Efficacy of testosterone replacement therapy plus alternate-day tadalafil for patients with late-onset hypogonadism: An open-label, randomized, crossover study.

OBJECTIVE: To examine the efficacy and safety of combination treatment with testosterone replacement therapy plus alternate-day tadalafil (10 mg) in patients with late-onset hypogonadism. METHODS: In this open-label, randomized, crossover study, 29 patients with late-onset hypogonadism were randomly assigned to receive testosterone replacement therapy for 12 weeks followed by combination treatment for 12 weeks (Group 1) or combination treatment for 12 weeks followed by testosterone replacement therapy (Group 2). Symptom questionnaires were administered and blood tests were performed prior to and following each treatment to assess safety and efficacy. At the end of the study, participants were asked about their treatment preferences. RESULTS: An adverse effect, a rheum symptom, occurred in only one participant, and 26 participants completed the study without any toxicity. Scores on the Aging Male Symptoms scale and the modified short version of the International Index of Erectile Function, and Overactive Bladder Symptom scores were significantly improved in the combination treatment phase of Group 2, whereas no significant difference between the phases were observed in Group 1. In total, 12 out of the 14 participants in Group 1 and 11 out of the 12 participants in Group 2 preferred combination treatment, which reached statistical significance (P = 0.008 and 0.004 for Groups 1 and 2, respectively). CONCLUSIONS: Testosterone replacement therapy with add-on alternate-day tadalafil is a safe and satisfactory treatment for patients with late-onset hypogonadism.

Efficacy of combined treatment of intramuscular testosterone injection and testosterone ointment application for late-onset hypogonadism: an open-labeled, randomized, crossover study.

INTRODUCTION: The best method for administering testosterone replacement therapy (TRT) for late-onset hypogonadism (LOH) remains controversial. This study aimed to compare the efficacy and safety of a combined treatment (CT) involving intramuscular testosterone injection and testosterone ointment application [Glowmin® (GL)] with intramuscular injection monotherapy (IMIM). MATERIALS AND METHODS: Patients were randomly assigned as follows: Group 1 received IMIM for 12 weeks and CT for 12 weeks and Group 2 received CT for 12 weeks and IMIM for 12 weeks. Patients were then asked about their treatment preferences: (A) IMIM, (B) a combination of IMIM and ointment, or (C) either A or B. RESULTS: Patients (n = 43) completed the study without any adverse effects. No significant differences between each treatment period were found. In Group 1, most patients chose B (n = 13) while in Group 2, most chose A (n = 10). In each group, patients preferred the second treatment phase; however, statistical significance was not reached between A and B (Group 1, p = 0.11 and Group 2, p = 0.47, respectively). CONCLUSION: TRT by CT is compatible with TRT by IMIM. Patients who cannot continue TRT because of polycythemia from IMIM may be suited to CT.

Nicardipine vs. saline injection as treatment for Peyronie's disease: a prospective, randomized, single-blind trial.

INTRODUCTION: Various conservative treatments for Peyronie's disease (PD) have been attempted over the years. Intralesional verapamil injection has been tested in prospective randomized studies, but the effect of this treatment seems insufficient. Nicardipine is a calcium antagonist alternative to verapamil and is reportedly more effective in vitro. AIM: The objective of our study was to evaluate the usefulness of intralesional nicardipine injection as a conservative treatment for PD in the transition period of acute and chronic phase. METHODS: Eighty-six patients (age: 38-72 years, mean: 52) were enrolled in this study. A total of 74 patients were assigned randomly to nicardipine group (10 mg diluted in 10 mL of distilled water daily, N=37) and control group (10 mL of saline water, N=37). A total of six injections were administrated biweekly. MEAN OUTCOME MEASURE: The subjects were assessed by International Index of Erectile Function (IIEF)-5 and international pain scale. The plaque size was measured by ultrasonography after 20 µg intracavernosal injection of alprostadil (prostaglandin E1). The penile curvature was also measured by taking a photograph at maximum rigidity. RESULTS: A reduction of pain score was seen throughout the course of treatment in both groups with a significant difference between the nicardipine and control groups (multiple analysis of variance test, P=0.019). A significant improvement of IIEF-5 score occurred only in the nicardipine group at 48 weeks after the initiation of treatment (P<0.01). The plaque size was significantly reduced at 48 weeks only in the nicardipine group (12 points, P=0.0004 by paired t-test). The penile curvature was significantly improved in both groups (P<0.01) without significant difference between them (P=0.14). There were no severe side effects, such as hypotension or other cardiovascular events. CONCLUSION: Our findings indicate that intralesional nicardipine injection is clinically effective as a conservative treatment for PD in the transition period of acute and chronic phase.

