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.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Menefee, S; Richter, HE; Myers, D; Weidner, A; Moalli, P; Harvie, H; Rahn, D; Jeppson, P; Paraiso, M; Thomas, S; Mazloomdoost, D; NICHD Pelvic Floor Disorders Network,

Published Date

  • July 2020

Published In

Volume / Issue

  • 26 / 7

Start / End Page

  • 415 - 424

PubMed ID

  • 31860566

Pubmed Central ID

  • 31860566

Electronic International Standard Serial Number (EISSN)

  • 2154-4212

Digital Object Identifier (DOI)

  • 10.1097/SPV.0000000000000803

Language

  • eng

Conference Location

  • United States