For the first time in Ukraine, the methodological recommendations "Peculiarities of Conducting Clinical Trials of Medicinal Products for the Treatment of Urinary Incontinence" have been developed.
In order to harmonize the regulatory framework in Ukraine regarding medicinal products, based on the guideline of the European Medicines Agency (EMA) EMA/CHMP/EWP/18/01 Rev.1 "Guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence" – June, 2013 (Guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence – June 2013) and the current regulatory framework for conducting clinical trials in Ukraine, specialists of the State Expert Center of the Ministry of Health of Ukraine have developed the methodological recommendations "Peculiarities of Conducting Clinical Trials of Medicinal Products for the Treatment of Urinary Incontinence", which were approved at a meeting of the Scientific Expert Council of the State Expert Center of the Ministry of Health of Ukraine (minutes dated 25.04.2024 No. 8). The methodological recommendations will be useful both for manufacturers of medicinal products and for specialists and researchers who will direct their efforts towards the development of methods for the modern treatment of urinary incontinence.
The purpose of the methodological recommendations is to improve the planning, development and organization of clinical trials of medicinal products for the treatment of urinary incontinence.
These methodological recommendations address:
- general information about the nosology, its prevalence, and the relevance of treatment;
- general principles of conducting clinical trials of medicinal products to prove their efficacy and safety;
- specifics of conducting clinical trials of medicinal products for the treatment of urinary incontinence (justification, clinical trial design, patient selection, assessment of efficacy criteria, safety aspects, etc.).
The text of the methodological recommendations can be found on the website of the State Expert Center of the Ministry of Health of Ukraine in the section "Audit Management/Guidelines and Methodological Recommendations on Conducting Preclinical and Clinical Trials" at
