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Cited by 27Pelvic floor disorders treatmentsUterine Myomas and TreatmentsReproductive Health and Contraception

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The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial)

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Nager, Charles W., Zyczynski, Halina, Rogers, Rebecca G., Barber, Matthew D., Richter, Holly E., Visco, Anthony G., Rardin, Charles R., Harvie, Heidi, Wallace, Dennis, Meikle, Susan F.·2016·Female Pelvic Medicine & Reconstructive Surgery
DOI 10.1097/spv.0000000000000270PMC PMC4919185
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Abstract

Objectives: We present the rationale for and design of a randomized controlled superiority trial comparing 2 vaginal surgical approaches for the treatment of uterovaginal prolapse. The Study of Uterine Prolapse Procedures Randomized Trial (SUPeR) trial compares the efficacy and safety of native tissue repair with vaginal hysterectomy and suture apical suspension versus uterine conservation with mesh hysteropexy through 36 to 60 months postoperatively for primary repair of uterovaginal prolapse. Methods: The selection of the primary outcome measure, timing of randomization, patient and evaluator masking to surgical intervention, collection and adjudication of adverse events, cost effectiveness evaluations, partnering with industry, and surgeon certification of competency to perform the 2 procedures is described. A composite primary outcome of success defined as no prolapse symptoms, no objective prolapse beyond the hymen, and no retreatment of prolapse, with a minimum of 36 months postsurgery follow-up using survival analyses is planned. Secondary outcomes measured at baseline and every 6 months postsurgery include validated condition-specific and general quality of life assessments, global impression of improvement, body image, and sexual function measures. Unique challenges during the trial design include maintenance of patient masking to the intervention with routine gynecologic health maintenance and maintenance of evaluator masking. Results: Recruitment and randomization of 180 participants is complete, and participants are currently in the follow-up phase. Conclusions: This trial will provide information to help surgeons counsel patients and contribute evidence-based information regarding risks and benefits of 2 approaches for the treatment of uterovaginal prolapse.

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Metadata

Authors
Nager, C. W., Zyczynski, H., Rogers, R. G., Barber, M. D., Richter, H. E., Visco, A. G., Rardin, C. R., Harvie, H., Wallace, D., & Meikle, S. F.
Affiliations
  • Cleveland Clinic (US)
  • University of Pittsburgh (US)
  • University of New Mexico (US)
  • National Institutes of Health (US)
  • University of Alabama at Birmingham (US)
  • Duke Medical Center (US)
  • Brown University (US)
Corresponding author
  • Nager, Charles W.
  • Rardin, Charles R.
ORCID
Venue
Female Pelvic Medicine & Reconstructive Surgery
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2016-07
Volume
22
Issue
4
Pages
182-189
ISSN
2151-8378 (ISSN-L)
DOI
10.1097/spv.0000000000000270
PMC
PMC4919185
OpenAlex
W2337628636
Cited by
27
References
4
Citations by year
2026: 1 · 2024: 1 · 2023: 2 · 2022: 3 · 2021: 5 · 2020: 3 · 2019: 4 · 2017: 6 · 2016: 2
FWCI
4.26
Type
journal article
Language
en
Open access
Locations
  • Urogynecology (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1HD069025, U10HD069025, U10HD041261, UG1HD041261, UG1HD069006, U10HD054214, U10HD054215, U10HD069010, UG1HD054215, U10HD069006, U01HD069031, U10HD069013, U10HD041267, UG1HD054214, UG1HD069010, U24HD069031, UG1HD041267, UG1HD069013)
Topics
  • Health Sciences › Medicine › Urology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
Keywords
uterovaginal prolapse, vaginal hysterectomy, uterine conservation, pelvic organ prolapse surgery, randomized controlled trial design, quality of life, sexual function, body image, cost-effectiveness
MeSH terms
Equivalence Trials as Topic, Adult, Clinical Protocols, Female, Humans, Hysterectomy, Vaginal, Research Design, Surgical Mesh, Uterine Prolapse, Uterus, Patient Preference, Organ Sparing Treatments

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