Minimally invasive meshless and minimal dissection ligament fixation system for apical organ prolapse procedures: A 4-year prospective follow up study.

Abstract

EnPlace™ (formerly named NeuGuide™) is a minimally invasive meshless anchoring system for pelvic organ prolapse (POP) repair designed to provide centro-apical pelvic floor support. We present a 4-year prospective follow up evaluation of this repair system. This was a single-center longitudinal prospective study of women with advanced POP who underwent pelvic floor apical repair using EnPlace™ with at least 4years of follow-up. The primary outcome was surgical success defined as anatomical success, no symptoms of vaginal bulging and no need for re-treatment. A standardized validated questionnaire to assess symptom burden was used. Fifteen women were enrolled in the study. Two patients were lost to follow-up. The median follow-up was 51months (range 42-57) with a surgical success rate of 92.3%. One patient (7.7%) reported symptoms of vaginal vault prolapse and underwent a repeated prolapse surgery. Using the UDI-6 questionnaire, an improvement in all domains was seen. The 4-year prospective follow up suggests that apical repair using the EnPlace™ device may be considered safe and effective for sacrospinous ligament fixation with a sustainable long-term success. This procedure is a minimally invasive meshless addition to pelvic surgeon's armamentarium.