A Phase 3 Study to Evaluate the 1-Year Efficacy and Safety of Udenafil 75 mg Once Daily in Patients With Erectile Dysfunction.

INTRODUCTION: Once-daily administration of phosphodiesterase type 5 inhibitors has been shown to correct erectile dysfunction (ED). AIM: To evaluate the long-term efficacy and safety after once-daily oral administration of udenafil 75 mg in men with ED. METHODS: This clinical trial was an open-label, fixed-dose, 24-week extension study (DA8159_EDDL_III) of a 24-week double-blinded efficacy and safety study of once-daily udenafil (parent study: DA8159_EDD_III). Subjects received udenafil 75 mg once daily for 24 weeks during this extension study, and the follow-up visit occurred during the 4-week ED treatment-free period. MAIN OUTCOME MEASURES: Subjects were asked to complete the International Index of Erectile Function questionnaire and the Global Assessment Questionnaire at the 24-week extension and after the 4-week ED treatment-free period, and the development of adverse drug reactions was investigated. RESULTS: In total, 302 subjects were enrolled in this extension study. Improvement was shown with an increased erectile function (EF) domain score compared with baseline (14.60 ± 4.57) at extension week 48 (23.98 ± 5.44) and a slight increase in EF domain score compared with the last time point (week 24) of the parent study (P < .001). The Global Assessment Questionnaire showed a high improvement rate of 95.4% at the extension 48-week time point. For shift to normal, almost half the subjects (45.1%) recovered "normal" EF, and 14.2% of subjects reported normal erections after the 4-week ED treatment-free period. The occurrence rate of adverse drug reactions was 8%, which consisted mainly of flushing and headache. CONCLUSION: Once-daily dosing of udenafil 75 mg showed excellent efficacy and safety with long-term administration and allowed a more spontaneous sexual life.

A forgotten double-J ureteral stent resulting in an emphysematous perinephric abscess: A case report.

RATIONALE: Double-J stents (DJSs) are urologic devices widely used for urinary tract obstruction treatment. Perinephric abscess is a condition with purulent accumulation resulting from urinary tract infection retained between the renal capsule and Gerota's fascia. Emphysematous urinary tract infection in patients with a forgotten DJS is extremely rare. Herein, we report a case of emphysematous perinephric abscess as a complication in a 56-year-old non-diabetic woman who neglected a 10-year-old DJS placed for obstructive uropathy treatment. PATIENT CONCERNS: The patient presented with fever and abdominal pain that persisted for 4 days. Laboratory examinations showed leukocytosis, hypoalbuminemia (2.3 g/dL), and elevated C-reactive protein level (305.5 mg/L) with no azotemia. DIAGNOSIS: Abdominal computed tomography scan revealed a DJS with encrustation and multiple stones in the right kidney as well as a perinephric abscess with gas formation. INTERVENTIONS: Intravenous administration of piperacillin/tazobactam was initiated immediately and percutaneous catheter drainage was performed. Extended-spectrum beta-lactamase-producing Escherichia coli was identified on abscess culture and antibiotics were switched to meropenem, resulting in gradual improvement of the inflammatory lesion. The patient was referred to the urology department for retained DJS removal and vesicolitholapaxy. A piece of fractured stent was removed via open ureterolithotomy. OUTCOMES: Since discharge on hospital day 42, she has been under regular follow-up, and the surgical wound has been healing with no significant sequelae. LESSONS: Prompt medical therapy for inflammation and thorough urologic correction of the stent-induced structural deformities are crucial in long-term neglected DJS and resulting emphysematous perinephric abscess. Patients who undergo DJS placement should be systematically followed up to prevent potential neglect of device management.

Patient-reported Goal Achievement after Treating Male Benign Prostatic Hyperplasia with Alpha-adrenergic Antagonist: A 12-week Prospective Multicenter Study.

PURPOSE: The study was designed to assess and predict patient-reported goal achievement after treatment of benign prostatic hyperplasia (BPH) patients with tamsulosin. MATERIALS AND METHODS: From November 2013 to October 2015, 272 patients initially diagnosed with BPH were prospectively enrolled in nine different centers. Before the treatment, subjective final goals were recorded by all patients. Every four weeks, the treatment outcomes were evaluated using international prostate symptom score (IPSS) and uroflowmetry, and adverse events were recorded. Patient-reported goal achievements were assessed after 12 weeks of treatment. RESULTS: Of the enrolled patients, 179 patients completed the study. The pretreatment patients' goals included the frequency improvement, nocturia improvement, residual urine sense improvement, well voiding, hesitancy improvement, weak urine stream improvement, urgency improvement, and voiding-related discomfort improvement. Of the 179 patients, 129 patients (72.1%) reported that they achieved their primary goals after three months of medical therapy. Logistic regression analysis revealed that pretreatment quality of life (OR = 8.621, 95% CI: 2.154-9.834), and improvement of quality of life (OR = 6.740, 95% CI: 1.908-11.490) were independent predictors of patient-reported goal achievement after tamsulosin monotherapy. CONCLUSION: Overall patient-reported goal achievement after medical therapy for BPH was high and the scores of pretreatment quality of life and improvement of quality of life can be important factors to predict the achievement of treatment goals.

Effect of Testosterone Replacement Therapy on Cognitive Performance and Depression in Men with Testosterone Deficiency Syndrome.

PURPOSE: We aimed to evaluate the effect of testosterone replacement therapy (TRT) on cognitive function and depression in men with testosterone deficiency syndrome. MATERIALS AND METHODS: We carried out a prospective, placebo-controlled trial involving 106 men with total testosterone levels <3.3 ng/mL and symptoms of hypogonadism. Based on whether the patients received TRT (injection with 1,000 mg testosterone undecanoate) or a placebo (advice to modify lifestyle), the study population was divided into a TRT group (n=54) and a control group (n=52). RESULTS: The age among patients in the TRT and control groups was 56.7±12.6 years and 57.8±11.4 years, respectively (p> 0.05). At baseline, no significant differences between the TRT and control groups were noted regarding serum testosterone or prostate-specific antigen levels, or regarding the scores for aging symptoms (Aging Males' Symptoms scale), erectile function (5-item International Index of Erectile Function questionnaire), cognitive function (Korean Mini-Mental State Examination), and depression (Beck Depression Inventory). At 8 months after intervention total serum testosterone levels and erectile function scores had significantly increased (p<0.05), whereas the scores for aging symptoms and depression had significantly decreased (p<0.05) in the TRT group; no significant improvement in any parameters was noted for the control group. Notably, significant improvement in cognitive function was noted among patients with cognitive impairment at baseline (cognitive function score <25) who received TRT. CONCLUSIONS: TRT may be considered in men with testosterone deficiency syndrome if low testosterone levels are associated with depression or cognitive impairment.

Adolescent varicocele: are somatometric parameters a cause?

PURPOSE: It has been reported that varicocele is found less frequently in obese men. Accordingly, we evaluated varicocele patients and statistically analyzed the correlation between varicocele and somatometric parameters. MATERIALS AND METHODS: A total of 211 patients underwent surgery for varicoceles. All patients underwent history taking, physical examination, and scrotal ultrasound to determine the presence and severity of varicocele. An age-matched control group consisted of 102 patients who were found not to have varicocele according to physical examinations and scrotal ultrasound. The age, weight, height, and body mass index (BMI) of the two groups were compared. The statistical analyses were performed by use of PASW Statistics ver. 18.0. A p-value of less than 0.05 was used for statistical significance. RESULTS: In the varicocele group, the mean age, height, weight, and BMI were 29.42±14.01 years, 168.53±9.97 cm, 62.14±13.17 kg, and 21.66±3.21 kg/m(2), respectively. The distribution of varicocele grade was as follows: 103 (48.8%) grade III, 72 (34.1%) grade II, and 36 (17.1%) grade I. In the control group, the mean age, height, weight, and BMI were 30.83±17.31 years, 161.93±19.83 cm, 64.69±17.86 kg, and 24.04±3.64 kg/m(2), respectively. Analyzing these data specifically in adolescents, they showed significant differences in age, height, and BMI (p=0.000, p=0.000, and p=0.004, respectively) between two groups. There were no significant differences in somatometric parameters between patients with different grades of varicocele. CONCLUSIONS: Our results showed that patients with varicoceles were significantly taller and had a lower BMI than did patients without varicoceles, especially among adolescents. Carefully designed future studies may be needed.

