Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Collagen Matrix

• Registration Number: NCT00860912
• Lead Sponsor: The Cleveland Clinic

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 Description

Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix

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Study Timeline

• Study Start: 2001-12
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

• Patient is equal or greater than 18 years old
• Female
• Meets follow-up evaluation time frame
• Understands the nature of the procedure and has provided written informed consent
• Is scheduled to undergo vaginal pelvic reconstructive surgery
• Has > 2nd degree midline cystocele

Exclusion Criteria

• Presence of severe mucosal ulceration
• Previous pelvic organ prolapse surgery using an implant that will affect the use of the VCM or affect the outcome of the study
• Allergy to bovine material
• Severe mucosal atrophy
• Shortened vaginal length as determined by Investigator
• Pregnant or intends to become pregnant during study
• Has a UTI
• Has vault prolapse < 2nd degree cystocele

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Native tissue repair	Collagen Matrix	Intervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues.
Intervention: Collagen matrix	Collagen Matrix	Cystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix

Primary Outcome Measures

Name	Time	Method
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	2 years	prolapse degree on pelvic exam

Secondary Outcome Measures

Name	Time	Method
To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery	2 years	subjective satisfaction