Locations

Country	Name	City	State
Sweden	Pelvic floor unit, University hospital of Linköping	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom diary		Up to eight months