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The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications.
The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIS graft | Experimental | this group will use a biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse. |
|
| 2 | Active Comparator | this group will use a traditional repair on correction of anterior vaginal wall prolapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional correction of anterior vaginal wall prolapse | Procedure | Traditional repair. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| surgical anatomic results | one year |
| Measure | Description | Time Frame |
|---|---|---|
| impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL); sexual function with FSFI; complications | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manoel João BC Girão, PhD | Department of Gynecology, Federal University of São Paulo | Study Chair |
| Paulo C Feldner Jr, MD | Department of Gynecology, Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of São Paulo | São Paulo | São Paulo/SP | 04025-001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18978116 | Result | Sung VW, Rogers RG, Schaffer JI, Balk EM, Uhlig K, Lau J, Abed H, Wheeler TL 2nd, Morrill MY, Clemons JL, Rahn DD, Lukban JC, Lowenstein L, Kenton K, Young SB; Society of Gynecologic Surgeons Systematic Review Group. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol. 2008 Nov;112(5):1131-42. doi: 10.1097/AOG.0b013e3181898ba9. | |
| 18779916 |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Biologic Graft (SIS) | Procedure | Biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery. |
|
| Bako A, Dhar R. Review of synthetic mesh-related complications in pelvic floor reconstructive surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):103-11. doi: 10.1007/s00192-008-0717-5. Epub 2008 Sep 9. |
| 18715243 | Result | Jia X, Glazener C, Mowatt G, MacLennan G, Bain C, Fraser C, Burr J. Efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse: systematic review and meta-analysis. BJOG. 2008 Oct;115(11):1350-61. doi: 10.1111/j.1471-0528.2008.01845.x. Epub 2008 Aug 19. |
| 18092333 | Result | Maher C, Baessler K, Glazener CM, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women: a short version Cochrane review. Neurourol Urodyn. 2008;27(1):3-12. doi: 10.1002/nau.20542. |
| 17513926 | Result | Chen CC, Ridgeway B, Paraiso MF. Biologic grafts and synthetic meshes in pelvic reconstructive surgery. Clin Obstet Gynecol. 2007 Jun;50(2):383-411. doi: 10.1097/GRF.0b013e31804b184c. |
| 16141767 | Result | Silva WA, Karram MM. Scientific basis for use of grafts during vaginal reconstructive procedures. Curr Opin Obstet Gynecol. 2005 Oct;17(5):519-29. doi: 10.1097/01.gco.0000180156.64879.00. |
| 17636742 | Result | Maher C, Baessler K, Glazener CM, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004014. doi: 10.1002/14651858.CD004014.pub3. |
| 15915320 | Result | Maher C, Baessler K. Surgical management of anterior vaginal wall prolapse: an evidencebased literature review. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Feb;17(2):195-201. doi: 10.1007/s00192-005-1296-3. Epub 2005 May 25. |