The Combination of Dapoxetine and Behavioral Treatment Provides Better Results than Dapoxetine Alone in the Management of Patients with Lifelong Premature Ejaculation
Luigi Cormio MD; Paolo Massenio MD; Roberto La Rocca MD; Paolo Verze MD, PhD;
Vincenzo Mirone MD; and Giuseppe Carrieri MD
ONLINE: June 16, 2015 – The Journal of Sexual Medicine
The International Society for Sexual Medicine (ISSM) classifies premature ejaculation (PE) in two ways. Lifelong PE refers to ejaculation that always or nearly always occurs within approximately one minute of vaginal penetration. Acquired PE refers to a “clinically significant and bothersome reduction in latency time,” usually three minutes or less.
Most of the time, if not all, men in both categories are unable to delay ejaculation. They also suffer negative personal consequences, including distress, frustration, and avoidance of sex.
Premature ejaculation (PE) is estimated to affect up to 30% of all men. The most commonly prescribed treatments include medications, topical anesthetics, and behavioral sex therapy. Dapoxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI) is the only approved on-demand drug for PE today. (While dapoxetine is available in many parts of the world, it has not been approved for use in the United States.)
Combining medication with sex therapy has not been widely studied, although past research has shown that combining approaches was more effective than medication alone. To date, no study has investigated the potential benefits of adding sex therapy to treatment with dapoxetine.
In this study, the researchers hypothesized that combining dapoxetine with behavioral therapy would yield better results for men with PE than dapoxetine alone.
Patients and Methods
Fifty men met the eligibility requirements for the study. They were between the ages of 18 and 70 years and had lifelong PE as defined by the ISSM. They had also been in stable, heterosexual relationships for at least six months, had intercourse at least four times each month, and had not been treated for PE before (nor were they being treated at the time of the study).
None of them used medications that could interfere with dapoxetine.
At the start of the study, the men completed two assessments: the International Index of Erectile Function (IIEF) and the Premature Ejaculation Diagnostic Tool (PEDT). For a four-week baseline period, the men were encouraged to have intercourse at least four times and use a stopwatch to measure ejaculatory latency time (IELT).
After the baseline period, the participants were divided into two groups for the next 24 weeks.
• Group A (25 men – mean age 34.16 ± 11.43) took 30 mg of on-demand dapoxetine. The medication was taken 2-3 hours before sex.
• Group B (25 men – mean age 34.44 ± 13.22) took 30 mg of on-demand dapoxetine and received face-to-face behavioral sex therapy, which included instruction on the stop/start method, the squeeze method, and recognizing the “point of no return.”
Throughout the study, couples recorded the IELT for each intercourse and any treatment-emergent adverse events (TEAEs). Follow-up appointments occurred at the 4-, 12-, and 24-week marks.
Dropout rates were 16.6% for Group A and 13.79% for Group B.
After 24 weeks, PEDT scores decreased for both Group A and Group B, suggesting improvements. However, Group B had a greater reduction than Group A. In fact, 80% of the men in Group B scored ≤ 8 points on the PEDT, which indicates no premature ejaculation. None of the men in Group A achieved this benchmark.
Both groups also developed greater IELT measurements over the 24 weeks. Group A’s mean IELT stood at 160.0 at 24 weeks up from a baseline of 85.0), but Group B’s mean registered 370.7 (vs. a baseline of 92.0). Group B’s increased performance vs Group A was already evident at the 4-week follow-up.
Nausea and headaches were the most commonly reported TEAEs, but there were no significant differences between groups. TEAEs usually resolved within 24 hours.
The results of this study are in line with previous research. However, behavioral therapy is not always considered an effective treatment for lifelong PE. Medication and therapy appeared to complement each other in this study.
The authors explained, “Based on our findings, we can confidently assume that providing dapoxetine can act positively on the dominant organic/neurobiological etiology of lifelong PE, and sex behavioral treatment can impact the physical and psychological control of sexual performance, thus providing better results than dapoxetine alone.”
However, the authors noted that the study was not set up to determine whether patients can be weaned off of dapoxetine once their PE has resolved. At the 24-week point, some men in Group B said they did not need to use medication anymore. Further research might explore whether dapoxetine can be weaned or stopped if behavioral treatment continues.
The authors acknowledged some limitations. First, the study was small and not blinded. Second, there was no group receiving behavioral therapy without dapoxetine. This could have provided further insights. Third, the follow-up was relatively short. This is particularly relevant since prior studies on behavioral therapy have demonstrated reduced benefits over time. Finally, there was no group crossover, so the exact role of each treatment component was unclear.
Overall, the authors concluded, “Restoration of normal ejaculatory function in those patients treated with combined therapy alone confirms the synergistic effects of the two treatments in patients with lifelong PE leading to better overall control over ejaculation.”