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A Randomized, Placebo-controlled, Double-blind Study Of The Use Of Dutasteride For Improving Peri-operative Outcomes Of Photoselective Vaporization Of The Prostate (DOP Trial)
Jennifer L Bepple*, Bethany B Barone*, Gregg R Eure Eastern Virginia Medical School, Norfolk, VA
Introduction: Benign Prostatic Hyperplasia is a common condition in aging men. Treatment options vary from medical therapy to surgery. 5-alpha reductase inhibitors can decrease prostate size and decrease bleeding during transurethral resection of the prostate. Specifically, dutasteride offers the most complete blockade in this class with no increase in side-effects. GreenLight Photoselective Vaporization of the Prostate (PVP) is an out-patient procedure. This is a pilot study to obtain preliminary data on the effects of dutasteride on surgical outcomes for patients undergoing PVP. Methods: This is a prospective, placebo-controlled, randomized, double-blind study. 47 patients were randomized to two arms, dutasteride 0.5 mg or placebo for 3 months prior to PVP. Clinical end points analyzed included surgical time, Joules used, estimated blood loss, and ease of the procedure. Results: Twenty-four patients received dutasteride prior to PVP and 23 received a placebo prior to PVP. Average surgical time, Joules used, and blood loss were 7%, 7%, and 21% less respectively for patients who had received dutasteride compared with placebo. However, these results were not statistically significant. Ease of the procedure, as rated by the surgeon, was comparable between the two groups Conclusions: Compared to patients randomized to placebo, patients randomized to dutasteride experienced decreased time, joules, and blood loss during surgery. While not statistically significant, our results suggest a benefit of treatment with dutasteride prior to surgery. A larger trial is recommended to confirm this. A future study will include longer follow-up as well as quality of life data.
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