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

NCT00303030 | Completed Phase 1

• 1 other identifier: Biofeedback or injections
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

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

Conditions

Fecal Incontinence

Keywords

Fecal incontinence; Biofeedback; Patient Satisfaction; Quality of LifeTreatment Outcome; Injections

Outcome Measures

Primary Outcomes (1)

• Incontinence measured by St.Marks incontinence score

  2 years

Secondary Outcomes (2)

• Health related Quality of Life measures

  2 years

• Physiologic measures

  2 years

Study Arms (2)

1. Anal injection

ACTIVE COMPARATOR

Procedure: 1. Anal injection

2. Biofeedback

ACTIVE COMPARATOR

Procedure: 2. Biofeedback

Interventions

1. Anal injection PROCEDURE

Submucosal injection just above the linea dentata in the anal canal of 4 x 1 ml of dextranomere.

Also known as: Solesta

1. Anal injection

2. Biofeedback PROCEDURE

Training under the guidance of a physiotherapist with the help of a biofeedback device with an anal probe.

2. Biofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fecal incontinence lasting more than 6 months
• St. Marks score of 4 or more
• No known local or general neurological disease
• years or older
• No constipation

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Norwegian Foundation for Health and Rehabilitation: collaborator

Study Sites (3)

Innlandssykehuset Hamar

Hamar, Norway

Location

Anorektallaboratoriet, Østfoldsykehuset Sarpsborg

Sarpsborg, 1723, Norway

Location

Avdeling for gastroenterologisk kirurgi, University hospital of North Norway

Tromsø, 9016, Norway

Location

MeSH Terms

Conditions

Fecal Incontinence; Patient Satisfaction

Interventions

dextranomer-hyaluronic acid copolymer

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Barthold Vonen, M.D., Ph.D.

  University of Tromsø, Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2006
• First Posted: March 15, 2006
• Study Start: May 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 17, 2011

Record last verified: 2011-11

Locations

NO (3)