Background: Recently, sildenafil has been demonstrated to be effective in treating premature ejaculation (PE). However, these studies ignored female factors and could not exclude the probability of drug interaction when combined with paroxetine. Therefore, the aim of this study was to evaluate the efficacy and safety of sildenafil alone in the treatment of primary PE, taking female factors into consideration.

Methods: One hundred and eighty potent men with primary PE were randomly divided into three groups and followed up for 6 months. Group A were treated with 50 mg sildenafil as needed, group B with 20 mg paroxetine daily and group C with squeeze technique daily. Intravaginal ejaculatory latency time (IELT), PE grade, intercourse satisfactory score (ISS), frequency of intercourse, and adverse effects of drugs were recorded before treatment, and 3 and 6 months after treatment.

Results: Compared with pretreatment, the three groups had significant differences in all the parameters after 3 or 6 months treatment, except the frequency of intercourse in Group C (all P = 0.00). However, there were no significant differences between 3 and 6 months. Compared with paroxetine and squeeze technique, after 3 or 6 months, sildenafil had significant differences in all the parameters (all P = 0.00). After 6 months, 1.7%, 18.3% and 36.7% patients in groups A, B and C, respectively, withdrew from the study and 86.7%, 60.0% and 45.0% patients, respectively, wanted to be treated further with the original administration, and this was statistically significant (both P = 0.00).

Conclusion: Sildenafil is very effective and safe to treat PE, and has much higher efficacy than paroxetine and squeeze technique.