Introduction Dapoxetine is a short-acting selective serotonin reuptake inhibitor that was recently approved for the on-demand treatment of premature ejaculation (PE). Aim To evaluate the efficacy and safety of dapoxetine 30 mg and 60 mg on demand (prn) in men with PE from the Asia-Pacific region. Methods This randomized, double-blind, parallel-group, placebo-controlled trial enrolled men who were 18 years or older; in a monogamous, heterosexual relationship for at least 6 months; met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision, criteria for PE for at least 6 months; and had an intravaginal ejaculatory latency time (IELT) of 2 minutes or less in at least 75% of sexual intercourse episodes. Subjects received placebo, dapoxetine 30 mg, or dapoxetine 60 mg prn (1–3 hours before intercourse) for 12 weeks. Main Outcome Measures Stopwatch-measured Average IELT, the Premature Ejaculation Profile (PEP), Clinical Global Impression (CGI) of change in PE, treatment-emergent adverse events (TEAEs). Results Of the 1,067 subjects randomized, 858 completed the study. Mean Average IELT increased from approximately 1.1 minutes at baseline (across groups) to 2.4, 3.9, and 4.2 minutes with placebo, dapoxetine 30 mg, and dapoxetine 60 mg, respectively, and geometric mean Average IELT increased from approximately 0.9 minutes at baseline (across groups) to 1.8, 2.7, and 3.1 minutes, respectively (fold-increases of 2.0, 2.8, and 3.3, respectively). All PEP measures and the CGI of change were significantly improved with dapoxetine vs. placebo at study endpoint (P ≤ 0.005 for all). The most common TEAEs with dapoxetine included nausea, dizziness, somnolence, headache, vomiting, diarrhea, and nasopharyngitis; TEAEs led to discontinuation in 0.3%, 1.7%, and 5.1% of subjects with placebo, dapoxetine 30 mg, and dapoxetine 60 mg, respectively. Conclusions Dapoxetine treatment significantly prolonged IELT and improved PEP measures and was generally well tolerated in men with PE in the Asia-Pacific region.

Introduction The prevalence of erectile dysfunction (ED) and associated risk factors has been described in many countries, but there are still only a few studies from Asia. Aim We investigated the prevalences of ED and premature ejaculation (PE) in Korean men and the impact of general health, lifestyle, and psychosocial factors on these conditions. Methods To assess ED and PE, 1,570 Korean men aged 40–79 years were interviewed with a self-administered questionnaire on sexual function and the International Index of Erectile Function (IIEF)-5. In addition, blood chemistry was analyzed for each subject. Main Outcome Measures The prevalences of ED and PE were obtained from self-reported ED, IIEF-5 scoring, EF (erectile function) domain scoring, and self-reported intravaginal ejaculatory latency time (IELT). The data were analyzed for the presence of risk factors and the relationship of general health, lifestyle, and psychosocial factors with ED. Results The prevalences of ED among Korean men were 13.4% (self-reported ED) and 32.4% (IIEF-5 score ≤ 17), and PE prevalences were 11% (IELT ≤ 2-min) and 33.1% (IELT ≤ 5-min). ED was more prevalent in the subject groups with older age, lower income, or lower education, and in subjects without a spouse. ED prevalence was positively associated with risk factors such as diabetes, hypertension, heart disease, psychological stress, and obesity. Levels of serum hemoglobin (Hb) A1c, triglycerides, testosterone, or dehydroepiandrosterone sulfate (DHEA-S) were significantly different between the ED and non-ED groups. Conclusions The prevalences of ED and PE in Korean men were 13.4% (self-reported ED) and 11% (IELT ≤ 2-min), respectively. Risk factors and other socioeconomic and mental health factors were associated with ED prevalence. Biochemical factors such as HbA1c, triglycerides, testosterone, and DHEA-S were significantly related to ED prevalence.

In this pilot study in Korean men, those with BPH and treated with tadalafil 5 mg or tamsulosin 0.2 mg once daily experienced a reduction in LUTS, which was numerically (but not statistically) significant compared with the placebo. Tadalafil was well tolerated and few subjects discontinued the study due to treatment-emergent adverse events. Larger studies in Asian men with BPH and LUTS treated with phosphodiesterase type 5 inhibitors are needed.

Introduction Mirodenafil is a newly developed oral phosphodiesterase type 5 inhibitor, currently under investigation as a treatment for erectile dysfunction (ED). Aim We investigated the efficacy and safety of on demand mirodenafil therapy at fixed doses (50 and 100 mg) in Korean men with a broad range of ED. Methods A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 223 subjects who were randomized to placebo or mirodenafil at fixed doses of 50 or 100 mg for 12 weeks on an “as needed” basis. Main Outcome Measures Primary efficacy measures were scores on the International Index of Erectile Function (IIEF) Question 3 (Q3) and Question 4 (Q4). Secondary efficacy measures included all domain scores of the IIEF, Sexual Encounter Profile Question 2 (SEP2), Sexual Encounter Profile Question 3 (SEP3), the Global Assessment Question (GAQ), and the Life Satisfaction Checklist (LSC). Safety assessments included laboratory tests, vital signs, physical examination, 12-lead electrocardiogram recordings, and patients’ reporting of adverse events. Results Mirodenafil 50 and 100 mg groups showed a significantly greater increase in IIEF Q3 (P = 0.0001, P < 0.0001, respectively) and Q4 scores (both P < 0.0001) at the end point compared with the placebo group. And mirodenafil in both doses significantly improved the scores of all five domains of the IIEF, SEP2, and SEP3 as well as the percentages of patients responding positively to the GAQ compared with the placebo group. As for LSC scores, the two mirodenafil groups showed significantly greater improvements in items regarding life as a whole, sexual life, and partner relationship than the placebo group. Most treatment-associated adverse events were of mild intensity, resolving spontaneously. Conclusions Mirodenafil, in doses of 50 or 100 mg, significantly improved erectile function and were well tolerated in a representative population of Korean men with broad-spectrum ED of various etiologies and severities.

