Tamsulosin 0.4 mg once daily: Effect on sexual function in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction

Objective: To evaluate the effect of tamsulosin, 0.4 mg once daily, on sexu al function in comparison with placebo and alfuzosin, 2.5 mg three times da ily, in patients with lower urinary tract symptoms (LUTS) suggestive of ben ign prostatic obstruction (BPO). Methods: Data from 830 patients randomized into three European multicenter studies with similar protocols were analyz ed. In two studies, patients were randomized to receive either tamsulosin, 0.4 mg once daily, or placebo, and in the third, patients were randomized t o receive either a fixed dose of tamsulosin, 0.4 mg once daily, or alfuzosi n, titrated to 2.5 mg three times daily. The studies employed a 2-week plac ebo run-in period, followed by a 12-week study period. Sexual function was assessed by related adverse events and by a sexual function score determine d from a life-style questionnaire. Results: Abnormal ejaculation occurred s ignificantly more frequently in patients treated with tamsulosin than in th ose receiving placebo (p = 0.045); however, the incidence of abnormal ejacu lation was similar in patients receiving tamsulosin or alfuzosin in the com parative study. Abnormal ejaculation was not perceived as a major problem b y the patients since it resulted in few treatment discontinuations (n = 3). It was also reversible on drug withdrawal. There was no difference between tamsulosin and placebo or alfuzosin with regard to the occurrence of decre ased libido or impotence. In addition, there was no significant difference in the change in sexual function score between patients treated with tamsul osin and those treated with alfuzosin. Compared with patients receiving pla cebo, there was, however, a significant improvement in total sexual functio n score in patients receiving tamsulosin (p = 0.042). Conclusions: Tamsulos in, 0.4 mg once daily, is well tolerated and has no overall negative impact on sexual function compared with placebo or alfuzosin. Compared with place bo, tamsulosin may even improve sexual function.