Clinical trial NCT00303030: A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence
Official title: A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fecal Incontinence
Keywords: Fecal incontinence
Biofeedback
Patient Satisfaction
Quality of LifeTreatment Outcome
Injections
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Norwegian Foundation for Health and Rehabilitation
First posted: 2006-03-15
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Incontinence measured by St.Marks incontinence score
timeFrame: 2 years
Secondary outcomes:
measure: Health related Quality of Life measures
timeFrame: 2 years
measure: Physiologic measures
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamar
country: Norway
facility: Innlandssykehuset Hamar
city: Sarpsborg
country: Norway
facility: Anorektallaboratoriet, Østfoldsykehuset Sarpsborg
city: Tromso
country: Norway
facility: Avdeling for gastroenterologisk kirurgi, University hospital of North Norway
Study officials:
affiliation: University of Tromsø, Norway
name: Barthold Vonen, M.D., Ph.D.
role: STUDY_DIRECTOR
References: