Combination of Korean Red Ginseng Extract and Hydrogen-Rich Water Improves Spermatogenesis and Sperm Motility in Male Mice / 中国结合医学杂志

OBJECTIVE@#To investigate the effect of hydrogen-rich Korean Red Ginseng (KRG) water (HRGW) mixture on the spermatogenesis and sperm motility of mice of different ages.@*METHODS@#Eighty young (3 month-old) and aged (12 month-old) male mice were randomly assigned to 4 groups (n =10 per group) including control group, hydrogen-rich water (HRW) group (10 mL/kg daily), KRG group (50 mg/kg daily) and HRGW group (10 mL/kg and 50 mg/kg daily) by an oral zoned needle for 4 weeks. Sperm count and motility were measured using sperm suspension released from cauda epididymis. Serum follicle stimulating hormone (FSH), luteinizing hormone (LH), testosterone, and reactive oxygen species (ROS) in serum have also been estimated. Tubular changes were examined through histological hematoxylin and eosin staining. Expression of antioxidation (PPx3, PPx4, GSTm5 and GPx4), spermatogenesis (inhibin-a, neptin-2 and CREM), antiaging (SIRT1 and SIRT2), and angiogenesis [visfatin and vascular endothelial growth factor (VEGF)] related genes were examined through real-time polymerase chain reaction.@*RESULTS@#HRW and KRG treatment stimulated spermatogenesis followed by increasing sperm production and sperm motility (P <0.05). These effects were strengthened synergistically by a HRGW mixture (P <0.05 or P <0.01). HRGW greatly increased the expressions of antioxidation, antiaging, spermatogenesis related genes and VEGF especially in aged mice (P <0.05). Serum testosterone and FSH levels also increased, while serum ROS level decreased (all P <0.05).@*CONCLUSION@#HRGW increases sperm production and motility by enhancing antioxidation and stimulating spermatogenesis and sex hormone production, particularly in aged mice.

Therapeutic Effects of Prolonged Release Melatonin (Circadin® ) in Patients with Overactive Bladder and Chronic Insomnia in More Than 55 Years Old / 고신대학교의과대학학술지

Objectives@#Bladder storage symptoms including nocturia is the most common cause of sleep disturbance in all age groups.Sleep disturbance is also a main cause of nocturia so that sleep recovery can clinically improve nocturia. Melatonin has main action to induce sleep and additional effects of smooth muscle relaxation, free radical scavenging, anti-inflammation, et cetera. This study was evaluated the improvement of sleep quality after administrating prolonged-release melatonin in elderly patients with overactive bladder and chronic insomnia. @*Methods@#This clinical trial was performed with a randomized single open study. Thirty-seven patients with overactive bladder and chronic insomnia were initially enrolled in this study. After 4 or 12 weeks treating with 2 mg of prolongedrelease melatonin, clinical outcomes were evaluated with OABSS, IPSS, PSQI and WHO 5 well-being index. @*Results@#Of the 37 patients, 34 (91.9%) were included in the ITT group and 26 (76.5%) in the PP group. In the primary outcome of PP group, significant improvements were observed in total OABSS and nocturia frequencies at 12 weeks, respectively. Secondary outcome measurement including in voiding, storage symptoms, and total IPSS scores showed the improvement at 4 and 12 weeks and in total and sleep quality PSQI scores at 12 weeks, and in quality of life scores of the WHO 5 well-being index at 12 weeks. Only one (3.8%) adverse event was observed. @*Conclusions@#These results suggest clearly that prolonged-release melatonin in elderly patients with overactive bladder and chronic insomnia has the potential to control concomitant voiding and sleep difficulty.

Therapeutic Effects of Prolonged Release Melatonin (Circadin® ) in Patients with Overactive Bladder and Chronic Insomnia in More Than 55 Years Old / 고신대학교의과대학학술지

Objectives@#Bladder storage symptoms including nocturia is the most common cause of sleep disturbance in all age groups.Sleep disturbance is also a main cause of nocturia so that sleep recovery can clinically improve nocturia. Melatonin has main action to induce sleep and additional effects of smooth muscle relaxation, free radical scavenging, anti-inflammation, et cetera. This study was evaluated the improvement of sleep quality after administrating prolonged-release melatonin in elderly patients with overactive bladder and chronic insomnia. @*Methods@#This clinical trial was performed with a randomized single open study. Thirty-seven patients with overactive bladder and chronic insomnia were initially enrolled in this study. After 4 or 12 weeks treating with 2 mg of prolongedrelease melatonin, clinical outcomes were evaluated with OABSS, IPSS, PSQI and WHO 5 well-being index. @*Results@#Of the 37 patients, 34 (91.9%) were included in the ITT group and 26 (76.5%) in the PP group. In the primary outcome of PP group, significant improvements were observed in total OABSS and nocturia frequencies at 12 weeks, respectively. Secondary outcome measurement including in voiding, storage symptoms, and total IPSS scores showed the improvement at 4 and 12 weeks and in total and sleep quality PSQI scores at 12 weeks, and in quality of life scores of the WHO 5 well-being index at 12 weeks. Only one (3.8%) adverse event was observed. @*Conclusions@#These results suggest clearly that prolonged-release melatonin in elderly patients with overactive bladder and chronic insomnia has the potential to control concomitant voiding and sleep difficulty.

Reasons of shortage for donated sperm and plan to resolve deficiencies in the sperm donor system

Sperm banking from recruited donors is an important way to help infertile couples who want to achieve pregnancy by therapeutic artificial insemination, even in the era of in vitro fertilization. Korea has the lowest population density of newborns among all Organization for Economic Co-operation and Development countries, with a total fertility rate of 1.17 and an annual birth rate of 300,000 or less as of 2017. This situation emerged due to various causes, including late marriage, fecundity problems, and air pollution. Nevertheless, we have imposed strict limits on basic research and clinical activities, including the operation of sperm banks, in the field of human reproduction under the 2005 Bioethics and Safety Act. Therefore, cryopreserved sperm for artificial insemination is almost absent in the sperm banks of major human reproduction centers. To resolve this difficult situation, as well as to increase the operation of sperm banks in Korea to the global standard level, the author evaluates the underlying reasons for donor sperm use by azoospermic patients from medical, ethical, legal, religious, and cultural perspectives, and then proposes a plan to resolve this situation including highly regulated standard operating procedures to ensure comprehensive safety practices for voluntary sperm donors and infertile couples, as well as to build an ideal sperm donation program.

Reasons of shortage for donated sperm and plan to resolve deficiencies in the sperm donor system

Sperm banking from recruited donors is an important way to help infertile couples who want to achieve pregnancy by therapeutic artificial insemination, even in the era of in vitro fertilization. Korea has the lowest population density of newborns among all Organization for Economic Co-operation and Development countries, with a total fertility rate of 1.17 and an annual birth rate of 300,000 or less as of 2017. This situation emerged due to various causes, including late marriage, fecundity problems, and air pollution. Nevertheless, we have imposed strict limits on basic research and clinical activities, including the operation of sperm banks, in the field of human reproduction under the 2005 Bioethics and Safety Act. Therefore, cryopreserved sperm for artificial insemination is almost absent in the sperm banks of major human reproduction centers. To resolve this difficult situation, as well as to increase the operation of sperm banks in Korea to the global standard level, the author evaluates the underlying reasons for donor sperm use by azoospermic patients from medical, ethical, legal, religious, and cultural perspectives, and then proposes a plan to resolve this situation including highly regulated standard operating procedures to ensure comprehensive safety practices for voluntary sperm donors and infertile couples, as well as to build an ideal sperm donation program.

Sperm Bank: From Laboratory to Patient

No abstract available.

Efficacy and Safety of a Mixed Extract of Trigonella foenum-graecum Seed and Lespedeza cuneata in the Treatment of Testosterone Deficiency Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

PURPOSE: The aim of this study was to investigate the efficacy and safety of a mixed extract of Trigonella foenum-graecum seed and Lespedeza cuneata (TFGL) for the treatment of testosterone deficiency syndrome (TDS). MATERIALS AND METHODS: Patients were instructed to take a placebo or 200 mg TFGL capsule twice per day for 8 weeks. The primary efficacy variable was the change from baseline in the Aging Males' Symptoms scale (AMS), as well as levels of serum total and free testosterone. Secondary efficacy measurements included changes from baseline in the number of ‘yes’ answers on the Androgen Deficiency in the Aging Male (ADAM) questionnaire, levels of serum total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglyceride, all domain scores of the International Index of Erectile Function (IIEF), perceived stress scale-10 (PSS-10), as well as changes in body composition. RESULTS: The TFGL group exhibited a significant improvement in the AMS scores at 8 weeks, total testosterone at 8 weeks, and free testosterone at 4 and 8 weeks. At 4 weeks, 25% of the TFGL group changed to negative in terms of ADAM scores and 34.1% of the TFGL group had negative scores at the end of the study. The TFGL group exhibited a significant improvement in total cholesterol, HDL-C, LDL-C, triglyceride, IIEF scores, and PSS-10 scores at 8 weeks. CONCLUSIONS: The mixed extract of TFGL resulted in significant improvements in symptoms of TDS, as measured by the AMS, ADAM, PSS-10 and testosterone levels.

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).

Inquiry Survey of Infertile Couples for Sperm Donation and Artificial Insemination by Donor

BACKGROUND: Artificial insemination by donor (AID) is important to chance the pregnancy in male infertile couples by requiring appropriate medical, legal and ethical reviews. The purpose of this study was to investigate the perception changes of AID to collect the basic information for establishing the sperm donation, cryopreservation and artificial insemination management system. METHODS: We evaluated the people's thought of sperm donation, cryopreservation, and artificial insemination by donor by means of national inquiry survey from 247 infertile couples for 4 weeks from October 2016. The questionnaires were composed of 4 areas, and each questionnaire consisted of 15 items. Changes in the perception of AID by year were investigated after review of domestic journals. RESULTS: 67.6% of respondents knew the growth of couples with difficulty getting pregnant due to male infertility. 82.2% of respondents replied the necessary of sperm bank as a treatment option for infertility and 40.5% knew the donation and receipt system of sperm. In the survey of change perception of AID according to year, 37.5% and 39.5% of respondents were got information about AID from doctor in 2003 and 2004, but 49.6% from broadcasting in 2016. As a child grows up, 4.0% (2003), 9.0% (2014), and 42.8% (2016) of respondents answered to tell the child about AID. CONCLUSIONS: Infertile couple's thought of AID about the extension of opportunities for male infertility treatment is changed. In conclusion, it is necessary to establish institutional system of sperm donation, cryopreservation and artificial insemination prior to public sperm bank operation.

Paraffin Granuloma Associated with Buried Glans Penis-Induced Sexual and Voiding Dysfunction

A paraffinoma is a type of inflammatory lipogranuloma that develops after the injection of an artificial mineral oil, such as paraffin or silicon, into the foreskin or the subcutaneous tissue of the penis for the purpose of penis enlargement, cosmetics, or prosthesis. The authors experienced a case of macro-paraffinoma associated with sexual dysfunction, voiding dysfunction, and pain caused by a buried glans penis after a paraffin injection for penis enlargement that had been performed 35 years previously. Herein, this case is presented with a literature review.

Restoration of Spermatogenesis Using a New Combined Herbal Formula of Epimedium koreanum Nakai and Angelica gigas Nakai in an Luteinizing Hormone-Releasing Hormone Agonist-Induced Rat Model of Male Infertility

PURPOSE: We investigated the protective effect of a mixture of 2 herbal extracts, KH-465, which consisted of Epimedium koreanum Nakai and Angelica gigas Nakai, on spermatogenesis in a luteinizing hormone-releasing hormone (LHRH) agonist-induced rat model of male infertility. MATERIALS AND METHODS: Seventy-five 12-week-old male Sprague-Dawley rats were randomly divided into 5 groups, containing 15 rats each: a normal control group that received no treatment and 4 experimental groups (I, II, III, and IV) in which an LHRH agonist was administered for 4 weeks to induce spermatogenic failure. Group I received distilled water, and groups II, III, and IV received 200 mg/kg/day of KH-465, 400 mg/kg/day KH-465, and depo-testosterone for 4 weeks, respectively. Weight changes of the testis and epididymis, sperm count motility, and levels of testosterone (T), free T, follicle-stimulating hormone (FSH), luteinizing hormone (LH), superoxide dismutase (SOD), and 8-hydroxy-2′-deoxyguanosine (8-OHdG) were estimated. RESULTS: Body, testis, and epididymis weight showed no significant differences among the control and experimental groups. Treatment with KH-465 increased the sperm count and motility. Serum hormone levels of T, free T, and FSH were not significantly different in the experimental groups, while the LH level was higher than in the LHRH agonist-induced control group, but not to a significant extent. Levels of SOD were higher and 8-OHdG were lower in the groups that received KH-465 than in the LHRH agonist-induced control group. CONCLUSIONS: Our results suggest that KH-465 increased sperm production via reducing oxidative stress and had a positive effect in a male infertility model.

Book Review: Curious Journey to the New Textbook of Penile Augmentation: Informed Text Briefing

No abstract available.

Controlling Legal Risk for Effective Hospital Management

PURPOSE: To analyze the types of medical malpractice, medical errors, and medical disputes in a university hospital for the proposal of countermeasures that maximize the efficiency of hospital management, medical departments, and healthcare providers. MATERIALS AND METHODS: This study retrospectively reviewed and analyzed 55 closed civil lawsuits among 64 medical lawsuit cases carried out in Pusan National University Hospital from January 2000 to April 2013 using medical records, petitions, briefs, and data from the Medical Dispute Mediation Committee. RESULTS: Of 55 civil lawsuits, men were the main plaintiffs in 31 cases (56.4%). The average period from medical malpractice to malpractice proceeding was 16.5 months (range, 1 month to 6.4 years), and the average period from malpractice proceeding to the disposition of a lawsuit was 21.7 months (range, 1 month to 4 years and 11 months). CONCLUSIONS: Hospitals can effectively manage their legal risks by implementing a systematic medical system, eliminating risk factors in administrative service, educating all hospital employees on preventative strategies, and improving customer service. Furthermore, efforts should be made to establish standard coping strategies to manage medical disputes and malpractice lawsuits, operate alternative dispute resolution methods including the Medical Dispute Mediation Committee, create a compliance support center, deploy a specialized workforce including improved legal services for employees, and specialize the management-level tasks of the hospital.

Effects of Korean red ginseng on semen parameters in male infertility patients: A randomized, placebo-controlled, double-blind clinical study / 中国结合医学杂志

<p><b>OBJECTIVE</b>To investigate the effects of Korean red ginseng (KRG) on semen parameters in male infertility patients in a randomized, double-blind, placebo-controlled study.</p><p><b>METHODS</b>A total of 80 male infertility patients with varicocele were recruited from April 2011 to February 2012. The subjects were then divided into the following four groups: non-varicocelectomy (V)+placebo (P) group, V+P group, non-V+KRG group (1.5-g KRG daily), and V+KGR group (1.5-g KRG daily). Semen analysis was performed and hormonal levels were measured in each treatment arm after 12 weeks.</p><p><b>RESULTS</b>All groups but not the non-V+P group, showed significant improvements in sperm concentrations, motility, morphology, and viability at the end of the study. However, there were no significant differences in serum follicle-stimulating hormone, luteinizing hormone, and testosterone among groups. The incidence of adverse events was low, and all events were assumed to be unrelated to the treatments administered.</p><p><b>CONCLUSIONS</b>Although the exact mechanism by which KRG improves spermatogenesis remains unclear, KRG may be a useful agent for the treatment of male infertility. Nevertheless, additional studies to evaluate the optimal dose and duration of treatment are needed.</p>

