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

Shawn Menefee, Holly E. Richter, Deborah Myers, Alison Weidner, Pamela Moalli, Heidi Harvie, David Rahn, Peter Jeppson, Marie Paraiso, Sonia Thomas, Donna Mazloomdoost

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)415-424
Number of pages10
JournalFemale Pelvic Medicine and Reconstructive Surgery
Volume26
Issue number7
DOIs
StatePublished - Jul 1 2020
Externally publishedYes

Keywords

  • pelvic organ prolapse
  • randomized controlled trial
  • sacral colpopexy
  • sacrospinous ligament suspension
  • transvaginal mesh
  • vaginal vault prolapse

ASJC Scopus subject areas

  • Surgery
  • Obstetrics and Gynecology
  • Urology

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