Veritas Collagen Matrix Cystocele Repair Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2007-05-31

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.

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Detailed Description

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

.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

collagen graft reinforcement

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention: Collagen matrix

Cystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix

Group Type EXPERIMENTAL

Collagen Matrix

Intervention Type PROCEDURE

surgical/reinforcing material

Native tissue repair

Intervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues.

Group Type OTHER

Collagen Matrix

Intervention Type PROCEDURE

surgical/reinforcing material

Interventions

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Collagen Matrix

surgical/reinforcing material

Intervention Type PROCEDURE

Other Intervention Names

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Veritas collagen matrix

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes