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Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial
Open accessAbstract
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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“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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The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction
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Higgins (2002) · doi:10.1002/(issn)1097-0258 · Cited by 1,248
Surgical management of pelvic organ prolapse in women
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Validation of two global impression questionnaires for incontinence
Yalcin, I., & Bump, R. C. (2003) · American Journal of Obstetrics and Gynecology · doi:10.1067/mob.2003.379 · Cited by 888
Surgical management of pelvic organ prolapse in women
Maher, C., Feiner, B., Baessler, K., & Schmid, C. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004014.pub5 · Cited by 784
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Jelovsek, J. E., & Barber, M. D. (2006) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2006.01.060 · Cited by 434
Barber, M. D., Brubaker, L., Burgio, K. L., Richter, H. E., Nygaard, I., Weidner, A. C., Menefee, S. A., Lukacz, E. S., Norton, P., Schaffer, J., et al. (2014) · JAMA · doi:10.1001/jama.2014.1719 · Cited by 428
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Wang, B., Chen, Y., Zhu, X., Wang, T., Li, M., Huang, Y., Xue, L., Zhu, Q., Gao, X., & Wu, M. (2022) · Frontiers in Public Health · doi:10.3389/fpubh.2022.975829 · Cited by 135
Surgery for women with apical vaginal prolapse
Maher, C., Yeung, E., Haya, N., Christmann-Schmid, C., Mowat, A., Chen, Z., & Baessler, K. (2023) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012376.pub2 · Cited by 114
Nager, C. W., Visco, A. G., Richter, H. E., Rardin, C. R., Komesu, Y., Harvie, H. S., Zyczynski, H. M., Paraiso, M. F. R., Mazloomdoost, D., Sridhar, A., et al. (2021) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2021.03.012 · Cited by 67
“Vaginal infections or atypical vaginal discharge, number/total (%) 4/90 (4) 9/91 (10) 5 ( 13 to 2) .”
Self-citationApical Suspension Repair for Vaginal Vault Prolapse
Menefee, S. A., Richter, H. E., Myers, D. L., Moalli, P., Weidner, A. C., Harvie, H. S., Rahn, D. D., Meriwether, K. V., Paraiso, M. F. R., Whitworth, R., et al. (2024) · JAMA Surgery · doi:10.1001/jamasurg.2024.1206 · Cited by 43
Self-citationAntosh, D. D., Dieter, A. A., Balk, E. M., Kanter, G., Kim-Fine, S., Meriwether, K. V., Mamik, M. M., Good, M. M., Singh, R., Alas, A., et al. (2021) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2021.05.042 · Cited by 33
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Metadata
- 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
- 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
- bronze
- doi.org
- 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 › Urology › 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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