Apical Suspension Repair for Vaginal Vault Prolapse
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Published:2024-08-01
Issue:8
Volume:159
Page:845
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ISSN:2168-6254
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Container-title:JAMA Surgery
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language:en
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Short-container-title:JAMA Surg
Author:
Menefee Shawn A.1, Richter Holly E.2, Myers Deborah3, Moalli Pamela4, Weidner Alison C.5, Harvie Heidi S.6, Rahn David D.7, Meriwether Kate V.8, Paraiso Marie Fidela R.9, Whitworth Ryan10, Mazloomdoost Donna11, Thomas Sonia10, , Tulikangas Paul12, Ihm Jenifer12, Perez Lea12, Kong Lan12, McClish Donna12, Rickey Leslie12, Shade David12, Tuteja Ashok12, Yount Susan12, Lavender Missy12, O'Dell Kate12, Gantz Marie12, McMillian Kimberly12, Sridhar Amaanti12, Nowak Kayla12, Swankie Taylor12, Shaffer Amanda12, Burson Katrina12, Koeller-Anna Kelly12, Carper Ben12, Honeycutt Emily12, Davis Tracey12, Pickett James12, Burdekin Kate12, Glass Kendra12, Brenizer Tucker12, Burd Andrew12, Barden Lindsey12, Wallace Dennis12, Sung Vivian12, Rardin Charles12, Wohlrab Kyle12, Korbly Nicole12, Carberry Cassandra12, Hampton Star12, Meers Ann12, Veera Sarashwathy12, Visco Anthony12, Siddiqui Nazema12, Amundsen Cindy12, Kawasaki Amie12, Bickhaus Jennifer12, Smith Katelynn12, Jelovsek Eric12, O'Shea Michele12, Yu Stephanie12, Huber Sherry12, Guerrero Magaly12, Green Paige12, Granger Summer12, Bruton Yasmeen12, Morehead Folayan12, Shaw Cassandra12, Byars Ellen12, Anderson Abigail12, Miller Michelle12, Barber Matthew12, Graham Annette12, Pung Ly12, Edington Maryori12, Ferrando Cecile12, Jelovsek John12, Walters Mark12, Jallad Karl12, Mackinnon Linda12, Zazueta Gisselle12, Ferrante Kimberly12, Dyer Keisha12, Diwadkar Gouri12, Doan Christine12, Hall Lynn12, Nguyen John12, Liao Christina12, Jakus-Waldman Sharon12, Zyczynski Halina12, Fairchild Pam12, Bradley Megan12, Ackenbom Mary12, Klump Beth12, Kunkle Lauren12, Rajkovich Margaret12, Gruss Judy12, Durst Rachel12, Baranski Lindsey12, Noel Jacqueline12, Mislanovich Karen12, Varner Edward12, Meyer Isuzu12, Ellington David12, Johnson Ryanne12, Carter Kathy12, Patel Sunita12, Willingham Robin12, Lukacz Emily12, Nager Charles12, Alperin Marianna12, Albo Michael12, Aughinbaugh Laura12, Brubaker Linda12, Burnett Lindsey12, Santiago-Lastra Yahir12, Herrala Kyle12, Rodriquez-Ponciano Dulce12, Smith Elia12, Dunivan Gena12, Komesu Yuko12, Rogers Rebecca12, Taylor Karen12, Jeppson Peter12, Connelly AnnaMarie12, Andy Uduak12, Arya Lily12, Carney Teresa12, Desai Kavita12, Kadam-Halani Priyanka12, Thompson Donna12, Kim Edward12, Brown Kimberly12, Meeks Jacqueline12, Lee Daniel12, Hassani Daisy12, Kennedy Zandra12, Flick Lorraine12, Borodyanskaya Yelizaveta12, Schaffer Joseph12, Corton Marlene12, Wai Clifford12, Balgobin Sunil12, Florian-Rodriguez Maria12, Reynolds Priscilla12, Atnip Shanna12, Schmidt Alison12, Lloyd Katherine12, Hegan Christina12, Medrano Rachael12, Burris Agnes12, Bonilla Juanita12, Ripperda Christopher12, Hamner Jennifer12, Jackson Lindsey12, Hare Adam12, Sawyer Polina12, Tappy Erryn12, Stork Abby12
Affiliation:
1. Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego, San Diego, California 2. Division of Urogynecology and Pelvic Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham 3. The Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island 4. Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology, and Reproductive Sciences, Magee Womens Research Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 5. Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina 6. Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia 7. Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas 8. The Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque 9. Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women’s Health Institute, Cleveland Clinic, Cleveland, Ohio 10. RTI International, Research Triangle Park, North Carolina 11. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland 12. for the NICHD Pelvic Floor Disorders Network
Abstract
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
Publisher
American Medical Association (AMA)
Cited by
2 articles.
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1. The Distortion of the Composite Prism;JAMA Surgery;2024-08-01 2. Error in Figure 2;JAMA Surgery;2024-08-01
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