The Combination of Dapoxetine and Behavioral Treatment Provides Better Results than Dapoxetine Alone in the Management of Patients with Lifelong Premature Ejaculation.

Abstract

It is not known whether the efficacy of dapoxetine, the only drug approved for the on-demand treatment of premature ejaculation (PE), can be increased by the addition of sexual behavioral treatment (SBTx). To test the hypothesis that combined dapoxetine and SBTx provide better result than dapoxetine alone in the management of patient with lifelong PE. After a 4-week run-in period, 50 patients with lifelong PE entered a 24-week, open-label, prospective study with a 1:1 assignment. Twenty-five patients (group A) received on-demand dapoxetine 30 mg alone, and the remaining 25 patients (group B) combined on-demand dapoxetine 30 mg and SBTx. The CONSORT 2010 statement was adhered to where possible. The intravaginal ejaculatory latency time (IELT), the premature ejaculation diagnostic tool (PEDT) score, and the treatment-emergent adverse events (TEAEs) were analyzed. Mean age was 34.16 years in group A and 34.44y in group B. From baseline to 4-, 12- and 24-week evaluation, both groups experienced a significant (P < 0.0001) increase in mean IELT and decrease in mean PEDT score, but patients in group A showed a significantly lower increase in mean IELT (85.0; 84.8; 130.7; 160.0 vs. 92.0; 137.9; 232.7; 370.7 seconds, respectively; P < 0.0001) and a significantly lower decrease in mean PEDT score (20.4; 18.16; 15.88; 14.68 vs. 19.56; 16.0; 11.96; 7.92, respectively; P < 0.0001) than those in group B. At 24-week evaluation, no patient in group A reached a PEDT score ≤8 (absence of PE) as opposed to 80% of patients in group B. There was no difference between groups in TEAEs rate (16% vs. 16%; P = 1.00). Limitations included the absence of a group receiving SBTx alone or group crossover. Combined dapoxetine and SBTx proved to be more effective than dapoxetine alone in treating patients with lifelong PE, up to restoring a normal ejaculatory function in most of them.