Format

Send to

Choose Destination
Female Pelvic Med Reconstr Surg. 2019 Dec 19. doi: 10.1097/SPV.0000000000000803. [Epub ahead of print]

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.

Author information

1
From the Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego, San Diego, CA.
2
Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.
3
Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Brown University, Providence, RI.
4
Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.
5
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.
6
Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania Health System, Philadelphia, PA.
7
Division of Female Pelvic Medicine and Reconstructive Surgery, University of Texas, Southwestern, Dallas, TX.
8
Division of Urogynecology, Department of Obstetrics and Gynecology, University of New.
9
Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, OH.
10
RTI International, Research Triangle Park, NC.
11
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.

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.

Supplemental Content

Full text links

Icon for Wolters Kluwer
Loading ...
Support Center