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A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse.
Seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair( NAZCA TC™ POP REPAIR SYSTEM) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, length of hospitalization, and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction were eligible for participation.traditional colporrhaphy in this group. |
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| 2 | Active Comparator | The NAZCA TC™ POP REPAIR SYSTEM (polypropylene mesh repair),promedon™ , cordoba, argentina, is used to repair anterior vaginal prolapse by a transobturator and pre pubic approach . Helical needles are used to anchor graft to the pelvic sidewall at two points transobturator, the other two arms pre pubic needles is used. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the procedure with polypropylene mesh with that of anterior colporrhaphy, with planned follow-up of 1 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical treatment of Anterior Vaginal Prolapse | Procedure | seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair (NAZCA TC™ POP REPAIR SYSTEM ) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is recurrent anterior vaginal prolapse | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes are, first, operative time (from first incision to closure of last incision), blood loss (preoperative minus postoperative day one hemoglobin), length of hospitalization, adverse events, PQol , FSFI and Dyspareunia . | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Patients were excluded if they had:
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| Name | Affiliation | Role |
|---|---|---|
| carlos a del roy, M D | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sao Paulo Hospital | São Paulo | São Paulo | 04024-002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18351281 | Result | Riccetto C, Miyaoka R, de Fraga R, Barbosa R, Dambros M, Teixeira A, Palma P. Impact of the structure of polypropylene meshes in local tissue reaction: in vivo stereological study. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1117-23. doi: 10.1007/s00192-008-0582-2. Epub 2008 Mar 20. |
| Label | URL |
|---|---|
| INTERNATIONAL UROGYNECOLOGICAL ASSOCIATION | View source |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| D052858 | Cystocele |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina. | Device | Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction . |
|
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| surgical treatment for anterior vaginal wall prolapse | Procedure | Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation. |
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |