Korean Multicenter Registry Study of EPIC Stents for the Treatment of Iliac Artery Disease: K-EPIC Registry

Background and Objectives@#The EPIC™ stent is a self-expanding, nitinol stent that has been designed to enhance flexibility and provide expansion within vessels. The aim of the present study was to investigate the clinical efficacy and safety of the EPIC™ stent when used to treat iliac artery diseases in a prospective Korean multicenter registry. @*Methods@#A total of 138 patients with iliac artery diseases who received endovascular treatment with EPIC™ stents at 9 Korean sites were enrolled in a prospective cohort and followed for 1 year. The primary endpoint was the 1-year freedom from target lesion revascularization (TLR). The secondary endpoints were 1-year clinical patency and freedom from major adverse events (MAEs). @*Results@#The mean age of the study subjects was 66.8±8.5 years and most subjects were male (86.2%). The most frequent lesion type was Trans-Atlantic Inter-Society Consensus B (43.5%) and the majority (56.5%) of the target lesions were located in the common iliac artery. Procedural success was obtained in 99.3% of patients. The freedom from TLR and the clinical patency at 1-year follow-up were 94.9% and 92.3%, respectively. The 1-year rate of MAEs was 5.1%. Combined coronary artery disease (hazard ratio [HR], 5.91; 95% confidence interval [CI], 1.13–30.89; p=0.035) and smaller stent diameter (HR, 0.38; 95% CI, 0.17–0.88;p=0.023) were identified as independent risk factors of TLR after EPIC™ stent implantation. @*Conclusions@#The EPIC™ stents demonstrated excellent immediate and 1-year efficacy and safety outcomes in iliac artery lesions in this multicenter, prospective, registry-based study.

Korean Multicenter Registry Study of EPIC Stents for the Treatment of Iliac Artery Disease: K-EPIC Registry

Background and Objectives@#The EPIC™ stent is a self-expanding, nitinol stent that has been designed to enhance flexibility and provide expansion within vessels. The aim of the present study was to investigate the clinical efficacy and safety of the EPIC™ stent when used to treat iliac artery diseases in a prospective Korean multicenter registry. @*Methods@#A total of 138 patients with iliac artery diseases who received endovascular treatment with EPIC™ stents at 9 Korean sites were enrolled in a prospective cohort and followed for 1 year. The primary endpoint was the 1-year freedom from target lesion revascularization (TLR). The secondary endpoints were 1-year clinical patency and freedom from major adverse events (MAEs). @*Results@#The mean age of the study subjects was 66.8±8.5 years and most subjects were male (86.2%). The most frequent lesion type was Trans-Atlantic Inter-Society Consensus B (43.5%) and the majority (56.5%) of the target lesions were located in the common iliac artery. Procedural success was obtained in 99.3% of patients. The freedom from TLR and the clinical patency at 1-year follow-up were 94.9% and 92.3%, respectively. The 1-year rate of MAEs was 5.1%. Combined coronary artery disease (hazard ratio [HR], 5.91; 95% confidence interval [CI], 1.13–30.89; p=0.035) and smaller stent diameter (HR, 0.38; 95% CI, 0.17–0.88;p=0.023) were identified as independent risk factors of TLR after EPIC™ stent implantation. @*Conclusions@#The EPIC™ stents demonstrated excellent immediate and 1-year efficacy and safety outcomes in iliac artery lesions in this multicenter, prospective, registry-based study.

Lifestyle Modification Strategy for Patients with Premature Ejaculation as Metabolic Syndrome

No abstract available.

Finasteride and Erectile Dysfunction in Patients with Benign Prostatic Hyperplasia or Male Androgenetic Alopecia

Finasteride is primarily used to treat benign prostatic hyperplasia (BPH) and male androgenetic alopecia (MAA). Five-alpha reductase inhibitors (5α-RIs) could induce male sexual dysfunction due to their effects on testosterone and dihydrotestosterone. There is evidence suggesting that 5α-RIs may independently increase the risk of erectile dysfunction (ED). However, many investigators believe that side effects of 5α-RIs will disappear with continuous treatment. Considerable controversy exists regarding the severity and persistence of side effects of finasteride on ED. The aim of this review was to summarize current research studies on finasteride associated with ED. The search strategy used each term of finasteride and ED against PubMed database to identify related studies. ED data reported from available trials for finasteride were summarized and reviewed. Although there is not enough evidence to prove the relationship between finasteride and ED, most studies in this review found that finasteride for BPH was correlated with ED. However, most studies included in this review revealed that finasteride for MAA was not correlated with ED. On the other hand, some studies reported side effects of finasteride associated with sexual dysfunction, including ED, male infertility, ejaculation problem, and loss of libido, even in MAA patients. Well-designed randomized controlled trials are needed to further determine the mechanism and effects of finasteride on ED. However, physicians should discuss with their patients possible long-term effects of finasteride on sexual function, although we do not have evidence showing that adverse events of sexual dysfunction are absolutely associated with 5α-RIs.