Renal function following curative surgery for renal cell carcinoma: who is at risk for renal insufficiency?

PURPOSE: To investigate the incidence and predictive factors associated with the development of chronic kidney disease (CKD) in patients undergoing curative surgery for renal cell carcinoma. MATERIALS AND METHODS: From 2003 to 2010, we retrospectively investigated 108 patients undergoing partial nephrectomy or radical nephrectomy (RN) for renal tumors with a preoperative glomerular filtration rate (GFR)≥60. The GFR was calculated by use of the four-variable modification of diet in renal disease (MDRD) formula. CKD was defined as an estimated GFR (eGFR) less than 60 mL/min per 1.73 m(2). Demographic and clinicopathologic parameters were evaluated by using the chi-square and Student t-tests and multivariate regression analysis to determine the variables independently associated with the development of postoperative CKD. RESULTS: Of the 108 patients without preoperative CKD, CKD developed in 43 patients (39.8%). In the analysis of clinical factors between patients with and those without CKD development, gender, body mass index, diabetes mellitus, hypertension, and tumor size were not significant clinical factors. Statistical significance for CKD development was found for age of 60 years or greater (p=0.013), decreased preoperative eGFR (p<0.001), and RN group (p<0.001). In the multivariate analysis, decreased preoperative eGFR (p=0.001) and RN group (p=0.002) were significant independent predictors. CONCLUSIONS: The results of our study show that decreased preoperative renal function and RN were significant independent predictors of postoperative CKD. In patients who had a relatively decreased preoperative eGFR, especially when estimated by use of the MDRD formula, nephron-sparing surgery should be considered for the treatment of small renal tumors.

Korean Society for Sexual Medicine and Andrology (KSSMA) Guideline on Erectile Dysfunction.

In February 2011, the Korean Society for Sexual Medicine and Andrology (KSSMA) realized the necessity of developing a guideline on erectile dysfunction (ED) appropriate for the local context, and established a committee for the development of a guideline on ED. As many international guidelines based on objective evidence are available, the committee decided to adapt these guidelines for local needs instead of developing a new guideline. Considering the extensive research activities on ED in Korea, data with a high level of evidence among those reported by Korean researchers have been collected and included in the guideline development process. The latest KSSMA guideline on ED has been developed for urologists. The KSSMA hopes that this guideline will help urologists in clinical practice.

Malignant mesothelioma of the spermatic cord.

Primary tumors arising from the spermatic cord are very rare. Mesothelioma derives from the mesothelial cells lining the serous membrane, such as the pleura, peritoneum, and tunica vaginalis of testis. Paratesticular malignant mesothelioma (MM), which usually presents as a hydrocele or intrascrotal mass, accounts for 0.3% to 1.4% of MMs. MMs of the spermatic cord account for less than 10% of paratesticular MMs. We report a case of MM of the spermatic cord in a 65-year-old man who primarily presented to the hospital with a left inguinal mass. Following the diagnosis after surgery, he was found to have a contralateral right inguinal mass and died in 6 months. Despite their rare occurrence in the spermatic cord, MMs need to be suspected, especially in patients with a history of asbestos exposure.