The trial enrolled 155 patients (mean age 65 years) with documented benign prostatic hyperplasia and lower urinary tracts symptoms (LUTS) (IPSS > 6). All the patients received permixon in a dose 160 mg twice a day for 2 years. The data on 130 patients eligible for assessment were processed statistically by dynamics of IPSS, quality of life (QOL), index of sexual function (MSF-4), size of the prostate, urodynamic and biological parameters which were estimated in 6 (V6), 12 (V12), 18 (V18) and 24 months (V24). Clinical examination with registration of all side effects was made each 3 months. Permixon was found to noticeably reduce IPSS and QOL and increase maximal urine flow speed. The size of the prostate diminished insignificantly. Sexual function remained unchanged for 1 year and improved markedly within the second year (p = 0.001). Permixon had no effect on the level of prostate-specific antigen. Plasma hormones (testosterone, DHT, estradiol, LH, androstendion) did not change. Nine patients developed 10 side effects but they were unrelated to the treatment.
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