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.

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).

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 efficacy of combination treatment with injectable testosterone undecanoate and daily tadalafil for erectile dysfunction with testosterone deficiency syndrome.

INTRODUCTION: Both testosterone therapy and chronic treatment with phosphodiesterase type 5 inhibitors (PDE5Is) have positive effects on the histology of penile corpora and erectile function. However, few clinical studies have evaluated the efficacy of combination therapy with both testosterone replacement and chronic PDE5Is. AIM: This study was designed to evaluate the efficacy and safety of combination treatment with long-acting injectable testosterone undecanoate (TU) and a once-daily tadalafil 5 mg for erectile dysfunction with testosterone deficiency syndrome. METHODS: Sixty patients were consecutively enrolled and followed for 36 weeks. Thirty patients were randomly assigned to group I and received 1,000 mg of parenteral TU on day 1, followed by additional injections at weeks 6 and 18 with on-demand tadalafil 10-20 mg during the 30 weeks of treatment. The remaining 30 patients received the same dose and schedule of TU as group I, and were prescribed once-daily tadalafil 5 mg during 30 weeks. MAIN OUTCOME MEASURES: Serological tests were performed, and the International Index of Erectile Function (IIEF), Aging Males' Symptoms (AMS) questionnaires, and Global Assessment Question (GAQ) were administered to the patients. RESULTS: Total IIEF and AMS scores were significantly improved during the 30 weeks of treatment in both groups. When IIEF scores were compared between the two groups, group II showed better symptom scores than group I at weeks 6 and 30. A similar pattern was observed when comparing AMS scores between the groups. At week 36, changes in IIEF and AMS scores that indicated worsened symptoms compared with week 30 were observed in both groups; group II showed better symptom scores than group I. On the GAQ, the ratio of patients reporting improvement in erectile function was significantly higher in group II than group I. CONCLUSIONS: The combination of long-acting injectable TU and once-daily tadalafil 5 mg produced a significant improvement in erectile function. Moreover, the improvement in erectile function was well maintained, even after the cessation of treatment.

Efficacy of once-daily administration of udenafil for 24 weeks on erectile dysfunction: results from a randomized multicenter placebo-controlled clinical trial.

INTRODUCTION: The method of administration of oral phosphodiesterase-5 inhibitors has been expanded to once-daily repeated administration with lower initial dosage than on-demand administration. AIM: The aim of this study was to evaluate the efficacy and safety of once-daily udenafil as a treatment for erectile dysfunction (ED) for intermediate-term period. METHODS: This multicenter, randomized, double-blind clinical trial included 346 ED patients (placebo, udenafil 50 mg, udenafil 75 mg). Subjects were treated with each medication once daily for 24 weeks. MAIN OUTCOME MEASURES: Subjects were asked to complete the International Index of Erectile Function (IIEF)-erectile function (EF) domain at baseline, 12 weeks, and 24 weeks and the development of adverse drug reactions (ADRs) was inspected. RESULTS: Both dosages of udenafil induced a significant increase in IIEF-EF compared with placebo at both 12 and 24 weeks. When patients were divided according to the severity of baseline EF score, significant improvement was observed only with udenafil 75 mg regardless of the degree of ED. At 24 weeks, the proportions of patients who reported a return to normal EF (IIEF-EF over 26) were 39.1% for udenafil 50 mg and 47.0% for udenafil 75 mg. In terms of safety, ADRs were observed in 6.1%, 12.9%, and 17.9% for placebo, udenafil 50 mg, and 75 mg, respectively. Although a statistically higher rate of ADRs was observed in the udenafil 75 mg group (P = 0.024), the majority were mild and recovered without treatment. CONCLUSIONS: Once-daily administration of udenafil 50 mg and 75 mg for 24 weeks resulted in improvement of EF. In particular, udenafil 75 mg improves EF regardless of the baseline degree of ED.

Terminal dribbling in male patients with lower urinary tract symptoms: relationship with International Prostate Symptom Score and with intravesical prostatic protrusion.

BACKGROUND: Terminal dribbling is one of the lower urinary tract symptoms (LUTS) that has not been widely studied. The aim of this study was to investigate the associations between terminal dribbling (TD) and other parameters such as International Prostate Symptom Score (IPSS) and intravesical prostatic protrusion (IPP). METHODS: Medical records of male patients with LUTS aged 40 years and older were prospectively collected. Data regarding TD defined by the International Continence Society standardization subcommittee, IPSS, prostate-specific antigen, total prostate volume, and IPP on transrectal ultrasonography were obtained. TD was confirmed by the subsequent uroflowmetry (uroflowmetry-confirmed TD). Logistic regression analysis was performed to identify the parameters affecting TD and uroflowmetry-confirmed TD. RESULTS: Among the 578 men, 226 patients (39.1%) complained of TD and 157 patients (27.2%) had objective findings of TD on uroflowmetry. In the logistic regression analysis, IPSS voiding subscore were correlated with TD (Odds ratio 1.06). In addition, IPP was the only significant risk factor for uroflowmetry-confirmed TD (Odds ratio 2.83). Each question of IPSS is not correlated with TD or uroflowmetry-confirmed TD. CONCLUSIONS: While the symptom of TD is well correlated with IPSS voiding subscore, objective evidence of TD on uroflowmetry had strong correlation with IPP. TD should be investigated further to reveal its clinical impact and guide a proper management.

Immunoglobulin G4-related paratesticular fibrous pseudotumor and retroperitoneal fibrosis: a case report.

A 46-year-old man with a past history of retroperitoneal fibrosis was admitted with an enlarged, hard right testis. The paratesticular lesion showed heterogeneous hypoechogenicity on ultrasonography, low signal intensity on T1- and T2-weighted magnetic resonance imaging (MRI), and lack of diffusion restriction on diffusion-weighted MRI. Following steroid treatment, the paratesticular mass was decreased in size on follow-up computed tomography. The radiologic and clinical features are recognized as a manifestation of immunoglobulin G4-related sclerosing disease involving the paratesticular region and retroperitoneum.

Prevalence of symptoms and associated comorbidities of testosterone deficiency syndrome in the Korean general population.

INTRODUCTION: Testosterone deficiency syndrome (TDS) is a prevalent disease of the aging male with much confusion to its associated presentation, diagnosis, and comorbidities. AIM: We investigated the overall prevalence of TDS and its putative symptoms and associated diseases in a nationwide study on participants recruited from routine checkup. METHODS: One thousand eight hundred seventy-five participants seeking biennial health checkup were enrolled from a nationwide distribution of randomly selected registry of primary clinics. Putative symptoms and comorbidities were assessed for serum testosterone-dependent prevalence change, independent of age. The identified symptoms were then assessed by multivariate backward stepwise binominal regression to determine the optimal reference level of testosterone and the strength of the associated comorbidities. MAIN OUTCOME MEASURES: TDS was assessed by serum testosterone, the Aging Males' Symptom scale, and the Androgen Deficiency in Aging Male questionnaire. Patient body habitus measurements and history of associated comorbidities were also described. The dependent variables included the age-specific prevalence of decreased testosterone and the probability of TDS-specific symptoms. RESULTS: Grossly 10.2% of the participants fell into the criteria for TDS. Testosterone was highly age dependent, and most putative symptoms of TDS showed significant age dependence but was not affected by serum testosterone levels. However, the symptoms of decreased libido and erectile dysfunction, and comorbidities such as hypertension, type 2 diabetes, and obesity showed relevant dependence on serum testosterone levels as well as age above 50 years of age. Furthermore, these symptoms were also affected at different serum testosterone thresholds. Decreased libido increased significantly at serum testosterone levels of 550 ng/dL (odds ratio [OR] = 1.295, 95% confidence interval [CI] = 1.047-1.601), and erectile dysfunction was affected by serum testosterone levels at 250 ng/dL (OR = 1.369, 95% CI = 1.005-1.866). CONCLUSIONS: Most symptoms and diseases thought to be associated with TDS are primarily age dependent. Few sexual symptoms and diseases such as hypertension, diabetes, and obesity show testosterone dependence only at older ages.

Prognostic factors for recurrence-free and overall survival after adrenalectomy for metastatic carcinoma: a retrospective cohort pilot study.

