Flavoxate treatment of micturition disorders accompanying benign prostatic hypertrophy: A double-blind placebo-controlled multicenter investigation

Abstract

To investigate the effect of flavoxate (Urispadol®) treatment on patients with symptomatic benign prostatic hypertrophy (BPH), with the main weight on the irritative symptoms, a randomized, double-blind, parallel-group, placebo-controlled and multicenter investigation was carried out. Seventy patients entered the study, 37 were allocated to flavoxate treatment on a daily dose of 1, 200 mg (400 mg t.i.d.) for 12 weeks, and 33 patients were allocated to placebo treatment. In spite of a sufficient power, the study did not discriminate the two treatment groups in a statistically significant way (p < 0.05), when considering the main endpoints: the irritative symptom score and the global patient evaluation. Conservative treatment of micturition disorders accompanying BPH with flavoxate in doses of 1, 200 mg/day cannot be recommended for clinical use. © 1995 S. Karger AG, Basel.