[The effectiveness and safety of Omnik OCAS in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia in the routine clinical practice in the Russian Federation (prospective multi-center observing program)].

ABSTRACT

AIM: To investigate changes in the IPSS after a six-month treatment with Omnic Ocas and its effect on the quality of life of patients in routine urological practice in the Russian Federation in a prospective, multicenter, observational study. PATIENTS AND METHODS: The study comprised 7000 patients with a verified diagnosis of lower urinary tract symptoms/benign prostatic hyperplasia who received Omnic Ocas (tamsulosin) administered by 700 urologists in various Russian medical institutions. The mean age of the patients was 63 years. The study program involved three visits. At the baseline visit, patients filled out the IPSS and EQ-5D-5L questionnaires, provided a blood sample for PSA, and underwent a digital rectal examination. At visits 2 and 3 scheduled at 3 and 6 months after visit 1 the patients were assessed for the outcomes of the prescribed therapy. RESULTS: During the 6-month treatment, the patients showed an improvement in the IPSS in the study's age groups. There was a gradual improvement in the storage and voiding symptoms subscale scores of the IPSS. The assessment of the EQ-5D-5L questionnaire results showed significant changes in the quality of life regarding various aspects of life. Adverse events were reported in 0.51% of patients during the study follow-up. CONCLUSION: The study findings suggest that Omnic Ocas is highly effective in all age groups of patients with LUTS/BPH and has a favorable safety profile.