BACKGROUND: The survival benefits of adrenalectomy (ADx) in the setting of metastatic cancer and prognostic factors for recurrence-free (RFS) and overall survival (OS) after adrenalectomy for metastatic carcinoma are still under debate. We evaluated the impact of clinicopathological variables on RFS and OS after ADx for metastatic carcinoma in patients with primary cancer. METHODS: A total of 32 patients undergoing ADx for metastatic cancer between 2004 and 2012 at two tertiary medical centers. Metastases were regarded as synchronous (<6 months) or metachronous (≥6 months) depending on the interval after primary surgery. Associations of perioperative clinicopathologic variables with RFS and OS were analyzed using Cox regression models. RESULTS: In total, 32 patients received ADx for metastatic primary tumors located in the lung (n = 11), colon (n = 4), liver (n = 5), stomach (n = 3), kidney (n = 4), pancreas (n = 2), glottis, esophagus, cervix, and ovary (n = 1 each). The overall recurrence rate after adrenalectomy was 62.5% (n = 20). By univariate analysis, C-reactive protein, inflammation-based prognosis score, and adrenalectomy for curative intent were associated with RFS and OS. Independent prognostic factors for shorter RFS were operative method (laparoscopy HR 4.68, 95% CI 1.61-13.61, p = 0.005) and inflammation-based prognostic score (HR 11.8, 95% CI 2.50-55.7, p = 0.002). For shorter OS, synchronous metastasis (HR 3.05, 95% CI 1.07-11.94, p = 0.048) and inflammation-based prognostic score (HR 6.65, 95% CI 1.25-35.23, p = 0.026) were identified as independent prognostic factors. CONCLUSIONS: Our pilot study suggests that synchronous disease and inflammation-based prognostic score are significant prognostic factors for survival and should be considered when performing ADx for metastatic diseases.

Prediction of persistent storage symptoms after transurethral resection of the prostate in patients with benign prostatic enlargement.

OBJECTIVE: To identify the prognostic factors causing persistent storage symptoms following transurethral resection of the prostate in patients with benign prostatic enlargement (BPE). METHODS: A total of 116 men with symptomatic BPE requiring surgery were enrolled in the study between January 2011 and December 2012. The patients underwent basic clinical evaluations including transrectal ultrasound, International Prostate Symptom Score and urodynamic study. After 6 months, International Prostate Symptom Score and uroflowmetry were rechecked. The definition of persistent storage symptoms was patients with storage scores >7 points. Logistic regression analysis and receiver operating characteristic analysis were conducted. RESULTS: The 116 patients were divided into a persistent storage symptom-positive group (n = 33) and a storage symptom-negative group (n = 83). Multivariate analysis showed that the degrees of worse initial storage symptoms (odds ratio [OR] = 8.32), small bladder capacity (OR = 4.31), impaired detrusor contractility (OR = 2.96) and age (OR = 1.05) were consistently associated with persistent storage symptoms. CONCLUSIONS: This short-term study confirms the positive and consistent correlations between the baseline degree of worse initial storage symptoms, bladder capacity, detrusor contractility and age and the improvement in storage symptoms.

Nocturnal polyuria and decreased serum testosterone: is there an association in men with lower urinary tract symptoms?

OBJECTIVES: To investigate the putative association between nocturia and decreased serum testosterone in men with lower urinary tract symptoms. METHODS: Frequency volume charts and serum testosterone levels of patients visiting the outpatient clinic for lower urinary tract symptoms were collected and analyzed. Age, prostate volume, body mass index and the presence of comorbidities were accounted for. Frequency volume charts were analyzed for pathophysiological components of nocturnal polyuria, global polyuria, decreased nocturnal bladder capacity and increased frequency to identify associated risks. Frequency volume charts were also used to chart 8-h changes of volume, frequency and capacity to identify time diurnal interactions with risk factors based on serum testosterone levels. RESULTS: A total of 2180 patients were enrolled in the study. Multivariate analysis showed testosterone decreased 0.142 ng/mL for every increase in nocturia, independent of other factors. Logistic regression analysis showed a significant difference between pathophysiological components. Decreased testosterone was shown to carry a significant independent risk for overall nocturia (odds ratio 1.60, 95% confidence interval 1.013-2.527, P = 0.044), and particularly nocturnal polyuria (odds ratio 1.934, 95% confidence interval 1.001-3.737, P = 0.027). Repeated measurement models showed patients with serum testosterone below 2.50 ng/mL to have a paradoxical increase in nocturnal urine volume at night. CONCLUSIONS: Nocturia, especially nocturnal polyuria, is associated with decreased serum testosterone. Patients with low serum testosterone show increased nocturnal urine output.

