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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
Menefee, S., Richter, H. E., Myers, D., Weidner, A., Moalli, P., Harvie, H., Rahn, D., Jeppson, P., Paraiso, M., Thomas, S., Mazloomdoost, D., & NICHD Pelvic Floor Disorders Network (2020). 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. Female Pelvic Medicine & Reconstructive Surgery, 26(7), 415-424. https://doi.org/10.1097/SPV.0000000000000803
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.
