• DOI:10.1097/SPV.0b013e318278cc29
• Corpus ID: 8798269

Elevate Anterior/Apical: 12-Month Data Showing Safety and Efficacy in Surgical Treatment of Pelvic Organ Prolapse

@article{Stanford2013ElevateA1,
  title={Elevate Anterior/Apical: 12-Month Data Showing Safety and Efficacy in Surgical Treatment of Pelvic Organ Prolapse},
  author={Edward J. Stanford and Robert D Moore and Jan-Paul W. R. Roovers and Christophe Courtieu and James Chivian Lukban and Eduardo Bataller and Bernhard Liedl and Suzette E. Sutherland},
  journal={Female Pelvic Medicine \& Reconstructive Surgery},
  year={2013},
  volume={19},
  pages={79–83}
}

• E. Stanford, Robert D Moore, +5 authors S. Sutherland
• Published 1 March 2013
• Medicine
• Female Pelvic Medicine & Reconstructive Surgery

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.