The current status of public sperm bank in Korea

Sperm banking is an important option to maintain the male fertilization capacity or induce pregnancy even though under the era of in vitro fertilization. The medical indications for sperm banking are generally consisted of 3 categories. There are cases on planning the permanent contraception like vasectomy or cancer patients to be scheduled the chemotherapy or radiotherapy as first category, male infertile patients with severe oligozoospermia or artificially harvested sperm ie, from microscopic epididymal sperm aspiration or testicular sperm extraction et cetera for the artificial insemination with husband sperm as second category, and the therapeutic donor insemination as third category. Of these three categories, the sperm donation program accompanies various complicated practical, ethical and legal issues. Therefore, highly regulated statements are mandatory in order to secure safety and the complete practices for voluntary sperm donors and infertile couples both. In aspect of administrative structure of sperm bank, there are 3 types that are national based to be established in the most of European countries and China, public based in Japan, and commercially available in the USA. Additionally, each country has different standard guidelines, regulation statements, act and law to control the sperm donation program as well as different cultural or religious background. Nevertheless, we need a consensus document to operate the sperm bank with the standard guidelines to be well revised according to each country's ethical perspectives as well as contemporary scientific evolution. This article will provide what is the Korean model for ideal sperm bank with the history of sperm cryopreservation and banking, background and prerequisite for the public sperm bank operation, and also expected effects.

Semen Analysis in Cancer Patients Referred for Sperm Cryopreservation before Chemotherapy over a 15-Year Period in Korea

PURPOSE: This study evaluated the demographics and semen parameters of males with cancer who banked their sperm prior to chemotherapy. MATERIALS AND METHODS: This is a retrospective study of 66 cases referred for sperm banking prior to initiation of chemotherapy over a 15-year period (1999~2014). Patients who had previously received cancer treatment including chemotherapy or radiotherapy were not included in this study. RESULTS: We studied a total of 66 cancer patients referred for cryopreservation of sperm prior to chemotherapy. The mean age of the patients at the time of banking was 32.0+/-7.9 years (range, 19~58 years). The types of cancer were testicular cancer (31 cases, 47.0%), non-Hodgkin's disease (10 cases, 15.1%), Hodgkin's disease (5 cases, 7.6%), leukemia (8 cases, 12.1%), gastrointestinal malignancy (5 cases, 7.6%), and musculoskeletal malignancy (5 cases, 7.6%). There were significant differences in sperm concentration and viability among the various types of cancer, but no significant difference in semen volume or sperm motility and morphology. CONCLUSIONS: In this study we found that sperm quality could decrease even before chemotherapy. Because chemotherapy can also negatively affect spermatogenesis, sperm cryopreservation prior to treatment should be strongly recommended for cancer patients of reproductive age.

Effect of Improvement in Lower Urinary Tract Symptoms on Sexual Function in Men: Tamsulosin Monotherapy vs. Combination Therapy of Tamsulosin and Solifenacin

PURPOSE: To evaluate how much the improvement of lower urinary tract symptoms (LUTS) affects sexual function and which storage symptoms or voiding symptoms have the greatest effect on sexual function. MATERIALS AND METHODS: A total of 187 patients were enrolled in this study. Patients were randomly assigned to receive either tamsulosin 0.2 mg (group A) or tamsulosin 0.2 mg and solifenacin 5 mg (group B). At 4 weeks and 12 weeks, the LUTS and sexual function of the patients were evaluated by use of the International Index of Erectile Function-5 (IIEF5), International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS) questionnaire, uroflowmetry, and bladder scan. RESULTS: Both groups A and B showed statistically significant improvements in IPSS, OABSS, and quality of life (QoL). Group A showed improved maximum flow rate, mean flow rate, and residual urine volume by time. Group B did not show an improvement in flow rate or residual urine volume but total voiding volume increased with time. The IIEF5 score was not improved in either group. In group A, the IIEF5 score dropped from 13.66+/-4.97 to 11.93+/-6.14 after 12 weeks (p=0.072). Group B showed a decline in the IIEF5 score from 13.19+/-5.91 to 12.45+/-6.38 (p=0.299). Although group B showed a relatively smaller decrease in the IIEF5 score, the difference between the two groups was not significant (p=0.696). CONCLUSIONS: Tamsulosin monotherapy and combination therapy with solifenacin did not improve erectile function despite improvements in voiding symptoms and QoL. The improvement in storage symptoms did not affect erectile function.

