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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pilsen, , Czechia
Košice, , Slovakia
Hradec Králové, , Czechia
Ostrava Poruba, , Czechia
Pardubice, , Czechia
Pilsen, , Czechia
Praha, , Czechia
Zlín, , Czechia
Trenčín, , Slovakia
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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