Hyung Ki Choi

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.

Somatosensory evoked potentials in patients with primary premature ejaculation

PURPOSE Premature ejaculation has been believed to be psychological in the majority of patients. With few exceptions organic conditions are rarely implicated. We investigated the possible role of sensory function in patients with primary premature ejaculation to determine whether there is an etiological basis for this condition. MATERIALS AND METHODS We performed somatosensory evoked potentials from the penis in 34 patients with primary premature ejaculation and in 30 normally potent men. The latencies and amplitudes of the evoked potentials were measured at the penile shaft (dorsal nerve) and at the glans penis. RESULTS Mean latency of dorsal nerve and glans penis somatosensory evoked potentials was 1.51 and 6.80 (significant) msec. shorter, respectively, in the patients than in the normal subjects. In the normal subjects the mean latency of glans penis somatosensory evoked potentials was 0.99 msec. longer than that of the dorsal nerve (not significantly different) but in patients the mean latency in the glans penis was 4.30 msec. shorter (p < 0.001). Mean amplitude of glans penis somatosensory evoked potentials was less than that of the dorsal nerve in both groups. However, mean amplitudes of dorsal nerve and glans penis somatosensory evoked potentials were significantly greater in patients than in normal men. CONCLUSIONS Patients with premature ejaculation have hypersensitivity and hyperexcitability of the glans penis, which may give rise to uncontrolled ejaculation and are believed to be organic implications for premature ejaculation.

Safety and efficacy study with various doses of SS-cream in patients with premature ejaculation in a double-blind, randomized, placebo controlled clinical study

Objectives: SS-cream is a topical agent made from the extracts of natural products for treating premature ejaculation (PE). To determine the optimal clinical dosage of SS-cream on PE, we investigated the safety and efficacy of SS-cream with various doses. A double blind, randomized placebo controlled clinical study was performed.Methods: Fifty patients completed the study. Mean age of the patients was 37.1±1.0 y and mean ejaculatory latency was 1.35±0.07 min. Sexual satisfaction rate of both the partner and patient was 16.2%. Each patient was instructed to apply the different cream (placebo, SS-cream 0.05, 0.10, 0.15, 0.20 g) on glans penis 1 h before sexual intercourse in random fashion. The ejaculatory latency was measured by stop watch and the satisfaction rate of both partner and patient was also recorded two times in the screening period and after the application of each test drugs. Clinical efficacy was considered if ejaculatory latency was prolonged more than 2 min and sexual satisfaction rate increased more than 20% than that of pretest values.Results: The mean ejaculatory latencies were significantly prolonged after using various test drugs (placebo 2.27±0.32, SS-cream 0.05 g 4.47±0.81, 0.10 g 5.34±0.79, 0.15 g 6.22±0.87, 0.20 g 11.06±1.17 min, respectively). Clinical efficacies evaluated by ejaculatory latency were placebo 18%, SS-cream 0.05 g 30%, 0.10 g 60%, 0.15 g 54%, 0.20 g 84%, respectively. The satisfaction rate was also significantly increased dose-dependently (placebo 26%, SS-cream 0.05 g 60%, 0.10 g 70%, 0.15 g 78%, 0.20 g 90%, respectively). A side effect such as local mild burning sensation was noted in 35/250 times (14%) and no adverse effect on sexual function and no systemic side effects were observed. From the result of logistic regression analysis on clinical efficacy, the ED50 of SS-cream was obtained as 0.10 g. SS-cream 0.20 g was effective in 84% without any serious systemic side effects.Conclusion: From the above results, our conclusions are that SS-cream is effective on the treatment of PE with a few local side effects and that clinical optimal dose of SS-cream is 0.20 g.

Effect of Korean red ginseng on the rabbit corpus cavernosal smooth muscle

The extracts of Korean red ginseng (EKG) is a complex mixture containing ginsenosides, polysaccharides, and several other products. Animal experiments have shown that the intravenous administration of extract of ginseng reduces blood pressure. Recently, it has been reported that ginseng has a relaxing effect on vascular smooth muscle and that the relaxation is associated with nitric oxide (NO) released from the vascular endothelium. The present study was undertaken to investigate the effects of EKG on isolated rabbit corpus cavernosal smooth muscle for evaluation of the possibility of developing EKG as an pharmacoerecting agent.Strips of rabbit corpus cavernosum were mounted in organ chambers to measure isometric tension. On the precontracted muscle strip with phenylephrine (PHE; 5×10−6 M), EKG began to exert a relaxing effect at the concentration of 1 mg/ml and the maximal relaxation effect was reached at 40 mg/ml in a dose-dependent manner. EKG was inhibited significantly by endothelial disruption and by pretreatment with methylene blue, pyrogallol, L-NNA or atropine. EKG partially inhibited the PHE (5×10−6 M) induced contraction up to 45.67% of the control in a dose-dependent fashion. EKG decreased basal tension as well as inhibited the contraction induced by addition of CaCl2 (10−3 M) dose-dependently in muscle strips at basal equilibrated state in Ca2+ free, high K+ depolarizing solution. EKG also inhibited the contraction induced by depolarization with 20, 40 and 60 mM of KCl. However, this inhibitory effect did not occur with high concentrations of KCl (80 and 120 mM).EKG has a relaxing effect on the rabbit corpus cavernosal tissue in a dose dependent manner. The relaxation action of EKG is mediated by multiple action mechanisms that include increasing the release of NO from the corporal sinusoids, increasing intracellular calcium sequestration, and a hyperpolarizing action.

IN VITRO AND IN VIVO EXPERIMENTAL EFFECT OF KOREAN RED GINSENG ON ERECTION

PURPOSE To elucidate the efficacy of Korean red ginseng (KRG) on penile erectile tissue and erectile response, the effect of ginseng was evaluated in both in vivo and in vitro experiments in laboratory animals. MATERIALS AND METHODS Fifty milligrams of KRG per kilogram in weight was mixed in physiologic saline and given by mouth for 3 months to both rabbits and rats. In vitro experiments were performed by observing the responses to acetylcholine (ACh) and KRG of strips of rabbit corpus cavernosum. In vivo experiments were performed by measuring the cavernosal pressures after the stimulation of pelvic nerves innervating rat corpus cavernosum. RESULTS On rabbit cavernosal muscle strips precontracted with phenylephrine (5x10(-6) M), increasing concentrations of ACh (10(-7), 10(-6), 10(-5), 10(-4) M) showed dose dependent relaxation in the control group (10(-7) M: 15.32%, 10(-6) M: 35.44%, 10(-5) M: 59.45%, 10(-4) M: 76.54%)(p<0.01). After 3 months of KRG administration, the relaxation responses to ACh were increased significantly (10(-7) M: 34.18%, 10(-6) M: 56.35%, 10(-5) M: 75.33%, 10(-4) M: 89.86%)(p<0.01). Relaxation effects of KRG were significantly increased after administering KRG for 3 months, as evident by the intracavernousal pressure to electrostimulation being 107.52 cm. water in the control group and significantly increased to 138.34 cm. water after 3 months administration of KRG (p<0.01). CONCLUSION We confirmed that the long-term administration of KRG enhances erectile capacity and that its action is mediated by endothelium-derived relaxing factor and peripheral neurophysiologic enhancement.

MECHANICAL RELIABILITY OF THE AMS 700CXM INFLATABLE PENILE PROSTHESIS FOR THE TREATMENT OF MALE ERECTILE DYSFUNCTION

Purpose: The AMS 700CXM * *American Medical Systems, Inc., Minnetonka, Minnesota. inflatable penile prosthesis with medium controlled expansion cylinders was introduced in 1990 to provide a device with controlled expansion in girth and fitness for Asian men. We reviewed our experience with the AMS 700CXM prosthesis with particular regard to postoperative complications and reliability.Materials and Methods: From January 1991 to April 1999, 273 men with erectile dysfunction underwent primary penile prosthesis implantation with the AMS 700CXM. Functional status of the prosthesis was assessed retrospectively by reviewing the medical records and a telephone interview.Results: Patient age was 24 to 78 years and mean followup was 49 months. Of the 28 complications (10.3%) 8 (3%) were nonmechanical and 20 (7.3%) were mechanical. Nonmechanical complications included infection in 2 cases, erosion in 3, surgical complications in 2 and tube kinking in 1. Mechanical complications involved a cylinder tear in 11 cases (...

AMS 700CX/CXM Inflatable Penile Prosthesis Has High Mechanical Reliability at Long-Term Follow-Up

INTRODUCTION AMS 700CX/CXM inflatable penile prosthesis is increasingly applied for the treatment of erectile dysfunction (ED). However, there are a few long-term survival data of the inflatable penile prosthesis (IPP) over 10 years. AIM To determine the long-term mechanical reliability of AMS 700CX/CXM inflatable penile prosthesis in patients with ED. METHODS A total of 438 consecutive patients with ED received implantation of an AMS 700CX/CXM penile prosthesis at our institution from January 1991 to April 2009. In 397 patients (90.7%), the medical records were available and current status of penile prosthesis could be obtained by a direct telephone interview. The overall and mechanical survival rates of penile prosthesis were evaluated using Kaplan-Meier method. MAIN OUTCOME MEASURES Assessing the mechanical and overall survival rates of the AMS 700CX/CXM penile prosthesis using Kaplan-Meier analysis, and looking for clinical factors related to survival of the CX/CXM using log-rank test. RESULTS Mean age of 397 patients was 63.1 years (range, 24-93) and follow-up duration was 113 months (range 1-219). Eighty-two patients (20.6%) experienced mechanical failure at a median follow-up of 82 months. Mechanical survival rate of the penile prosthesis was 97.6%, 93.2% and 78.2% at 3, 5, and 10 years after implantation, respectively. 12 patients (3.0%) experienced nonmechanical failure including infections, tissue erosion resulting in cylinder protrusion at the meatus and chronic discomfort. Overall survival rate of the penile prosthesis was 95.0%, 91.0% and 75.5% at 3, 5, and 10 years after implantation, respectively. Patients with neurogenic cause for ED showed lower median overall survival of penile prosthesis compared with patients with non-neurogenic cause. Patient age, obesity, and diabetes mellitus had no association with overall survival of penile prosthesis after implantation. CONCLUSIONS The AMS 700CX/CXM could be accepted and applied in more patients as a reliable treatment alternative of ED.

A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea

The efficacy and safety of sildenafil was evaluated in a randomiSed, double-blind, placebo-controlled, flexible-dose study in Korean men aged 28–78 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months duration. A total of 133 patients were randomised at six centres in Korea to receive either sildenafil (50 mg initially, increased if necessary to l00 mg or decreased to 25 mg depending on efficacy and tolerance) (n=66) or matching placebo (n=67) taken on an ‘as needed’ basis l h prior to anticipated sexual activity for a period of 8 weeks. At the end of this time, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the International Index of Erectile Function (IIEF) scale, (2) the percentage of successful intercourse attempts, and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P<0.0001). Treatment-related adverse events occurred in 56.1% of patients receiving sildenafil and 20.9% receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache and abnormalities in colour vision (31.8, 22.7 and 6.1% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in this population of Korean men appears similar to that reported in other studies in western populations.

Erotic Erection Versus Nocturnal Erection

To clarify the correlation between erotic and nocturnal erections, and to evaluate the diagnostic efficacy of the audiovisual stimulation penogram as an initial screening test for impotent patients, a comparative study of 137 impotent patients was designed. The audiovisual stimulation penogram shows dynamic penile blood flow change during audiovisual stimulation using a radioisotope (99mtechnetium) and is classified as type 1--similar findings to normal volunteers, type 2A--impossible erection due to insufficient blood flow, type 2B--unstable erection due to severe fluctuation in blood flow and type 2C--delayed erection. The compatibility ratios of the audiovisual stimulation penogram types 1, 2A and 2C with some tests for nocturnal erection were relatively high (63 to 80%) and when compared to the final diagnosis all but 1 of the compatible cases with nocturnal erection studies were able to be diagnosed correctly. However, the compatibility ratio of the audiovisual stimulation penogram type 2B was markedly low (35%) and this group had complicated etiologies, including many more psychogenic than organic causes. Although the mechanisms of the erotic and nocturnal erections have not been fully elucidated to date, our results suggest that the audiovisual stimulation penogram seems to be an appropriate initial screening step if we refine the criteria for type 2B, and a comprehensive interpretation of the tests for erotic and nocturnal erections will result in a more accurate diagnosis.

Efficacy and safety of oral SK3530 for the treatment of erectile dysfunction in Korean men: a multicenter, randomized, double- blind, placebo-controlled, fixed dose, parallel group clinical trial

AIM To evaluate the efficacy and safety of SK3530, a newly developed type 5 phosphodiesterase inhibitor (PDE5I), in Korean men with erectile dysfunction (ED). METHODS A total of 119 patients were randomized at 10 centers in Korea to receive either SK3530 (50, 100, or 150 mg; n = 89) or placebo (n = 30) taken l h before anticipated sexual activity for an 8-week period. The patients were evaluated at baseline and 4 and 8 weeks after beginning therapy. Efficacy was assessed using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and the Global Assessment Question (GAQ). Safety was analyzed by adverse events, laboratory values and vital signs. RESULTS At the end of the study, all the primary and secondary efficacy end-points were statistically significantly improved by SK3530 compared with placebo (P<0.05). Of the 89 patients in the treatment arm, 36 (42.3%) achieved normal erectile function after treatment, including six patients with severe ED. Treatment-related adverse events occurred in 32 patients. The most common adverse events were flushing, headache, dizziness and eye redness (10.9%, 7.6%, 2.5% and 2.5%, respectively), and most were mild. Only two patients discontinued treatment during the study period because of adverse events. CONCLUSION The results of our phase II study have confirmed the efficacy and safety of SK3530 in a broad population of men with ED of various etiologies and severity. The optimal doses in terms of efficacy and safety were determined to be 50 mg and 100 mg, respectively.