Efficacy and safety of avanafil for treating erectile dysfunction: results of a multicentre, randomized, double-blind, placebo-controlled trial.

UNLABELLED: Study Type--Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Avanafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor newly developed for treating erectile dysfunction (ED). Preclinical and clinical phase I studies showed that avanafil had enhanced selectivity, faster onset of action and a favourable side-effect profile relative to currently available PDE5 inhibitors. As the result of phase III clinical trial for the efficacy and safety of avanafil treatment (100 and 200 mg), taken as needed over a period of 12 weeks, in Korean patients with ED, avanafil is an effective and well-tolerated therapy for ED of broad-spectrum aetiology and severity. OBJECTIVE: • To evaluate the efficacy and safety of avanafil, a new potent selective phosphodiesterase type 5 (PDE5) inhibitor, in patients with erectile dysfunction (ED). PATIENTS AND METHODS: • The present study was a multicentre, randomized, double-blind, placebo-controlled, fix-dosed phase three clinical trial involving 200 patients with ED. • The subjects were treated with placebo or avanafil (100 or 200 mg) for 12 weeks and were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ). • The primary outcome variable was the change from baseline for IIEF erectile function domain (EFD) score. • The secondary outcome variables were SEP Q2 and Q3, the shift to normal rate (EFD ≥ 26), and response to the GAQ. RESULTS: • Compared with placebo, patients who took 100 or 200 mg of avanafil had significantly improved IIEF-EFD score. • There were similar results when comparing Q2 and Q3 in the SEP diary and the GAQ. • Flushing was the most common treatment-related adverse event. • Most adverse events were transient and mild or moderate in severity. CONCLUSION: • Avanafil is an effective and well-tolerated therapy for ED of broad-spectrum aetiology and severity.

Effects of smoking on plasma testosterone level and erectile function in rats.

INTRODUCTION: There have been several conflicting reports of the effects of smoking on plasma testosterone levels and erectile function in clinical and animal studies. AIM: This study was conducted to determine the actual effects of smoking on plasma testosterone levels and erectile function in rat-smoking models. METHODS: For the exposure to cigarette smoke, the rats in a cage had a constant influx of smoke using a specially constructed device. Twenty-four Sprague Dawley (SD) rats for the acute cigarette exposure were allocated randomly into two groups: an experimental group and a control group. Thirty-six SD rats for the chronic cigarette smoke exposure were randomly divided into three groups: a control group and two experimental groups. MAIN OUTCOME MEASURES: After exposure to smoking, the rats were subjected to electrical field stimulation of the cavernosal nerve to assess the erectile function, and blood was collected to measure the levels of plasma thiocyanate, testosterone, luteinizing hormone, and follicle-stimulating hormone. The histological changes of testes and corpora cavernosum (CC) were examined. RESULTS: In the smoking groups, the thiocyanate levels were significantly higher than in the control group. Also, the mean arterial pressure (MAP) was significantly higher in the smoking groups, but the corpora cavernosal filling rate and maximal intracavernosal pressure/MAP were significantly lower than in the control group. The testosterone levels of experimental groups were significantly lower than those of control group, and the testosterone and thiocyanate levels were significantly correlated with erectile function components in chronic smoking groups. There was no significant histological change in the testes; however, in the CC, there was an increase in collagen fibers and decrease in smooth muscle and sinusoidal space in chronic smoking groups. CONCLUSION: The results suggest that both the vasoconstrictor effects of smoking and the decrease in testosterone levels after chronic smoking had some effects on erectile function in rats.

The efficacy of in-and-out catheterization as a way of trial without catheterization strategy for treatment of acute urinary retention induced by benign prostate hyperplasia: variables predicting success outcome.

