Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

June 17, 2014 updated by: Jenny Sjödahl, University Hospital, Linkoeping

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden, 58185
        • Pelvic floor unit, University hospital of Linköping

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofeedback
Behavioral: Biofeedback
Experimental: medical treatment
Drug: Loperamide
Drug: Stool bulking agent (stericulia or isphagula husk)
Experimental: combination of the two treatments
Other: Combination of biofeedback and medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
symptom diary
Time Frame: Up to eight months
Up to eight months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Estimate)

June 18, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 02-220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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