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

Abstract

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 Despite the fact that the Elevate kit produced by AMS was withdrawn from the market and it is no longer available, we believe that it is helpful to have data about the outcomes of a transvaginal mesh implant.

Significant Improvement in Quality of Life, Positive Effect on Sexuality, Lasting Reconstructive Result and Low Rate of Complications Following Cystocele Correction Using a Lightweight, Large-Pore, Titanised Polypropylene Mesh

“…Whether a mesh-aided surgical treatment of the posterior compartment can decrease the rate of recurrence even further here should be investigated in additional studies. Overall, this rate of recurrence, as other studies on mesh-aided prolapse surgery have shown 11 , 44 , 46 , is superior to that of autologous tissue reconstruction in the sense of anterior colporrhaphy 3 , 7 . Most of the 19 documented adverse events which occurred during the 12-month follow-up observation period can be attributed to the typical complications following surgical prolapse correction, e.g.…”

“…However, the data on quality of life, sexuality, and the complications presented here give an indication that, with the further development of implants, the surgical treatment of pelvic organ prolapse with the implantation of an alloplastic mesh has had fewer complications and has become more satisfactory for patients with regard to the postoperative quality of life, including sexuality. In the past 3 years, short-term as well as long-term data on vaginal mesh implantations have been continuously published 43 , 44 , 45 , 46 , 48 . This shows that this surgical method represents a treatment which is currently widely used.…”

“…Ob eine netzgestützte operative Therapie des hinteren Kompartiments hier die Rezidivrate noch weiter absenken kann, sollte in weiteren Studien untersucht werden. Insgesamt ist diese Rezidivrate, wie auch andere Studien zur netzgestützten Deszensuschirurgie zeigten 11 , 44 , 46 , jener der Eigengewebsrekonstruktion i. S. einer Kolporrhaphia anterior 3 , 7 überlegen. Die meisten der 19 dokumentierten unerwünschten Ereignisse, die während der 12-monatigen Nachbeobachtungszeit auftraten, sind den typischen Komplikationen nach operativer Deszensuskorrektur, z.…”

“…Allerdings geben die hier präsentierten Daten zur Lebensqualität, Sexualität und den Komplikationen durchaus einen Hinweis, dass mit der Weiterentwicklung der Implantate die operative Therapie des Descensus genitalis mit Implantation eines alloplastischen Netzes komplikationsärmer und für die Patientinnen im Hinblick auf die postoperative Lebensqualität inklusive der Sexualität zufriedenstellender geworden ist. In den letzten 3 Jahren wurden kontinuierlich Daten, sowohl Kurz- als auch Langzeit, zu vaginalen Netzimplantationen veröffentlicht 43 , 44 , 45 , 46 , 48 . Dies zeigt, dass dieses operative Verfahren eine aktuell vielfach eingesetzte Therapie darstellt.…”

Health-related quality of life after pelvic organ prolapse surgery in Ethiopia: A 6 month follow-up study

“…The better QoL scores compared to baseline scores were also observed in all the 3 P-QoL components (PC, PSC and PRC) after 6 months. Previous studies in Western countries using P-QoL instrument also con rmed that correction of POP via alloplastic vaginal meshes can signi cantly improve patients' QoL [24,[38][39][40][41][42].…”