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Search / Trial NCT05602246

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Launched by CHARLES UNIVERSITY, CZECH REPUBLIC · Oct 31, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Pelvic Organ Prolapse Quality Of Life Tocr Anterior Vaginal Wall Repair Transobturator Cystocele Repair

ClinConnect Summary

This clinical trial is studying two different surgical methods for treating a condition called cystocele, which is a type of pelvic organ prolapse where the bladder bulges into the vagina. The trial aims to compare a newer surgery called transobturator cystocele repair (TOCR) with a traditional method known as native tissue repair. Both procedures are designed to fix the support structure of the vagina to help relieve symptoms like a bulge sensation. Researchers want to find out which method is safer and more effective for women facing this issue.

To participate in the trial, women must be at least 50 years old and have a specific level of prolapse (at least stage 2) that causes symptoms. They should also be able to communicate in Czech or English. Participants will receive one of the two surgical treatments and will be monitored to see how well the surgery works and if there are any side effects. It's important to note that women with any type of cancer are not eligible for this study. Overall, this trial hopes to improve treatment options for women experiencing cystocele and help them feel better.

Gender

FEMALE

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

About Charles University, Czech Republic

Charles University, located in the Czech Republic, is a prestigious institution renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, the university leverages its extensive academic expertise and state-of-the-art facilities to conduct innovative research that aims to improve patient outcomes and contribute to the global medical community. With a focus on ethical standards and rigorous scientific methodologies, Charles University collaborates with various stakeholders to explore new therapies and enhance healthcare practices, fostering a culture of excellence in clinical research.

Locations

Pilsen, , Czechia

Košice, , Slovakia

Hradec Králové, , Czechia

Ostrava Poruba, , Czechia

Pardubice, , Czechia

Pilsen, , Czechia

Praha, , Czechia

Zlín, , Czechia

Trenčín, , Slovakia

Patients applied

0 patients applied

Trial Officials

Vladimir Kalis, prof. MD PhD

Study Chair

Faculty of Medicine in Plzen, Charles University

Khaled MK Ismail, MBBCh, MSc, MD, PhD, FRCOG

Study Director

Faculty of Medicine in Plzen, Charles University

Zdenek Rusavy, assoc. prof. MD PhD

Principal Investigator

Faculty of Medicine in Plzen, Charles University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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