Fecal Incontinence Clinical Trial
Verified date | April 2017 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female - Age 18 years or older - fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles - Fecal incontinence severity score of 10 or more - Fecal incontinence episodes of 4 or more over a 2 week period Exclusion Criteria: - History of diabetes - History of allergy to porcine derivatives - History of infection in the anal area (abscess, fistula) - History of inflammatory bowel disease - History of hidradenitis suppurativa - History of immunosuppression - History of HIV positivity - History of radiation to the study site within the last 12 months - Patients who cannot travel to keep follow up appointments - Patients who are prisoners - Patients who are mentally handicapped - Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding - Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment. - Patients with a FIQL baseline score of = 4 - Patients participating in another clinical trial for the same indication - Patients unwilling to give informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Massarat Zutshi | Cook |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of incontinence episodes per week | 12 months | ||
Secondary | Change in Quality of Life | 24 months |
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