Persistent Erectile Dysfunction after Discontinuation of 5-Alpha Reductase Inhibitor Therapy in Rats Depending on the Duration of Treatment

PURPOSE: The current study is aimed to assess whether a longer duration of 5α-reductase inhibitor (5α-RI) exposure was associated with higher rate of permanent erectile dysfunction (ED) in a rat model. MATERIALS AND METHODS: Male Sprague-Dawley rats (n=76) were assigned to five groups: (i) normal control group; (ii) dutasteride (0.5 mg/rat/d) for 4-weeks group; (iii) dutasteride for 4-weeks plus 2-weeks of resting group; (iv) dutasteride for 8-weeks group; and (v) dutasteride for 8-weeks plus 2-weeks of resting group. In vivo erectile responses to electrical stimulation, and changes of fibrotic factors and smooth muscle/collagen contents in the corpus cavernosum were evaluated in each group. RESULTS: Dutasteride administration for 4 and 8 weeks significantly decreased erectile parameters compared with the control group. Reduced erectile responses were recovered during 2 weeks of drug-free time in the 4-week treatment group, but were not in the 8-week group. Protein levels of fibrosis-related factors transforming growth factor (TGF)-β1, TGF-β2, and p-Smad/Smad (Smad 2/3) in the corpus cavernosum showed no significant change after 4 weeks of dutasteride oral administration, but were enhanced after 8 weeks. Dutasteride markedly decreased smooth muscle content and increased collagen after 4 and 8 weeks of use, but no nuclear size changes; however, neither group showed significant improvement in the smooth muscle to collagen ratio after the rest period. CONCLUSIONS: Our study showed that recovery from ED depended on the duration of medication, and administration of dutasteride for more than 8-weeks in rats could result in irreversible ED even after discontinuation of medication.

Letter to the Editor regarding the Article: “Anti-Inflammatory and Antimicrobial Effects of a Novel Herbal Formulation (WSY-1075) in a Chronic Bacterial Prostatitis Rat Model” by Park et al. World J Mens Health 2016;34(3):179-185

No abstract available.

Is It Worth Treating Non-Bothering Nocturia? Results of a Multicenter Prospective Observational Study

PURPOSE: The purpose of this study was to evaluate the efficacy of treatment in patients with non-bothering nocturia. MATERIALS AND METHODS: In this prospective multicenter study, patients who visited hospitals for treatment of voiding symptoms were enrolled. Inclusion criteria were: 1) men >45 years, and 2) nocturia ≥2 confirmed by a three-day voiding diary. Subjects were divided into non-bothering and bothering groups based on International Consultation on Incontinence Questionnaire Nocturia (ICIQ-N) question 2b. Changes in voiding symptoms, frequency of nocturia, and bothersomeness were evaluated with international prostate symptom score (IPSS), ICIQ-N, and three-day voiding diary at 4 and 12 weeks after treatment. RESULTS: A total of 48 patients in the non-bothering nocturia group and 50 patients in the bothering nocturia group who completed the 12-week treatment were analyzed. The total IPSS was decreased by 5.8 in the non-bothering group and 5.2 in the bothering group. There was no significant difference in decrease of IPSS between the two groups. Both groups showed significant reduction in discomfort of nocturia. The ICIQ-N 2b score decreased from 3.9 to 2.7 (p=0.01) in the non-bothering group and from 6.9 to 4.6 (p=0.02) in the bothering group. The number of nocturia episodes was significantly decreased in both groups. CONCLUSIONS: Regardless of discomfort associated with nocturia, both groups showed significant improvement in nocturia-related discomfort and voiding symptoms. These results suggest that patients with nocturia who were unaware of its discomfort benefited from treatment.

