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Tadalafil Improves Urinary Obstruction Symptoms of Benign Prostatic Hypertrophy: Presented at AUA By Em Brown CHICAGO -- April 30, 2009 -- The erectile dysfunction drug tadalafil has been found to improve urinary flow and other symptoms of urinary-tract obstruction in men with benign prostatic hypertrophy-lower urinary tract symptoms (BPH-LUTS), researchers reported here at the 2009 American Urological Association (AUA) Annual Meeting. Results of a phase 3 study of 200 men aged 40 years and older with BPH-LUTS were presented here on April 29 by lead investigator Claus Roehrborn, MD, University of Texas, Southwestern Medical Center, Dallas, Texas. All of the subjects in this study had had BPH-LUTS for at least 6 months, as well as an International Prostate Symptom Score (IPSS) of 13 or greater before they were randomised to tadalafil 20 mg daily (n = 99) or placebo for 12 weeks (n = 101). Subjects were divided into 3 groups according to their baseline Bladder Outflow Obstruction Index (BOOI) measurement -- mild (13-20), moderate (20-40) or severe (>40) -- and according to LUTS severity -- moderate (LUTS score <20) or severe (LUTS score >=20). Multiple pressure-flow and free-flow urodynamic measures were taken, and IPSS was assessed at follow-up. Most patients (86%) completed 12 weeks of treatment. "The proportion of obstructed patients in the placebo group increased [after 12 weeks], while the proportion in the tadalafil group decreased," Dr. Roehrborn commented. Total IPSS after 12 weeks of tadalafil treatment dropped 4.22 (P < .001), BOOI dropped 2.83 points (P < .001) and symptoms of bladder irritation dropped 1.39 points (P = .006) compared with placebo. "Relative symptom improvement in IPSS was significantly better for tadalafil than placebo," he added. While Dr. Roehrborn acknowledged that the results were not strongly significant, he did note that "the results of this study indicate that tadalafil 20 mg once daily may have an impact on obstruction." Tadalafil is currently approved only for the treatment of erectile dysfunction. [Presentation title: Changes in Bladder Outlet Obstruction Index in Men With Signs and Symptoms of Benign Prostatic Hyperplasia Treated With Tadalafil. Abstract 1924] E-mail this page to a friend or colleague! To print, use this version