A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence
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|ClinicalTrials.gov Identifier: NCT00303030|
Recruitment Status : Completed
First Posted : March 15, 2006
Last Update Posted : November 17, 2011
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.
- 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.
Trond Dehli, Department of gastroenterological surgery, University hospital North Norway, Breivika, 9038 Tromsø firstname.lastname@example.org tlf: +47 776 26 000
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Procedure: 1. Anal injection Procedure: 2. Biofeedback||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence.|
|Study Start Date :||May 2006|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
|Active Comparator: 1. Anal injection||
Procedure: 1. Anal injection
Submucosal injection just above the linea dentata in the anal canal of 4 x 1 ml of dextranomere.
Other Name: Solesta
|Active Comparator: 2. Biofeedback||
Procedure: 2. Biofeedback
Training under the guidance of a physiotherapist with the help of a biofeedback device with an anal probe.
- Incontinence measured by St.Marks incontinence score [ Time Frame: 2 years ]
- Health related Quality of Life measures [ Time Frame: 2 years ]
- Physiologic measures [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303030
|Anorektallaboratoriet, Østfoldsykehuset Sarpsborg|
|Sarpsborg, Norway, 1723|
|Avdeling for gastroenterologisk kirurgi, University hospital of North Norway|
|Tromso, Norway, 9016|
|Study Director:||Barthold Vonen, M.D., Ph.D.||University of Tromsø, Norway|