Apical Suspension Repair for Vaginal Vault Prolapse
Authors: Shawn A. Menefee, Holly E. Richter, Deborah Myers, Pamela Moalli, Alison C. Weidner, Heidi S. Harvie, David D. Rahn, Kate V. Meriwether, Marie Fidela R. Paraiso, Ryan Whitworth, Donna Mazloomdoost, Sonia Thomas, Paul Tulikangas, Jenifer Ihm, Lea Perez, Lan Kong, Donna McClish, Leslie Rickey, David Shade, Ashok Tuteja, Susan Yount, Missy Lavender, Kate O'Dell, Marie Gantz, Kimberly McMillian, Amaanti Sridhar, Kayla Nowak, Taylor Swankie, Amanda Shaffer, Katrina Burson, Kelly Koeller-Anna, Ben Carper, Emily Honeycutt, Tracey Davis, James Pickett, Kate Burdekin, Kendra Glass, Tucker Brenizer, Andrew Burd, Lindsey Barden, Dennis Wallace, Vivian Sung, Charles Rardin, Kyle Wohlrab, Nicole Korbly, Cassandra Carberry, Star Hampton, Ann Meers, Sarashwathy Veera, Anthony Visco, Nazema Siddiqui, Cindy Amundsen, Amie Kawasaki, Jennifer Bickhaus, Katelynn Smith, Eric Jelovsek, Michele O'Shea, Stephanie Yu, Sherry Huber, Magaly Guerrero, Paige Green, Summer Granger, Yasmeen Bruton, Folayan Morehead, Cassandra Shaw, Ellen Byars, Abigail Anderson, Michelle Miller, Matthew Barber, Annette Graham, Ly Pung, Maryori Edington, Cecile Ferrando, John Jelovsek, Mark Walters, Karl Jallad, Linda Mackinnon, Gisselle Zazueta, Kimberly Ferrante, Keisha Dyer, Gouri Diwadkar, Christine Doan, Lynn Hall, John Nguyen, Christina Liao, Sharon Jakus-Waldman, Halina Zyczynski, Pam Fairchild, Megan Bradley, Mary Ackenbom, Beth Klump, Lauren Kunkle, Margaret Rajkovich, Judy Gruss, Rachel Durst, Lindsey Baranski, Jacqueline Noel, Karen Mislanovich, Edward Varner, Isuzu Meyer, David Ellington, Ryanne Johnson, Kathy Carter, Sunita Patel, Robin Willingham, Emily Lukacz, Charles Nager, Marianna Alperin, Michael Albo, Laura Aughinbaugh, Linda Brubaker, Lindsey Burnett, Yahir Santiago-Lastra, Kyle Herrala, Dulce Rodriquez-Ponciano, Elia Smith, Gena Dunivan, Yuko Komesu, Rebecca Rogers, Karen Taylor, Peter Jeppson, AnnaMarie Connelly, Uduak Andy, Lily Arya, Teresa Carney, Kavita Desai, Priyanka Kadam-Halani, Donna Thompson, Edward Kim, Kimberly Brown, Jacqueline Meeks, Daniel Lee, Daisy Hassani, Zandra Kennedy, Lorraine Flick, Yelizaveta Borodyanskaya, Joseph Schaffer, Marlene Corton, Clifford Wai, Sunil Balgobin, Maria Florian-Rodriguez, Priscilla Reynolds, Shanna Atnip, Alison Schmidt, Katherine Lloyd, Christina Hegan, Rachael Medrano, Agnes Burris, Juanita Bonilla, Christopher Ripperda, Jennifer Hamner, Lindsey Jackson, Adam Hare, Polina Sawyer, Erryn Tappy, Abby Stork
Journal: JAMA Surgery (2024)

Importance The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration ClinicalTrials.gov Identifier: NCT02676973