[Results of three-year clinical study of prostamol uno efficacy and safety in patients with initial symptoms of prostatic adenoma and risk of its progression]

Abstract

Prostamol Uno (PU) efficacy and safety were studied in a multicenter, open-population, randomized and comparative trial. PU was given in a single daily dose 320 mg for 36 months to 50 patients with initial symptoms of prostatic adenoma (PA) in comparison with 50 matched controls. The trial evaluated PU action on the symptoms progression and quality of life with application of questionnaires IPSS and QoL (BS). It was found that PU treatment relieved PA symptoms by IPSS, while these symptoms progressed in the controls. QoL improved in the study group and deteriorated in the control one. Administration of PU significantly increased urinary flow rate though in the controls urinary flow rate decreased, size of the prostate diminished and increased, respectively. Changes in the PSA were not seen and were insignificant, respectively. The results of the study say that prostamol Uno in a dose 320 mg/day can prevent PA progression without side effects.