Safety and efficacy of tamsulosin in the treatment of painful ejaculation: a randomized, double-blind, placebo-controlled study.

We evaluate the efficacy and safety of tamsulosin a selective alpha(1A)-receptor antagonist in patients with painful ejaculation (PE) as a sole entity. A total of 118 men with PE were included in the study. Patients were randomly assigned to receive 0.4 mg oral daily tamsulosin (group 1, n=59) or placebo (group 2, n=59), during a 6-week period for each agent. Pretreatment evaluation included history and physical examination, International Index of Erectile Function (IIEF) and a visual analog scale (VAS) for pain. The efficacy of two treatments was assessed every 2 weeks during treatment, and at the end of the study using responses to IIEF, VAS evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. In all, 104 patients (88%) completed the whole treatment schedule. Pain resolved in 16 and 13% of the patients treated with tamsulosin and placebo, respectively (P=0.1). Baseline mean intercourse satisfaction domain values of IIEF 10 and 11 reached to 12 and 10 at 6-week treatment in groups 1 and 2, respectively (P=0.08). The VAS after tamsulosin and placebo decreased from 5.7 and 5.8 to 5.1 and 5.5, respectively (P=0.1). The mean weekly intercourse episodes increased from pretreatment values of 1.8 and 1.6 to 1.9 and 1.7, for tamsulosin and placebo, respectively (P=0.08). Mean number of adverse events was 11 for tamsulosin and 5 for placebo (P<0.05). Tamsulosin is no better than placebo in improvement of PE as a sole entity.