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Recruiting NCT05602246

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Trial Parameters

Condition Pelvic Organ Prolapse
Sponsor Charles University, Czech Republic
Study Type INTERVENTIONAL
Phase N/A
Enrollment 592
Sex FEMALE
Min Age 50 Years
Max Age N/A
Start Date 2022-12-01
Completion 2029-11-01
Interventions
Transobturator cystocele repairAnterior colporrhaphy

Brief 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.

Eligibility Criteria

Inclusion Criteria: * (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1) * Age ≥ 50 years * Symptom bulge * Ability to speak Czech or English Exclusion Criteria: * Malignancy

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