Status:
COMPLETED
Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair: A Pilot Study
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Cook Group Incorporated
Alberta Health services
Conditions:
Anterior Pelvic Organ Prolapse
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotat...
Eligibility Criteria
Inclusion
- Women who require surgical correction for anterior compartment prolapse. (Concomitant surgery is permitted.)
- Point Ba of 0 or greater: that is a positive Ba, indicating that the prolapse is beyond the introitus, not within the vagina.
- Patient must consent to participate in the study.
Exclusion
- Having an obliterative procedure (Lefort procedure or colpocleisis).
- Allergy to graft material.
- Immunocompromised.
- Previous anterior compartment repair.
- Are unable to understand English.
- Will be unavailable for follow-up.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00955448
Start Date
December 1 2009
End Date
April 1 2012
Last Update
August 31 2016
Active Locations (1)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 1C5