Ki Hak Moon

Clinical study of SS-cream in patients with lifelong premature ejaculation

OBJECTIVES To investigate the clinical efficacy of SS-cream, the topical agent made from the extracts of nine natural products for the treatment of premature ejaculation, we performed a double-blind, randomized, placebo-controlled Phase III clinical study of patients with lifelong premature ejaculation in three medical centers. METHODS One hundred six patients (mean age 38.7 +/- 0.61 years) completed this study. The ejaculatory latency measured by stopwatch and sexual satisfaction ratio of both partner and patient were investigated twice in the screening period and once after each treatment (1 placebo 0.20 g and 5 SS-cream 0.20 g for a total of six treatments). Patients were instructed to apply the cream on the glans penis 1 hour before sexual intercourse in a double-blind randomized fashion. Clinical efficacy was compared with the prolongation of ejaculatory latency and improvement of the sexual satisfaction ratio before and after each treatment. RESULTS In the screening period, the mean ejaculatory latency was assessed at 1.37 +/- 0.12 minutes, and neither the patients nor their partners were satisfied with their sexual lives. After treatment, the mean ejaculatory latency was prolonged to 2.45 +/- 0.29 minutes in the placebo group and 10.92 +/- 0.95 minutes in the SS-cream group. The clinical efficacy of placebo and SS-cream as judged by an ejaculatory latency time prolonged more than 2 minutes was 15.09% and 79.81%, respectively. The improvement of sexual satisfaction to a grade higher than effective was 19.81% and 82.19%, respectively, for placebo and SS-cream. Of 530 trials of SS-cream, 98 (18.49%) resulted in a sense of mild local burning and mild pain. No adverse effect on sexual function or partner and no systemic side effects were observed. CONCLUSIONS According to these results, SS-cream is effective and safe in the treatment of premature ejaculation, with mild local side effects.

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

Study Type – Therapy (RCT)

Effect of obesity on prostate-specific antigen, prostate volume, and international prostate symptom score in patients with benign prostatic hyperplasia.

Purpose We examined the correlation between body mass index (BMI) as a marker of obesity and prostate-specific antigen (PSA), prostate volume (PV), and International Prostate Symptom Score (IPSS) in patients with benign prostatic hyperplasia (BPH). Materials and Methods From January 2008 to December 2008, we examined 258 patients diagnosed with BPH. Patients taking 5α-reductase inhibitors or those diagnosed with prostate cancer were excluded from this study. BPH was defined as PV≥25 ml and IPSS≥8. BMI (kg/m2) was categorized into 4 groups as follows: BMI<18.5 (underweight), BMI 18.5-23.0 (normal), BMI 23.0-27.5 (overweight), and BMI>27.5 (obese). The relationships between PSA, PV, IPSS, and BMI were analyzed by correlation analysis and one-way ANOVA. Results The mean age of the patients was 65.19±9.13 years and their mean BMI was 23.7±4.4 kg/m2. The mean PSA values of each BMI group were as follows: 3.42±1.53, 3.07±1.88, 2.74±1.75, and 2.60±1.44 ng/ml. The PSA value was lowest in the obese group. The correlation analysis showed a negative correlation between BMI and PSA (Pearsons correlation coefficient=-0.142, p=0.023) and positive correlations between BMI and PV (Pearsons correlation coefficient=0.32, p=0.001) and IPSS (Pearsons correlation coefficient=0.470, p=0.02). These correlations were also confirmed by one-way ANOVA. Conclusions Patients with an elevated BMI tended to have lower PSA values, larger PVs, and a higher IPSS. We suggest that weight loss could be helpful for BPH symptom relief as well as for detection of coexisting prostate cancer in BPH patients.

ORIGINAL RESEARCH—ED PHARMACOTHERAPY: The Efficacy and Safety of Udenafil [Zydena] for the Treatment of Erectile Dysfunction in Hypertensive Men Taking Concomitant Antihypertensive Agents

INTRODUCTION Erectile dysfunction (ED) and hypertension are frequent comorbid conditions. The vasodilating properties of type 5 phosphodiesterase inhibitor (PDE5I) are the major concerns for the treatment of ED patients on antihypertensive medications. AIM To evaluate the efficacy and safety of Udenafil [Zydena] (Dong-A, Seoul, Korea), a newly developed PDE5I, for the treatment of ED patients on antihypertensive medication. METHODS It was a multicentered, randomized, double-blind, placebo-controlled, fix-dosed clinical trial among 165 ED patients receiving antihypertensive medications. The subjects treated with placebo, 100 mg or 200 mg of Udenafil for 12 weeks were asked to complete the Sexual Encounter Profile (SEP) diary, the International Index of Erectile Function (IIEF), and the Global Assessment Question (GAQ) during the study period. MAIN OUTCOME MEASURES Primary parameter: the change from baseline for IIEF erectile function domain (EFD) score; Secondary parameters: the IIEF Question 3 and 4, SEP Question 2 and 3, the rate of achieving normal erectile function (EFD > or = 26) and the response to GAQ. RESULTS Compared to placebo, patients receiving both doses of Udenafil showed significantly improved the IIEF-EFD score. The least squares means for the change from baseline in IIEF-EFD scores were 8.4 and 9.8 for 100 mg and 200 mg Udenafil groups, respectively; those values were significantly higher than that of placebo (2.4, P < 0.0001). Similar results were observed in the comparison of Q3 and Q4 of IIEF, SEP diary and GAQ. Headache and flushing were the most common treatment-emergent adverse events, which were transient and mild-to-moderate in nature. No parameters of efficacy and safety were affected among the subsets stratified according to either the number of antihypertensive medication received or the previous experience of PDE5Is treatment. CONCLUSION Udenafil significantly improved erectile function among ED patients with hypertensive symptom treated with concomitant antihypertensive medication. The treatment did not increase the frequency or severity of adverse events.

Testosterone Replacement Alone for Testosterone Deficiency Syndrome Improves Moderate Lower Urinary Tract Symptoms: One Year Follow-Up

Purpose To evaluate the actual impact of testosterone replacement therapy (TRT) on patients with lower urinary tract symptom (LUTS), without benign prostate hyperplasia (BPH) medication. Materials and Methods Two hundreds forty-six patients underwent TRT using intramuscular injection of 3 months bases injection of testosterone 100 mg undecanoate over a year. Among them, 17 patients had moderate LUTS with a maximal flow rate of at least 10 ml/s but did not take any BPH-specific medication during TRT. The changes in prostate specific antigen (PSA), International Prostate Symptom Score (IPSS), and uroflowmetery were measured before and after TRT. Results After TRT, PSA remained unchanged after a year of treatment (p=0.078). Compared with their counterparts (n=229), the patients without BPH medication had similar baseline prostate characteristics in all variables, including prostate volume, IPSS, maximal flow rate, voiding volume, and PSA, except the median amount of residual urine, which was higher in the patients without BPH medication (21 ml vs. 10 ml). In the no-BPH medication group, the total IPSS score was decreased significantly (p=0.028), both in storage symptoms (questionnaire 2, 4, 7) and voiding symptoms (questionnaire 1, 3, 5, 6), while the maximal flow rate and residual urine amount remained unchanged after a year of TRT. During the median follow up of 15.1 months, no patients experienced urinary retention, BPH-related surgery, or admission for urinary tract infection. Conclusions Over a year of TRT for the no-BPH medication patients with moderate LUTS and maintained a relatively high maximal flow rate and improved both storage and voiding symptoms, without the clinical progression of BPH or rising PSA.

Microsurgical Ligation for Painful Varicocele: Effectiveness and Predictors of Pain Resolution.

Purpose We evaluated the effectiveness of microsurgical ligation for painful varicocele and predictive factors of pain resolution. Materials and Methods Between January 2006 and March 2009, a total of 114 patients (mean age, 30.2±8.9 years), who underwent microsurgical inguinal varicocelectomy for painful varicocele, were included and followed up for 1 year after the surgery. The quantity of preoperative and postoperative pain was assessed by means of 11-point numeric rating scale (NRS). We retrospectively analyzed the outcome of surgical ligation and predictive factors of pain resolution using patient age, height, weight, body mass index, grade and location of varicocele, duration, quantity and quality (dull, dragging, aching) of pain, and postoperative pain resolution. Results In 104 patients (91.2%), complete or marked resolution of pain was reported at follow-up 1 year after surgery. Only 10 patients (8.8%) had recurrent or persistent pain (≥3 points in NRS scores). On multivariate analysis, low quantity (≤6 points in NRS scores) and dull or dragging natured preoperative pain were independent factors associated with surgical success rates (p=0.004; odds ratio=1.62, p=0.012; odds ratio=1.76, respectively). Conclusion Microsurgical ligation is an effective treatment of painful varicocele. The quantity and quality of preoperative pain are independent predictive factors of pain resolution after surgery.

Priapism: Current Updates in Clinical Management

Priapism is a persistent penile erection that continues for hours beyond, or is unrelated to, sexual stimulation. Priapism requires a prompt evaluation and usually requires an emergency management. There are two types of priapism: 1) ischemic (veno-occlusive or low-flow), which is found in 95% of cases, and 2) nonischemic (arterial or high-flow). Stuttering (intermittent or recurrent) priapism is a recurrent form of ischemic priapism. To initiate appropriate management, the physician must decide whether the priapism is ischemic or nonischemic. In the management of an ischemic priapism, resolution should be achieved as promptly as possible. Initial treatment is therapeutic aspiration with or without irrigation of the corpora. If this fails, intracavernous injection of sympathomimetic agents is the next step. Surgical shunts should be performed in cases involving failure of nonsurgical treatment. The first management of a nonischemic priapism should be observation. Selective arterial embolization is recommended for the management of nonischemic priapism in cases that request treatment. The goal of management for stuttering priapism is prevention of future episodes. This article provides a review of recent clinical developments in the medical and surgical management of priapism and an investigation of scientific research activity in this rapidly developing field of study.

Effect of tamsulosin on ejaculatory function in BPH/LUTS

This study was undertaken to determine the impact on ejaculatory function of tamsulosin (0.2 mg) given once daily (OD) for 12 weeks and to identify risk factors for ejaculatory dysfunction in patients undergoing this treatment. Males with an International Prostatic Symptom Score (IPSS) ≥8 were enrolled in this study. All participants completed questionnaires, including the IPSS and the Male Sexual Health Questionnaire (MSHQ), and serum prostate-specific antigen, transrectal ultrasound and uroflowmetry with post-void residual were measured. After initiating 0.2 mg OD tamsulosin, patients were re-evaluated on the fourth and twelfth weeks of medication. The chi-squared test, the independent t-test and one-way ANOVA were used to compare means. Binary logistic regression analysis was used to calculate the odds ratio for all risk factors. A total of 177 men constituted the study cohort. No significant difference was observed between baseline and follow-up for the erectile function, ejaculatory function, satisfaction, sexual activity and desire domains (EFD, EjFD, SDA and ADD) or for erectile or ejaculatory bother mean scores. After 12 weeks, the overall incidence of ejaculatory dysfunction (EjD) was 13.4%. Incidences of the seven different types of EjD (decreased frequency, delay, dryness, decreased strength/force, decreased volume, decreased pleasure and pain at ejaculation) were 2.4%, 3.1%, 3.9%, 3.9%, 6.3%, 7.1% and 3.1%, respectively. Baseline EjFD scores were higher for IPSS responders than for non-responders (26.09 vs. 24.06, P=0.03). An EjFD score reduction was more frequent in IPSS responders. The incidence of EjD was small, but not negligible and was more frequent in patients with less lower urinary tract symptoms, a smaller prostate, higher baseline MSHQ totals and higher EjFD scores.

Long-term survival and patient satisfaction with inflatable penile prosthesis for the treatment of erectile dysfunction

Purpose We investigated the long-term survival and patient satisfaction with an inflatable penile prosthesis as a treatment for refractory erectile dysfunction (ED). Materials and Methods Between July 1997 and September 2014, a total of 74 patients underwent implantation of an inflatable penile prosthesis. The present mechanical status of the prosthesis was ascertained by telephone interview and review of medical records, and related clinical factors were analyzed by using Cox proportional hazard regression model. To investigate current status and satisfaction with the devices, novel questionnaires consisting of eight items were administered. Results The mean (±standard deviation) age and follow-up period were 57.0±12.2 years and 105.5±64.0 months, respectively. Sixteen patients (21.6%) experienced a mechanical failure and 4 patients (5.4%) experienced a nonmechanical failure at a median follow-up of 98.0 months. Mechanical and overall survival rates of the inflatable penile prosthesis at 5, 10, and 15 years were 93.3%, 76.5%, and 64.8% and 89.1%, 71.4%, and 60.5%, respectively, without a statistically significant correlation with host factors including age, cause of ED, and presence of obesity, hypertension, and diabetes mellitus. Overall, 53 patients (71.6%) completed the questionnaires. The overall patient satisfaction rate was 86.8%, and 83.0% of the patients replied that they intended to repeat the same procedure. Among the 8 items asked, satisfaction with the rigidity of the device received the highest score (90.6%). In contrast, only 60.4% of subjects experienced orgasm. Conclusions The results of our study suggest that excellent long-term reliability and high patient satisfaction rates make the implantation of an inflatable penile prosthesis a recommendable surgical treatment for refractory ED.

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.