Clinical efficacy of alternative antiandrogen therapy in Japanese men with relapsed prostate cancer after first-line hormonal therapy.

BACKGROUND: To confirm the effectiveness of alternative antiandrogen therapy (AAT) in Japanese patients with prostate cancer relapse after first-line hormonal therapy. METHODS: A total of 80 patients who had successive serum prostate-specific antigen (PSA) progression after first-line hormonal therapy (luteinizing hormone-releasing hormone agonist alone: 21 cases; combined antiandrogen blockade therapy: 59 cases) were enrolled. We evaluated the positive ratio of antiandrogen withdrawal syndrome (AWS), the PSA responses with second- and third-line AAT, and cause-specific survival in terms of the effectiveness of AAT. RESULTS: The overall positive AWS ratio after first-line therapy was 33%, while that after second-line therapy was 7%. There was no correlation between the first-line PSA response and the positive AWS. Of the 10 positive and the 20 negative AWS cases, secondary antiandrogen administration was effective in 50% and 60% of cases, respectively. The positive PSA responders at second- and third-line therapy were 51% and 13%, respectively. For second-line therapy, the effective rates from steroidal to non-steroidal, from non-steroidal to non-steroidal antiandrogen, and from non-steroidal to steroidal were 83%, 43%, and 14%, respectively. The cause-specific survival of the second-line responders was significantly better than that of the non-responders. CONCLUSION: There was a substantial number of patients who found second-line AAT to be modestly effective. Flutamide was effective as an alternative antiandrogen for the patients' relapse treatment with bicalutamide in Japanese men.

[A case report of idiopathic hypogonadotropic hypogonadism with particular reference to monitoring of prostate volume].

A 23-year-old man visited our hospital, complaining of a lack of secondary sexual characteristics. Based on both clinical and endocrinological examinations, he was diagnosed as suffering from idiopathic hypogonadotropic hypogonadism (IHH). With human chorionic gonadotropin (hCG)/human menopausal gonadotropin (hMG) replacement therapy, clinical symptoms and serum testosterone levels improved to normal ranges. Interestingly, prostate volume as measured by transrectal ultrasonography increased considerably from 3.6 ml before treatment to 20.2 ml after treatment. The monitoring of prostate volume might be a parameter useful for evaluating the treatment effect of hCG/hMG replacement therapy in IHH.

[Systematic prostate biopsy before transurethral resection of the prostate].

PURPOSE: With the aim of evaluating the clinical significance of systematic prostate biopsy before transurethral resection of the prostate (TUR-P), clinical data were reviewed retrospectively in patients who had underwent prostate biopsy prior to scheduled TUR-P. PATIENTS AND METHODS: Between July, 1994 and June, 2000, TUR-P was scheduled in a total number of 456 patients with clinically diagnosed benign prostatic hyperplasia (BPH). RESULTS: In 218 (47.8%) out of 456 cases, prostatic biopsy was conducted prior to TUR-P due to abnormally elevated serum prostate specific antigen (PSA) levels of 4.0 ng/ml or more, revealing only 22 (10.1%) cases of prostatic cancer. Between these 22 cases with biopsy proven prostatic cancer and 189 cases with BPH confirmed both by biopsy and following TUR-P, statistically significant differences were noted in age (p < 0.05), prostate volume (p < 0.0001) and PSA density (p < 0.01). CONCLUSION: Considering the low positive rate of preoperative prostatic biopsy, it might be suggested that a considerable number of biopsy could be avoided in patients with clinically diagnosed BPH. Based on the results obtained from this study, prostatic biopsy might be unnecessary before TUR-P for those with prostate volume greater than 60 ml or PSA density less than 0.15.

[Primary symptoms of 301 patients with prostate cancer: Nagoya Urology Hospital experience].

PURPOSE: Primary symptoms were reviewed retrospectively in patients with prostate cancer diagnosed in our hospital with the aim of promoting early detection. MATERIALS AND METHODS: The subjects included 301 cases with prostate cancer diagnosed histologically in Nagoya Urology Hospital from August, 1988 to December, 2001. The mean age was 72.7 years, and the median PSA was 20.0 ng/ml. Primary symptoms were classified according to the General Rule for Clinical and Pathological Studies on Prostate Cancer (The 3rd Edition). RESULTS: Out of 301 cases, 274 (91%) visited our hospital with clinical symptoms. Of them, 272 had primary urological symptoms. In these 272 cases, 250 (92%) and 19 (7%) had lower urinary tract symptoms (LUTS) and macroscopic or microscopic hematuria, respectively. The majority of patients (82%) referred from other urologists had already undergone PSA measurement, compared to 50% in those referred from physicians other than urologists (p < 0.0005). CONCLUSION: The present data revealed that LUTS were important primary symptoms for the detection of prostate cancer, particularly in an area like Nagoya where the mass screening for prostate cancer is still unavailable. In terms of the early detection of prostate cancer, PSA has to be measured in patients with LUTS even when they visit physicians who are not urologists.

[A case of primary adenocarcinoma of the epididymis].

A 68-year-old man presented with right intrascrotal swelling. On palpation, a hard tumor without pain was recognized at the head of the right epididymis. Power Doppler ultrasonography revealed blood flow signals within the tumor. Surgical exploration was performed under the tentative diagnosis as possible malignant tumor of the epididymis. The right epididymis adhered to the testis so strongly, that the epididymis was resected with the testis. Pathological diagnosis was moderately differentiated adenocarcinoma of the epididymis. The results of general examinations on possible presence of primary lesions in other organs were all negative. Finally, the diagnosis of primary adenocarcinoma of the epididymis was obtained. He remains free of disease 17 months after surgery.

Acute urethritis caused by Neisseria meningitidis.

A 48-year-old heterosexual Japanese man visited the outpatient clinic of Nagoya Urology Hospital, complaining of burning pain at voiding and pus discharge from the urethral orifice. These symptoms appeared the day following oral-genital contact (fellatio) with a commercial sex worker. On the basis of the presumptive clinical diagnosis of gonorrhea because of the microscopic detection of diplococci in the urethral discharge, he was treated with levofloxacin (300 mg per day) for 7 days. His symptoms responded quickly and urinalysis taken 7 days later was normal. Microbiological examinations isolated Neisseria meningitidis in the urethral discharge by culture with the use of enzymatic profiles. Further prevalence of sexually transmitted diseases (STD) through oral-genital contact would lead to an increase in meningococcal urethritis.

Familial central diabetes insipidus detected by nocturnal enuresis.

A 10-year-old male referred to our clinic with the chief complaint of nocturnal enuresis also complained of daytime polyuria, frequency, and polydipsia. The clinical diagnosis was central diabetes insipidus. Since the patient's father had complained of similar symptoms, the arginine vasopressin-neurophysin II gene was examined. This revealed a single base substitution in one of two alleles in the patient, his father, and his grandfather (a C to T transition at nucleotide position 280 at codon 19 in the first exon). In conclusion, a history of polyuria or polydipsia should be carefully noted and the urinary volume and urine gravity or osmolarity examined in cases of nocturnal enuresis.