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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.

Publication ,  Journal Article
Menefee, S; Richter, HE; Myers, D; Weidner, A; Moalli, P; Harvie, H; Rahn, D; Jeppson, P; Paraiso, M; Thomas, S; Mazloomdoost, D ...
Published in: Female Pelvic Med Reconstr Surg
July 2020

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.

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Published In

Female Pelvic Med Reconstr Surg

DOI

EISSN

2154-4212

Publication Date

July 2020

Volume

26

Issue

7

Start / End Page

415 / 424

Location

United States

Related Subject Headings

  • Vagina
  • Surgical Mesh
  • Randomized Controlled Trials as Topic
  • Plastic Surgery Procedures
  • Pelvic Organ Prolapse
  • Multicenter Studies as Topic
  • Humans
  • Gynecologic Surgical Procedures
  • Female
  • Adult
 

Citation

APA
Chicago
ICMJE
MLA
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Menefee, S., Richter, H. E., Myers, D., Weidner, A., Moalli, P., Harvie, H., … 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 Med Reconstr Surg, 26(7), 415–424. https://doi.org/10.1097/SPV.0000000000000803
Menefee, Shawn, Holly E. Richter, Deborah Myers, Alison Weidner, Pamela Moalli, Heidi Harvie, David Rahn, et al. “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 Med Reconstr Surg 26, no. 7 (July 2020): 415–24. https://doi.org/10.1097/SPV.0000000000000803.
Menefee S, Richter HE, Myers D, Weidner A, Moalli P, Harvie H, Rahn D, Jeppson P, Paraiso M, Thomas S, Mazloomdoost D, NICHD Pelvic Floor Disorders Network. 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 Med Reconstr Surg. 2020 Jul;26(7):415–424.

Published In

Female Pelvic Med Reconstr Surg

DOI

EISSN

2154-4212

Publication Date

July 2020

Volume

26

Issue

7

Start / End Page

415 / 424

Location

United States

Related Subject Headings

  • Vagina
  • Surgical Mesh
  • Randomized Controlled Trials as Topic
  • Plastic Surgery Procedures
  • Pelvic Organ Prolapse
  • Multicenter Studies as Topic
  • Humans
  • Gynecologic Surgical Procedures
  • Female
  • Adult