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Introduction and hypothesis: Randomized controlled trials (RCTs) provide the best quality clinical evidence. The aim of this study was to assess the quality of RCTs published by the International Urogynecology Journal (IUJ) in 2007-2016.Methods: RCTs in original articles were extracted from PubMed and IUJ homepage. Change in RCT quality over time was assessed with Jadad and van Tulder scales and Cochrane Collaboration’s risk of bias tool (CCRBT). Jadad scores of 3-5 or van Tulder scores of >5 indicated high-quality RCTs. The effect on RCT quality of including funding source and institutional review board (IRB) approval statements and describing the intervention was assessed. In addition, changes in RCT topics over time were assessed.Results: Annual RCT frequencies did not change significantly (6.7-15.7%): 36.1% and 25.7% described blinding and allocation concealment, respectively. Both tended to increase between 2013 and 2016, particularly 2013 and 2014. Funding statement inclusion (39.1% overall) and intervention description (78.2% overall) tended to increase steadily. IRB statement inclusion (60.4% overall) increased significantly (p < 0.01). Jadad scores and van Tulder rose significantly until 2014 (p < 0.01). Frequencies of high-quality RCTs tended to rise. CCRBT indicated that RCTs with a low risk of bias tended to increase until 2014. However, from 2015, Jadad scores, van Tulder, and CCRBT the low risk tended to decreased. RCTs with funding and IRB approval statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and p < 0.01, respectively). Intervention description did not associate with better quality.Conclusions: RCT quality improved over time, but a dip in quality was observed in 2015-2016 because of decreased blinding and allocation concealment. [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]

What's known on the subject? and What does the study add? LESS-NU may be an alternative minimally-invasive treatment option for patients eligible to undergo laparoscopic surgery for upper urinary tract urothelial carcinoma., The true benefits of LESS-NU remain to be determined and require randomized control trials in the future. Despite encouraging early findings, clinical trials still are warranted before this procedure is adopted widely, and longer follow-up is needed to determine its oncological durability., Objective To report a large multi-institutional series of laparoendoscopic single-site ( LESS) nephroureterectomy ( NU)., Materials and Methods Data on all cases of LESS-NU performed between 2008 and 2012 at 15 institutions were retrospectively gathered., The main demographic data and perioperative outcomes were analysed., Results The study included 101 patients whose mean ( sd) age was 66.4 (9.9) years and mean ( sd) body mass index was 24.8 (4) kg/m2, and of whom 29.7% had undergone previous abdominal/pelvic surgery., The mean ( sd) operating time was 221.4 (73.7) min, estimated blood loss 231.7 (348.0) mL., A robot-assisted LESS technique was applied in 25.7% of cases. An extra trocar was inserted in 28.7% of cases to complete the procedure. Conversion to open surgery was necessary in three cases (3.0%). There was no bladder cuff excision in 20.8% of cases, and excision was carried out using a variety of techniques in the remaining cases., Six intra-operative complications occurred (5.9%). The mean ( sd) length of hospital stay was 6.3 (3.5) days. The overall postoperative complication rate was 10.0%, and most of the complications were low grade ( Clavien grades 1 and 2)., The mean tumour size was 3.1 (1.9) cm. Pathological staging was pTis in two patients, pTa in 12 patients, pT1 in 42 patients, pT2 in 20 patients, pT3 in 23 patients and pT4 in two patients. Pathological grade was high in 71 and low in 30 patients., At a mean follow-up of 14 months, six patients (5.9%) had died. Disease recurrence (including distant and bladder recurrence) was detected in 22.8% of patients, with a mean time to recurrence of 11.5 months., Conclusions This study reports the largest multi-institutional experience of LESS-NU to date., Peri-operative outcomes mirror those of published standard laparoscopy series., Despite encouraging early findings, longer follow-up is needed to determine the oncological efficacy of the procedure. [ABSTRACT FROM AUTHOR]

Purpose: We measured the effectiveness of inhibition of adhesion and fibrosis on patient outcomes after epididymectomy as a treatment for chronic epididymitis. Materials and Methods: An initial cohort of 152 patients was treated conservatively for chronic epididymitis. Of these patients 43 did not respond to conservative treatment and following informed consent they were enrolled in the clinical trial. The patients were randomized into 2 groups so that 22 underwent epididymectomy with concurrent administration of the inhibitors of adhesion and fibrosis hyaluronic acid and carboxymethylcellulose (group 1), and 21 underwent epididymectomy only (group 2). Visual analog pain scores and patient satisfaction scores were obtained at postoperative weeks 4, 12 and 24. Results: There were no postoperative complications such as wound infection or hematoma in either group. One patient was lost to followup from group 1 and 2 were lost from group 2. At postoperative week 24, 12 patients (57.1%) from group 1 and 3 (15.8%) from group 2 were pain-free, 6 (28.6%) from group 1 and 6 (31.6%) from group 2 exhibited limited pain relief, 2 (9.5%) from group 1 and 7 (36.8%) from group 2 exhibited no pain relief, and 1 (4.8%) from group 1 and 3 (15.8%) from group 2 exhibited recurrence of pain after initial resolution at earlier followup intervals (p = 0.028). Conclusions: Inhibition of adhesion and fibrosis after epididymectomy as a treatment for chronic epididymitis improves pain relief and patient satisfaction. [ABSTRACT FROM AUTHOR]

Purpose: We evaluated the improvement in erectile dysfunction and lower urinary tract symptoms as well as the safety of once daily administration of 50 mg mirodenafil in men with erectile dysfunction. Materials and Methods: A total of 226 patients visited for treatment of erectile dysfunction and were recruited for the study. Of these men 180 met the study inclusion criteria after completing a 2-week screening period (visit [V]1). The patients were randomly allocated into 2 groups. Group 1 (90 patients) received 50 mg mirodenafil once daily and group 2 (90 patients) received a placebo daily. Blood pressure, heart rate, IIEF-5 (5-item version of the International Index of Erectile Function), and SEP (Sexual Encounter Profile) questions 2 and 3 were assessed at 4 (V2), 8 (V3) and 12 weeks after the start of treatment (V4). I-PSS (International Prostate Symptom Score), maximal flow rate and post-void residual volume were also assessed for the evaluation of lower urinary tract symptoms. Results: Of the 180 patients 71 in group 1 and 63 in group 2 completed the 12-week clinical trial. IIEF-5 and I-PSS significantly improved in group 1 (p <0.001 for both). Facial flushing was the most common adverse effect, followed by headaches. Notably there were no statistically significant differences in either of the variables related to the cardiovascular system. Conclusions: Once daily administration of 50 mg mirodenafil was efficacious and safe for the treatment of erectile dysfunction and lower urinary tract symptoms. [ABSTRACT FROM AUTHOR]

Background Phosphodiesterase type 5 inhibitors and α-adrenergic blocking agents (α-blockers) are widely used for the treatment of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Aims To assess the efficacy and safety of fixed-dose combinations (FDCs) of tamsulosin and tadalafil compared with tadalafil monotherapy in patients with comorbid BPH-associated LUTS and ED. Methods A randomized, double-blinded, active-controlled trial was conducted of 510 men with BPH-associated LUTS and ED. Patients were treated with FDCs of tamsulosin 0.4 mg plus tadalafil 5 mg (FDC 0.4/5 mg), tamsulosin 0.2 mg plus tadalafil 5 mg (FDC 0.2/5 mg), or tadalafil 5 mg for a 12-week treatment period. For a subsequent 12-week extension period, the patients were administered FDC 0.4/5 mg. Outcomes The primary outcomes were changes from baseline in total International Prostate Symptom Score (IPSS) and International Index of Erectile Function erectile function domain (IIEF-EF) score at week 12 to prove superiority and non-inferiority of FDCs compared with tadalafil 5 mg. The safety assessments were adverse reactions, laboratory test results, and vital signs at week 24. Results The mean changes in total IPSS and IIEF-EF scores were −9.46 and 9.17 for FDC 0.4/5 mg and −8.14 and 9.49 for tadalafil 5 mg, respectively, which indicated superiority in LUTS improvement ( P = .0320) and non-inferiority in ED treatment with FDC 0.4/5 mg compared with tadalafil 5 mg. However, the results from FDC 0.2/5 mg failed to demonstrate superiority in LUTS improvement. No clinically significant adverse events regarding the investigational products were observed during the 24-week period. Clinical Implications The FDC 0.4/5 mg is the first combined formulation of an α-blocker and a phosphodiesterase type 5 inhibitor that offers benefits in patient compliance and as add-on therapy in patients with comorbid BPH-associated LUTS and ED. Strengths and Limitations The study clearly demonstrated the advantage of FDC 0.4/5 mg. The main advantage of FDC 0.4/5 mg was the enhanced efficacy on BPH-associated LUTS comorbidity with ED, the lower incidence of side effects, and the simplification and convenience of therapy, which led to better overall patient compliance. However, the lack of a tamsulosin monotherapy control group was a limitation of this study. Conclusion The FDC 0.4/5 mg therapy was safe, well tolerated, and efficacious, indicating that combination therapy could provide clinical benefits for patients with BPH-associated LUTS complaints and ameliorate the comorbidity of ED. Kim SW, Park NC, Lee SW, et al. Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial. J Sex Med 2017;14:1018–1027. [ABSTRACT FROM AUTHOR]

Introduction Quality assessment of randomized controlled trials ( RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice. Aim The aim of this study was to analyze the quality of studies reporting RCTs in andrology journals ( The Journal of Sexual Medicine [ JSM], the Asian Journal of Andrology [ AJA], the Journal of Andrology [ JOA], the International Journal of Andrology [ IJA]). Methods A quality assessment was conducted on all studies identified as RCTs published in andrology journals ( JSM, AJA, JOA, IJA) until 2011. The review period was divided into three terms: early, mid, and late each journal. Main Outcome Measures The Jadad scale, van Tulder scale, and the Cochrane Collaboration Risk of Bias Tool ( CCRBT) were employed. The RCTs were also categorized by country of origin, the inclusion of institutional review board ( IRB) approval, funding, and blindness. Results There were1,954 original articles published in the JSM, 893 articles in the AJA, 2,527 articles in the JOA, and 2,086 articles in the IJA for the review period. There were 172 studies reporting on RCTs in the JSM, 33 RCTs in the AJA, 63 RCTs in the JOA, and 29 RCTs in the IJA. No significant increase in Jadad or van Tulder scale scores were found over time, nor were there any significant changes in the number of high-quality articles as assessed by CCRBT. However, significant differences in quality analysis were found according to blinding, funding, and IRB approval. Conclusion The number of original articles and RCTs in andrology increased over time. However, the ratio of RCTs to original articles as well as RCT quality was statistically insignificant. It would be required for the researchers to focus efforts in performing high-quality studies to ensure appropriate randomization, reviews by IRB, financial support, and inclusion of allocation concealment during study performance. Jo JK, Chung JH, Kim KS, Song SH, and Lee SW. Reporting of randomized controlled trials in andrology journals: A quality assessment. J Sex Med 2015;12:350-357. [ABSTRACT FROM AUTHOR]

Introduction Quality assessment of randomized clinical trials ( RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice. Aim The aim if this study was to analyze the quality of studies reporting RCTs in the Journal of Sexual Medicine ( JSM) and to find relevant clinical impact. Methods A quality assessment was conducted in all studies identified as RCTs published in the JSM from 2004 to 2012. The review period was divided into three periods: early (2004-2006), mid (2007-2009), and late (2010-2012). Main Outcome Measures The Jadad scale, van Tulder scale, and the Cochrane Collaboration Risk of Bias Tool ( CCRBT) quality scoring instruments were used. The RCTs were also categorized by country of origin, topic, the inclusion of institutional review board ( IRB) approval, funding, citation rate, and impact factor. Results A total of 2,418 original articles were published in the JSM during the review period, and 188 were reports of RCTs. There were 39 (14.89%), 70 (7.77%), and 76 (6.29%) RCTs published during the early, mid, and late terms, respectively ( P < 0.001). No significant increases in Jadad or van Tulder scale scores were found over time nor were there any significant changes in the number of low-risk articles as assessed by the CCRBT. However, significant differences in quality analysis were found in funding and IRB approval. Citation rates and impact factor were not correlated with RCT quality using any of the tools. Conclusions The number of original articles and RCTs published in the JSM increased over time. However, the ratio of RCTs to original articles did not increase significantly. Adequate randomization and blinding methods, IRB review, and financial support are required for the conduct of high-quality RCTs. Jo JK, Chung JH, Kim KS, Lee JW, Lee SW, and International Evidence-Based Medicine Research (IEMR) Group. Randomized controlled trials in the Journal of Sexual Medicine: A quality assessment and relevant clinical impact. J Sex Med 2014;11:894-900. [ABSTRACT FROM AUTHOR]