A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence

Summary

A short presentation of a randomized clinical trial of biofeedback and anal injections as a first treatment option of faecal incontinence.

Background: Faecal incontinence affects mainly women who have suffered sphincter disruption from vaginal delivery, but individuals of all ages can be affected. The treatment of this debility is not uniform between institutions or internationally. Often is surgical reconstruction of the anal sphincter performed, or other invasive, costly treatment options.

The study: We intend to conduct a randomized, controlled, clinical trial where we compare the effect of two less invasive, less costly treatment options as a first alternative: biofeedback and anal injections. Our hypothesis is that anal injections will give a better and more lasting effect than biofeedback. The primary endpoint will be change in faecal incontinence assessed by the St. Marks incontinence score. Secondary endpoints will include change in quality of life and several physiological parameters. We intend to include 62 patients in both groups, 124 all together, from 2 centres in Norway. The observation time is 2 years. We plan to include the first patient April 2006, and conclude the study by December 2010. This study can contribute to a more appropriate treatment-algorithm for these patients.

Study group:

* Barthold Vonen MD PhD, Department of gastroenterological surgery, University Hospital of North Norway
* Rolv-Ole Lindsetmo MD PhD, Department of gastroenterological surgery, University Hospital of North Norway
* Arvid Stordahl MD PhD., Department of Surgery, Østfold Hospital Fredrikstad
* Ylva Sahlin MD PhD, Department of Surgery, Innlandet Hospital Hamar
* Trond Dehli, MD, Department of gastroenterological surgery, University Hospital of North Norway
* Kjersti Mevik, Stud. Med, University of Tromso

Project manager: Trond Dehli

Funding, approvals, publication: This study is funded from Northern Norway Regional Health Authority and The Institution of Norwegian Health- and rehabilitation-organizations. It has been approved by the Regional Committee for Medical Research Ethics and Norwegian Social Science Data Services. The results will be published in an international peer-reviewed journal after the Vancouver-convention's guidelines. The results will also be presented at national and international conferences.

Contact:

Trond Dehli, Department of gastroenterological surgery, University hospital North Norway, Breivika, 9038 Tromsø [email protected] tlf: +47 776 26 000

Conditions

• Fecal Incontinence

Interventions

PROCEDURE

1. Anal injection

Submucosal injection just above the linea dentata in the anal canal of 4 x 1 ml of dextranomere.

PROCEDURE

2. Biofeedback

Training under the guidance of a physiotherapist with the help of a biofeedback device with an anal probe.

Sponsors & Collaborators

• Norwegian Foundation for Health and Rehabilitation

  collaborator OTHER

• University Hospital of North Norway

  lead OTHER

Principal Investigators

• Barthold Vonen, M.D., Ph.D. · University of Tromsø, Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2011-06-30

Completion

2011-06-30

Countries

• Norway

Study Locations