[Efficiency and safety of Prostatex in patients with chronic prostatitis/chronic pelvic pain syndrome. Results of the phase IV PRESTIGE trial].

INTRODUCTION

A large number of both preclinical and clinical studies demonstrates the efficiency of bioregulatory peptides for the treatment of prostatitis and chronic pelvic pain syndrome (CPPS). A relatively new drug in this group is Prostatex, the active ingredient of which is bovine prostate extract.

AIM

To evaluate the effect of taking Prostatex on the intensity of CPPS, the sexual function, and the results of microscopy of expressed prostate secretions and urinalysis.

MATERIALS AND METHODS

A cohort of patients aged 25-65 years with chronic abacterial prostatitis and complaints of chronic pelvic pain was analyzed. The abacterial type of prostatitis was confirmed by bacteriological examination of expressed prostate secretions. The patients received Prostatex for 30 days according to the following scheme: 1 suppository rectally 1 time per day. The follow-up was 30 days. Before starting the drug and at the end of the 30-day course, patients completed the Chronic Prostatitis Symptom Index (NIH-CPSI) and the sexual function questionnaire. In addition, urinalysis and microscopic study of expressed prostate secretions was performed.

RESULTS

A total of 1700 patients were included in the study. While taking the drug, there was a significant decrease in pain during digital rectal examination, as well as in the intensity of pain as a symptom of CPPS. The severity of symptoms after treatment was lower in all domains of NIH-CPSI. Microscopic study of the expressed prostate secretions during treatment showed a decrease in the number of patients with excessive number of leukocytes. The sexual function improved, while urinalysis and microscopy of expressed prostate secretions returned to the reference values.

CONCLUSION

The use of Prostatex for the treatment of patients with CPPS reduces the severity of pain and other symptoms of chronic prostatitis, increases sexual function and normalizes the expressed prostate secretions and urinalysis. In order to obtain data of a higher level of evidence, it is necessary to carry out randomized, blind, placebo-controlled studies.