One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse - 23/12/11
, Cheryl B. Iglesia, MD a, Bela I. Kudish, MD a, Robert E. Gutman, MD a, David Shveiky, MD a, Richard Bercik, MD b, Eric R. Sokol, MD c
Reprints: Andrew I. Sokol, MD, National Center for Advanced Pelvic Surgery, Washington Hospital Center, 106 Irving St., NW, Suite 405 S POB, Washington, DC 20010Résumé |
Objective |
The purpose of this study was to show 12-month outcomes of a randomized trial that compared vaginal prolapse repair with and without mesh.
Study Design |
Women with stage ≥2 prolapse were assigned randomly to vaginal repair with or without mesh. The primary outcome was prolapse stage ≤1 at 12 months. Secondary outcomes included quality of life and complications.
Results |
All 65 evaluable participants were followed for 12 months after trial stoppage for mesh exposures. Thirty-two women had mesh repair; 33 women had traditional repair. At 12 months, both groups had improvement of pelvic organ prolapse-quantification test points to similar recurrence rates. The quality of life improved and did not differ between groups: 96.2% mesh vs 90.9% no-mesh subjects reported a cure of bulge symptoms; 15.6% had mesh exposures, and reoperation rates were higher with mesh.
Conclusion |
Objective and subjective improvement is seen after vaginal prolapse repair with or without mesh. However, mesh resulted in a higher reoperation rate and did not improve 1-year cure.
Le texte complet de cet article est disponible en PDF.Key words : exposure, prolapse repair, randomized trial, vaginal mesh
Plan
| Supported by a grant from the American Urogynecologic Society Foundation and a MedStar Health Research Institute Intramural Grant. |
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| R.B. has received payment from Gynecare for lectures, consulting, and proctoring surgical cases within the last 3 years. The other authors report no conflict of interest. Prolift mesh kits for this study were donated by Ethicon Women's Health and Urology, Somerville, NJ. |
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| Cite this article as: Sokol AI, Iglesia CB, Kudish BI, et al. One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse. Am J Obstet Gynecol 2012;206:86.e1-9. |
Vol 206 - N° 1
P. 86.e1-86.e9 - janvier 2012 Retour au numéro
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