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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
Information provided by (Responsible Party):

Study Description
Brief 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.


Trond Dehli, Department of gastroenterological surgery, University hospital North Norway, Breivika, 9038 Tromsø trond.dehli@unn.no tlf: +47 776 26 000

Condition or disease Intervention/treatment Phase
Fecal Incontinence Procedure: 1. Anal injection Procedure: 2. Biofeedback Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Incontinence measured by St.Marks incontinence score [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Health related Quality of Life measures [ Time Frame: 2 years ]
  2. Physiologic measures [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303030

Innlandssykehuset Hamar
Hamar, Norway
Anorektallaboratoriet, Østfoldsykehuset Sarpsborg
Sarpsborg, Norway, 1723
Avdeling for gastroenterologisk kirurgi, University hospital of North Norway
Tromso, Norway, 9016
Sponsors and Collaborators
University Hospital of North Norway
Norwegian Foundation for Health and Rehabilitation
Study Director: Barthold Vonen, M.D., Ph.D. University of Tromsø, Norway
More Information

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00303030     History of Changes
Other Study ID Numbers: Biofeedback or injections
First Posted: March 15, 2006    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: November 2011

Keywords provided by University Hospital of North Norway:
Fecal incontinence
Patient Satisfaction
Quality of LifeTreatment Outcome

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases