[Effectiveness of Omnic and Omnic Ocas in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia (multi-center observing program)].

Aim: To investigate the effectiveness and safety of six-month treatment course of Omnic and Omnic Ocas in patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in a routine urology practice in Kazakhstan.

Design: This was a multicenter prospective observational program involving the collection of data from patients with LUTS caused by BPH, who received Omnic Ocas or Omnic as the first line treatment.

Materials And Methods: The program comprised 1513 patients with a verified diagnosis of LUTS/BPH, who received Omnic Ocas or Omnic (tamsulosin) administered by urologists at hospitals in the Republic of Kazakhstan. According to the program protocol, 1381 patients completed the study. The mean age of the patients was 63 years. The study program involved three follow-up visits: Visit 1 (baseline), during which the patient completed the IPSS questionnaire concerning urinary symptoms and quality of life. After that they underwent a baseline examination including maximum urinary flow rate (Qmax) measured by uroflowmetry, prostate volume determined by digital rectal examination and the serum PSA level. Visit 2 and Visits 3 were scheduled on average at three and six months after Visit 1, respectively, and aimed at assessing the treatment outcomes during the follow-up.

Results: During the 6-month treatment, patients of different age groups reported an improvement in the prostate symptom score (IPSS). The drug therapy was more effective in patients with a flow rate of <10 ml/s. There was a gradual decrease in the mean scores of both the storage and voiding I-PSS subscales. Uroflowmetry at six months showed a clinically significant increase in the urinary flow rate. Adverse events were reported by1.9% of patients.

Discussion: The study findings suggesting a significantly improved voiding function in all study participants with LUTS and BPH who received Omnic Ocas or Omnic (tamsulosin) (n=1381) indicate that: the groups "<55 years", "55-65 years" and ">65 years" showed a decrease in symptoms (the total IPSS score after 6-month treatment decreased by 41.6%), in feeling of incomplete emptying and the need to urinate more often than 2 hours after urination; there was less terminal dribbling. Therapy was well tolerated: adverse events were noted in 1.6% of patients. Thus, it can be concluded that Omnic and Omnic Ocas are effective in all age groups of patients with LUTS/BPH and have a favorable safety profile.

Conclusion: The findings of this study suggest that Omnic and Omnic Ocas are highly effective in patients with LUTS/BPH of all age groups and have a favorable safety profile.