Je Jong Kim

Antidiuretic hormone in elderly male patients with severe nocturia: a circadian study

To investigate the circadian variation of plasma antidiuretic hormone (ADH) and urine output in patients with severe nocturia (> three times per night) and to assess the effect of oral desmopressin on nocturnal urine output in these patients.

Efficacy and Safety of Once-Daily Dosing of Udenafil in the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

BACKGROUND A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0-1.5h and a terminal half-life of 11-13 h make udenafil a good candidate for once-daily dosing. OBJECTIVE To evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED. DESIGN, SETTING, AND PARTICIPANTS This multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25mg, 50mg, or 75 mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study. MEASUREMENTS The primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥ 26), and the response to the GAQ. RESULTS AND LIMITATIONS Compared with placebo, patients who took 50mg or 75 mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity. CONCLUSIONS Udenafil significantly improved erectile function among ED patients when administered in doses of 50mg or 75 mg once daily for 12 wk. Daily administration of udenafil (50mg) may be another treatment option for ED.

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

Study Type – Therapy (RCT)

Tadalafil Administered Once Daily for Treatment of Lower Urinary Tract Symptoms in Korean men with Benign Prostatic Hyperplasia: Results from a Placebo-Controlled Pilot Study Using Tamsulosin as an Active Control

Objectives: Assess the efficacy and safety of once‐daily tadalafil or tamsulosin versus placebo during 12 weeks on lower urinary tract symptoms (LUTS) in Korean men with benign prostatic hyperplasia (BPH).

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.

Correlation between Serum Total Testosterone and the AMS and IIEF Questionnaires in Patients with Erectile Dysfunction with Testosterone Deficiency Syndrome

Purpose This study was conducted to investigate the relationship between serum total testosterone levels and scores on the Aging Males Symptom (AMS) scale and the International Index of Erectile Function (IIEF) in men with erectile dysfunction with testosterone deficiency syndrome (TDS). Materials and Methods From January 2005 to July 2008, 134 patients who complained of sexual dysfunction such as erectile dysfunction or decreased libido as the main symptoms of TDS with serum total testosterone levels less than 3.5 ng/ml were evaluated by independent t-test and linear regression analysis, respectively. Patients with treated hypogonadism within 6 months, with a history of taking a PDE5 inhibitor or an antidepressant for a depressive disorder, or who had metabolic syndrome were excluded from this study. Results The AMS scale and its 3 subdomain scores were not significantly correlated with the total testosterone level. By contrast, the total IIEF score and the score of each IIEF domain except sexual desire showed a weakly significantly positive correlation with serum total testosterone. Conclusions In TDS patients with erectile dysfunction, there was a low relationship between serum total testosterone levels and the AMS scale and a weakly positive correlation between total testosterone levels and all IIEF domains except sexual desire. There was a low relationship between the AMS scale, the sexual desire domain score of the IIEF, and total testosterone. We should understand these limitations when evaluating patients with erectile dysfunction with TDS. New scales should be developed for the evaluation of erectile dysfunction in these patients.

Is There a Correlation Between the Presence of Idiopathic Detrusor Overactivity and the Degree of Bladder Outlet Obstruction

OBJECTIVE To assess the factors associated with the presence of idiopathic detrusor overactivity (IDO) in male patients with clinical benign prostatic hyperplasia (BPH). MATERIALS AND METHODS We prospectively evaluated 193 men who presented with lower urinary tract symptoms. Each patient underwent urodynamic evaluation, International Prostate Symptom Score (IPSS), uroflowmetry, residual volume check, and transrectal ultrasound for estimation of prostate volume. IDO was defined according to the new International Continence Society classification (2002) as involuntary detrusor contractions during cystometry, which may be spontaneous or provoked, regardless of amplitude. Patients were divided into groups according to the presence of detrusor overactivity and bladder outlet obstruction index (BOOI) greater than 40. Variables associated with the presence of IDO were analyzed using Students t-test, chi-square test, linear-by-linear association test, and logistic regression analysis. RESULTS Of 193 patients, IDO was present in 49 (25.4%). BOOI and prostate volume showed significant but weak correlation. On univariate analysis, patients with IDO were older and showed smaller maximal bladder capacity (MBC), higher BOOI, higher maximal detrusor pressure at maximal flow rate, and higher irritative IPSS subscores. On logistic regression analysis, MBC and BOOI were the factors affecting the presence of IDO, with odds ratios of 0.981 and 1.046, respectively. Positive linear association was noted between BOOI and prevalence of DO by linear association test with prevalence of DO rising continuously with increasing BOOI. CONCLUSION BOO is responsible for IDO and because the prevalence of IDO is inversely associated with the degree of obstruction, the treatment of BOO is potentially able to reverse the DO.

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.

Laparoscopic Ureterolithotomy as a Primary Modality for Large Proximal Ureteral Calculi: Comparison to Rigid Ureteroscopic Pneumatic Lithotripsy

OBJECTIVE To define the role of laparoscopic ureterolithotomy (LU) as a primary modality for large proximal ureteral stones, we compared the outcomes of primary LU with those of ureterorenoscopy (URS), the currently established modality in this circumstance. MATERIALS AND METHODS Among 71 patients who underwent LU in our institution between February 2005 and January 2010, 32 patients with stone size over 1.5 cm who underwent LU as a primary modality without prior shockwave lithotripsy or URS and for whom LU was conducted as a separate procedure were exclusively enrolled. Based on preoperative characteristics of patients and stones, this patient group was matched with the URS group (n = 32, rigid pneumatic lithotripter) during the same period. RESULTS The LU group and the URS group were similar in age, gender distribution, body mass index, stone size (18.1 ± 4.2 versus 17.9 ± 3.6 mm; P = .88), and stone location. Members of the LU group required a longer operative time (118 ± 53 versus 59 ± 41 minutes; P < .001) and hospital stay (5.9 ± 2.1 versus 3.4 ± 2.4 days; P < .001) and had greater blood loss (155 ± 62 mL). However, stone clearance rate (no remnant stone in postoperative X-ray of the kidney, ureter, and bladder) in a single session was marginally higher in the LU group (93.8% versus 68.8%; P = .06). Total complication rate was not significant and was slightly higher in the URS group (12.5% versus 21.9%, P = .51). Stone migration into the kidney (n = 2 versus 5), ureteral perforation (n = 0 versus 3), open conversion (n = 1 versus 2), and ureteral stricture (n = 1 versus 2), as long-term complications, occurred more frequently in the URS group. CONCLUSIONS For large proximal ureteral stones, LU can be conducted safely as a first-line procedure without increase of complication rate, compared with conventional URS. Although LU required a prolonged operative time and a longer hospital stay and blood loss was greater, our data showed an advantage of LU in high clearance rate in a single procedure.

ORIGINAL RESEARCH—OUTCOMES ASSESSMENT: Development of a Korean Version of the Female Sexual Distress Scale

INTRODUCTION This article presents data based on the responses of more than 100 women who contributed to the development of a Korean version of the Female Sexual Distress Scale (FSDS). AIM The FSDS was developed to measure sexually related personal distress in women. This article aims to test the usefulness and analyze factors of the 20-item version of the FSDS in a Korean female sample. METHODS The original two-item FSDS was translated with cultural modifications. A total of 104 healthy, married women were recruited through a survey. A second survey was undertaken after 2 weeks for test-retest reliability. Validity, internal consistency reliability, and test-retest reliability were evaluated. An exploratory factor analysis was also performed. MAIN OUTCOME MEASURES A Korean version of the FSDS. RESULTS The test-retest coefficients of stability over a 2-week period was 0.99 (P < 0.01). The 20 items of the FSDS have good internal consistency, with an alpha of 0.96. The FSDS discriminated between women with and without sexually related distress (t = -7.34, P < 0.01). The optimal cut-off score was 20 (sensitivity 71.4%, specificity 92.2%). By principal axis factoring, the Korean version of the FSDS was found to consist of two factors. A 16-item FSDS had good internal consistency with an alpha of 0.97. The test-retest reliability was good (r = 0.99, P < 0.01). The items of the 16-item FSDS were somewhat different from the original 12-item FSDS. CONCLUSIONS The Korean version of the FSDS (20-item) might be a useful tool for screening sexually distressed women in Korea. Instead of the 12-item version of the original FSDS, the 16-item FSDS was validated in this study. These results could reflect cultural differences between Eastern Asian and Western societies.