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Cited by 103Pelvic floor disorders treatmentsUterine Myomas and TreatmentsHernia repair and management

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial

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Nager, Charles W., Visco, Anthony G., Richter, Holly E., Rardin, Charles R., Rogers, Rebecca G., Harvie, Heidi S., Zyczynski, Halina M., Paraiso, Marie Fidela R. +5 more·2019·JAMA
DOI 10.1001/jama.2019.12812PMC PMC6749543
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Abstract

Importance: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option. Objective: To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy. Design, Setting, Participants: At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018. Interventions: Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension. Main Outcomes and Measures: The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate. Results: A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, -45.2 [95% CI, -57.7 to -32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%). Conclusions and Relevance: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension. Trial Registration: ClinicalTrials.gov Identifier: NCT01802281.

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  • The mismatch between expectations and goals may be influenced by inadequate counselling, poor 'customer' care, consideration of the impact of prolapse on body image, sexual function, and perhaps other indirect effects; those on a woman's anxiety, depression, and cognitive state.

    “This mismatch, and that between expectations and goals, may be influenced by inadequate counselling, poor ‘customer’ care, consideration of the impact of prolapse on body image, sexual function, and perhaps other indirect effects; those on a woman's anxiety, depression, and cognitive state [25, 26, 27, 28, 29].”

    From How Can We Improve the Assessment and Indifferent Outcomes From Pelvic Organ Prolapse Management From Conservative and Surgical Therapies? ICI‐RS 2025 (2026) · cites this paper as [25]

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Authors
Nager, C. W., Visco, A. G., Richter, H. E., Rardin, C. R., Rogers, R. G., Harvie, H. S., Zyczynski, H. M., Paraiso, M. F. R., Mazloomdoost, D., Grey, S., Sridhar, A., Wallace, D., & NICHD Pelvic Floor Disorders Network
Affiliations
  • UC San Diego Health System (US)
  • Duke Medical Center (US)
  • University of Alabama at Birmingham (US)
  • Brown University (US)
  • University of New Mexico (US)
  • University of Pennsylvania (US)
  • Magee-Womens Research Institute (US)
  • Cleveland Clinic (US)
  • National Institutes of Health (US)
  • RTI International (US)
Corresponding author
Nager, Charles W.
ORCID
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2019-09-17
Volume
322
Issue
11
Pages
1054
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.2019.12812
PMC
PMC6749543
OpenAlex
W2973277500
Cited by
103
References
36
Citations by year
2026: 12 · 2025: 9 · 2024: 13 · 2023: 18 · 2022: 20 · 2021: 21 · 2020: 9 · 2019: 1
FWCI
9.66
Type
journal article
Language
en
Open access
Locations
  • JAMA (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Yale University
  • Brown University
  • University of Pennsylvania
  • Cleveland Clinic
  • Cleveland Clinic Foundation
  • University of Connecticut
  • Johns Hopkins University
  • University of Pittsburgh
  • RTI International
  • Pennsylvania State University
  • Virginia Commonwealth University
  • Magee-Womens Research Institute
  • University of North Carolina at Chapel Hill
  • Johns Hopkins Bloomberg School of Public Health
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD069025, U10HD041261, UG1HD041261, UG1HD069006, U10HD054215, U10HD069010, UG1HD054215, U10HD069006, U01HD069031, U10HD069013, U10HD041267, UG1HD054214, UG1HD069010, U24HD069031)
Topics
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
  • Health Sciences › Medicine › Surgery › Hernia repair and management
Keywords
vaginal hysterectomy, uterosacral ligament suspension, uterovaginal prolapse, treatment failure, postmenopausal women, mesh exposure, operative time, surgical complications, pelvic organ prolapse surgery, adverse events, reoperation, granulation tissue
MeSH terms
Aged, Female, Follow-Up Studies, Humans, Hysterectomy, Vaginal, Ligaments, Middle Aged, Postoperative Complications, Gynecologic Surgical Procedures, Surgical Mesh, Uterine Prolapse, Uterus, Vagina, Treatment Outcome, Postmenopause, Kaplan-Meier Estimate

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