A prospective, placebo-controlled study of the luteinizing hormone-releasing hormone agonist leuprolide as treatment for patients with benign prostatic hyperplasia.

Several physicians have used luteinizing hormone-releasing hormone agonists for small, selected groups of patients with benign prostatic hyperplasia but their clinical role in this indication is still not well defined. We investigated the effect of the luteinizing hormone-releasing hormone agonist leuprolide given as an injection every 28 days for 24 weeks in a double-blind, placebo-controlled trial with 50 evaluable patients along an extensive protocol with the main emphasis on objective parameters for outcome assessment. Prostate volume decreased by 34.5% (2.6% in the placebo group). Maximum flow rate at spontaneous micturition and after instillation of saline improved by 2.0 ml. per second (32%) and 3.0 ml. per second (54%) more than with placebo. Detrusor pressure during micturition decreased by approximately 24% for patients who received leuprolide compared to placebo and was accompanied by a 25% increase in flow rate, which indicated decreased bladder outlet resistance. Improvement in urodynamic parameters generally was of statistical significance. Symptom scores improved significantly for both groups throughout the study when compared to those before treatment. At between group comparison, the improvement for irritative symptoms in favor of leuprolide reached statistical significance at week 48. With few exceptions, leuprolide patients tolerated the treatment well even if they had side effects, such as flushing and decreased sexual function.