INTRODUCTION AND HYPOTHESIS: The objective of this study was to assess the safety and efficacy of the Elevate Apical and Posterior single-incision mesh system (SIMS) with IntePro Lite for pelvic organ prolapse repair. METHODS: This prospective multicenter study included 139 women with ≥ stage II posterior vaginal prolapse and/or apical descent who underwent placement of type I polypropylene mesh through a single transvaginal incision with no external needle passes. Primary endpoint was the percent of patients with posterior and/or apical stage ≤ I ("cure") at follow-up. Secondary endpoints included, but were not limited to, rate of mesh extrusion and disease-specific quality of life outcomes. RESULTS: At 12 months, objective posterior wall and apical cure rates were 92.5 and 89.2 %, respectively, with an extrusion rate of 6.5 %. CONCLUSIONS: The SIMS appears to be effective and safe in treating patients with posterior vaginal and/or apical prolapse. The risks and benefits of transvaginal synthetic mesh insertion should be considered.
INTRODUCTION AND HYPOTHESIS: The objective of this study was to assess the safety and efficacy of the Elevate Apical and Posterior single-incision mesh system (SIMS) with IntePro Lite for pelvic organ prolapse repair. METHODS: This prospective multicenter study included 139 women with ≥ stage II posterior vaginal prolapse and/or apical descent who underwent placement of type I polypropylene mesh through a single transvaginal incision with no external needle passes. Primary endpoint was the percent of patients with posterior and/or apical stage ≤ I ("cure") at follow-up. Secondary endpoints included, but were not limited to, rate of mesh extrusion and disease-specific quality of life outcomes. RESULTS: At 12 months, objective posterior wall and apical cure rates were 92.5 and 89.2 %, respectively, with an extrusion rate of 6.5 %. CONCLUSIONS: The SIMS appears to be effective and safe in treating patients with posterior vaginal and/or apical prolapse. The risks and benefits of transvaginal synthetic mesh insertion should be considered.
Authors: R C Bump; A Mattiasson; K Bø; L P Brubaker; J O DeLancey; P Klarskov; B L Shull; A R Smith Journal: Am J Obstet Gynecol Date: 1996-07 Impact factor: 8.661
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