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INTRODUCTION: The phosphodiesterase inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH. This study was conducted to evaluate the role of Tadalafil (a PDE-5 inhibitor) in combination with standard therapy for the treatment of BPH. MATERIALS AND METHODS: In this randomized clinical trial of 165 patients with obstructive and irritative urinary tract symptoms due to BPH, IPSS ≥8, IIEF ≥11, Q-max from 5 mL/s to 15 mL/s and residual urine volume (RUV) <120 mL, there was indication for surgical intervention. These patients were randomly allocated in three groups. Each patient received a therapeutic treatment daily for 12 weeks. Group A received treatment with tamsulosin 0.4 mg and tadalafil 5 mg, Group B received a standard treatment with tamsulosin 0.4 mg for BPH and Group C received only one treatment with tadalafil 5 mg. RESULTS: There was no significant difference in terms of IPSS score, Qmax and RUV before treatment in the three groups tested. Analysis of the data shows that in patients treated with tamsulosin and tadalafil IPSS, IIEF and QoL were significantly improved in a different way than in the other two groups, while the Qmax and RUV did not show a significant change in the three groups, remaining almost constant. CONCLUSIONS: The PDE-5 inhibitor improves quality of life and urinary symptoms in patients with LUTS suggestive of BPH, but doesn't have any significant effect on Qmax and RUV. [ABSTRACT FROM AUTHOR]