Long-term outcome after surgical repair of pelvic organ prolapse with Elevate Prolapse Repair System.

Female pelvic organ prolapse (POP) is a common condition and the correction of prolapse remains a major challenge for the surgical community. A retrospective study of women with POP undergoing pelvic reconstructive surgery with the Elevate System followed-up for 48 months. A total of 138 women with POP were included in the study. We observed an objective cure rate of 94.9% for the anterior wall after 4 years' follow-up. The subjective cure rate was 97.1%. Improvement in the urinary symptoms was seen after the surgery: the number of asymptomatic patients increased from 14.5 to 77% after the 4 years of follow-up. We reported no cases of bleeding, haematoma, mesh infection and bowel injury, while we had four cases of bladder injury and one case of sepsis. The mesh extrusion rate was 7.3%, all cases interested the anterior compartment. Postoperative dyspareunia and pelvic pain were rare. In this cohort, the Elevate Prolapse Repair System was associated with excellent long-term results, for both anatomical corrections of prolapse, with a high objective and subjective cure rate and a functional urinary outcome. Impact statement What is already known on this subject? Female pelvic organ prolapse is a common condition and the correction of prolapse remains a major challenge for the surgical community. The optimal treatment of POP has still to be determined. What do the results of this study add? The findings from this study shows that the Elevate Prolapse Repair System had high anatomic results associated with a good durability, low morbidity and excellent subjective outcome. To the best of our knowledge, this is the first study that reports a follow-up up to 48 months. What are the implications of these findings for clinical practice and/or further research? The Elevate Prolapse Repair System was associated with excellent long terms results in terms of safety, durability and tolerability during the 4 years' follow-up. Despite the fact that the Elevate kit produced by AMS was withdrawn from the market and it is no longer available, we believe that it is helpful to have data about the outcomes of a transvaginal mesh implant.

A 2-Year Evaluation of Quality of Life Outcomes of Patients With Pelvic Organ Prolapse Treated With an Elevate Prolapse Repair System.

OBJECTIVES: To evaluate 2-year quality of life of women with pelvic organ prolapse submitted to prosthetic correction with Elevate. METHODS: We enrolled 116 consecutive patients with a stage ≥ to 2 prolapse. The Prolapse Quality of Life questionnaire was administered in the preoperative time and after 2 years of follow-up. The statistical results were obtained by using the SPSS Advanced Statistical™ 11.0 Software. RESULTS: Patient's quality of life improved substantially following prosthetic vaginal surgery. In particular, a clear improvement in the "general state of patients health" (P < 0.05), and a reduction in the daily physical, social, and psychological quality of life (P < 0.05) connected to the prolapse of pelvic organ were observed. Furthermore, a significant reduction in the percentage of patients with urinal disturbances (86.2% preoperative vs 20.7% postoperative; P < 0.05), and an improvement in patient's relations with their partners with 12 patients resuming sexual activity were found. CONCLUSIONS: This study demonstrates that prosthetic vaginal correction represents a long-term efficient clinical instrument for women with symptomatic pelvic organ prolapse. It also achieves a resolution for urinary symptomatology and embarrassment, social limitation, physical and psychological difficulties of women, which, in great part, resulted in many overcoming surgical therapy, worried about fixed outcomes.