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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design

Study acronym: ASPIRe
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 20 words
    • Site details revised at 1 of 10 sites
    • Publications: details revised at 4 of 4 entries
    • Study description expanded, about 3 words
  2. 2 versions Re-verified since Mar 6, 2025, no change to tracked fieldsv15-v16
  3. Results first posted: May 17, 2024v14 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: estimated 363 to confirmed 360
    • Study completion date: Dec 2026 to Dec 31, 2026
    • Secondary endpoints shortened, about 460 words
  4. Primary completion date changed from estimate of Nov 2022 to Jul 28, 2022
    • Start date: Mar 2016 to Feb 29, 2016
    v13
  5. Primary completion date: Jun 2022 to Nov 2022
    • Study completion date: Jun 2022 to Dec 2026
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Primary and study completion dates: Feb 2021 to Jun 2022v10
  3. Secondary endpoints revised (28)
    • Collaborators reordered
    v9
  4. Primary endpoint revisedv8
  5. Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
    • Interventions: Open, Robotic, or Laparoscopic (Procedure), Transvaginal Native Tissue Repair (Procedure), Uphold™ LITE or Elevate™-AA (Procedure) to Open, Robotic, or Laparoscopic (Procedure), Transvaginal Native Tissue Repair (Procedure), Uphold™ LITE (Procedure)
    • Study description expanded, about 60 words
    • Site details revised at 10 of 10 sites
    • Eligibility criteria expanded, about 1 word
  6. Study sites revised (10)v6
  7. Re-verified, no change to tracked fieldsv5
  8. Site details revised at 1 of 10 sitesv4
  9. Study sites: 9 to 10
    • Collaborators: 11 to 12
    v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2016 to Mar 2016
    • Site details revised at 9 of 9 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach. Participants will be followed for at least 36-months (3-years) post surgery and up to a maximum of 60-months (5-years) during the primary trial. Participants who complete the primary trial will be approached for consent for long-term follow-up as part of a study extension and will be followed up to a maximum of 120-months (10-years). The investigators hypothesize that treatment failure will not differ between vaginally and abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of implantation) will be superior to native tissue apical suspension.
Trial Details
NCT Number NCT02676973
Lead Sponsor NICHD Pelvic Floor Disorders Network
Collaborators: The Cleveland Clinic, University of Alabama at Birmingham, University of California, San Diego, Duke University, University of New Mexico, Women and Infants Hospital of Rhode Island, RTI International, University of Pennsylvania, University of Pittsburgh, Kaiser Permanente, University of Texas Southwestern Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Visceral Prolapse
Related terms Cystocele, Pelvic Organ Prolapse, Uterine Prolapse, Visceral Prolapse
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov