[Clinical study of TZP-4238 on patients with benign prostatic hypertrophy--with special reference to urodynamics]

Twenty four cases of benign hypertrophy with bladder outlet obstruction were treated with 17 alpha-acetoxy-6-chloro-2-oxa-4,6-pregnadiene-3,20-dione (TZP-4238), and the effects on urodynamic parameters, clinical efficacy, safety, and usefulness were evaluated. Improvement rate of subjective rate of subjective symptoms was 52.9%. Obstructive symptoms improved more prominently than irritation symptoms. A significant improvement in flow rate of nomograms for maximum flow rate (MFR) and average flow rate (AFR) accompanied with the decrease in the prostatic weight were observed. However, no changes were observed on the urethral sphincter electromyography and the urethral pressure profile. A significant decrease of maximum cystometric capacity was observed, although the effective cystometric capacity was not changed. The overall improvement rate for urodynamic parameters was 43.7%. A significant decrease in weight and diameter of the prostate was observed. The prostatic weight decreased in 57.1%, and the average reduction rate was 15.4%. The overall improvement rate concerning clinical efficacy evaluating both subjective symptoms and objective parameters was 58.8%. Adverse reactions were observed in 5 cases. They were judged as not clinically problematic. Taking into account clinical safety and clinical efficacy, the clinical usefulness was 50.0%. TZP-4238 was considered to be an appropriate agent for treating patients with benign prostatic hypertrophy with bladder outlet obstruction.