The study was made of dalphas-retard safety and effectiveness in 940 patients with benign prostatic hyperplasia and relevant urination problems. The drug was given in a dose 5-10 mg/day for 12 weeks. The results were assessed in 881 patients who had completed the treatment course. 18 patients (1.9%) discontinued the treatment because of side effects. 38 patients (4%) had side effects once or more times.