AIM: To evaluate the efficacy and proper use of in-and-out catheterization as a strategy for trial without catheterization (TWOC) for treatment of acute urinary retention (AUR). METHODS: Retrospective analysis of 515 patients who visited the emergency room with AUR from January 2004 to December 2008 was conducted. Patients were segregated to one of two groups, depending on management of AUR (in-and-out catheterization at one time: Group 1 or indwelling catheter: Group 2). To characterize the optimal patient characteristics particularly fitting for Group 1 among each success subgroup, Fisher's linear discriminant analysis (LDA) was then conducted. Using an equation from LDA, the hit ratio was evaluated in a prospective trial from July to December 2009. RESULTS: TWOC success rate was 25.1% for Group 1 and 30.3% for Group 2. In successful cases, age, retention volume, and prostate sizes were significantly lower than those of failure counterparts in both Groups 1 and 2. Among these, age and retention volume were finally selected for LDA. When comparing successful cases, these two were significantly lower in Group 1 than Group 2. LDA showed an 81.6% hit ratio for cases with successful TWOC. In a prospective trial of 28 patients, using an equation from LDA, five of seven patients in Group 1 (71.4%) and 16 of 21 patients (76.2%) in Group 2 succeeded in their initial TWOC. CONCLUSIONS: These results suggest the efficacy of in-and-out catheterization as a way of attempting TWOC, particularly for the patient with relatively low retention volume and younger age.

The impact of therapeutic delay time on acute scintigraphic lesion and ultimate scar formation in children with first febrile UTI.

We assessed the role of therapeutic delay time (TDT) in acute renal cortical scintigraphic lesion (ASL) and ultimate scar formation (USF) in children with first febrile UTI and whether it is affected by the presence of vesico-ureteral reflux (VUR). 230 children, 90 girls and 140 boys with first febrile UTI were included. Radiologic (USG, DMSA, and VCUG), clinical (age, gender, peak fever, therapeutic delay time) and laboratory (CBC with differential count, ANC (absolute neutrophil count), BUN, Creatinine, urine analysis, gram stain, culture, CRP and ESR) variables were analysed. DMSA was performed within 5 days and after six months. VCUG was performed after acute phase of UTI. The differences in TDT according to the presence of ASL, USF and VUR were assessed. And the correlation between ASL or USF with the duration of TDT was assessed. Of 230 patients enrolled, 142 patients had refluxing UTI and 88 patients had non-refluxing UTI. TDT was the risk factor associated with ASL and USF along with presence of VUR. TDT was longer in ASL positive group compared with the ASL negative group. Also USF group showed longer TDT compared with those without USF in both refluxing UTI and non refluxing UTI. The TDT was significantly shorter in USF group with the presence of VUR. Positive linear association was noted between prevalence of ASL and USF and duration of TDT. In conclusion, the impact of UTI on formation of USF may be enhanced by the presence of VUR with shorter duration of TDT.

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.

The effects of penile girth enhancement using injectable hyaluronic acid gel, a filler.

INTRODUCTION: Despites the debates on penile girth enhancement (PGE), demands for enhancement are increasing. Recently, various fillers have been widely used for soft tissue augmentation with proven efficacy and safety. AIMS: To identify the feasibility and efficacy of PGE by injection of filler. METHODS: Fifty patients with subjective small penis who visited Korea University Guro outpatient clinic were enrolled and prospectively followed. Restylane Sub-Q (Q-med, Upssala, Sweden) was injected into the fascial layer of penile body via 21G cannula with "Back & Forth Technique" and homogenized with a roller. MAIN OUTCOME MEASURES: From April 2006 to February 2008, 50 patients were enrolled and 41 patients were followed until 18 months after PGE. Changes in penile girth at midshaft were measured by tapeline at 1 and 18 months. Patient's visual estimation of residual volume (Gr 0-4), patient's satisfaction (Gr 0-4), and any adverse reactions were also evaluated. RESULTS: Mean injected volume was 20.56 cc (18-22). Compared with basal girth of 7.48 ± 0.35 cm, maximal circumference was significantly increased to 11.41 ± 0.34 cm at 1 month (P < 0.0001) and maintained as 11.26 ± 0.33 cm until 18 months. In patient's visual estimation, two patients complained the decrease as Gr 3 with focal depression at 1 month. At 18 months, all patients answered as Gr 4 without asymmetry. Patient's and partner's satisfaction score was 3.71 ± 0.46 and 3.65 ± 0.48 at 1 month and 3.34 ± 0.53 and 3.38 ± 0.49 at 18 months. There were no inflammatory signs or serious adverse reactions in all cases. CONCLUSIONS: Considering the property of material, methods, and follow-up results of 18 months, PGE using filler is a very effective and safe technique for penile augmentation.

Corpus cavernosal smooth muscle relaxation effect of a novel AMPK activator, beta-lapachone.

