title: Efficacy and safety of Elevate® system on apical and anterior compartment prolapse repair with personal technique modification.
abstract: OBJECTIVE
  To evaluate the effectiveness and safety of Anterior Elevate® mesh kit system (AES) in woman with symptomatic stage 3 or 4 anterior and/or apical pelvic organ prolapse (POP).
  
  
  METHODS
  This retrospective, monocentric, single surgeon study enrolled between May 2010 and January 2013 fifty-six woman experiencing symptomatic anterior vaginal prolapse with or without apical descent (POP-Q stage 3 or 4). All women received a AES and 7 (12.5%) received a concomitant transvaginal hysterectomy. Primary endpoint was anatomic correction of prolapse; success was defined as POP-Q stage ≤ 1 or asymptomatic stage 2. Secondary endpoints were quality-of-life (QOL) results and patients' safety outcomes, which were assessed by 3 validated self-reporting questionnaires at baseline and annually: ICIQ-UI short form, ICIQ-VS and P-QOL. All patients completed 2-years and 28 women 3-years of follow-up. Surgical approach was modified in women with uterus, moving the two-propylene strips anteriorly around the cervix itself crossing one another, so the left will take place in the right side and the right on the opposite. This modification was made in order to better support the uterus.
  
  
  RESULTS
  Vaginal mesh exposure was present in 3 (5,3%) patients. Very good anatomical outcomes were seen, with one (1,8%) failure at 6-months, 4 (7,1%) at 1-year, 6 at 2-years (10,7%). Statistically significant improvements were seen in the ICIQ-VS and P-QOL questionnaires throughout follow-up.
  
  
  CONCLUSIONS
  Our data suggest that AES is a minimally-invasive transvaginal procedure to repair anterior and apical POP, with good evidence related to mid-term safety and efficacy.
authors.affiliation: Department of Life, Health & Environmental Sciences, University of L'Aquila, Urology Unit, "Giuseppe Mazzini" Hospital, Teramo, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Castellani
authors.affiliation: Department of Life, Health & Environmental Sciences, University of L'Aquila, Urology Unit, "Giuseppe Mazzini" Hospital, Teramo, Italy.
authors.forename: Vikiela
authors.initials: V
authors.lastname: Galica
authors.affiliation: Department of Life, Health & Environmental Sciences, University of L'Aquila, Urology Unit, "Giuseppe Mazzini" Hospital, Teramo, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Saldutto
authors.affiliation: Department of Life, Health & Environmental Sciences, University of L'Aquila, Urology Unit, "Giuseppe Mazzini" Hospital, Teramo, Italy.
authors.forename: Giuseppe Paradiso
authors.initials: GP
authors.lastname: Galatioto
authors.affiliation: Department of Life, Health & Environmental Sciences, University of L'Aquila, Urology Unit, "Giuseppe Mazzini" Hospital, Teramo, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Vicentini
mesh_terms: D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D012189:Retrospective Studies; D013526:Surgical Mesh / Q000009:adverse effects; D016896:Treatment Outcome; D014596:Uterine Prolapse / Q000601:surgery
keywords: Pelvic Organ Prolapse; Surgical Mesh; Surgical Procedures, Operative