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Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Study acronym: STARS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Nov 1, 2024 to Nov 1, 2029
    • Study completion date: Nov 1, 2025 to Nov 1, 2034
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 8
    • Start date changed from estimate of Nov 1, 2022 to Dec 1, 2022
    v3
  3. Minor Secondary endpoints: details revised at 4 of 15 entriesv2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Surgical correction of the prolapse in the anterior compartment remains one of the major challenges in urogynecology. Paravaginal defect in level II of vaginal fixation results in the majority of cystoceles. Clinically, these defects are often combined and/or may be bilateral. Hence, careful assessment and individualized planning of the surgical procedure is essential to optimize cystocele repair outcome. Several surgical techniques and approaches have been used for cystocele repair. After the ban on transvaginal meshes, the interest in native tissue repair has risen. Paravaginal defect repair is an effective surgery for paravaginal defect reconstruction. There is a current trend to utilize transvaginal surgery instead of more invasive transabdominal surgery. A novel method of transvaginal paravaginal defect repair - TOCR (transobturator cystocele repair) was suggested. The principle objective of the present trial is to compare its efficacy and safety to preexisting method of native tissue cystocele repair.
Trial Details
NCT Number NCT05602246
Lead Sponsor Charles University, Czech Republic
Conditions
(from sponsor)
Pelvic Organ Prolapse, Cystocele, Cystocele and Incomplete Uterovaginal Prolapse
Related terms Cystocele, Pelvic Organ Prolapse
Enrollment 592 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov