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

Masha Ben Zvi, Adi Y. Weintraub, Talia Friedman, Menahem Neuman, Alexander Tsivian

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: 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. Methods: This was a single-center longitudinal prospective study of women with advanced POP who underwent pelvic floor apical repair using EnPlace™ with at least 4 years 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. Results: Fifteen women were enrolled in the study. Two patients were lost to follow-up. The median follow-up was 51 months (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. Conclusion: 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.

Original languageEnglish
JournalInternational Journal of Gynecology and Obstetrics
DOIs
StateAccepted/In press - 2021

Keywords

  • anchor
  • meshless
  • minimally invasive
  • pelvic organ prolapse
  • sacrospinous fixation

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