Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05602246
NA

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Sponsor: Charles University, Czech Republic

View on ClinicalTrials.gov

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

PROCEDURE

Transobturator cystocele repair

Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.

PROCEDURE

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