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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.
Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix
.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Collagen matrix | Experimental | Cystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix |
|
| Native tissue repair | Other | Intervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen Matrix | Procedure | surgical/reinforcing material |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo W Davila, MD | Cleveland Clinic Florida | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19546759 | Derived | Guerette NL, Peterson TV, Aguirre OA, VanDrie DM, Biller DH, Davila GW. Anterior repair with or without collagen matrix reinforcement: a randomized controlled trial. Obstet Gynecol. 2009 Jul;114(1):59-65. doi: 10.1097/AOG.0b013e3181a81b41. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D052858 | Cystocele |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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collagen graft reinforcement
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |