Comparing two surgical methods for pelvic organ prolapse repair
Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
This study is testing two different surgical methods to see which one works better for women over 50 with pelvic organ prolapse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 592 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 8 sites (Hradec Králové and 7 other locations) |
| Trial ID | NCT05602246 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and safety of transobturator cystocele repair (TOCR) with traditional anterior colporrhaphy for treating pelvic organ prolapse, specifically focusing on anterior compartment defects. The study involves women aged 50 and older who experience symptomatic bulge due to at least a second stage prolapse. By assessing the outcomes of these two surgical techniques, the trial seeks to optimize surgical planning and improve patient quality of life. The research is conducted in multiple locations in the Czech Republic, ensuring a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 50 and older with at least a second stage prolapse of the anterior compartment and experiencing symptoms of bulge.
Not a fit: Patients with malignancy or those unable to communicate in Czech or English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for women suffering from pelvic organ prolapse.
How similar studies have performed: Other studies have shown success with similar surgical approaches, but the specific comparison of TOCR to anterior colporrhaphy is a novel focus.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hradec Králové and 7 other locations
- Faculty of Medicine in Hradec Kralove, Charles University — Hradec Králové, Czechia (Not_yet_recruiting)
- Medical Faculty, Ostrava University — Ostrava-Poruba, Czechia (Not_yet_recruiting)
- Hospital Pardubice Region, Inc. — Pardubice, Czechia (Not_yet_recruiting)
- Faculty of Medicine in Pilsen, Charles University — Pilsen, Czechia (Recruiting)
- Hospital na Bulovce, 1st Medical Faculty, Charles University — Prague, Czechia (Not_yet_recruiting)
- Tomas Bata Regional Hospital in Zlin — Zlín, Czechia (Not_yet_recruiting)
- Košice Medical University — Košice, Slovakia (Not_yet_recruiting)
- Trenčianska univerzita Alexandra Dubčeka — Trenčín, Slovakia (Not_yet_recruiting)
Study contacts
- Principal investigator: Zdenek Rusavy, assoc. prof. MD PhD — Faculty of Medicine in Plzen, Charles University
- Study coordinator: Vladimir Kalis, prof. MD PhD
- Email: kalisv@fnplzen.cz
- Phone: +420377105228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.