Actively Recruiting

Phase Not Applicable
Age: 50Years +
FEMALE
NCT05602246

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Led by Charles University, Czech Republic · Updated on 2026-03-19

592

Participants Needed

8

Research Sites

621 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Who Can Participate

Age: 50Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 2nd stage prolapse of the anterior compartment (Ba 81)
  • Age 50 years or older
  • Symptom of bulge
  • Ability to speak Czech or English
Not Eligible

You will not qualify if you...

  • Presence of malignancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Faculty of Medicine in Hradec Kralove, Charles University

Hradec Králové, Czechia, 500 05

Not Yet Recruiting

2

Medical Faculty, Ostrava University

Ostrava-Poruba, Czechia, 708 52

Not Yet Recruiting

3

Hospital Pardubice Region, Inc.

Pardubice, Czechia, 530 03

Not Yet Recruiting

4

Faculty of Medicine in Pilsen, Charles University

Pilsen, Czechia, 30000

Actively Recruiting

5

Hospital na Bulovce, 1st Medical Faculty, Charles University

Prague, Czechia, 18000

Not Yet Recruiting

6

Tomas Bata Regional Hospital in Zlin

Zlín, Czechia, 762 75

Not Yet Recruiting

7

Košice Medical University

Košice, Slovakia, 040 11

Not Yet Recruiting

8

Trenčianska univerzita Alexandra Dubčeka

Trenčín, Slovakia, 911 01

Not Yet Recruiting

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Research Team

V

Vladimir Kalis, prof. MD PhD

CONTACT

Z

Zdenek Rusavy, assoc. prof. MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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