INTRODUCTION: Adenosine monophosphate-activated protein kinase (AMPK) activation is suggested to relax smooth muscle by endothelial nitric oxide synthase (eNOS) phosphorylation. AIM: To assess the mechanism and effect of a novel AMPK activator, beta-lapachone, upon cavernosal smooth muscle relaxation and the therapeutic potential for erectile dysfunction. METHODS: Human umbilical vein endothelial cells (HUVECs) were treated with beta-lapachone. The lysates were blotted with specific antibodies for phosphorylated AMPK (p-AMPK) or phosphorylated eNOS (p-eNOS). The membranes were re-blotted for total AMP total eNOS, or beta-actin. The eNOS activity was measured by the conversion of L-14C-arginine to L-14C-citrulline in HUVECs lysates. In a separated experiment, cavernosal strips from New Zealand white rabbits were harvested for organ bath study and the relaxation effect of beta-lapachone on phenylephrine-induced contracted strips was evaluated and compared with sodium nitroprusside, zaprinast, metformin, and aminoimidazole carboxamide ribonucleotide (AICAR). Methylene blue and L-NAME were used to assess the inhibition of cyclic guanosine monophosphate/nitric oxide pathway. Zinc-protoporphyrin-IX (ZnPP) was also used to investigate the contribution of mevalonate pathway. MAIN OUTCOME MEASURES: The expression of p-AMPK, p-eNOS, AMPK and eNOS induced by beta-lapachone in HUVECs study and the percent relaxation of cavernosal tissue in organ bath study. RESULTS: Beta-lapachone clearly induced AMPK phosphorylation and, as a consequence, eNOS phosphorylation in HUVECs. Beta-lapachone-induced upregulation of eNOS activity was also observed in HUVECs and steadily increased up to 1 hour. In organ bath study, beta-lapachone significantly relaxed the phenylephrine pretreated strips in a dose-dependent manner. This relaxation effect was not totally blocked by methylene blue or L-NAME. After removing endothelium, the relaxation was totally blocked by ZnPP. CONCLUSIONS: A novel AMPK activator, beta-lapachone has a strong relaxation effect on precontracted cavernosal smooth muscle strips in the rabbit. And phosphorylation of AMPK and eNOS strongly related to the action of beta-lapachone. Mevalonate pathway also might be considered as a suggestive mechanism.

A therapeutic confirmatory study to assess the safety and efficacy of Zydena (udenafil) for the treatment of erectile dysfunction in male patients with diabetes mellitus.

INTRODUCTION: Patients with diabetes mellitus (DM) are reported to experience more severe erectile dysfunction (ED) symptoms and respond less to ED treatments compared with patients with ED of other etiologies. AIM: This study was undertaken to evaluate the safety and efficacy of udenafil for the treatment of ED in a larger number of patients with DM. METHODS: A placebo-controlled, randomized, double-blind, double-dummy, parallel-group design multicenter study, fixed-dose trial was conducted. The trial involved seven study sites in Korea, with 174 ED patients with DM. The subjects, treated with placebo, 100 mg, or 200 mg of udenafil for 12 weeks, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Question (GAQ) during the study period. MAIN OUTCOME MEASURES: The primary efficacy parameter was the change in the erectile function domain (EFD) score of IIEF from baseline. Secondary parameters were IIEF questions 3 (Q3) and Q4, SEP Q2 and Q3, rate of achieving normal erectile function (EFD ≥ 26), and the response to GAQ. RESULTS: Compared with the placebo, patients receiving both doses of udenafil showed statistically significant improvements in the IIEF-EFD score, respectively. However, statistically significant difference was not observed between the udenafil 100 mg and the udenafil 200 mg groups. Similar results were observed in the comparison of Q3 and Q4 of IIEF, SEP diary, and GAQ. The percentages of subjects experiencing at least one adverse event related to the study drugs were 3.6%, 15.8%, and 22.4% for the placebo, udenafil 100 mg, and udenafil 200 mg groups, respectively. However, these events were all mild in severity. Major adverse events were flushing, headache, nausea, and conjunctival hyperemia. CONCLUSION: Udenafil was significantly effective for the treatment of ED, demonstrating statistically significant improvement in erectile function in patients with DM. The incidence of adverse events was relatively low and well tolerated in patients with DM.