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Cited by 11Pelvic floor disorders treatmentsUterine Myomas and TreatmentsHernia repair and management

Design of a 3-arm randomized trial for posthysterectomy vault prolapse involving sacral colpopexy, transvaginal mesh, and native tissue apical repair: the Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial

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Menefee, Shawn, Richter, Holly E., Myers, Deborah, Weidner, Alison, Moalli, Pamela, Harvie, Heidi, Rahn, David, Jeppson, Peter +3 more·2020·Female Pelvic Medicine & Reconstructive Surgery
DOI 10.1097/spv.0000000000000803PMC PMC7326314
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Abstract

Objective: The objective of this study was to present the design of the Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial (ASPIRe), which compares the efficacy and safety of 3 apical repairs: native tissue (NT) transvaginal repair, transvaginal mesh, and sacral colpopexy. Methods: Patient selection criteria, primary and secondary outcome measures including patient-reported outcome questionnaires, masking, surgeon certification, procedure standardization, adverse events collection and adjudication, and cost analysis will be described for this multi-centered randomized trial. Given the unique risks/benefits of each technique, a noninferiority design will be used to compare apical transvaginal mesh to mesh sacral colpopexy. A superiority design will be used to compare the 2 mesh repairs to NT transvaginal apical repair. Survival analysis will be used to assess a composite primary outcome for success composed of a subjective measure (no prolapse symptoms), objective measure (no prolapse beyond the hymen), and no prolapse retreatment, with a minimum follow-up of 36 months. Secondary outcome measures collected every 6 months include assessment of validated general and condition-specific quality of life measures, global impression of improvement, satisfaction and regret, body image, and sexual function. Results: Randomization and surgical treatment of 360 participants are complete, and the study is in the follow-up phase. Conclusions: This report will provide valuable insight on the design of a novel 3-arm surgical trial using mesh versus NT to repair vaginal vault prolapse. This trial will provide level 1 evidence on the risks and benefits of mesh augmented versus NT apical repairs.

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  • Given the number of failures (n=30), the final multivariable model was restricted to 3 variables in addition to site and treatment group.

    “Given the number of failures (n=30), the final number of variables was restricted to 3 in addition to site and treatment group, with these selected based on p-value in the minimally-adjusted analysis but also on biologic plausibility and review of the literature for variables most reported as associated with failure.17,18”

    From Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair (2024) · cites this paper as [18]

    The Statistical Design > Data Analysis section describes a prospective survival-analysis model and says it will include site and age category. It does not report 30 failures or a final multivariable model restricted to three additional variables. Searches for the failure count and variable-selection rationale found no matching passage in our copy; page numbers were not provided. (LLM, conf=0.76)

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Cited by

Sorted by citations

Authors
Menefee, S., Richter, H. E., Myers, D., Weidner, A., Moalli, P., Harvie, H., Rahn, D., Jeppson, P., Paraiso, M., Thomas, S., & Mazloomdoost, D.
Affiliations
  • Kaiser Permanente (US)
  • University of Alabama at Birmingham (US)
  • Brown University (US)
  • Duke University (US)
  • University of Pittsburgh Medical Center (US)
  • University of Pennsylvania Health System (US)
  • University of New Mexico (US)
  • Cleveland Clinic (US)
Corresponding author
  • Menefee, Shawn
  • Rahn, David
ORCID
Venue
Female Pelvic Medicine & Reconstructive Surgery
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2019-12-20
Volume
26
Issue
7
Pages
415-424
ISSN
  • 2151-8378 (ISSN-L)
  • 2154-4212
DOI
10.1097/spv.0000000000000803
PMC
PMC7326314
OpenAlex
W2995544050
Cited by
11
References
3
Citations by year
2025: 3 · 2024: 3 · 2023: 2 · 2022: 1 · 2020: 2
FWCI
0.57
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 (U10HD069025, U10HD041261, UG1HD041261, UG1HD069006, U10HD054214, U10HD054215, U10HD069010, UG1HD054215, U10HD069006, U01HD069031, U10HD069013, U10HD041267, UG1HD054214, UG1HD069010, UG1HD054241, 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
sacrocolpopexy, transvaginal mesh, patient-reported outcomes, quality of life, sexual function, body image, surgical technique standardization, cost analysis
MeSH terms
Equivalence Trials as Topic, Adult, Female, Humans, Gynecologic Surgical Procedures, Surgical Mesh, Vagina, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Plastic Surgery Procedures, Pelvic Organ Prolapse

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