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

Study Overview
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Brief Summary
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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 trond.dehli@unn.no tlf: +47 776 26 000

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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Procedure: 1. Anal injection
* Procedure: 2. Biofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fecal incontinence lasting more than 6 months St. Marks score of 4 or more No known local or general neurological disease 18 years or older No constipation Exclusion Criteria: Total rupture of the sphincter of more than 120 degrees Diabetes mellitus with late complications (neurological og cardiovascular) Ulcus simplex/rectal ulcus Anal/rectal prolapse ileo-anal anastomosis Cancer recti or cancer ani last 2 years Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Anal injection<br> | Procedure: 1. Anal injection<br>* Submucosal injection just above the linea dentata in the anal canal of 4 x 1 ml of dextranomere.<br>* Other names: Solesta;|
| Active Comparator: 2. Biofeedback<br> | Procedure: 2. Biofeedback<br>* Training under the guidance of a physiotherapist with the help of a biofeedback device with an anal probe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence measured by St.Marks incontinence score |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related Quality of Life measures |  | 2 years | 
| Physiologic measures |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal incontinence, Biofeedback, Patient Satisfaction, Quality of LifeTreatment Outcome, Injections