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 ago nists for small, selected groups of patients with benign prostatic hyp erplasia but their clinical role in this indication is still not well defined. We investigated the effect of the luteinizing hormone-releasi ng 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 object ive parameters for outcome assessment. Prostate volume decreased by 34 .5% (2.6% in the placebo group). Maximum flow rate at spontaneous mict urition and after instillation of saline improved by 2.0 ml. per secon d (32%) and 3.0 ml. per second (54%) more than with placebo. Detrusor pressure during micturition decreased by approximately 24% for patient s who received leuprolide compared to placebo and was accompanied by a 25% increase in flow rate, which indicted decreased bladder outlet re sistance. Improvement in urodynamic parameters generally was of statis tical significance. Symptom scores improved significantly for both gro ups throughout the study when compared to those before treatment. At b etween group comparison, the improvement for irritative symptoms in fa vor of leuprolide reached statistical significance at week 48. With fe w exceptions, leuprolide patients tolerated the treatment well even if they had side effects, such as flushing and decreased sexual function .