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.
The Elevate Anterior/Apical is safe and effective in supporting the apical and anterior vaginal compartments with few complications demonstrated at 12 months.
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: firstname.lastname@example.org.
The authors have declared they have no conflicts of interest.
Supported by the American Medical Systems, Inc, Minnetonka, MN.