Effects of Schisandra chinensis fruit extract and gomisin A on the contractility of penile corpus cavernosum smooth muscle: a potential mechanism through the nitric oxide - cyclic guanosine monophosphate pathway

BACKGROUND/OBJECTIVES: This study evaluated the effects and molecular mechanisms of the Schisandra chinensis fruit extract (SC) and its major compound gomisin A (GA), on the contractility of rabbit penile corpus cavernosum smooth muscle (PCCSM). MATERIALS/METHODS: PCCSM was exposed to SC or GA after appropriate pretreatment with nitric oxide synthase (NOS) blocker, guanylate cyclase blocker, adenylyl cyclase blocker or protein kinase A blocker. Subsequently, we evaluated the cyclic nucleotide in the perfusate by radioimmunoassay, protein expression level of neuronal NOS (nNOS) and endothelial NOS (eNOS) by western blot, and the interaction of SC or GA with udenafil and rolipram. RESULTS: Both SC and GA induce PCCSM relaxations in a concentration-dependent manner. Pretreatment with NOS blocker, guanylate cyclase blocker, adenylyl cyclase blocker or protein kinase A blocker result in significantly decreased relaxation. SC and GA also induce the levels of cyclic nucleotide in the perfusate in a concentration-dependent manner. Perfusion with GA also showed significantly higher levels of eNOS protein. Furthermore, the udenafil and rolipram induced relaxations of PCCSM were enhanced after exposure to SC and GA. Our results indicate that SC and GA induce the relaxation of PCCSM via the nitric oxide (NO)-cGMP and cAMP signaling pathways. CONCLUSIONS: The SC and GA are potential alternative treatments for men who want to consume natural products to ameliorate erectile function, or who do not respond to the commercially available medicines.

Let's Take Advantage of Mixtures of Bupivacaine or Ropivacaine in Urologic Inguinal and Scrotal Surgery

No abstract available.

Quercetin Relaxed the Smooth Muscle of Rabbit Penile Corpus Cavernosum by Activating the NO-cGMP Signaling Pathway

The aim of this study was to investigate the effect and action mechanism of quercetin on penile corpus cavernosum smooth muscle (PCCSM). PCCSM precontracted with phenylephrine (Phe) was treated with four different concentrations of quercetin (10−7, 10−6, 10−5 and 10−4 M). PCCSM were preincubated with N-Nitro-L-arginine methyl ester hydrochloride (L-NAME) and 1H-[1,2,4]oxadiazolo[4,3-a]quinoxalin-1-one (ODQ) to block nitric oxide synthase and guanylate cyclase, respectively. The changes in PCCSM tension were recorded, and cyclic nucleotides in the perfusate were measured by radioimmunoassay. The interactions of quercetin with phosphodiesterase type 5 inhibitors (PDE5-Is) such as sildenafil, udenafil and mirodenafil, were also evaluated. PCCSM relaxation induced by quercetin occurred in a concentrationdependent manner. The application of quercetin to PCCSM pre-treated with L-NAME and ODQ significantly inhibited the relaxation. Quercetin significantly increased cGMP in the perfusate. Furthermore, quercetin enhanced PDE5-Is-induced relaxation of PCCSM. Quercetin relaxed the PCCSM by activating the NO-cGMP signaling pathway, and it may be a therapeutic candidate or an alternative treatment for patients with erectile dysfunction who do not completely respond to PDE5-Is.

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).

Penile Erection Induced by Scoparone from Artemisia capillaris through the Nitric Oxide-Cyclic Guanosine Monophosphate Signaling Pathway

PURPOSE: The objective of this study was to evaluate the relaxant effect of scoparone from Artemisia capillaris on rabbit penile corpus cavernosum smooth muscle (PCCSM) and to elucidate the mechanism of action of scoparone for the treatment of erectile dysfunction (ED). MATERIALS AND METHODS: PCCSM that had been precontracted with phenylephrine was treated with 3 Artemisia herbs (A. princeps, A. capillaris, and A. iwayomogi) and 3 fractions (n-hexane, ethyl acetate, and n-butanol) with different concentrations (0.1, 0.5, 1.0, and 2.0 mg/mL). Four components (esculetin, scopoletin, capillarisin, and scoparone) isolated from A. capillaris were also evaluated. The PCCSM was preincubated with Nω-nitro-L-arginine methyl ester hydrochloride (L-NAME) and 1H-[1,2,4] oxadiazolo [4,3-a]quinoxalin-1-one (ODQ). Cyclic nucleotides in the perfusate were measured by a radioimmunoassay. The interactions of scoparone with udenafil and rolipram were also evaluated. RESULTS: A. capillaris extract relaxed PCCSM in a concentration-dependent manner. Scoparone had the highest relaxant effect on PCCSM among the 4 components (esculetin, scopoletin, capillarisin, and scoparone) isolated from the ethyl acetate fraction. The application of scoparone on PCCSM pretreated with L-NAME and ODQ led to significantly less relaxation. Scoparone also increased the cyclic guanosine monophosphate (cGMP) levels in the perfusate in a concentration-dependent manner. Furthermore, scoparone enhanced udenafil- and rolipram-induced relaxation of the PCCSM. CONCLUSIONS: Scoparone relaxed the PCCSM mainly by activating the nitric oxide-cGMP signaling pathway, and it may be a new promising treatment for ED patients who do not completely respond to udenafil.

Rooibos™: Automated schedule broadcast software for clinical pharmacology studies

Pharmacokinetic blood sampling is a prerequisite for successful early clinical trials. It is essential to take samples at the precise designated times to ensure the reliability of the clinical trial data; however, investigators have encountered difficulties in conducting procedures with limited manpower. We have recently developed automated schedule broadcast software (Rooibos™) to manage the precise scheduling of procedures for clinical trial centers. Rooibos™ is platform independent because it is programmed in the Java language. It generates scheduled times based on a reference time. It alarms at the scheduled times and pages subjects and alerts staff to prepare for the upcoming procedures. Rooibos™ can also group subjects when multiple clinical trials are conducted simultaneously in one or more clinical trial wards. This software may be applied to any study involving procedures that must be performed at designated times.

Risk Factors for Urethral Condyloma among Heterosexual Young Male Patients with Condyloma Acuminatum of Penile Skin / 감염과화학요법

To our knowledge, this is the first study that focuses on risk factor of urethral condyloma (UC). The subjects of our study included genital warts patients who had been diagnosed as having condyloma acuminatum of penile skin (CAPS) with/without UC. Relationship with UC of number of life time female partners, co-infection with urethritis, circumcision status, number of CAPS and wart diameter were studied by use of multivariate analysis. Co-infection with urethritis, circumcision status were risk factors of UC in heterosexual young male patients with CAPS. This information will be helpful for providing more professional counseling to patients with genital warts.

The Characteristic Doppler Pattern of the Left Ventricular Outflow Tract in a Patient with Orthostatic Hypotension

No abstract available.

Current Status and Clinical Studies of Oriental Herbs in Sexual Medicine in Korea

Erectile dysfunction (ED) is one of the most common diseases among aging men. Although previous studies have shown that type 5 phosphodiesterase inhibitors (PDE5-Is) are very effective for the treatment of ED, many researchers are currently attempting to identify therapeutic agents from natural sources with comparable or better effects than PDE5-Is. Herbal medicine is thought to be advantageous because it is natural; moreover, it not only treats isolated symptoms, but also maintains general well-being. Furthermore, since newly created chemical compound libraries have limited structural diversity with regard to pharmaceutical agents, more attention has recently been paid to the ability of oriental herbs to enhance physical health, including sexual function. Herein, we review the current status of Korean preclinical or clinical studies of the application of oriental herbs to sexual medicine.

Alpha-Blocker Treatment Response in Men With Lower Urinary Tract Symptoms Based on Sympathetic Activity: Prospective, Multicenter, Open-Labeled, Observational Study / 대한배뇨장애요실금학회지

PURPOSE: In this study, we compared the treatment outcomes for an alpha-blocker between 2 groups of men, one with high sympathetic activity (HSA) and another with low sympathetic activity (LSA) or normal sympathetic activity. METHODS: A total of 159 men (> or =50 years of age) with lower urinary tract symptoms resulting from benign prostatic hyperplasia were analyzed. We assigned patients to groups according to their sympathetic activity, which was evaluated by heart ratevariability measurements. HSA was defined as a low frequency/high frequency ratio greater than 1.6. All patients received 10mg of alfuzosin once a day for 12 weeks. The primary end point was a change in the total International Prostate SymptomScore (IPSS) at 12 weeks from baseline. RESULTS: Sixty-seven men were assigned to the HSA group and 92 men were assigned to the LSA group. The baseline characteristics were not significantly different between the 2 groups, and the response to alfuzosin was good in both groups. Themean total IPSS change was not different between the groups. Both groups were not significantly different with respect to the changes in maximal flow rate, IPSS voiding or storage symptom subscores, quality of life, and rates of adverse drug events. TheHSA group showed a similar willingness to continue treatment compared to the LSA group, although their treatment satisfaction rating was lower. CONCLUSIONS: The therapeutic effects of alfuzosin did not differ in regards to the differences in sympathetic activity, but treatment satisfaction ratings were lower in the HSA group.

Efficacy and Safety of the Selective alpha1A-Adrenoceptor Blocker Silodosin for Severe Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Prospective, Single-Open-Label, Multicenter Study in Korea

PURPOSE: To evaluate the efficacy and safety of silodosin 8 mg once daily in a 12-week treatment of subjects with severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 100 subjects from 10 urology centers in Korea were included in this study. The inclusion criteria were as follows: age > or =50 years, International Prostate Symptom Score (IPSS) > or =20, quality of life (QoL) score > or =3, urine volume > or =120 mL and maximal urinary flow rate (Qmax) <15 mL/s, and postvoid residual volume (PVR) <100 mL. We assessed the improvement of LUTS with change in IPSS, QoL score, Qmax, PVR, and adverse events at baseline and 4 and 12 weeks after treatment with silodosin 8 mg once daily. RESULTS: The IPSS values were 23.27+/-3.34, 15.89+/-6.26, and 13.80+/-6.31 at baseline, 4, and 12 weeks, respectively, with significant improvements (p<0.0001, p=0.0214, respectively). QoL scores were 4.44+/-0.85, 3.38+/-1.20, and 3.04+/-1.20 at baseline, 4, and 12 weeks, respectively, and the differences were statistically significant (p<0.0001). There was a significant difference in Qmax between baseline and 12 weeks (p<0.0001) but not in PVR (p=0.9404) during the clinical trial. The most frequent adverse event in this study was ejaculation failure with 13 cases. However, no subject dropped out because of ejaculation failure, and in 12 of the 13 cases it was fully resolved without further treatment. CONCLUSIONS: Silodosin 8 mg once daily may be effective and safe in Korean patients with severe LUTS associated with BPH.

Multidetector Computed Tomography for the Evaluation of Coronary Artery Disease; The Diagnostic Accuracy in Calcified Coronary Arteries, Comparing with IVUS Imaging

PURPOSE: Contrast enhanced multidetector computed tomography (MDCT) has been used as an alternative to coronary angiography for the assessment of coronary artery disease in the patient of the intermediate risk group. However, coronary calcium is a known limiting factor for MDCT evaluation. We investigated the diagnostic accuracy of 64-channel MDCT with each coronary artery calcium score (CACS) by compared with intravascular ultrasound (IVUS) imaging. MATERIALS AND METHODS: A total of 54 symptomatic patients with intermediate-risk (10 females, mean age 59.9+/-6.9 years, Framingham point scores 9-20) with 162 sites who had a culprit lesion on 64-channel MDCT before performing coronary angiography with IVUS were enrolled. Patients were divided into 4 subgroups depending on CACS: 0, 1-99, 100-399, and >400. Lesion length, external elastic membrane (EEM) cross sectional area (CSA), minimal luminal area, and plaque area were measured and compared between IVUS and MDCT. RESULTS: The correlation coefficients for the measurements of the EEM CSA, lumen CSA, and plaque area were r=0.514, r=0.837, and r=0.578, respectively. Furthermore, there were close correlation of plaque area between four subgroups of CACS (r=0.671, r=0.623, r=0.562, r=0.571, respectively). CONCLUSION: Despite the increase in CACS, the geometric analysis of coronary arteries using with 64-channel MDCT was comparable with IVUS in symptomatic patient of the intermediate risk group.

Efficacy of Repeated Transrectal Prostate Biopsy in Men Younger Than 50 Years With an Elevated Prostate-Specific Antigen Concentration (>3.0 ng/mL): Risks and Benefits Based on Biopsy Results and Follow-up Status

PURPOSE: Prostate cancer is rare in men younger than 50 years. Digital rectal examination (DRE) and measurement of prostate-specific antigen (PSA) concentrations are standard screening methods for detecting prostate cancer. We retrospectively investigated the risks and benefits of repeated transrectal ultrasonography-guided prostate needle biopsies in relation to the follow-up status of men younger than 50 years with a consistently high PSA concentration (>3.0 ng/mL). MATERIALS AND METHODS: During the period from January 2000 through February 2013, we reviewed patient's ages, dates of procedures, DRE results, frequencies of biopsies, results of the biopsies, periods of follow-up, PSA concentrations, and prostate volumes in Chonbuk National University Hospital records. We conducted telephone interviews in patients who did not undergo regular follow-up. RESULTS: The mean age of the patients was 44.7 years, and the mean PSA concentration was 8.59 ng/mL (range, 3.04-131 ng/mL) before biopsy. The PSA concentration was significantly different (p3.0 ng/mL).