Efficacy and Safety of Penile Girth Enhancement Using Hyaluronic Acid Filler and the Clinical Impact on Ejaculation: A Multi-Center, Patient/Evaluator-Blinded, Randomized Active-Controlled Trial.

PURPOSE: We aimed to evaluate the efficacy and safety of penile girth enhancement (PGE) using hyaluronic acid (HA) filler with different physical properties from previous studies. Additionally, we evaluated the clinical impact on ejaculation after PGE. MATERIALS AND METHODS: This was a prospective, patient/evaluator-blinded, randomized, active-controlled, multicenter trial. Patients recruited between December 2017 and March 2018 were randomly assigned to the HA filler or control group (polylactic acid [PLA] filler). Penile girth, satisfaction level, Premature Ejaculation Profile (PEP), and self-estimated intravaginal ejaculation latency time (IELT) were assessed at baseline and at 24 weeks post-injection. RESULTS: Sixty-four subjects (32 in each group) completed the trial. The mean increase in girth was 22.74±12.60 mm and 20.23±8.73 mm in the HA and control groups, respectively. Satisfaction level regarding penile appearance and sexual life significantly increased in both groups. There was no statistically significant difference between the groups in terms of increase in penile girth or change in satisfaction level. Both groups showed significant improvements in PEP index scores. Self-estimated IELT also significantly increased in the HA group (from 5.36±3.51 to 7.86±4.73 minutes, p=0.0001) and control group (from 5.23±3.55 to 6.43±4.22 minutes, p=0.021). No serious adverse events (AEs) were reported. CONCLUSIONS: PGE with HA and PLA fillers resulted in significant enhancement of girth without serious AEs with no significant differences. Furthermore, PGE using filler improved clinical symptoms related to ejaculation.

Molecular and Histologic Evidence of Novel Erectile Dysfunction Rat Model as an Aging Atherosclerosis Model: A Preliminary Study.

PURPOSE: To validate a novel arteriogenic erectile dysfunction (ED) model with atherosclerosis (AS) based on molecular and histologic evidence induced by chronic pelvic ischemia (CPI) and determine effect of phosphodiesterase-5 inhibitor treatment. MATERIALS AND METHODS: Twenty 16-week-old male Sprague-Dawley rats were divided into three experimental groups (Group I, untreated sham-operated rats with regular diet; Group II, CPI with cholesterol diet; Group III, CPI model with cholesterol diet and mirodenafil). Erectile function was accessed using maximum intracavernous pressure (ICP) and ICP/mean arterial pressure (MAP). Molecular changes were examined by western blot analysis using hypoxia inducible factor 1-alpha (HIF-1α), endothelial nitric oxide synthase (eNOS), and transforming growth factor beta-1 (TGF-ß1) antibodies. Collagen change was evaluated by Masson's trichrome staining. RESULTS: In vivo measurements of ICP and ICP/MAP in Group II were significantly lower than those in Group I (p<0.01). Smooth muscle/collagen ratio in Group II was significantly lower than that in Group I (p<0.05). After treatment with mirodenafil for four weeks, Group III showed significantly higher levels of ICP and ICP/MAP than Group II (p<0.05). Western blot analysis showed that HIF-1α and TGF-ß1 levels were significantly higher in Group II whereas eNOS levels were significantly lower in Group II than those in Group I or III. CONCLUSIONS: A novel arteriogenic ED with AS model is successfully induced by CPI and validated based on molecular and histologic evidences.

Complications of glans penis augmentation.

Despite the controversy regarding penile augmentation (PA), glans penis augmentation (GPA) is used in penile reconstructive surgery in selected patients with small glans penis. Since 2003, injectable hyaluronic acid (HA) gel has been used for GPA. The attractiveness of HA gel fillers and interest in this technique have led to the use of other fillers for GPA, particularly irreversible fillers that improve the longevity of HA gels. Conversely, indirect glans augmentation via implantation of dermofat grafts or scaffolds between the corpus spongiosum and the distal tip of the corpus cavernosum is used to overcome poor longevity of the gel and glans surface undulation, which are the primary limitations of GPA using HA gel. Unfortunately, these implants form hard painful lumps over time in most patients and are difficult to remove. Blunt dissection is an invasive procedure that may cause vascular compromise and consequent glans necrosis in a few patients. We present our review regarding the current status of GPA for a more comprehensive understanding of this subject. Additionally, we have discussed a few complicated cases that were referred to us.

Comparison of effective teaching methods to achieve skill acquisition using a robotic virtual reality simulator: Expert proctoring versus an educational video versus independent training.

BACKGROUND: To compare the superiority of teaching methods for acquiring a proficient level of surgical skill in a robotic surgery-naïve individual using a robotic virtual reality simulator. METHODS: This study employed a prospective, randomized study design to assess student's learning curve. We divided 45 subjects into 3 groups: those with expert proctoring (group I), those who watched only an educational video (group II), and those with independent training (group III; n = 15 per group). The task used in this study was the Tube 2 and it imitates a vesicourethral anastomosis in robotic prostatectomy. The effects were analyzed by the time to end the task after overcoming the learning curve which is determined by several performance parameters. RESULTS: The number of task repetitions required to reach the learning curve plateau was 45, 42, and 37 repetitions in groups I, II, and III, which means that there was continuous improvement in performing the task after 40 repetitions only in groups I and II. The mean time for completing the task during the stabilization period was significantly different between group I and group III and group II and group III, which means that the independent training method was inferior to the other methods (group I vs. group II vs. group III: 187.38 vs. 187.07 vs. 253.47 seconds, P < .001). CONCLUSIONS: This study's findings showed that an educational video can be as beneficial as expert proctoring, which implies that the development of a standardized educational video would be worthwhile.

Practice Patterns Among Korean Urologists for Glans Penis Augmentation Using Hyaluronic Acid Filler in the Management of Premature Ejaculation.

INTRODUCTION: Glans penis augmentation (GPA) using hyaluronic acid (HA) gel has been developed for treating premature ejaculation (PE) with penile hypersensitivity. The injected HA filler creates a barrier that reduces the tactile stimuli to the hypersensitive dorsal nerve. Although the HA filler is biodegradable and is believed to not cause permanent loss of sexual function, the current International Society for Sexual Medicine guideline for PE does not recommend this procedure owing to concerns regarding sexual dysfunction. AIM: To investigate the practice patterns for GPA using HA filler among Korean urologists, and to identify whether urologist experienced patient reports of sexual dysfunction post-treatment. METHODS: Between March 2016 and July 2016, a specially designed questionnaire was mailed to 86 selected Korean urologists who had used injectable materials to treat PE. MAIN OUTCOME MEASURES: The prevalence and awareness of sexual dysfunction after GPA using HA filler were evaluated. RESULTS: Overall, 56 urologists completed the survey (response rate: 69.2%), of which 36 (64.3%) had performed GPA using HA filler. They reported having performed a combined total of 4,344 such GPA procedures. Most urologists (72.7%) performed GPA using HA filler in patients who benefit from topical anesthetics. Patients with a history of failed pharmacotherapy (59.1%) and selective dorsal nerve neurotomy (45.5%) were selected for GPA using HA filler. The respondents (44.4%) encountered overall 206 (4.7%) cases of patients reports of recurrence of PE. Interestingly, only 36 (0.8%) cases of glans pain or paresthesia and no cases of erectile dysfunction post-treatment were reported. CONCLUSION: Korean urologists performed GPA using HA filler when pharmacotherapy failed or if there was a response to topical treatment. Paresthesia and hypoesthesia after GPA using HA filler are rare, and no cases of erectile dysfunction were encountered by Korean urologists. Jeong HG, Ahn ST, Kim JW, et al. Practice Patterns Among Korean Urologists for Glans Penis Augmentation Using Hyaluronic Acid Filler in the Management of Premature Ejaculation. Sex Med 2018;6:297-301.

Predictive Validation of a Robotic Virtual Reality Simulator: The Tube 3 module for Practicing Vesicourethral Anastomosis in Robot-Assisted Radical Prostatectomy.

OBJECTIVE: To predict actual performance in real surgery when vesicourethral anastomosis (VUA) is performed in patients after Tube 3 module training of robot-naive surgeons. METHODS: Forty-five patients were enrolled and divided into 3 groups according to chronological trends (each containing 15 patients). Three robot-naive surgeons in a single center completed VUA in robot-assisted radical prostatectomy (RARP) following robotic virtual reality simulator (RVRS) training. The practicing tool used in robotic virtual reality simulator was Tube 3, which was invented for the dV-Trainer that imitates a VUA in RARP. The effects of performance were investigated by analyzing the number of repetitions and the time required to complete the task until achieving the predetermined proficiency level. RESULTS: The targeted time (predetermined proficiency level) for completing tasks of Tube 3 and the number of required task repetitions to achieve the proficiency level were 283.1 s and 36 times, respectively, whereas in actual VUA procedures, the number of required attempts was 24, with an average time of 14.9 minutes. The mean time for completing VUA in real surgery significantly decreased with serial cases among all surgeons (1-15 vs 16-30 vs 31-45 cases, P <.001), as well as comparisons between groups (P <.001). CONCLUSION: The Tube 3 module can represent a valuable educational tool for procedure-specific robotic training by bridging the gap between safe acquisition of surgical skills and effective performance during actual VUA in RARP.

Decreased expression of bone morphogenetic protein-2 is correlated with biochemical recurrence in prostate cancer: Immunohistochemical analysis.

We evaluated the prognostic value of BMP-2 expression in prostate cancer tissue via immunohistochemistry in prostate cancer patients. From July 2007 to August 2010, radical prostatectomy specimens from 90 patients with clinically localized prostate cancer (mean age, 62.7 years, mean follow-up 90.4 months) were assessed for BMP-2 expression using immunohistochemistry. We used stepwise multivariate Cox regression models stratified by study to assess the independent effects of the predictive factors and estimated hazard ratios (HRs). There were significant differences in the baseline characteristics of Gleason score (GS) and biochemical recurrence (BCR) between the groups with decreased and normal BMP-2 expression. Univariate analysis revealed GS, T stage (≥T3), and decreased BMP-2 expression as significant predictive determinants of BCR. In addition, GS (7: HR 2.836, p = 0.022; ≥8: HR 3.506, p = 0.048) and decreased BMP-2 expression (HR 2.007, p = 0.047) were significantly correlated with BCR in multivariate analysis. Overall five-year BCR-free survival rates in the group with decreased BMP-2 expression were worse than those in the group with normal expression. Therefore, decreased BMP-2 expression in prostate cancer tissue was correlated with the prognostic factors for BCR-free survival in patients with prostate cancer.

Author Correction: Decreased expression of bone morphogenetic protein-2 is correlated with biochemical recurrence in prostate cancer: Immunohistochemical analysis.

A correction to this article has been published and is linked from the HTML and PDF versions of this paper. The error has not been fixed in the paper.

Androgen Receptor CAG Repeat Length as a Risk Factor of Late-Onset Hypogonadism in a Korean Male Population.

BACKGROUND: Testosterone action is mediated through the androgen receptor (AR), whose sensitivity is influenced by the AR CAG repeat polymorphism. However, the relation between late-onset hypogonadism (LOH) and AR CAG repeat length is unclear and studies of Asian populations are limited. AIM: To investigate the relation between AR CAG repeat length and LOH in Korean men. METHODS: 263 Korean men (mean age = 63.43 ± 10.9 years) were enrolled from 2014 to 2015. LOH diagnosis was based on a serum testosterone level lower than 3.5 ng/mL and positive androgen deficiency according to the Aging Males' Symptom Scale (AMS). Total testosterone levels and answers to the LOH-related questionnaire were analyzed. OUTCOMES: The relation between AR CAG repeat length and LOH was determined. RESULTS: Mean CAG repeat length was 22.1 ± 4.6 and mean serum testosterone levels were 2.6 ± 0.7 and 6.0 ± 2.0 ng/mL in men with and without LOH, respectively. Men with LOH showed significantly longer AR CAG repeat lengths than men without LOH (26.1 vs 21.6, P < .001). Longer CAG repeat lengths were correlated with higher AMS total scores (r = 0.454, P = .001) and AMS psychotic, somatic, and sexual sub-scores (r = 0.276, 0.246, and 0.571, P = .006, .007, .001, respectively) and significantly lower 5-item International Index of Erectile Function scores (r = -0.261, P = .001). Multivariate analysis showed that patient age and CAG repeat length were independently associated with LOH (odds ratio = 1.05 and 1.29, P = .041 and <.001, respectively). CLINICAL IMPLICATIONS: A longer CAG repeat length is associated with LOH symptoms and LOH. STRENGTHS AND LIMITATIONS: Associations between CAG repeats and LOH were verified in Korean patients. Moreover, a longer CAG repeat length was shown to be an independent risk factor for LOH. Limitations included the small number of LOH patients studied and that other sex hormone-associated factors were not measured. CONCLUSIONS: AR CAG repeat length was associated with LOH prevalence and clinical symptoms in this Korean male population. Thus, it is important to measure CAG repeat length for patients with LOH symptoms with normal testosterone levels. Kim JW, Bae YD, Ahn ST, et al. Androgen Receptor CAG Repeat Length as a Risk Factor of Late-Onset Hypogonadism in a Korean Male Population. Sex Med 2018;6:203-209.

Detection and recurrence rate of transurethral resection of bladder tumors by narrow-band imaging: Prospective, randomized comparison with white light cystoscopy.

Purpose: The purpose of this study was to evaluate the efficacy of narrow-band imaging (NBI) as a diagnostic tool for detecting bladder tumors during cystoscopy compared with white light cystoscopy (WLC). Materials and Methods: From December 2013 to June 2017, a randomized prospective study was conducted on 198 patients underwent transurethral resection of bladder tumor by a single surgeon. The patients were divided into two groups according to diagnostic method. In Group I, WLC only was performed. In Group II, NBI was additionally performed after WLC. We analyzed the rate of detection of bladder tumors as a primary endpoint. In addition, we evaluated rates of recurrence in each group. Results: There were no significant differences between the two groups in characteristics except hypertension. In the analysis of rates of detection, the probability of diagnosing cancer was 80.9% (114/141) in the WLC group, and the probability of diagnosing cancer using WLC in the NBI group was 85.5% (159/186). After switching from WLC to NBI for second-look cystoscopy in the NBI group, NBI was shown to detect additional tumors with a detection rate of 35.1% (13/37) from the perspective of the patients and 42.2% (27/64) from the perspective of the tumors. The 1-year recurrence-free rate was 72.2% in the WLC group and 85.2% in the NBI group (p=0.3). Conclusions: NBI had benefits for detecting tumors overlooked by WLC. Although the difference in the 1-year recurrence-free rate was not statistically significant, our results showed a trend for higher recurrence in the NBI group.

The effects of a heating pad on anxiety, pain, and distress during urodynamic study in the female patients with stress urinary incontinence.

AIMS: Although generally well tolerated, a urodynamic study is an unpleasant and stressful procedure for some patients. This study evaluated the effects of a heating pad on anxiety, pain, and distress during urodynamic studies in female patients with stress urinary incontinence. METHODS: A total of 74 female patients with stress urinary incontinence who underwent a urodynamic study between May 2015 and October 2015 were randomized to either the experimental group using a heating pad (n = 37) or control group (n = 37). In the experimental group, a heating pad was applied on the patient's sacrum during the urodynamic study. All patients completed the State-Trait Anxiety Inventory (20-80) before and after the procedure and assessed their degree of pain and distress after the procedure by the visual analog scale (0-10). Systolic and diastolic blood pressure and pulse rate were also checked before and after the procedure. RESULTS: Demographic characteristics, mean age, procedure duration, pre and post-procedural systolic, and diastolic blood pressures, and pulse rate were statistically similar between the experimental and control groups. The mean State-Trait Anxiety Inventory was significantly lower in the experimental group than in the control group (30.9 ± 7.5 vs 42.5 ± 10.1, P < 0.001). The experimental group showed significantly lower pain and distress scores (Visual Analog Scale, 2.7 ± 1.5, 3.0 ± 1.5) compared with the control group (4.0 ± 1.6, 4.7 ± 2.0, both P < 0.001). CONCLUSIONS: Using a heating pad for female patients with stress urinary incontinence during a urodynamic study is a simple, economical, and effective therapy that enhances patient comfort and decreases anxiety, pain, and distress.

Positive Correlation between Androgen Receptor CAG Repeat Length and Metabolic Syndrome in a Korean Male Population.

PURPOSE: In epidemiological studies, there are various associations of androgen receptor (AR) CAG with several diseases or phenotypes. However, the relationship between CAG repeat length and metabolic syndrome (MS) remains unclear, especially in Asian populations. This study was designed to evaluate the relationship between AR CAG repeat length polymorphism and MS in a Korean male population. MATERIALS AND METHODS: We explored the relationship between AR CAG repeat length polymorphism and MS in a Korean male population (n=337) from 2013 to 2014. AR CAG repeat were determined by microsatellite fragment sizing. Components of MS and laboratory data (lipid profile, fasting glucose, and glycated hemoglobin (HbA1c)) were analyzed with AR CAG repeat length. RESULTS: The mean AR CAG repeat length was 22.3±4.7. Sixty-nine men (20.5%) were diagnosed with MS. Men with MS showed significantly longer AR CAG repeat lengths compared with men without MS (26.2 vs. 21.4, p<0.001). With increasing CAG repeat, the number of components meeting the NCEP criteria increased significantly. AR CAG repeat length was associated significantly with high density lipoprotein (HDL), triglyceride, and HbA1c levels. In the multivariate analysis, CAG repeat length, waist circumference, and levels of HDL were independently associated with MS. (odds ratio (OR)=1.37, 1.19 and 0.90, p<0.001, 0.045, and 0.001, respectively). CONCLUSIONS: AR CAG repeat length was associated with MS and laboratory test results, such as those for HDL, triglycerides, and HbA1c, in Korean males. Longer CAG repeat length was identified as a risk factor for MS in Korean males.

Efficacy of holmium laser enucleation of the prostate (HoLEP) in men with bladder outlet obstruction (BOO) and non-neurogenic bladder dysfunction.

We aimed to compare the short-term outcomes of men who had urodynamic evidence of detrusor underactivity (DU) or detrusor overactivity (DO) of a non-neurogenic etiology as well as bladder outlet obstruction (BOO) and who underwent Holmium Laser Enucleation of the prostate (HoLEP). A database of 322 patients who underwent HoLEP between 2010 and 2014 was analyzed. Patients were classified into three groups according to the results of a preoperative urodynamic study. Preoperative parameters such as International Prostate Symptom Score (IPSS), Quality of Life (QoL) index, IPSS grade, uroflowmetry were compared with postoperative parameters measured at 6 months. There were 138 patients with BOO-only and 89 patients with BOO and detrusor dysfunction including 56 with DO and 33 with DU. The degree of improvement in IPSS-total (BOO: 10.7, DO: 8.3, DU: 7.0; p = 0.023) was greater in the BOO-only group than in the DU group. There were more patients whose IPSS grade improved in the BOO-only group (71%) than in the detrusor dysfunction group (DO: 53.6% and DU: 45.5%). Postoperative IPSS-voiding (4.5 vs 7.0), and Qmax (18 vs 13.7) in the BOO-only group were significantly better than those in the DU group. Additionally, postoperative IPSS-storage (4.7 vs 6.7), and IPSS-total (9.1 vs 12.3) in the BOO-only group were significantly better than in the DO group (all p < 0.05). In conclusion, early surgical management for men with severe LUTS and associated BPH before secondary degeneration occurs may be beneficial for preserving detrusor function and yield better treatment outcomes.

The usefulness of flexible cystoscopy for preventing double-J stent malposition after laparoscopic ureterolithotomy.

BACKGROUND: The aim of this study was to evaluate the role of flexible cystoscopy in preventing malpositioning of the ureteral stent after laparoscopic ureterolithotomy in male patients. METHODS: From April 2009 to June 2015, 97 male patients with stones >1.8 cm in the upper ureter underwent intracorporeal double-J stenting of the ureter after laparoscopic ureterolithotomy performed by four different surgeons. In the last 50 patients who underwent laparoscopic ureterolithotomy flexible cystoscopy was performed through the urethral route to confirm the position of the double-J stent, while in the first 47 correct positioning of the stent was confirmed through postoperative KUB. The demographic data and perioperative outcomes were reviewed retrospectively. Penalized logistic regression analysis was used to evaluate the effects of flexible cystoscopy. RESULTS: Upward malpositioning of the ureteral stent was found in 9 of the 47 (19.1%) patients who underwent surgery without flexible cystoscopy. Among the 50 most recent patients who underwent surgery with flexible cystoscopy through the urethral route, upward malpositioning was observed in 10 (20%) patients. The factors preventing upward malpositioning of the double-J catheter in multivariate analysis were surgeon (p = 0.039) and use of flexible cystoscopy (p = 0.008). CONCLUSION: Flexible cystoscopy is a simple, safe, quick, and effective method to identify and correct malpositioning of double-J stents, especially in male patients. TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov Registry on May 11, 2017 (retrospective registration) with a trial registration number of NCT03150446 .

