Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

The Cleveland Clinic94 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pelvic Organ Prolapse

Interventions

Collagen MatrixPROCEDURE

surgical/reinforcing material

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery

subjective satisfaction

Time frame: 2 years

Data from ClinicalTrials.gov

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