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 - Funding Information:
From the *Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego, San Diego, CA; †Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL; ‡Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Brown University, Providence, RI; §Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC; ||Women’s Center for Bladder and Pelvic Health, Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh; ¶Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania Health System, Philadelphia, PA; **Division of Female Pelvic Medicine and Reconstructive Surgery, University of Texas, Southwestern, Dallas, TX; ††Division of Urogynecology, Department of Obstetrics and Gynecology, University of New; Mexico, Albuquerque, NM; ‡‡Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women’s Health Institute, Cleveland Clinic, Cleveland, OH; §§RTI International, Research Triangle Park, NC; and ||||Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD. Correspondence: Shawn Menefee, MD. E‐mail: shawn.a.menefee@kp.org. The authors have declared they have no conflicts of interest. This study was supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD041261, U10 HD069013, U10 HD054214, U10 HD054215, U10 HD041267, U10 HD069025, U10 HD069010, U10 HD069006, U01 HD069031) and the National Institutes of Health Office of Research on Women’s Health. ClinicalTrials.gov NCT0276973. Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/SPV.0000000000000803 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.
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
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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 -