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| Sponsors and Collaborators: |
University Hospital of North Norway Norwegian Foundation for Health and Rehabilitation |
|---|---|
| Information provided by: | University Hospital of North Norway |
| ClinicalTrials.gov Identifier: | NCT00303030 |
Purpose
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:
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-organisations. 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-rewied 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
| Condition | Intervention | Phase |
|---|---|---|
|
Fecal Incontinence |
Procedure: Anal injection Procedure: Biofeedback |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Trond Dehli, M.D. | +47 776 26 000 | trond.dehli@unn.no |
| Contact: Barthold Vonen, M.D., Ph.D | +47 776 26 000 | barthold.vonen@unn.no |
| Norway | |
| Avdeling for gastroenterologisk kirurgi, University hospital of North Norway | Recruiting |
| Tromso, Norway, 9016 | |
| Principal Investigator: Trond Dehli, M.D. | |
| Anorektallaboratoriet, Østfoldsykehuset Sarpsborg | Recruiting |
| Sarpsborg, Norway, 1723 | |
| Contact: Arvid Stordahl, M.D., Ph.D. +47 69 86 00 00 stordah@online.no | |
| Principal Investigator: Arvid Stordahl, MD, PhD | |
| Sub-Investigator: Arvid Jacobsen, MD, PhD | |
| Study Director: | Barthold Vonen, M.D., Ph.D. | University of Tromsø, Norway |
More Information
| Study ID Numbers: | Biofeedback or injections |
| Study First Received: | March 14, 2006 |
| Last Updated: | March 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00303030 History of Changes |
| Health Authority: | Norway: Norwegian Social Science Data Services |
|
Fecal incontinence Biofeedback Patient Satisfaction Quality of LifeTreatment Outcome Injections |
|
Signs and Symptoms Fecal Incontinence Digestive System Diseases Urologic Diseases Urination Disorders |
Gastrointestinal Diseases Urinary Incontinence Intestinal Diseases Rectal Diseases |
|
Signs and Symptoms Urological Manifestations Fecal Incontinence Digestive System Diseases Urologic Diseases |
Urination Disorders Gastrointestinal Diseases Urinary Incontinence Intestinal Diseases Rectal Diseases |