Effect of Improvement in Lower Urinary Tract Symptoms on Sexual Function in Men: Tamsulosin Monotherapy vs. Combination Therapy of Tamsulosin and Solifenacin

PURPOSE: To evaluate how much the improvement of lower urinary tract symptoms (LUTS) affects sexual function and which storage symptoms or voiding symptoms have the greatest effect on sexual function. MATERIALS AND METHODS: A total of 187 patients were enrolled in this study. Patients were randomly assigned to receive either tamsulosin 0.2 mg (group A) or tamsulosin 0.2 mg and solifenacin 5 mg (group B). At 4 weeks and 12 weeks, the LUTS and sexual function of the patients were evaluated by use of the International Index of Erectile Function-5 (IIEF5), International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS) questionnaire, uroflowmetry, and bladder scan. RESULTS: Both groups A and B showed statistically significant improvements in IPSS, OABSS, and quality of life (QoL). Group A showed improved maximum flow rate, mean flow rate, and residual urine volume by time. Group B did not show an improvement in flow rate or residual urine volume but total voiding volume increased with time. The IIEF5 score was not improved in either group. In group A, the IIEF5 score dropped from 13.66+/-4.97 to 11.93+/-6.14 after 12 weeks (p=0.072). Group B showed a decline in the IIEF5 score from 13.19+/-5.91 to 12.45+/-6.38 (p=0.299). Although group B showed a relatively smaller decrease in the IIEF5 score, the difference between the two groups was not significant (p=0.696). CONCLUSIONS: Tamsulosin monotherapy and combination therapy with solifenacin did not improve erectile function despite improvements in voiding symptoms and QoL. The improvement in storage symptoms did not affect erectile function.

Mirodenafil for the Treatment of Erectile Dysfunction: A Systematic Review of the Literature

Phosphodiesterase type 5 (PDE5) inhibitors are the most commonly used treatment for erectile dysfunction (ED). Since the launch of sildenafil, several drugs-including mirodenafil, sildenafil citrate (sildenafil), tadalafil, vardenafil HCL (vardenafil), udenafil, and avanafil-have become available. Mirodenafil is a newly developed pyrrolopyrimidinone compound, which is a potent, reversible, and selective oral PDE5 inhibitor. Mirodenafil was launched in Korea in 2007, and an orally disintegrating film of mirodenafil was developed in 2011 for benefitting patients having difficulty in swallowing tablets. This study aimed to review the pharmacokinetic characteristic profile of mirodenafil and report evidence on its efficacy in the case of ED. In addition, we reviewed randomized controlled studies of mirodenafil's daily administration and efficacy for lower urinary tract symptoms.

The Efficacy of Mirodenafil for Chronic Prostatitis/Chronic Pelvic Pain Syndrome in Middle-Aged Males

PURPOSE: The aim of this study was to investigate the efficacy of mirodenafil in middle-aged male patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). MATERIALS AND METHODS: Eighty-eight males with CP/CPPS were randomized to receive either levofloxacin (500 mg/d) (group L, 40 patients) or levofloxacin (500 mg/d) and mirodenafil (50 mg/d) (group ML, 48 patients) for six weeks. The International Prostate Symptom Score (IPSS), National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), and erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire were used to grade symptoms at baseline and 6 weeks after treatment. RESULTS: The mean change in total IPSS from baseline was higher in group ML than that in group L (group L, -1.1 vs. group ML, -4.3; p<0.05). Significant improvements were also seen in the IPSS voiding subscore (group L, -0.7 vs. group ML, -3.0; p<0.05). Changes observed in the NIH-CPSI of group ML at six weeks were greater than those at baseline (group L, -3.2 vs. group ML, -7.2; p<0.05). Significant improvements were seen in the NIH-CPSI voiding (group L, -0.5 vs. group ML, -1.7; p<0.05) and quality of life domains (group L, -1.0 vs. group ML, -1.8; p<0.05). Group ML showed a significantly greater increase in the IIEF-EF score than did group ML (group L, +0.2 vs. group ML, +7.8; p<0.05). CONCLUSIONS: Mirodenafil (50 mg once daily) was well tolerated and resulted in significant symptomatic improvement in middle-aged males with CP/CPPS.