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

Stanford, Edward J. MD, MS*; Moore, Robert D. DO; Roovers, Jan-Paul W.R. MD, PhD; Courtieu, Christophe MD§; Lukban, James C. DO; Bataller, Eduardo MD; Liedl, Bernhard MD#; Sutherland, Suzette E. MD**

Female Pelvic Medicine & Reconstructive Surgery:
doi: 10.1097/SPV.0b013e318278cc29
Original Articles
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.

In Brief

The Elevate Anterior/Apical is safe and effective in supporting the apical and anterior vaginal compartments with few complications demonstrated at 12 months.

Author Information

From the *Private Practice, Western Colorado; †Atlanta Medical Research Institute, Atlanta, GA; ‡Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; §CMC Beausoleil, Montpellier, France; ||Division of Urogynecology, Eastern Virginia Medical School, Norfolk, VA; ¶Hospital Clínic i Provincial de Barcelona, Universidad de Barcelona, Spain; #Pelvic Floor Center, Munich, Germany; and **Metro Urology, Centers for Continence Care and Female Urology, Center for Pelvic Floor Disorders, Mpls/St Paul, MN.

Reprints: Edward J. Stanford, MD, MS. E-mail: ejs222@aol.com.

The authors have declared they have no conflicts of interest.

Supported by the American Medical Systems, Inc, Minnetonka, MN.

© 2013 by Wolters Kluwer Health | Lippincott Williams & Wilkins