Introduction and hypothesis
We compared treatment success and adverse events between women undergoing open abdominal sacrocolpopexy (ASC) vs vaginal repair (VAR) using data from women enrolled in one of three multicenter trials. We hypothesized that ASC would result in better outcomes than VAR.
Participants underwent apical repair of stage 2–4 prolapse. Vaginal repair included uterosacral, sacrospinous, and iliococcygeal suspensions; sacrocolpopexies were via laparotomy. Success was defined as no bothersome bulge symptoms, no prolapse beyond the hymen, and no retreatment up to 24 months. Adverse events were collected at multiple time points. Outcomes were analyzed using longitudinal mixed-effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random. Comparisons were controlled for center, age, body mass index (BMI), initial Pelvic Organ Prolapse Quantification (POP-Q) stage, baseline scores, prior prolapse repair, and concurrent repairs.
Of women who met inclusion criteria (1022 of 1159 eligibile), 701 underwent vaginal repair. The ASC group (n = 321) was older, more likely white, had prior prolapse repairs, and stage 4 prolapse (all p < 0.05). While POP-Q measurements and symptoms improved in both groups, treatment success was higher in the ASC group [odds ratio (OR) 6.00, 95% confidence interval (CI) 3.45–10.44). The groups did not differ significantly in most questionnaire responses at 12 months and overall improvement in bowel and bladder function. By 24 months, fewer patients had undergone retreatment (2% ASC vs 5% VAR); serious adverse events did not differ significantly through 6 weeks (13% vs 5%, OR 2.0, 95% CI 0.9–4.7), and 12 months (26% vs 13%, OR 1.6, 95% CI 0.9–2.9), respectively.
Open sacrocolpopexy resulted in more successful prolapse treatment at 2 years.
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University of Iowa: CS Bradley, K Kreder; University of Alabama, KL Burgio, RE Varner, A Ballard, J Burge, K Carter, P Goode, AD Markland, C Parker-Autry, TS Wilson; University of Michigan YW Casher, B Marchant, JT Wei, PA Wren, YH Chen, D DiFranco, C Spino, B Marchant; University North Carolina of Chapel Hill AM Connolly, W Whitehead; Johns Hopkins GW Cundiff, VL Handa; Baylor P Fine; Magee Women’s Hospital J Gruss, P Moalli, HM Zyczynski; Duke AG Visco, CL Amundsen, I Harm-Ernandes, M Raynor, J Wu, NY Siddiqui; UCSD ME Albo, C Grimes, ES Lukacz, CW Nager; UTSW S Atnip, EK Moore, D Rahn, C Wai; University of Utah J Baker, M Masters, A Orr; Kaiser San Diego G Diwadkar, KY Dyer, LM Hall, LM Mackinnon, JN Nguyen, G Zazueta-Damian, J Tan-Kim; Cleveland Clinic A Frick, B O’Dougherty, L Pung, B Ridegeway, C Williams; RTI M Gantz, LK Warren, D Matthews, A Shaffer, KA Wilson, RE Whitworth, J Thornberry, TT Terry; Steering Committee Chair K Hartmann; Kaiser Bellflower S Jakus-Waldman; Loyola E Mueller, M Tulke; University of New Mexico Y Komesu, G Dunivan, C Cichowski, P Jeppson.
Research Support: Supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (2U01HD41249, 2 U10 HD41250, 2 U10 HD41261, 2 U10 HD41267, 1 U10 HD54136, 1 U10 HD54214, 1 U10 HD54215, 1 U10 HD54241, U10 HD069013, U10 HD069025, U10 HD069010, and U01 HD069031) and the National Institutes of Health Office of Research on Women’s Health.
Conflicts of interest
Rogers: royalties, travel and stipend from ABOG for work on the board; travel and stipend from IUGA for work related to the editor in chief for the IUJ, DSMB chair for the TRANSFORM trial sponsored by American Medical Systems. Richter: Pelvalon, research grant and consultant; Kimberly Clarkt, royalties. Shepherd : site PI for Synergy trial sponsored by Astellas. Brubaker: editorial stipends, Female Pelvic Medicine and Reconstructive Surgery and royalties. Schaffer: McGraw Hill, royalties; Boston Scientific, research; Astellas, speaker. Harvie, Jelovsek, Menefee, Myers, Hsu, Wallace, Meikle: no conflict of interest.
Presented at the Society of Gynecologic Surgeons 2014 annual meeting in Orlando, FL, USA.
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Rogers, R.G., Nolen, T.L., Weidner, A.C. et al. Open sacrocolpopexy and vaginal apical repair: retrospective comparison of success and serious complications. Int Urogynecol J 29, 1101–1110 (2018). https://doi.org/10.1007/s00192-018-3666-7