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Objective: To verify the efficacy and safety of tamsulosin 0.4 mg and tamsulosin 0.2 mg compared with those of placebo in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).Methods: A total of 494 patients from multiple centers participated in this double-blind, randomized, phase 3 trial. Eligible patients were randomly assigned to the tamsulosin 0.4 mg group, tamsulosin 0.2 mg group or placebo group. The International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), post-void residual (PVR) urine volume, blood pressure, heart rate and adverse events were compared among the three groups at 4, 8 and 12 weeks.Results: A total of 494 BPH patients were analyzed. There were no differences in the baseline characteristics among the three groups. After 12 weeks of treatment, total IPSS was improved in the 0.2 mg and 0.4 mg tamsulosin groups; however, the extent of improvement was greater in the 0.4 mg group than in the 0.2 mg group (0.4 mg: -9.59 vs. 0.2 mg: -5.61; least-squares mean difference [95% confidence interval]: -3.95 [-5.01, -2.89], p < .0001). In addition, in the patients with severe symptoms (IPSS ≥20), total IPSS was improved the most in the 0.4 mg group (-11.27 ± 5.00, p < .0001). Qmax and PVR were improved in the 0.4 mg and 0.2 mg groups; however, the differences were not statistically significant between treatment groups. No patients experienced any serious adverse effects in any of the three groups.Conclusions: Tamsulosin 0.4 mg and 0.2 mg appear to be superior to placebo treatment, and tamsulosin 0.4 mg is more effective than 0.2 mg in terms of total IPSS improvement. Tamsulosin 0.4 mg has favorable efficacy and tolerability in Asian men with symptomatic BPH. ClinicalTrials.gov Identifier: NCT02390882. [ABSTRACT FROM AUTHOR]

Objectives Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Methods Randomized controlled trials articles published in International Journal of Urology were found using the Pub Med MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. Results A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 ( P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. Conclusions The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. [ABSTRACT FROM AUTHOR]

Purpose: We compared postoperative outcomes in patients treated with laparoendoscopic single site varicocele ligation with or without testicular artery and lymphatic preservation. Materials and Methods: A total of 80 patients with left varicocele were randomly divided into 2 groups and treated with laparoendoscopic single site varicocele ligation with preservation of the testicular artery and lymphatics (40 in group 1) or complete ligation of the testicular vessels and lymphatics (40 in group 2). Operative time, hospital stay, return to normal activity, postoperative visual analog scale pain scores and complications were analyzed. In patients with subfertility preoperative and 3-month postoperative semen analyses were performed. In patients with scrotal pain preoperative and 12-month postoperative visual analog scale pain scores were analyzed. Results: A total of 35 patients per group completed the study. Hospital stay, return to normal activity and postoperative pain scores did not differ between the groups. No major complications were observed. Mean ± SD operative time was 60.7 ± 10.7 and 48.6 ± 6.0 minutes in groups 1 and 2, respectively (p <0.001). Patients with subfertility, including 22 in group 1 and 21 in group 2, showed improved semen parameters 3 months postoperatively but postoperative values did not differ between the groups. The 17 patients in each group with scrotal pain showed decreased pain scores 12 months postoperatively with no difference between the groups. Conclusions: Laparoendoscopic single site varicocele ligation is feasible. No differences in postoperative outcomes and complications were observed when preserving or not preserving the testicular artery and lymphatics. [ABSTRACT FROM AUTHOR]

Aim: In patients with a renal cyst and concurrent symptoms, we examined the effectiveness and safety of laparoendoscopic single-site surgery (LESS) for renal cyst marsupialization using a homemade single-port device (HSPD) by a single surgeon (S.W.L.). Patients and Methods: The present study was conducted on a total of 31 patients with a renal cyst. A LESS renal cyst marsupialization was performed using a HSPD based on the Alexis® wound retractor and a powder-free surgical glove. In our study, the mean age was 55.29 ± 10.86 (range 31-73) years and the mean size of the renal cyst was 6.83 ± 1.09 cm. Results: All the surgical procedures were successfully performed. The mean operative time was 101.35 ± 16.04 min. Of the patients who underwent the procedure, none presented with major complications. In 7 patients who had pain preoperatively, there was a significant difference in the visual analogue pain scale score at 6.86 ± 0.69 preoperatively and 1.71 ± 0.49 at postoperative week 4 (p < 0.001). The number of patients who were satisfied with the postoperative outcome was 29 (93.5%). Conclusions: In patients with a simple renal cyst, LESS renal cyst marsupialization using a HSPD might be considered as a feasible, safe surgical treatment option. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Objective. Endoscopic submucosal dissection (ESD) of gastric neoplasia has been reported to have a higher bleeding rate than conventional endoscopic mucosal resection (EMR). The aim of this study was to identify the risk factors for bleeding associated with ESD. Material and methods. The records of consecutive patients who underwent ESD for gastric adenoma/early gastric cancer were reviewed. Potential risk factors included patient age, lesion size, gross findings, location, and histology of the tumor. The primary end-point was the incidence of immediate or delayed bleeding related to ESD. Results. A total of 144 patients were studied; bleeding occurred in 32 cases (22.2%) with immediate bleeding in 29 cases. Delayed bleeding (3 cases) occurred at day 2 (2 patients) and at day 7 in 1 patient. In all cases of immediate bleeding, immediate hemostatic therapy was successful. The histology of tumor was the only factor that was statistically significantly associated with bleeding (adjusted hazard ratio 6.770, 95% confidence interval 1.830--25.048, p=0.004). Conclusions. The only factor that correlated with an increased risk of bleeding with ESD was the presence of gastric malignancy. We found no factor that would, prospectively, be amenable to prevention of bleeding. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study is to compare the efficacy of the treatment strategies for in-stent restenosis (ISR) of drug-eluting stents (DES) according to the morphologic pattern of restenosis. Background: Optimal treatment strategies for ISR within DES have not been adequately addressed yet. Methods: Patients with ISR of DES were randomized according to the lesion length to compare outcomes of sirolimus-eluting stent (SES) versus cutting balloon angioplasty for focal type (≤10 mm) and SES versus everolimus-eluting stent (EES) for diffuse type (>10 mm). The primary endpoint was in-segment late loss at 9 months. Overall 162 patients, 96 with focal ISR and 66 with diffuse ISR, were enrolled. Results: In focal lesions, in-segment late loss was significantly higher in the cutting balloon group (n = 48) than in the SES group (n = 48; 0.25 mm, interquartile range [IQR]: −0.01 to 0.68 mm vs. 0.06 mm, IQR: −0.08 to 0.17 mm; p = 0.04). Consequently, in-segment restenosis rate tended to be higher in the cutting balloon group than in the SES group (20.7% vs. 3.1%, p = 0.06) with comparable incidences of the composite of death, myocardial infarction, or target vessel revascularization at 12 months of clinical follow up (6.3% vs. 6.3%, p > 0.99). In 66 cases of diffuse ISR, in-segment late loss (0.11 mm, IQR: −0.02 to 0.30 mm; vs. 0.00 mm, IQR: −0.08 to 0.25 mm; p = 0.64), in-segment restenosis rate (5.0% vs. 14.3%, p = 0.32), and the composite incidence of death, myocardial infarction, or target lesion revascularization (9.6% vs. 8.8%, p > 0.99) did not differ between SES group (n = 32) and EES group (n = 34). Conclusions: For lesions of focal DES restenosis, repeat implantation of SES is more effective in reducing late luminal loss and subsequent restenosis rate than cutting balloon angioplasty. For diffuse DES restenosis, implantation of SES or EES is comparably effective in terms of angiographic and clinical outcomes. [ABSTRACT FROM AUTHOR]