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| Name | Class |
|---|---|
| American Medical Systems | INDUSTRY |
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Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. New meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published.
The investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elevate meshes | Other | The use of Elevate (American Systems trade mark) meshes for the treatment of pelvic prolapse. |
|
| Sacrocolpopexy | Other | Sacrocolpopexy for the correction of the prolapse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elevate mesh | Device | The correction of the prolapse can be made by this new technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional and anatomical efficacy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| operating time, cost and complications of both techniques | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Bataller, M.D., Ph. D. | Hospital Clinic, Barcelona, Spain. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19716533 | Background | Sanses TV, Shahryarinejad A, Molden S, Hoskey KA, Abbasy S, Patterson D, Saks EK, Weber LeBrun EE, Gamble TL, King VG, Nguyen AL, Abed H, Young SB; Fellows' Pelvic Research Network. Anatomic outcomes of vaginal mesh procedure (Prolift) compared with uterosacral ligament suspension and abdominal sacrocolpopexy for pelvic organ prolapse: a Fellows' Pelvic Research Network study. Am J Obstet Gynecol. 2009 Nov;201(5):519.e1-8. doi: 10.1016/j.ajog.2009.07.004. Epub 2009 Aug 28. | |
| Background | Cosson M, Rosenthal C, Clave H, et al. Prospective clinical assessment of the total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse-6 and 12 month results. Int Urogynecol J 2006; 17: S142. | ||
| 15458906 |
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First article has been submitted to the European Urology on feb 13th 2017, was rejected.
Article accepted for publishing in may 2018 in IUJ
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D006547 | Hernia |
| D014596 | Uterine Prolapse |
| D052858 | Cystocele |
| D020047 | Rectocele |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
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| Sacrocolpopexy | Device | Attach a mesh between the vagina and the promontorium. |
|
|
| Background |
| Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. doi: 10.1097/01.AOG.0000139514.90897.07. |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |