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

ImportanceThe optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined.ObjectiveTo compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy.Design, Setting, and ParticipantsThis 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.InterventionsMesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair.Main Outcomes and MeasuresThe 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.ResultsOf 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 RelevanceAmong 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 RegistrationClinicalTrials.gov Identifier: NCT02676973