Comparing two surgical methods for pelvic organ prolapse repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Faculty of Medicine in Pilsen, Charles University
  Pilsen, Czechia Recruiting
• 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
• Hospital na Bulovce, 1st Medical Faculty, Charles University
  Prague, Czechia Not yet recruiting
• Tomas Bata Regional Hospital in Zlin
  Zlín, Czechia 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.