On-demand use of tramadol, sildenafil, paroxetine and local anaesthetics for the management of premature ejaculation: A randomised placebo-controlled clinical trial

OBJECTIVES To compare the clinical efficacy of the on-demand use of four drugs in the management of patients with premature ejaculation (PE), as the off-label use of selective serotonin-reuptake inhibitors and topical penile anaesthetics is frequently indicated for the management of patients with PE, and tramadol HCl and sildenafil citrate were also tried for managing this disorder, but with recommendations based on weak evidence. PATIENTS AND METHODS This was a single-centre, single-blind, placebo-controlled clinical trial conducted on 150 patients who had PE for >1 year. Patients were randomised equally into five groups. On-demand tramadol, sildenafil, paroxetine, local lidocaine gel or placebo was given for patients in groups 1-5, respectively. During the month before treatment, the intravaginal ejaculation latency time (IELT) and sexual satisfaction scores (on a 0-5-point scale) were measured and compared to the mean IELT and sexual satisfaction scores recorded during 4 weeks of on-demand drug administration, with monitoring of any possible side-effects. RESULTS Tramadol-treated patients had a significantly longer mean (SD) IELT, of 351 (119) s, than the other groups. Local anaesthetic was significantly better than paroxetine in prolonging the IELT, at 278 (111) vs. 186 (65) s, respectively. The improvement in sexual satisfaction was significantly better in the sildenafil group, with a mean (SD) improvement of 2.9 (1) points, than in the paroxetine and local anaesthetic groups, at 2.2 (0.9) and 1.9 (0.9) points, respectively. CONCLUSIONS The four drugs significantly improved IELT values over placebo. Tramadol was associated with significantly longer IELT values, whilst sildenafil induced significantly better sexual satisfaction than the other drugs. The four drugs had tolerable side-effects.