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

Introduction: 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).

Aim: To test the hypothesis that combined dapoxetine and SBTx provide better result than dapoxetine alone in the management of patient with lifelong PE.

Methods: 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.

Main outcome measures: The intravaginal ejaculatory latency time (IELT), the premature ejaculation diagnostic tool (PEDT) score, and the treatment-emergent adverse events (TEAEs) were analyzed.

Results: 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.

Conclusions: 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.