OBJECTIVES: To compare the efficacy of sildenafil (Viagra) only, sildenafil plus topical anesthetic cream (EMLA), and topical EMLA-cream-only to that of placebo in treating premature ejaculation. METHODS: A total of 84 patients were enrolled in this study. The duration of premature ejaculation in the patients ranged from 9 to 60 months (mean 32.5 +/- 14.6). Patients were randomized into four groups. Group 1 consisted of 20 patients who took placebo for 2 months. Groups 2 and 3 consisted of 20 and 22 patients, respectively, and they received 50 mg sildenafil 45 minutes before coitus for 2 months. In addition, patients in group 3 applied topical EMLA cream to the glans penis 15 minutes before coitus. The 22 patients in group 4 used topical EMLA-cream-only. After at least eight sexual attempts, the patients' clinical responses were assessed using the patient self-description method. Effectiveness was described as improvement plus cure. RESULTS: The effectiveness was 40% in group 1, 55% in group 2, 86.4% in group 3, and 77.3% in group 4. Of the groups, a significant difference was found in the effectiveness of the treatments (Pearson chi-square= 0.00). No significant difference was found between groups 1 and 2 (P = 0.26). Efficacy was more successful in groups 3 and 4 than in the others (P = 0.00). The difference between groups 3 and 4 was not significant (Pearson chi-square = 0.42). CONCLUSIONS:Sildenafil-only was not superior to placebo or combination treatment. Topical EMLA-cream-only had equal effectiveness to that of sildenafil plus topical EMLA treatment. The use of topical EMLA-cream-only seems to be an effective treatment of premature ejaculation.
RCT Entities:
OBJECTIVES: To compare the efficacy of sildenafil (Viagra) only, sildenafil plus topical anesthetic cream (EMLA), and topical EMLA-cream-only to that of placebo in treating premature ejaculation. METHODS: A total of 84 patients were enrolled in this study. The duration of premature ejaculation in the patients ranged from 9 to 60 months (mean 32.5 +/- 14.6). Patients were randomized into four groups. Group 1 consisted of 20 patients who took placebo for 2 months. Groups 2 and 3 consisted of 20 and 22 patients, respectively, and they received 50 mg sildenafil 45 minutes before coitus for 2 months. In addition, patients in group 3 applied topical EMLA cream to the glans penis 15 minutes before coitus. The 22 patients in group 4 used topical EMLA-cream-only. After at least eight sexual attempts, the patients' clinical responses were assessed using the patient self-description method. Effectiveness was described as improvement plus cure. RESULTS: The effectiveness was 40% in group 1, 55% in group 2, 86.4% in group 3, and 77.3% in group 4. Of the groups, a significant difference was found in the effectiveness of the treatments (Pearson chi-square= 0.00). No significant difference was found between groups 1 and 2 (P = 0.26). Efficacy was more successful in groups 3 and 4 than in the others (P = 0.00). The difference between groups 3 and 4 was not significant (Pearson chi-square = 0.42). CONCLUSIONS:Sildenafil-only was not superior to placebo or combination treatment. Topical EMLA-cream-only had equal effectiveness to that of sildenafil plus topical EMLA treatment. The use of topical EMLA-cream-only seems to be an effective treatment of premature ejaculation.
Authors: Tarek A Gameel; Ahmad M Tawfik; Mohamed O Abou-Farha; Mohamed G Bastawisy; Mohamed A El-Bendary; Abd El-Naser El-Gamasy Journal: Arab J Urol Date: 2013-06-29