Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial
Open accessAbstract
Background Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market.Objective Our objective was to compare the efficacy and adverse events of these 2 procedures.Study design At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes.Results A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively.Conclusion Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.
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In the SUPeR trial, among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral ligament suspension over 5 years (aHR 0.58; 95% CI 0.36-0.94; P=.03).
“Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the vaginal hysterectomy with uterosacral ligament suspension (USLS) vs sacrospinous hysteropexy with graft suspension (Study for Uterine Prolapse Procedures Randomized Trial [SUPeR]) trial, sacrospinous hysteropexy with graft resulted in a lower composite surgical failure rate than vaginal hysterectomy with USLS over”
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Hu, P., Lubin, L. I. U., Wei, L., Ying, W. A. N. G., & Li, L. (2023) · Research Square · doi:10.21203/rs.3.rs-2462893/v1
Management of Vaginal Posterior Compartment Prolapse: Is There Ever a Case for Graft/Mesh?
Chang, O. H., & Sutherland, S. E. (2023) · Springer eBooks · doi:10.1007/978-3-030-71112-2_38-1
Iglesia, C. B. (2023) · Urogynecology · doi:10.1097/spv.0000000000001408
The Distortion of the Composite Prism
Matthews, C. A. (2024) · JAMA Surgery · doi:10.1001/jamasurg.2024.1207
At the Scrub Sink: Uterine Preservation Surgery
Meyer, I. (2024) · Urogynecology · doi:10.1097/spv.0000000000001531
The Pelvic Floor Disorders Network: Evolution Over Two Decades of Female Pelvic Floor Research
Richter, H. E., Visco, A. G., Brubaker, L. T., Sung, V. W., Nygaard, I. E., Arya, L. A., Menefee, S. A., Zyczynski, H. M., Schaffer, J. I., Rogers, R. G., et al. (2024) · Urogynecology · doi:10.1097/spv.0000000000001571
Self-citationIncorporating Perineorrhaphy into the LeFort Colpocleisis: A Modified Surgical Approach
Telek, S. B., Martin, B. S., & Harmanli, O. (2025) · International Urogynecology Journal · doi:10.1007/s00192-025-06041-0
Repair of Advanced Pelvic Organ Prolapse Using an Anchorless Vaginal Implant
Fridman-Kogan, Z., Marcus-Braun, N., & Levy, G. (2025) · IntechOpen eBooks · doi:10.5772/intechopen.1009890
Kılıççı, Ç., Karakuş, R., İşcan, R. G., Karakuş, S. S., Tosun, Ö., Uzun, M. G., & Aran, T. (2025) · International Urogynecology Journal · doi:10.1007/s00192-025-06305-9
The EnPlace® Device for Advanced Apical Prolapse: Anatomical Outcomes and Long-Term Satisfaction
Rotem, R., Neuman, J., Hirsch, A., Neuman, M., & Weintraub, A. Y. (2026) · Uro · doi:10.3390/uro6040027
Wolff, D. T., D'Amico, M. J., Santis‐Moya, F., Koven, A. B., Antosh, D. D., Rotem, R., Schmeil, I., Pizarro-Berdichevsky, J., Deprest, J. A., Kang, K., et al. (2026) · International Urogynecology Journal · doi:10.1007/s00192-026-06933-9
- Authors
- 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., & Thomas, S.
- 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
- American Journal of Obstetrics and Gynecology
- Publisher
- Elsevier BV
- Published
- 2021-08
- Volume
- 225
- Issue
- 2
- Pages
- 153.e1-153.e31
- ISSN
- 0002-9378 (ISSN-L)
- PMC
- PMC8328912
- OpenAlex
- W3137134282
- Cited by
- 67
- References
- 24
- Citations by year
- 2026: 5 · 2025: 12 · 2024: 12 · 2023: 14 · 2022: 22 · 2021: 2
- FWCI
- 9.40
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- www.elsevier.com/legal/tdmrep-license (tdm)
- www.elsevier.com/open-access/userlicense/1.0/ (am, 361 d)
- doi.org/10.15223/policy-017 (stm-asf)
- doi.org/10.15223/policy-037 (stm-asf)
- doi.org/10.15223/policy-012 (stm-asf)
- doi.org/10.15223/policy-029 (stm-asf)
- doi.org/10.15223/policy-004 (stm-asf)
- Locations
- American Journal of Obstetrics and Gynecology (acceptedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Boston Scientific Corp
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Topics
- Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
- Health Sciences › Medicine › Obstetrics and Gynecology › Gynecological conditions and treatments
- Keywords
- uterovaginal prolapse, vaginal hysterectomy, uterosacral ligament suspension, treatment failure, postmenopausal women, long-term outcomes, POP-Q, surgical complications, mesh removal, pelvic floor dysfunction, randomized controlled trials
- MeSH terms
- Patient Reported Outcome Measures, Aged, Female, Humans, Hysterectomy, Vaginal, Ligaments, Middle Aged, Sacrum, Gynecologic Surgical Procedures, Surgical Mesh, Suture Techniques, Uterine Prolapse, Treatment Failure, Plastic Surgery Procedures
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