FLAVOXATE TREATMENT OF MICTURITION DISORDERS ACCOMPANYING BENIGN PROSTATIC HYPERTROPHY - A DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER INVESTIGATION

To investigate the effect of flavoxate (Urispadol(R)) treatment on pat ients with symptomatic benign prostatic hypertrophy (BPH), with the ma in weight on the irritative symptoms, a randomized, double-blind, para llel-group, placebo-controlled and multicenter investigation was carri ed out. Seventy patients entered the study, 37 were allocated to flavo xate treatment on a daily dose of 1,200 mg (400 mg t.i.d.) for 12 week s, and 33 patients were allocated to placebo treatment. In spite of a sufficient power, the study did not discriminate the two treatment gro ups in a statistically significant way (p > 0.05), when considering th e main endpoints: the irritative symptom score and the global patient evaluation. Conservative treatment of micturition disorders accompanyi ng BPH with flavoxate in doses of 1,200 mg/day cannot be recommended f or clinical use.