Introduction Premature ejaculation (PE) has negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy. In Japan, no oral drugs or devices are approved or used clinically to treat PE. The Men’s Training Cup Keep Training (MTCK), a masturbation aid, was developed for PE. MTCK offers 5 grades of tightness and strength. Aim We aimed to investigate the efficacy of the MTCK in patients who are unable to delay ejaculation. Methods Inclusion criteria were 20- to 60-year-old men feeling distressed and frustrated by PE and who had the same sexual partners throughout the study period. Exclusion criteria were neurologic disease and uncontrolled diabetes mellitus, as well as the use of antidepressants, α-blockers, and 5α-reductase inhibitors. The protocol comprised an 8-week training period with the MTCK from level 1 to level 5, with each level used twice before moving to the next level. Outcome Measures The main outcome measure was the extension of intravaginal ejaculation latency time (IELT). The secondary outcome measures were score improvements on the Premature Ejaculation Diagnostic Tool, Sexual Health Inventory for Men, Erection Hardness Score, and Difficulty in Performing Sexual Intercourse Questionnaire–5. Results We enrolled 37 patients, and after 19 patients withdrew, 18 concluded the study without experiencing any adverse events. The mean patient age was 39.9 years. Geometric IELT after the 8-week training with the MTCK increased significantly (mean ± SE; 232.10 ± 72.16 seconds) vs baseline (103.91 ± 50.61 seconds, P = .006). Mean scores on the Premature Ejaculation Diagnostic Tool, Difficulty in Performing Sexual Intercourse Questionnaire–5, and Erection Hardness Score after 8-week training improved significantly vs the baseline values. The mean score on the Sexual Health Inventory for Men did not improve significantly after the 8-week training, but domain 1 did significantly improve after 8 weeks of MTCK use. Clinical Implications The MTCK may be one possible treatment option for patients who are unable to delay ejaculation. Strengths and Limitations This is the first study to show that the MTCK is effective for patients who are unable to delay ejaculation. A major limitation is that the present study was not strictly limited to an IELT <3 minutes. Conclusions The MTCK may offer benefits not only for delay of ejaculation but also for erectile function.

Purpose Although patients with late-onset hypogonadism (LOH) often experience lower urinary tract symptoms (LUTS), LUTS are not generally included in LOH symptoms. No study has examined the direct relation of the Aging Males Symptoms rating scale (AMS) and the International Prostate Symptom Score (IPSS) with the quality of life (QOL) index. We analyzed the relation between the IPSS and QOL index and various factors including the AMS in patients with LOH syndromes. Materials and Methods This study comprised 1,688 men with LOH symptoms who visited our hospital or affiliated clinic. Factors associated with the IPSS were assessed in terms of age, scores of several questionnaires including the AMS, endocrinological variables, and serum concentration of PSA. Among these same factors, those associated with the QOL index were also evaluated. Finally, the same analyses were repeated in 187 patients with low serum testosterone concentration (<3.0 ng/mL). Results In a multivariate analysis using the significant items from the univariate analysis, AMS, age, and Erection Hardness Score correlated significantly with the IPSS. A trend analysis using items other than the AMS as adjustment factors also confirmed the relationship between an increase in QOL index and an increase in AMS. Similar results were obtained in the analysis of patients with low serum testosterone concentration. Conclusions We revealed that the relation of IPSS with the QOL index for LUTS is closely associated with the AMS for LOH, regardless of testosterone level. When patients complain of LOH symptoms, a careful, detailed inquiry into LUTS is required.

Introduction The standard treatment for late-onset hypogonadism (LOH) is testosterone replacement therapy (TRT). In Japan, testosterone enanthate intramuscular injection is recommended for LOH. But it needs regular clinic visits every 2-3 week, and it elicit pain. The 2% testosterone gel (AndroForte2®) is available for treatment LOH. Because of imported drug, AndroForte2® (AF2) is expensive. We have created a 2 % novel testosterone gel (NTG). Objective We hypothesized that our NTG improves Aging males' symptoms (AMS) scores, and serum testosterone in patients with LOH. Methods In this active control equivalence, randomized, double-blind, crossover study, it enrolled that were men with low serum free-testosterone (defined as below 11.8pg/mL), and symptoms of androgen deficiency (defined as AMS scores more than 27). The patients were randomly divided into two groups (A group, men receiving the NTG first; and B group, men receiving the AF2 first). Men with LOH received 2% AF2 for 28 days or 2% NTG for another 28 days separated by a 14-day washout period. The AMS score and serum hormonal data, and adverse events were assessed. Results Twenty-three patients aged 42–71 years old were enrolled in and concluded the study with no adverse events experienced. Serum testosterone and free-testosterone concentrations were significantly higher with NTG and AF2. And more, both concentrations were significantly higher in NTG than AF2. The AMS total score, physical subscore, mental subscore, and sexual subscore were significantly improved with NTG, but not significant with AF2. Conclusions This is the first study to show that our NTG may not be effective for improvement serum testosterone level but also for physical, mental, and sexual symptoms in patient with LOH. Disclosure Work supported by industry: no.

Late-onset hypogonadism (LOH) is generally treated with testosterone replacement therapy. Intramuscular injection of testosterone enanthate is used for LOH in Japan but requires regular painful injections administered every 2-3 weeks at a clinic. Testosterone 2% (AndroForte 2 ® [AF2]) is available for treating LOH but is expensive because it is imported. We developed a new 2% testosterone gel (NTG) and hypothesized that in patients with LOH, NTG would improve serum testosterone concentrations and Aging Males' Symptoms (AMS) scores compared with AF2. We enrolled men with low levels of serum free testosterone (<11.8 pg/mL) and androgen deficiency symptoms (AMS score >27). The primary endpoint was equivalent change in serum testosterone concentrations with NTG compared to AF2. Secondary endpoints were equivalent change in AMS scores for each question with NTG compared to AF2. Each of AF2 or NTG was administered to the study subjects (23 men aged 42-71 years) for 4 weeks separated by a washout period of 2 weeks. The subjects were randomly divided into men who first received NTG and those who first received AF2. No subject experienced any adverse events throughout the study. Compared with the baseline values of serum testosterone, those following NTG and AF2 treatment were significantly higher and were also significantly higher in the subjects taking NTG versus AF2. NTG administration significantly improved the AMS score, whereas AF2 did not. This initial study has shown that this new NTG formulation may be effective in improving serum testosterone concentrations and also LOH-related symptoms.

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