ABSTRACT
INTRODUCTION AND HYPOTHESIS: Pullout force of mesh from tissue is one of the important mechanical properties of an implanted mesh to repair pelvic organ prolapse (POP). The EndoFast Reliant™ system kit allows mesh attachment with soft-tissue fasteners. The aim of this study was to compare the pullout force that developed in mesh that was attached by EndoFast Reliant fasteners to mesh that was attached by trocar-based methods (tunnel, pocket) in a sheep model. METHODS: Six sheep underwent mesh attachment with three methods (EndoFast Reliant, tissue pocket, tissue tunnel), and each method was repeated five times in both thighs of the same sheep. The pullout force was measured at different time intervals from surgery: 0, 3, 7, 15, 30, and 45 days. Statistical analysis was performed by using the appropriate one-way analysis of variance (ANOVA) for each time interval and a general linear model for repeated measures using IBM® SPSS® software version 20.0.0. RESULTS: During the immediate postoperative period (0-3 days), pullout force was significantly higher with EndoFast Reliant than with tissue pocket or tissue tunnel. At day 7, this trend continues without statistical significance. Pullout force increased progressively until day 15, when the force caused the mesh to tear; it was similar in all three groups. ANOVA showed significant effect of time and study group. CONCLUSIONS: The EndoFast Reliant system provides significantly stronger attachment in the immediate postoperative period (0-3 days) compared with trocar-based techniques, and this difference disappeared at day 15 postsurgery.
Subject(s)
Gynecologic Surgical Procedures/methods , Pelvic Organ Prolapse/surgery , Suburethral Slings , Surgical Mesh , Animals , Disease Models, Animal , Female , Gynecologic Surgical Procedures/instrumentation , Mechanical Phenomena , SheepABSTRACT
INTRODUCTION AND HYPOTHESIS: EndoFast Reliant system is a novel technology for pelvic organ prolapse (POP) repair that attaches mesh directly with metal fasteners. METHODS: This was a prospective multicenter study in 20 women who underwent vaginal POP repair to evaluate safety and efficacy. The patients were followed for 12 months, using POP-Q measures, questionnaires on symptoms (PFDI), and sexual function (FSFI). RESULTS: No intraoperative complications occurred. Prolapse has been anatomically resolved (< stage 2) in 85% at 1-year follow-up (17/20 patients). Pelvic Floor Distress Inventory (PFDI) scores showed significant improvement for 1 year in symptoms related to prolapse (4.1-0.7, p < 0.001) and bladder (1.4-0.7, p = 0.06) but not to rectum. Female Sexual Function Index (FSFI) scores did not change significantly. One case of mesh exposure was found (5%) and treated conservatively. No migration of fasteners was observed on X-ray. CONCLUSIONS: The EndoFast Reliant system was found safe and efficacious. Future studies are needed to evaluate its advantages over techniques using trocars.
