Introduction: In this study, we aimed to evaluate the effectiveness of prophylactic dexamethasone added to tamsulosin (Flomax®) in reducing urinary symptoms after I 125 prostate brachytherapy (PI) for prostate adenocarcinoma. Materials and Methods: A single institution, randomized, double blind, placebo controlled trial of patients undergoing PI for prostate adenocarcinoma comparing the use of prophylactic dexamethasone plus tamsulosin before PI versus placebo plus tamsulosin was conducted. Patients undergoing permanent PI, who were not taking tamsulosin or other alpha-blockers prior to PI were eligible for the trial. All patients were given tamsulosin (0.8 mg, orally once a day) and were randomized to receive either placebo or dexamethasone (4 mg per day for the first 10 days after PI and then 2 mg per day for 4 additional days). Tamsulosin use was started four days prior to PI and continued for 60 days. Urinary symptoms were assessed with the American Urologic Association (AUA) symptom index score. The questionnaire was administered prior to PI and then on a weekly basis for the first eight weeks after PI and again at weeks 10 and 12 after PI. The primary endpoint of the trial was change in the AUA score from baseline. Patients were taken off of the study if they developed urinary retention, had intolerable urinary symptoms, or wished to discontinue with the trial. Results: One-hundred patients were enrolled in the study. Ninety-four patients started the study and 72 completed all 12 weeks. Patients were evenly matched according to pre-treatment and post-treatment characteristics except with regard to pre-treatment AUA score: the dexamethasone group had a median score of 3 while the placebo group had a median score of 5 (p=0.0023). When comparisons were made between the groups relative to percent change in overall AUA score from baseline, there was a significant difference in favor of the placebo group (p=0.0030). Conclusion: The combination of prophylactic dexamethasone and tamsulosin yields worse post-operative
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