A Multicenter Prospective Study of Posterior Transvaginal Mesh Compared to Native Tissue Repair for Pelvic Organ Prolapse: 36 Month Outcomes.

Abstract

<h4>Study objective</h4>This multicenter, prospective cohort study aimed to evaluate the efficacy and safety of Restorelle® DirectFix transvaginal mesh compared to native tissue repair (NTR) in pelvic organ prolapse (POP). This manuscript reports on the 12- and 36-months follow-up data in the posterior and apical compartment cohort of this study.<h4>Design</h4>Participants, stratified into mesh (163 women) and NTR (76 women) groups, were seen at 2, 6, 12, 18, 24, and 36 months postsurgery.<h4>Setting</h4>The study was conducted at 38 hospitals in the United States, Canada, the Netherlands, Belgium, France, and Australia.<h4>Patients</h4>A total of 239 women were enrolled in the posterior arm of this FDA-mandated Restorelle DirectFix 522 study postmarket surveillance study between September 2014 and August 2018.<h4>Interventions</h4>Restorelle® DirectFix transvaginal mesh compared to native tissue repair (NTR) MEASUREMENTS: The primary efficacy endpoint was prolapse recurrence in the target compartment at 12 months, with secondary outcomes assessing prolapse recurrence at 36 months, serious adverse events, quality of life improvements, and surgical satisfaction based on various validated instruments.<h4>Main results</h4>At 12 months, and despite notable differences in baseline characteristics with a poorer prognostic population in the posterior mesh-arm, the prolapse recurrence rate was 11.7% in the posterior mesh-arm and 13.2% in the NTR-arm, increasing to 18% and 27% at 36 months, respectively. Quality of life scores showed significant improvement in both groups, with similar levels of surgical satisfaction. Serious adverse events were low and comparable between the groups. Mesh exposure occurred in 3.5% of the mesh group without any serious complications.<h4>Conclusion</h4>Restorelle® DirectFix Posterior mesh demonstrated comparable efficacy and safety to NTR for treating posterior and apical compartment prolapse over a 36-month period. Clinical Trial Identification Number: NCT02162615. https://clinicaltrials.gov/study/NCT02162615. Registration date June 11, 2014.