Effects of Leuprolide as an adjunctive treatment of benign Prostatic Hyperplasia, a randomized-controlled clinical trial

Objective: To observe the effects of adding luteinizing hormone-releasing hormone (LHRH) agonist (leuprolide acetate) to the standard treatment (5-alpha reductase plus alpha-1-adrenergic inhibitor) of benign prostate hyperplasia. We assessed improvement in international prostate symptom score (IPSS), patients' satisfaction of voiding, and catheter removal. Method: 77 patients diagnosed with BPH who presented with the first episode of urinary retention were randomly divided into two different groups; intervention group (Leuprorelin acetate + tamsulosin and finasteride) and control group (Placebo injection + tamsulosin and finasteride) as a routine treatment. T-test was used to compare the mean differences in IPSS before and after 12 weeks of the treatment.  Results: The mean ± SD IPSS reduction in the intervention group was 2.47 ± 1.5 while in the control group was 1.51 ± 1.5. Results indicated a statistically significant mean difference in IPSS reduction of the intervention group compared to the control group, t (75) =2.8, p = 0.007. The odds of patient satisfaction of voiding and the catheter removal after one month of treatment were 1.2 in the intervention group compared with the control group; however, their association was not statistically significant (OR 1.2, 95%CI 0.3-4.3, P=0.78). Conclusion: The study showed statistically a significant decrease of IPSS in the intervention group, but did not show any significant differences in the catheter removal and patient’s satisfaction of voiding after 12 weeks of treatment.