Status:
COMPLETED
A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence
Lead Sponsor:
University Hospital of North Norway
Collaborating Sponsors:
Norwegian Foundation for Health and Rehabilitation
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00303030
Start Date
May 1 2006
End Date
June 1 2011
Last Update
November 17 2011
Active Locations (3)
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1
Innlandssykehuset Hamar
Hamar, Norway
2
Anorektallaboratoriet, Østfoldsykehuset Sarpsborg
Sarpsborg, Norway, 1723
3
Avdeling for gastroenterologisk kirurgi, University hospital of North Norway
Tromsø, Norway, 9016