Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Aug 1;159(8):845-855.
doi: 10.1001/jamasurg.2024.1206.

Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial

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
Collaborators, Affiliations
Randomized Controlled Trial

Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial

Shawn A Menefee et al. JAMA Surg. .

Erratum in

  • Error in Figure 2.
    [No authors listed] [No authors listed] JAMA Surg. 2024 Aug 1;159(8):960. doi: 10.1001/jamasurg.2024.2789. JAMA Surg. 2024. PMID: 38985465 Free PMC article. No abstract available.

Abstract

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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Menefee reported receiving grants from National Institute of Child Health and Human Development (NICHD) and royalties from UpToDate outside the submitted work. Dr Richter reported receiving grants from NICHD, Patient-Centered Outcomes Research Institute, National Institutes of Health (NIH)/National Institute on Aging, NIH/University of Pennsylvania; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/Mayo Clinic, NIDDK/University of Alabama at Birmingham, Cosm Medical, and NIH–Small Business Innovation Research/Liv Labs; being on the data safety monitoring board of BlueWind Medical and Veristat; receiving royalties from UpToDate; being on the board of directors of WorldWide Fistula Fund and Solace; being on the editorial board of International Urogynecology Journal; serving as editor for Current Geriatric Reports; and serving as consultant for Neomedic, Coloplast, Palette Life Sciences, Cosm, Laborie, and Moremme. Dr Myers reported receiving grants from NICHD during the conduct of the study. Dr Moalli reported receiving grants from the NIH outside the submitted work and having a patent for Elastomeric Auxetic Membrane for Urogynecological and Abdominal Implantations. Dr Weidner reported receiving grants from the NIH and Ethicon and serving as consultant for Urocure and Inspire Medical outside the submitted work. Dr Meriwether reported receiving consultant/advisory board fees from RBI Medical; nonfinancial support from Caldera Medical; royalty fees from Elsevier publishing; serving on the executive board of the Society of Gynecologic Surgeons; and serving on the editorial board of Obstetrics and Gynecology and Urogynecology outside the submitted work. Dr Thomas reported receiving grants from NIH/NICHD during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Consolidated Standards of Reporting Trials Diagram
A participant completed the study if they had not discontinued the study by July 2022, when the last participant completed their 36-month visit.
Figure 2.
Figure 2.. Failure Probability for Time to Surgical Treatment Failure Comparing Native Tissue Repair (NTR), Sacrocolpopexy (SCP), and Transvaginal Mesh (TVM)
Primary piecewise exponential (PWE) analysis is from an interval-censored proportional hazard model with an assumed underlying piecewise exponential hazard with 5 constant-hazard periods: (0, 12; 12, 24; 24, 36; 36, 48; 48, 60) controlled for pooled site and age category (<65 years and ≥65 years). Nonparametric interval-censored Kaplan-Meier (KM) log-rank test is supportive. HR indicates hazard ratio. A, Descriptive display of failure probabilities for the 3 treatment groups in the modified intention-to-treat (MITT) population (all randomized and treated). B, Failure probabilities with 95% CIs indicated by shading in the per-protocol population (randomized and treated, excluding all treatment-related protocol violations) for the evaluation of noninferiority of TVM to SC based on a noninferiority hazard ratio margin of 1.93, evaluated at α = .03 (upper 1-sided 97% confidence limit [CL] <1.93 concludes noninferiority). C and D, Failure probabilities with 99% CIs indicated by shading in the MITT-NTR population for the evaluation of superiority of TVM or SCP to NTR, evaluated at α = .01. MITT-NTR is a subset of MITT that excludes 2 participants intraoperatively switched from SCP to TVM.
See this image and copyright information in PMC

Comment on

References

    1. Handa VL, Garrett E, Hendrix S, Gold E, Robbins J. Progression and remission of pelvic organ prolapse: a longitudinal study of menopausal women. Am J Obstet Gynecol. 2004;190(1):27-32. doi:10.1016/j.ajog.2003.07.017 - DOI - PubMed
    1. Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women’s Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002;186(6):1160-1166. doi:10.1067/mob.2002.123819 - DOI - PubMed
    1. Lowder JL, Ghetti C, Nikolajski C, Oliphant SS, Zyczynski HM. Body image perceptions in women with pelvic organ prolapse: a qualitative study. Am J Obstet Gynecol. 2011;204(5):441.e1-441.e5. doi:10.1016/j.ajog.2010.12.024 - DOI - PubMed
    1. Friedman T, Eslick GD, Dietz HP. Risk factors for prolapse recurrence: systematic review and meta-analysis. Int Urogynecol J. 2018;29(1):13-21. doi:10.1007/s00192-017-3475-4 - DOI - PubMed
    1. Smith FJ, Holman CDAJ, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010;116(5):1096-1100. doi:10.1097/AOG.0b013e3181f73729 - DOI - PubMed

Associated data