Clinical Trial

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Study acronym: STARS
Recruiting
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-10-31; most recent amendment 2026-03-18.
Status change: Not Yet Recruiting → Recruiting 2023-02-11
Trial Details
NCT Number NCT05602246
Lead Sponsor Charles University, Czech Republic
Conditions Pelvic Organ Prolapse, Cystocele, Cystocele and Incomplete Uterovaginal Prolapse
Enrollment 592 participants
Start Date 2022-12-01
Primary Completion 2029-11-01 (estimated)
Study Completion 2034-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-19