Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

NeuroTherapia, Inc.

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Procedure: Collagen Matrix

Study type

Interventional

Funder types

Other

Identifiers

NCT00860912

IRB# 85852010

Details and patient eligibility

About

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.

Full description

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

Enrollment

94 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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