Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00303030
First received: March 14, 2006
Last updated: November 16, 2011
Last verified: November 2011
  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:

  • 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


Condition Intervention Phase
Fecal Incontinence
Procedure: 1. Anal injection
Procedure: 2. Biofeedback
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence.

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Incontinence measured by St.Marks incontinence score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related Quality of Life measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Physiologic measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: May 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303030

Locations
Norway
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
Investigators
Study Director: Barthold Vonen, M.D., Ph.D. University of Tromsø, Norway
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00303030     History of Changes
Other Study ID Numbers: Biofeedback or injections
Study First Received: March 14, 2006
Last Updated: November 16, 2011
Health Authority: Norway: Norwegian Social Science Data Services

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

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

ClinicalTrials.gov processed this record on November 27, 2014