Kweon Sik Min

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).

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.

Early Experience with Hyaluronic Acid Instillation to Assist with Visual Internal Urethrotomy for Urethral Stricture

Purpose The clinical usefulness of hyaluronic acid (HA) instillation during visual internal urethrotomy (VIU) for decreasing the incidence of recurrent urethral stricture was assessed. Materials and Methods Twenty-eight patients were treated by VIU with HA instillation between May 2007 and June 2009. After insertion of a Foley catheter following urethrotomy, HA was instilled via an 18-gauge tube catheter between the urethral lumen and Foley catheter. Seventeen cases were analyzed retrospectively 12 months postoperatively. We evaluated the success rate of this procedure by comparing retrograde urethrography (RGU) results, maximum flow rates, and postvoid residual urine volumes preoperatively and 3 and 12 months postoperatively. Success was defined as either a maximum flow rate of at least 15 ml/s or no visible urethral stricture on RGU at 12 months postoperatively. Results Total success rates were 76.5% (13/17) and 52.9% (9/17) at 3 and 12 months postoperatively, respectively. By etiology, success rates at 3 and 12 months postoperatively, respectively, were 66.7% and 33.3% for inflammation, 66.7% and 50.0% for trauma, and 83.3% and 66.7% for unknown causes. Success rates were 63.6% for strictures less than 10 mm in length and 33.3% for strictures of 10 mm or more in length at 12 months postoperatively. Success rates were 61.5% for single strictures and 25% for multiple strictures at 12 months postoperatively. Conclusions The success rate of VIU with HA instillation was not better than that observed in the literature for conventional VIU.

Generic and disease-specific health-related quality of life in women with coital incontinence: a prospective, multicenter study.

Objective: This study was carried out to evaluate the impact of coital incontinence on health-related quality of life (HRQOL) in women with lower urinary tract symptoms. Methods: A total of 180 women with sexual activity were evaluated. To obtain HRQOL assessments, patients were asked to fill out the Bristol Female Lower Urinary Tract Symptoms and the Medical Outcomes Study Short Form (SF-36) questionnaires. Results: The coital incontinence group had more frequently symptoms including urgency, urge incontinence, bladder pain, stress incontinence, unpredictable incontinence, nocturnal incontinence, reduced stream, and stopping flow than the no coital incontinence group. The frequency of incontinence and volume of leakage were also higher in the coital incontinence group than the no coital incontinence group. All symptom questions regarding sexual matters and quality of life except cutting down on fluid were more frequent in patients with coital incontinence than those without coital incontinence. Of the eight domains in the SF-36 questionnaire, five domains, namely, Physical functioning, Role-physical functioning, Social functioning, Role-emotional functioning, and Mental health were significantly different between the two groups. When comparing the Bristol Female Lower Urinary Tract Symptoms scores in the two groups, the scores in all domains except Voiding symptoms in the coital incontinence group were significantly higher than those in the no coital incontinence group. Patients with coital incontinence had more HRQOL impairment than those without coital incontinence. Conclusions: Our study reveals that more emphasis should be placed on coital incontinence in the terminology of urinary incontinence.

Short term effect and safety of antidiuretic hormone in the patients with nocturia.

Purpose To investigate the short-term safety of antidiuretic hormone in elderly patients with nocturnal polyuria, focus on hyponatremia and others electrolytes disturbances and to assess short-term effects on nocturnal urine output and number of nocturnal voids. Methods Between June 2005 and August 2006, a total of 34 patients with nocturnal polyuria were orally administered 0.2 mg desmopressin tablet at bedtime for two weeks. Serum sodium, others electrolytes, urine sodium and urine osmolarity were assessed in the third days, one week and two weeks after treatment with desmopressin and compared adult group (<65 years of age) with elderly group (≥65 years of age). We assessed the effect of desmopressin using a frequency-volume charts and analysed. Results In total 34 patients (20 adult, 14 elderly) were analyzed. Desmopressin treatment did not significantly change serum and urine electrolytes include soduim concentration in elderly patients comparied with adult patients. Serum sodium concentration below normal range was recorded in 2 patients in elderly group, but no serious adverse events occurred and recovered without sequelae. The mean number of nocturnal voids decresed (54% reduction) and nocturnal urine output decreased (57% reduction) after using desmopressin. Conclusions Desmopressin was well tolerated and effective in elderly patients with nocturnal polyuria without clinically significant hyponatremia.

