Evaluation of the efficacy and safety of Adenoprosin® in patients with category IIIA chronic prostatitis.

Introduction. Chronic prostatitis (СР) is an actual problem of modern urology as it leads to significant deterioration of life quality of able-bodied male population. Frequent relapses of the disease in spite of timely prescribed therapy leads to the necessity to search for alternative drugs. Objective of the study. To evaluate efficacy and safety of Adenoprosin® in patients with CP/chronic pelvic pain syndrome (CРРS) of IIIA category according to USA National Health Institute classification. Materials and methods. The prospective observational study of efficacy and safety of Adenoprosin® was carried out from 10.2021 till 10.2022 on the basis of the Center of Urology and Andrology of the State Research Center named after Burnazyan, Federal Medical and Biological Center of the Russian Federation. Men aged 35 to 60 with diagnosed CKD (IIIA according to the US National Institutes of Health classification) took part in the study. Patients were divided into 2 comparable groups. The control group was treated with an alfa1-adrenoblocker (Tamsulosin 0.4 mg 1 once daily), antibacterial agent (Levofloxacin 500 mg 1 once daily) for 30 days. In the main group, in addition to the standard therapy, Adenoprosin® 150 mg, one suppository a day was administered rectally for 30 days. The study requirements were included 4 Visits: Visit 0-1 – the baseline visit; Visit 2 on Day 14 from the therapy start; Visit 3 on Day 30 from the therapy start; Visit 4 on Day 90 from the therapy start. Clinical monitoring was performed with standardized questionnaires «International system of summarizing prostate disease symptoms» (IPSS), «Chronic prostatitis symptoms index (NIH-CPSI)», WBC counting in prostate secretion. Results. Statistical analysis of NIH-CPSI, IPSS questionnaires, as well as WBC count in the prostate secretion before and after the beginning of treatment, showed that the therapy was significantly effective in both groups (p <0,05). In the main group (Adenoprosin® group) the results were statistically better (p<0,05) if all questionnaires and WBC count in the prostate secretion were evaluated after 90 days from the therapy start as compared to the control group. Conclusions. The results of investigation showed that Adenoprosin® preparation is effective and safe as a part of combination therapy of CP/CPTB and leads to significant improvement of urination and pain syndrome relief according to NIH-CPSI, IPSS questionnaires and decrease of WBC count in prostate secretion.