Is Transurethral Resection of Prostate Made Safer by Preoperative Dutasteride Therapy? A Randomized Controlled Trial

Introduction: Bleeding and hyponatremia are important complications of transurethral resection of the prostate (TURP). 5-alpha reductase inhibitors (5-ARI) are reported to reduce angiogenesis and bleeding in benign prostatic hyperplasia (BPH). We therefore performed a double blinded randomized clinical trial to assess the role of preoperative Dutasteride therapy before TURP. Material and Methods: All patients undergoing TURP in JIPMER Urology Dept. during September 2006 - December 2010 were randomized into two groups – one receiving Dutasteride 0.5mg daily for 2 weeks and the other a placebo. The surgeons and the patients were blinded to the nature of preoperative therapy. Blood hemoglobin, hematocrit and serum sodium levels were estimated a day before and after surgery. The post-operative changes in hemoglobin, hematocrit and sodium concentrations were assessed in both groups. Blood transfusion requirements, ease of surgery and operating times were also assessed. Results: 104 patients were randomly distributed to receive either Dutasteride (n=52) or placebo (n=52). There was no significant difference between hemoglobin difference (P value0.41), hematocrit difference (P value- 0.98), sodium levels (P value- 0.48), amount of resected tissue (P value- 0.67), operating times (P value- 0.24), surgeon’s ease score (P value- 0.33) and blood transfusion requirements between the two groups. There were no side-effects attributable to Dutasteride. Conclusion: There were no significant reductions in blood loss or hyponatremia during TURP with Dutasteride compared with placebo. Though the preoperative use of Dutasteride seems logical and rational, this study shows that there is no real benefit from the use of a short course Dutasteride before performing TURP.