Introduction and hypothesis: To compare the efficacy and safety of the Elevate™ anterior and posterior prolapse repair system and traditional vaginal native tissue repair in the treatment of stage 2 or higher pelvic organ prolapse.
Methods: A cohort study was conducted between January 2010 and July 2012. Patients who underwent transvaginal pelvic reconstruction surgery for prolapse were recruited. The primary outcome was anatomical success 1 year after surgery. The secondary outcome included changes in the quality of life and surgical complications. Recurrence of prolapse was defined as stage 2 or higher prolapse based upon the pelvic organ prolapse qQuantification system.
Results: Two hundred and one patients (100 in the Elevate™ repair group and 101 in the traditional repair group) were recruited and analyzed. The anatomical success rate of the anterior compartment was significantly higher in the Elevate™ repair group than in the traditional repair group (98 % vs 87 %, p = 0.006), but not for the apical (99 % vs. 6 %, p = 0.317) or posterior (100 % vs 97 %, p = 0.367) compartments after a median 12 months of follow-up. Both groups showed significant improvements in the quality of life after surgery with no statistical difference. Mesh-related complications included extrusion (3 %) and the need for revision of the vaginal wound (1 %). Those in the mesh repair group had a longer hospital stay (p = 0.04), operative time (p < 0.001), and greater estimated blood loss (p = 0.05). Other complications were comparable with no statistical difference.
Conclusions: The Elevate™ prolapse repair system had a better 1-year anatomical cure rate of the anterior compartment than traditional repair, with slightly increased morbidity.