Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

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

Official Title
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Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Collagen Matrix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: collagen graft reinforcement
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Collagen matrix<br>Cystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix | Procedure: Collagen Matrix<br>* surgical/reinforcing material<br>* Other names: Veritas collagen matrix;|
| Other: Native tissue repair<br>Intervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues. | Procedure: Collagen Matrix<br>* surgical/reinforcing material<br>* Other names: Veritas collagen matrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | prolapse degree on pelvic exam | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery | subjective satisfaction | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veritas, Cystocele, Prolapse