Pelvic Organ Prolapse
Conditions
Keywords
Veritas, Cystocele, Prolapse
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 .
Interventions
PROCEDURECollagen Matrix
surgical/reinforcing material
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
collagen graft reinforcement
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery | 2 years | subjective satisfaction |
Outcome results
None listed