Varicocelectomy is a management option for patients with painful varicocele. In this study, we assessed the effectiveness of varicocelectomy for painful varicocele and examined the factors that might be predictive of outcome. All patients who underwent a varicocelectomy for pain between February 2007 and July 2009 were included. A review of patient medical records was conducted; patient age, body mass index (BMI), grade, location of the varicocele, testicular volume, duration and quality of the pain (dull, dragging, throbbing or sharp) and surgical technique (inguinal versus subinguinal) were documented. All parameters were compared with the resolution of pain (complete, partial or failure). We followed up on 53 of 104 patients (51.0%). Complete postoperative resolution of pain was reported by 28 patients (52.8%), whereas 22 (41.5%) reported partial resolution. Only three patients (5.7%) reported failure. No relationship was observed between postoperative pain resolution and age, BMI, grade of varicocele, location of varicocele, ipsilateral testicular hypotrophy, quality of pain or surgical technique. The duration of pain before surgery was the only factor that correlated with postoperative pain resolution (univariate, P=0.004; multivariate, P=0.002). Our results indicate that varicocelectomy is an effective treatment for painful varicocele in properly selected patients, and that duration of pain before surgery may be predictive of outcome.

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Introduction Long-acting injectable testosterone undecanoate (TU, Nebido®), a new parenteral testosterone preparation, has recently been introduced to avoid frequent injections of the conventional injectable esters. Aims To assess the efficacy and safety of long-acting injectable testosterone undecanoate (TU, Nebido®) in Korean patients with testosterone deficiency syndrome (TDS). Methods One hundred thirty-three patients who complain of erectile dysfunction with serum testosterone level less than 3.5 ng/mL were injected with 1,000 mg of TU (4 mL/ample) on day 1, followed by another injection after 6 weeks and 18 weeks. For the safety profiles, serum hemoglobin (Hb), hematocrit (Hct), glucose, lipid profile, and prostate-specific antigen (PSA) were measured. Main Outcome Measures Body mass index (BMI) was measured at the time of the first visit and after 12, 24 weeks. Primary efficacy was evaluated according to changes in the International Index of Erectile Function (IIEF) from the initial visit to the final visit (24 weeks) and from the initial visit to each visit. Secondary efficacy was assessed with changes of the Aging Males’ Symptoms (AMS) Scale and the Global Efficacy Question (GEQ) for improvement of erectile function. Results Mean age of patients was 54 ± 9.6 years. Compared with pretreatment, no significant improvement in BMI was observed. Serum total testosterone and free testosterone were significantly increased at 12 weeks and were maintained until 24 weeks (P <0.001). TU significantly decreased cholesterol (P <0.0001). TU significantly improved total IIEF, all five domain scores of IIEF (P <0.0001) and total AMS, all three domain scores of AMS (P <0.0001). On GEQ, TU improved erectile function in 76.9% of subjects. On safety profile, TU significantly elevated Hb, Hct, and PSA at 24 weeks but within normal range. No serious adverse reactions were observed. Drop-out rate was 15.0%. Conclusions In this prospective multicenter study, TU was effective, safe, and tolerable until 24 weeks in Korean TDS patients. Further well-controlled, long-term study should follow.

Introduction Mirodenafil is a newly developed selective phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED). Aim To evaluate the efficacy, safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes. Methods A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 112 subjects who were randomized to either placebo or mirodenafil 100 mg on demand for 12 weeks. Main Outcome Measures Primary efficacy variable was the erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables included change in the scores of IIEF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ) and the Life Satisfaction Checklist (LSC). Results After 12 weeks of treatment, mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared with the placebo group (9.3 vs. 1.4, P <0.0001). The changes from baseline in the mirodenafil group in IIEF Q3 (1.7 vs. 0.4, P <0.0001) and Q4 (1.7 vs. 0.3, P <0.0001) were higher compared with the placebo group. Differences between the mirodenafil and placebo groups were significant in the SEP2 (82.0% vs. 55.2%, P = 0.0003), SEP3 (68.9% vs. 22.3%, P <0.0001). Difference in GAQ “YES” responses was also significant (76.9% vs. 19.1%, P <0.0001). Normal EF domain scores (≥26) at study end were achieved by 32.7% and 9.4% in the mirodeniafl and placebo groups, respectively (P = 0.0031). As for the LSC scores, the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group. Most treatment-associated AEs were mild that resolved spontaneously. Conclusions Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea.