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.
Shawn A Menefee,1 Holly E Richter,2 Deborah Myers,3 Pamela Moalli,4 Alison C Weidner,5 Heidi S Harvie,6 David D Rahn,7 Kate V Meriwether,8 Marie Fidela R Paraiso,9 Ryan Whitworth,10 Donna Mazloomdoost,11 Sonia Thomas,10 NICHD Pelvic Floor Disorders Network
- Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego, San Diego, California.
- Division of Urogynecology and Pelvic Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham.
- The Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.
- 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.
- Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina.
- Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
- Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas.
- The Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque.
- Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio.
- RTI International, Research Triangle Park, North Carolina.
- Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.