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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00303030 |
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Date of registration:
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14/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence
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Scientific title:
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A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence. |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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126 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00303030 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Norway
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Contacts
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Name:
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Barthold Vonen, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Tromsø, Norway |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fecal Incontinence
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Intervention(s)
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Procedure: 2. Biofeedback
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Procedure: 1. Anal injection
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Primary Outcome(s)
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Incontinence measured by St.Marks incontinence score
[Time Frame: 2 years]
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Secondary Outcome(s)
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Physiologic measures
[Time Frame: 2 years]
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Health related Quality of Life measures
[Time Frame: 2 years]
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Secondary ID(s)
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Biofeedback or injections
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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