TY - JOUR
T1 - Design of a 3-arm randomized trial for posthysterectomy vault prolapse involving sacral colpopexy, transvaginal mesh, and native tissue apical repair
T2 - The apical suspension repair for vault prolapse in a three-arm randomized trial
AU - Menefee, Shawn
AU - Richter, Holly E.
AU - Myers, Deborah
AU - Weidner, Alison
AU - Moalli, Pamela
AU - Harvie, Heidi
AU - Rahn, David
AU - Jeppson, Peter
AU - Paraiso, Marie
AU - Thomas, Sonia
AU - Mazloomdoost, Donna
N1 - Publisher Copyright:
© Wolters Kluwer Health, Inc. All rights reserved.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - 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.
AB - 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.
KW - pelvic organ prolapse
KW - randomized controlled trial
KW - sacral colpopexy
KW - sacrospinous ligament suspension
KW - transvaginal mesh
KW - vaginal vault prolapse
UR - http://www.scopus.com/inward/record.url?scp=85087468886&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85087468886&partnerID=8YFLogxK
U2 - 10.1097/SPV.0000000000000803
DO - 10.1097/SPV.0000000000000803
M3 - Article
C2 - 31860566
AN - SCOPUS:85087468886
SN - 2151-8378
VL - 26
SP - 415
EP - 424
JO - Female Pelvic Medicine and Reconstructive Surgery
JF - Female Pelvic Medicine and Reconstructive Surgery
IS - 7
ER -