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Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Sponsor: Charles University, Czech Republic
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.
Key Details
Gender
FEMALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
592
Start Date
2022-12-01
Completion Date
2034-11-01
Last Updated
2026-03-19
Healthy Volunteers
No
Interventions
Transobturator cystocele repair
Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.
Anterior colporrhaphy
The traditional transvaginal surgery for cystocele treatment used as a comparator in the study
Locations (8)
Faculty of Medicine in Hradec Kralove, Charles University
Hradec Králové, Czechia
Medical Faculty, Ostrava University
Ostrava-Poruba, Czechia
Hospital Pardubice Region, Inc.
Pardubice, Czechia
Faculty of Medicine in Pilsen, Charles University
Pilsen, Czechia
Hospital na Bulovce, 1st Medical Faculty, Charles University
Prague, Czechia
Tomas Bata Regional Hospital in Zlin
Zlín, Czechia
Košice Medical University
Košice, Slovakia
Trenčianska univerzita Alexandra Dubčeka
Trenčín, Slovakia