A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Therapeutic Confirmatory Study to Evaluate the Safety and Efficacy of Avanafil in Korean Patients with Erectile Dysfunction.

A multi-center, randomized, double-blind, placebo-controlled study was conducted with 158 subjects who were randomized to placebo or avanafil 50, 100, and 200 mg on demand for 8 weeks to evaluate the safety, tolerability, and efficacy of avanafil in the treatment of erectile dysfunction (ED) in Korean men. The primary outcome was the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire. Secondary outcomes included changes in the scores of IIEF questions 3 and 4 (IIEF Q3, Q4) from baseline, changes in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2-5 (SEP2-5), the Global Efficacy Assessment Question (GEAQ), and the number of subjects whose EF domain score at the 8th week visit was ≥ 26. After 8 weeks of treatment, the dose groups except avanafil 50 mg scored significantly higher on the IIEF-EF domain from baseline than the placebo group. The changes from baseline in the avanafil group in IIEF Q3 (all doses) and Q4 (200 mg alone) were higher than the placebo group. The differences between avanafil and placebo groups were significant in SEP2 (100 and 200 mg) and SEP3-5 (200 mg). The differences in the GEAQ "Yes" response were also significant in the avanafil 100 and 200 mg groups. Regarding the ratio of normal EF at the end of the study, avanafil 200 mg differed significantly from the placebo. Most treatment-associated adverse events were mild and resolved spontaneously. This is a clinical trial study and was registered at www.ClinicalTrials.gov (Identifier: NCT02477436).

Can Listening to Music Decrease Pain, Anxiety, and Stress During a Urodynamic Study? A Randomized Prospective Trial Focusing on Gender Differences.

OBJECTIVE: To evaluate the effect of listening to music on pain, anxiety, or stress during a urodynamic study (UDS). MATERIALS AND METHODS: A total of 74 female and 74 male patients who underwent UDS between March 2013 and October 2013 were prospectively randomized. The patients were divided into 2 groups according to gender (female, n = 74 vs male, n = 74) and into 2 subgroups according to whether they listened to music or not. Music group subjects played their preferred music during UDS. Before and after UDS, all subjects completed the State-Trait Anxiety Inventory (STAI) form and their degree of pain, anxiety, and satisfaction during examination were assessed by the visual analog scale (VAS, 0-10). Basic vital signs were also checked before and after the procedure. RESULTS: In the analysis of anxiety, pain, and stress scores, the mean shame, discomfort, and satisfaction scores (VAS) were significantly higher in female patients, whereas the mean score of willingness to retry the procedure was higher in male patients whether listening to music or not (P < .001). In the analysis of differences of STAI total, state anxiety, and trait anxiety, there were no statistical significances between the music group and the no-music group in either gender. CONCLUSION: In our study, music during UDS did not reduce anxiety, pain, and stress in either gender. In the analysis focusing on gender difference, female patients showed statistically higher levels of pain, anxiety, and stress scores than male patients whether listening to music or not.

A prospective, multicenter analysis of pseudocapsule characteristics: Do all stages of renal cell carcinoma have complete pseudocapsules?

OBJECTIVES: To assess the characteristics of pseudocapsule (PC) in localized renal cell carcinoma (RCC) by analyzing the rates of completeness of PC and pseudocapsular invasion and clinical and pathological risk factors of it. MATERIALS AND METHODS: Between February 2013 and September 2015, data were gathered prospectively from 180 consecutive patients who underwent partial nephrectomy or radical nephrectomy at 3 institutions, and 161 were enrolled. Evaluated factors included age and sex; histologic factors such as tumor diameter, stage, tumor subtype, necrosis, and Fuhrman grade; and clinical factors such as RENAL score; and completeness of PC. RESULTS: Only 94 tumors (58.4%) were surrounded by a continuous PC completely, 62 (38.5%) were partially surrounded, and 5 (3.1%) had no PC. Overall, 56 PCs (34.8%) were free from invasion, 58 PCs (36.0%) had partial invasion of PC without parenchymal invasion, and 47 PCs (29.2%) had parenchymal invasion. Defining parenchymal invasion as true pseudocapsular invasion, histologic diameter, RCC subtype, and completeness of PC were significant predictors for parenchymal invasion on multivariate analysis (P = 0.006, 0.046, and 0.002, respectively). CONCLUSIONS: Rate of complete PC in RCC is relatively low in this study. The risk factors for pseudocapsular invasion were a histologic diameter greater than 4cm, non-clear cell histology, and an incomplete PC. Surgeons must prepare for the possibility of a positive surgical margin if a tumor has at least one of these risk factors.

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.

The Outcome of Multiple Slit on Plaque with Plication Technique for the Treatment of Peyronie's Disease.

PURPOSE: To evaluate the postoperative outcome of the multiple slit on plaque plication technique for the treatment of Peyronie's disease. MATERIALS AND METHODS: We retrospectively evaluated 22 patients who underwent plaque incision with penile plication for the surgical treatment of Peyronie's disease, who had failed medical treatment between 2009 and 2014. Patients were grouped by preoperative degree of penile curvature into Group I: mild (n=5, 22.7%), Group II: moderate (n=11, 50.0%), and Group III: severe (n=6, 27.3%). After a thorough review of the medical records, we evaluated (a) the correction of the curvature; (b) sexual function; and (c) any penile shortening or other complications. RESULTS: The mean postoperative follow-up period was 39 months. Complete correction of the curvature was attained in 21 patients (95.5%). As an inevitable complication, minimal penile shortening (<1.5 cm) was reported by 14 patients (82.4%) but did not adversely affect sexual intercourse (0%), and all patients found the extent of penile shortening to be acceptable. Nineteen patients had good erectile function (International Index of Erectile Function >21). The most frequent complication was subcutaneous penile edema in three patients (13.6%), which was resolved within about 3 months following surgery. CONCLUSIONS: As a modified technique, multiple slit on plaque with plication is a simple, minimally-invasive and effective technique for correcting penile curvature regardless of curvature severity. The degree of penile curvature does not significantly predict the amount of penile length loss.

The Efficacy of Medical Treatment of Peyronie's Disease: Potassium Para-Aminobenzoate Monotherapy vs. Combination Therapy with Tamoxifen, L-Carnitine, and Phosphodiesterase Type 5 Inhibitor.

PURPOSE: This study was designed to evaluate the efficacy of medical treatment of Peyronie's disease. MATERIALS AND METHODS: A total of 109 patients with Peyronie's disease who had been treated from January 2011 to December 2014 were retrospectively reviewed in this study. Forty-four patients (Group 1) were treated with 12 mg of potassium para-aminobenzoate daily. Sixty-five patients (Group 2) were treated with combination therapy: tamoxifen (20 mg) and acetyl-L-carnitine (300 mg) twice daily in addition to a phosphodiesterase type 5 inhibitor. Ability to perform sexual intercourse, pain during erection, size of plaque, and penile curvature angle were assessed. RESULTS: In Group 1, 30 of 44 patients (68.2%) discontinued treatment within 12 weeks, while 5 patients (7.7%) in Group 2 discontinued treatment. Pain during erection and plaque size were improved in both groups but showed no statistical difference due to the high dropout rate in Group 1. In both groups, penile curvature was improved, but demonstrated no statistical difference between the treatment groups. However, combination therapy demonstrated a better response rate in patients whose penile curvature angle was less than 30° (44.4% vs. 79.1%, p=0.048). The rate of successful sexual intercourse was significantly higher in Group 2 (42.8% vs. 78.3%, p=0.034). The number of patients who underwent surgical correction despite medical treatment was significantly higher in Group 1 (35.7% vs. 13.3%, p=0.048). CONCLUSIONS: Early medical combination therapy in Peyronie's disease may present better results in patients whose curvature angle is less than 30°.