Clinical Trial: Veritas Collagen Matrix Cystocele Repair Study - Postmarketing
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004
Brief Summary: The purpose of this study is to evaluate the Veritas Collagen Matrix in treating female patients with documented occurence of Pelvic Organ Prolapse as evidenced by a cystocele.
Detailed Summary:
Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix
Sponsor: The Cleveland Clinic
Current Primary Outcome: To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery [ Time Frame: 2 years ]
Original Primary Outcome: To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery
Current Secondary Outcome: To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery [ Time Frame: 2 years ]
Original Secondary Outcome: To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery
Information By: The Cleveland Clinic
Dates:
Date Received: March 12, 2009
Date Started: December 2001
Date Completion:
Last Updated: April 18, 2017
Last Verified: April 2017