A Study Assessing the Quality of Life Related to Voiding Symptoms and Sexual Functions in Menopausal Women

Purpose To investigate the impact of menopause on the quality of life (QoL) of middle-aged and older women, including their general well-being, voiding-related symptoms, and sexual distress. Materials and Methods To assess QoL, we administered a questionnaire that included questions about voiding-related symptoms and female sexual distress and part of the Womens Health Questionnaire. The self-administered questionnaires were completed by 1,679 women in the Korea. Data for 1,262 women were available for analysis, including premenopausal (n=307), perimenopausal (n=240), and postmenopausal (n=715) groups. Results Voiding-related discomfort increased significantly in perimenopausal and postmenopausal women compared with premenopausal women (p<0.001). General well-being worsened as menopause progressed (p<0.001). Menopausal women who were older (p=0.014), had a hysterectomy (p=0.005), or had urinary incontinence (p=0.001) had more voiding-related symptoms. Hypertension (p=0.026), cardiac disease (p=0.013), and arthritis (p=0.001) resulted in significantly decreased general well-being. Women with a hysterectomy (p=0.017) and those with arthritis (p=0.004) had high sexual distress. In the menopausal group, employed women had better general well-being than did unemployed women. Conclusions Menopause negatively affected the QoL of middle-aged and older women because of decreased general well-being and increased voiding-related symptoms. General health, even in menopausal women, was important to maintain a better QoL. To preserve the QoL of women undergoing menopause, control of menopause and underlying disease should be considered.

Assessing Quality of Life Related to Voiding Symptoms and Sexual Function in Menopausal Women

Purpose To evaluate the correlation between lower urinary tract symptoms (LUTS) and premature ejaculation (PE) in Korean men older than 40 years. Materials and Methods In total, 258 men older than 40 years completed the International Prostate Symptom Score (IPSS; total score, storage symptoms [ST], and voiding symptoms [VD]), a 5-item version of the International Index of Erectile Function (IIEF-5), and the Premature Ejaculation Diagnostic Tool (PEDT). The study examined the relationship between LUTS and PE. In the PEDT, PE is defined as a score ≥11. Results The prevalence of PE was 29.1% with the PEDT versus a self-reported value of 49.5%. The prevalence of PE was 30.9% in 40 to 59-year-old men (21.3%) and 28.1% in 60 to 79 year-old men (78.7%). In men 40 to 59 and 60 to 79 years old, the mean PEDT, IPSS, and IIEF-5 scores were 8.65 and 7.88, 13.5 and 12.38, and 15.83 and 13.69, respectively. No significant correlations were observed between the total and subscale scores of the IPSS (p=0.204) and the PEDT (p=0.309) with increasing age, whereas a significant negative correlation was detected between the IIEF-5 and age (p=0.002). The PEDT score was significantly correlated with the IPSS-ST (r=0.326, p<0.001), IPSS-VD (r=0.183, p=0.005), IPSS-total (r=0.310, p<0.001), and IIEF-5 total (r=-0.248, p<0.001). Conclusions LUTS, especially storage symptoms, were related to PE. In elderly men, control of both erectile dysfunction and LUTS may play an important role in managing PE.

Multicenter, prospective, comparative cohort study evaluating the efficacy and safety of alfuzosin 10 mg with regard to blood pressure in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia with or without antihypertensive medications.

Background The objective of this study was to assess the efficacy and safety of alfuzosin 10 mg monotherapy or combined antihypertensive medication on blood pressure (BP) in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS) with or without antihypertensive medication. Methods This was a 3-month, multicenter, randomized, open-label study in 335 patients aged ≥45 years with a clinical diagnosis of BPH/LUTS by medical history and clinical examination, a total International Prostatic Symptom Score (IPSS) ≥8 points, a maximum flow rate >5 mL/sec and ≤15 mL/sec, and a voided volume ≥120 mL. Eligible subjects were randomized to receive alfuzosin 10 mg as monotherapy (group 1) or alfuzosin 10 mg + antihypertensive combination therapy (group 2). Based on baseline BP and hypertensive history with or without antihypertensive medications at first medical examination, group 1 was divided into two subgroups of normotensive and untreated hypertensive patients, and group 2 into two subgroups of controlled hypertensive and uncontrolled hypertensive patients. The primary study outcomes were change in IPSS, BP, and heart rate from baseline. Secondary outcomes were change in IPSS-quality of life score, maximum flow rate, average flow rate, voided volume, and post-voided volume. Results The overall BP change was not significantly different between groups 1 and 2 (systolic BP, P=0.825; diastolic BP, P>0.999). In patients with uncontrolled or untreated hypertension, alfuzosin 10 mg alone or combined with antihypertensive therapy significantly decreased systolic and diastolic BP. The mean difference in total IPSS and IPSS-quality of life scores from baseline between groups 1 and 2 was 0.45 (95% CI: −1.26, 2.16) and 0.12 (95% CI: −0.21, 0.45), respectively (both P>0.05). Maximum flow rate, average flow rate, voided volume, and post-voided volume at endpoint were numerically, but not significantly, changed from baseline (all P>0.05). Conclusion This study shows that alfuzosin 10 mg is effective and well tolerated in patients with BPH/LUTS with or without antihypertensive medications. However, in patients with uncontrolled or untreated hypertension, alfuzosin 10 mg alone or in combination with antihypertensive medication appears to decrease systolic and diastolic BP, and these patients should be warned about a decrease in BP on initiation of therapy.