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

Affiliations

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; Mexico, Albuquerque, NM.
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.

PMID: 31860566
PMCID: PMC7326314
DOI: 10.1097/SPV.0000000000000803

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 et al. Female Pelvic Med Reconstr Surg. 2020 Jul.

. 2020 Jul;26(7):415-424.

doi: 10.1097/SPV.0000000000000803.

Authors

Affiliations

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; Mexico, Albuquerque, NM.
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.

PMID: 31860566
PMCID: PMC7326314
DOI: 10.1097/SPV.0000000000000803

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.

Trial registration: ClinicalTrials.gov NCT02676973.

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References

1. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women In: Maher C, ed. Cochrane Database of Systematic Reviews. Chichester, UK: John Wiley & Sons, Ltd; 2013:CD004014. doi:10.1002/14651858.CD004014.pub5 - DOI - PubMed
1. Barber MD, Brubaker L, Burgio KL, et al. Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse. JAMA. 2014;311(10):1023. doi:10.1001/jama.2014.1719 - DOI - PMC - PubMed
1. Sung VW, Rogers RG, Schaffer JI, et al. Graft Use in Transvaginal Pelvic Organ Prolapse Repair. Obstet Gynecol. 2008;112(5):1131–1142. doi:10.1097/AOG.0b013e3181898ba9 - DOI - PubMed
1. Krlin RM, Murphy AM, Goldman HB. Pro: the contemporary use of transvaginal mesh in surgery for pelvic organ prolapse. Curr Opin Urol. 2012;22(4):282–286. doi:10.1097/MOU.0b013e32835459a7 - DOI - PubMed
1. Urogynecologic Surgical Mesh Implants | FDA; https://www.fda.gov/medical-devices/implants-and-prosthetics/urogynecolo....

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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

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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

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