title: Elevate anterior/apical:  12-month data showing safety and efficacy in surgical treatment of pelvic organ prolapse.
abstract: OBJECTIVE
  This study aimed to assess the safety and efficacy of the Elevate Anterior/Apical transvaginal mesh procedure in pelvic organ prolapse (POP) repair at 12-months follow-up.
  
  
  METHODS
  This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal prolapse with or without apical descent (POP-Q ≥ stage II). Each patient received a single-incision transvaginal polypropylene mesh implantation anchored to the sacrospinous ligaments bilaterally. Primary outcome was treatment success defined as POP-Q less than or equal to stage I at 1 year using the Last Failure Carried Forward method. Secondary outcomes included validated quality-of-life measures. Fourteen subjects who received a concomitant posterior apical support procedure were excluded from the analysis.
  
  
  RESULTS
  Of the 128 subjects, 112 (87.5%) completed the 12-months follow-up. The mean age was 64.7 years. The anatomic success rate was 87.7% (95% confidence interval, 80.3%-93.1%) for the anterior compartment and 95.9% (95% confidence interval, 88.5%-99.1%) for the apical compartment. POP-Q measurements (Aa, Ba, and C) improved significantly (P < 0.001) with no significant changes to TVL (P = 0.331). Related adverse events reported at greater than 2% were mesh exposure (8; 6.3%), urinary tract infection (7; 5.5%), transient buttock pain (5; 3.9%), de novo stress incontinence (5; 3.9%), retention (5; 3.9%), dyspareunia (3; 3.2%), and hematoma (3; 2.3%). All quality-of-life scores significantly improved from baseline (P < 0.001).
  
  
  CONCLUSIONS
  Twelve-month data show that Elevate Anterior/Apical support procedure completed through a single vaginal incision yields favorable objective and subjective outcomes.
authors: ejs222@aol.com
authors: Edward J
authors: EJ
authors: Stanford
authors: Robert D
authors: RD
authors: Moore
authors: Jan-Paul W R
authors: JP
authors: Roovers
authors: Christophe
authors: C
authors: Courtieu
authors: James C
authors: JC
authors: Lukban
authors: Eduardo
authors: E
authors: Bataller
authors: Bernhard
authors: B
authors: Liedl
authors: Suzette E
authors: SE
authors: Sutherland
mesh_terms: D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires