Effect of 5α-reductase inhibitors on the efficiency of thulium:yttrium-aluminium-garnet (RevoLix®) vaporesection for treating benign prostatic hyperplasia.

Purpose: Preoperative use of 5α-reductase inhibitors (5ARIs) may cause fibrosis of the prostate tissue and reduce the efficiency of thulium laser surgery for treating benign prostate hyperplasia (BPH). Thus, we investigated the effects of preoperative 5ARI use in this setting. Materials and Methods: This retrospective study examined 184 patients who underwent thulium laser surgery for BPH during 2012-2017. Patients were grouped according to their 5ARI use in order to compare their preoperative and intraoperative characteristics and subsequent outcomes. Surgical efficiency was assessed using vaporesection efficiency. The total operation time, vaporesection time and prostate volume change were measured. Results: The 5ARI+ group included 83 patients (45.1%) and the 5ARI- group included 101 patients (54.9%). There were no significant differences in the two groups' preoperative characteristics, postoperative prostate size, thulium laser energy use, or prostate volume reduction rate. However, relative to the 5ARI- group, the 5ARI+ group had a significant shorter total operative time (65.0 min vs. 70.0 min, p=0.013) and a significantly shorter vaporesection time (48.0 min vs. 54.0 min, p=0.014), which resulted in significantly higher vaporesection efficiency in the 5ARI+ group (0.66 mL/min vs. 0.51 mL/min, p<0.001). Both groups exhibit significant improvements in their quality of life score and International Prostate Symptom Score during the 12-month follow-up. Conclusions: In contrast with our expectations, the preoperative use of 5ARI increased the efficiency of thulium laser surgery for BPH. Thus, it may not be necessary to stop 5ARI treatment before performing thulium laser surgery in this setting.

Efficacy and Safety of Tolterodine and Pilocarpine in Patients with Overactive Bladder.

PURPOSE: We evaluated the efficacy and safety of a combination of 2 mg tolterodine and 9 mg pilocarpine, vs tolterodine monotherapy in patients with overactive bladder. MATERIALS AND METHODS: We enrolled patients with overactive bladder symptoms in a multicenter, randomized, double-blind, parallel, active control study. Patients were randomized to the combination or 2 mg tolterodine twice daily for 12 weeks. After the double-blind period finished all patients were started on the combination for 12 weeks. Study co-primary end points were the change from baseline in the mean number of daily micturitions and cumulative incidence of dry mouth at the end of 12 weeks. Secondary end points were other overactive bladder symptoms, the total xerostomia inventory score and results of a visual analogue scale for dry mouth at the end of 12 and 24 weeks. RESULTS: The mean change in the number of daily micturitions from baseline to 12 weeks was -1.49 and -1.74 in the combination and tolterodine monotherapy groups, respectively. The mean difference was -0.26 (95% CI -0.79-0.27), confirming noninferiority. At 12 weeks the incidence of dry mouth was lower in the combination group than in the tolterodine monotherapy group (30.0% vs 42.9%, p = 0.009). All secondary and other efficacy outcomes related to overactive bladder symptoms improved in each group with no significant differences between the groups at 12 weeks. Changes from baseline in the total xerostomia inventory score and the visual analogue scale for dry mouth were significantly lower in the combination group than in the tolterodine monotherapy group. CONCLUSIONS: Tolterodine and pilocarpine alleviated dry mouth in patients with overactive bladder while maintaining anticholinergic efficacy similar to that of tolterodine.

Is It Worth Treating Non-Bothering Nocturia? Results of a Multicenter Prospective Observational Study.

PURPOSE: The purpose of this study was to evaluate the efficacy of treatment in patients with non-bothering nocturia. MATERIALS AND METHODS: In this prospective multicenter study, patients who visited hospitals for treatment of voiding symptoms were enrolled. Inclusion criteria were: 1) men >45 years, and 2) nocturia ≥2 confirmed by a three-day voiding diary. Subjects were divided into non-bothering and bothering groups based on International Consultation on Incontinence Questionnaire Nocturia (ICIQ-N) question 2b. Changes in voiding symptoms, frequency of nocturia, and bothersomeness were evaluated with international prostate symptom score (IPSS), ICIQ-N, and three-day voiding diary at 4 and 12 weeks after treatment. RESULTS: A total of 48 patients in the non-bothering nocturia group and 50 patients in the bothering nocturia group who completed the 12-week treatment were analyzed. The total IPSS was decreased by 5.8 in the non-bothering group and 5.2 in the bothering group. There was no significant difference in decrease of IPSS between the two groups. Both groups showed significant reduction in discomfort of nocturia. The ICIQ-N 2b score decreased from 3.9 to 2.7 (p=0.01) in the non-bothering group and from 6.9 to 4.6 (p=0.02) in the bothering group. The number of nocturia episodes was significantly decreased in both groups. CONCLUSIONS: Regardless of discomfort associated with nocturia, both groups showed significant improvement in nocturia-related discomfort and voiding symptoms. These results suggest that patients with nocturia who were unaware of its discomfort benefited from treatment.

Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial.

BACKGROUND: Phosphodiesterase type 5 inhibitors and α-adrenergic blocking agents (α-blockers) are widely used for the treatment of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). AIMS: To assess the efficacy and safety of fixed-dose combinations (FDCs) of tamsulosin and tadalafil compared with tadalafil monotherapy in patients with comorbid BPH-associated LUTS and ED. METHODS: A randomized, double-blinded, active-controlled trial was conducted of 510 men with BPH-associated LUTS and ED. Patients were treated with FDCs of tamsulosin 0.4 mg plus tadalafil 5 mg (FDC 0.4/5 mg), tamsulosin 0.2 mg plus tadalafil 5 mg (FDC 0.2/5 mg), or tadalafil 5 mg for a 12-week treatment period. For a subsequent 12-week extension period, the patients were administered FDC 0.4/5 mg. OUTCOMES: The primary outcomes were changes from baseline in total International Prostate Symptom Score (IPSS) and International Index of Erectile Function erectile function domain (IIEF-EF) score at week 12 to prove superiority and non-inferiority of FDCs compared with tadalafil 5 mg. The safety assessments were adverse reactions, laboratory test results, and vital signs at week 24. RESULTS: The mean changes in total IPSS and IIEF-EF scores were -9.46 and 9.17 for FDC 0.4/5 mg and -8.14 and 9.49 for tadalafil 5 mg, respectively, which indicated superiority in LUTS improvement (P = .0320) and non-inferiority in ED treatment with FDC 0.4/5 mg compared with tadalafil 5 mg. However, the results from FDC 0.2/5 mg failed to demonstrate superiority in LUTS improvement. No clinically significant adverse events regarding the investigational products were observed during the 24-week period. CLINICAL IMPLICATIONS: The FDC 0.4/5 mg is the first combined formulation of an α-blocker and a phosphodiesterase type 5 inhibitor that offers benefits in patient compliance and as add-on therapy in patients with comorbid BPH-associated LUTS and ED. STRENGTHS AND LIMITATIONS: The study clearly demonstrated the advantage of FDC 0.4/5 mg. The main advantage of FDC 0.4/5 mg was the enhanced efficacy on BPH-associated LUTS comorbidity with ED, the lower incidence of side effects, and the simplification and convenience of therapy, which led to better overall patient compliance. However, the lack of a tamsulosin monotherapy control group was a limitation of this study. CONCLUSION: The FDC 0.4/5 mg therapy was safe, well tolerated, and efficacious, indicating that combination therapy could provide clinical benefits for patients with BPH-associated LUTS complaints and ameliorate the comorbidity of ED. Kim SW, Park NC, Lee SW, et al. Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial. J Sex Med 2017;14:1018-1027.

Longitudinal changes in erectile function after thulium:YAG prostatectomy for the treatment of benign prostatic obstruction: a 1-year follow-up study.

This study aimed to evaluate the impact of thulium:yttrium-aluminum-garnet (Tm:YAG) (RevoLix®) laser prostatectomy for the treatment of benign prostatic obstructions on erectile function (EF). A total of 208 patients who underwent Tm:YAG laser prostatectomies participated in this study. All cases were evaluated preoperatively and at 3, 6, and 12 months postoperatively using the International Prostate Symptom Score (IPSS), quality of life (QoL) score, and the International Index of Erectile Function (IIEF-5) questionnaires. Patients were divided into groups A (severe erectile dysfunction [ED]), B (moderate ED), and C (mild-to-normal ED), according to their IIEF-5 scores. The median patient ages were 69, 65, and 62 years in groups A, B, and C, respectively. Significant improvements occurred in the IPSS and QoL score within the groups during the 12-month follow-up period. The IIEF-5 scores at 3 months postoperatively were lower than the preoperative scores in groups B and C. The IIEF-5 scores subsequently improved during the 12-month follow-up period. The slope of the relationship between the IIEF-5 score and the time since Tm:YAG laser prostatectomy had a ß value of 0.2210 (95% confidence interval 0.103 to 0.338, p = 0.0003); hence, each postoperative month was associated with an increase of 0.2210 in the IIEF-5 score. The IIEF-5 scores gradually increased and reached the preoperative levels by the 12-month follow-up assessment. Although the IIEF-5 score dropped significantly during the first 3 months postoperatively, it improved over the following 12 months. Tm:YAG laser prostatectomy did not impact on EF ultimately.

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.

Correlation between lower urinary tract symptoms and premature ejaculation in Korean men older than 40 years old [corrected].

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.

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

UNLABELLED: Study Type--Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Avanafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor newly developed for treating erectile dysfunction (ED). Preclinical and clinical phase I studies showed that avanafil had enhanced selectivity, faster onset of action and a favourable side-effect profile relative to currently available PDE5 inhibitors. As the result of phase III clinical trial for the efficacy and safety of avanafil treatment (100 and 200 mg), taken as needed over a period of 12 weeks, in Korean patients with ED, avanafil is an effective and well-tolerated therapy for ED of broad-spectrum aetiology and severity. OBJECTIVE: • To evaluate the efficacy and safety of avanafil, a new potent selective phosphodiesterase type 5 (PDE5) inhibitor, in patients with erectile dysfunction (ED). PATIENTS AND METHODS: • The present study was a multicentre, randomized, double-blind, placebo-controlled, fix-dosed phase three clinical trial involving 200 patients with ED. • The subjects were treated with placebo or avanafil (100 or 200 mg) for 12 weeks and were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ). • The primary outcome variable was the change from baseline for IIEF erectile function domain (EFD) score. • The secondary outcome variables were SEP Q2 and Q3, the shift to normal rate (EFD ≥ 26), and response to the GAQ. RESULTS: • Compared with placebo, patients who took 100 or 200 mg of avanafil had significantly improved IIEF-EFD score. • There were similar results when comparing Q2 and Q3 in the SEP diary and the GAQ. • Flushing was the most common treatment-related adverse event. • Most adverse events were transient and mild or moderate in severity. CONCLUSION: • Avanafil is an effective and well-tolerated therapy for ED of broad-spectrum aetiology and severity.

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.

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.

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). METHODS: Following a 4-week placebo run-in period, 151 Korean men were randomly assigned to receive once-daily tadalafil 5 mg, tamsulosin 0.2 mg, or placebo for 12 weeks. RESULTS: The International Prostate Symptom Score (IPSS) least squares mean changes from baseline to endpoint were numerically but not significantly improved in the tadalafil (-5.8) and tamsulosin (-5.4) groups compared with placebo (-4.2, P > 0.05). Decreases in IPSS obstructive and irritative subscores, IPSS Quality of Life score, and BPH Impact Index from baseline to endpoint were largest in the tadalafil group followed by tamsulosin, though none separated significantly from placebo. Increases in maximum urinary flow rate were small and not significantly different than placebo; the increase was largest in the tadalafil group (2.5 mL/sec), followed by the placebo (2.3 mL/sec) and tamsulosin (2.1 mL/sec) groups. The percentage of subjects reporting at least one treatment-emergent adverse event was 26.5, 13.7 and 3.9% in the tamsulosin, tadalafil and placebo groups, respectively. CONCLUSIONS: In this pilot study in Korean men, those with BPH and treated with tadalafil 5 mg or tamsulosin 0.2 mg once daily experienced a reduction in LUTS, which was numerically (but not statistically) significant compared with the placebo. Tadalafil was well tolerated and few subjects discontinued the study due to treatment-emergent adverse events. Larger studies in Asian men with BPH and LUTS treated with phosphodiesterase type 5 inhibitors are needed.

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 Women's 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.

Prevalence of premature ejaculation in young and middle-aged men in Korea: a multicenter internet-based survey from the Korean Andrological Society.

In this study, we aimed to investigate the prevalence and perception of premature ejaculation (PE) in young and middle-aged Korean men. The study was conducted using an Internet-assisted questionnaire. A total of 2 037 Korean male adults, aged 20 years or older, were randomly sampled based on age and residency. The questionnaire developed by the PE Study Group of the Korean Andrological Society includes four categories (overall sexual function, symptoms, distress and treatment) with a total of 16 questions. For each question, symptoms were evaluated by a scale ranging from 0 to 10. Intravaginal ejaculation latency time was '5-10 min' in 38.6%, followed by 'longer than 10 min' in 29.9%, '2-5 min' in 23.6%, '1-2 min' in 5.4% and 'shorter than 1 min' in 2.5%. In our series, 27.5% of respondents reported having PE. Control over ejaculation within a recent 3-month period was 6.2 points on average. Respondent complaints of PE-related stress averaged 7.1 points and stress-related complaints from sexual partners averaged 7.1 points. The effect of PE on sexual life was 6.8 points. Of the respondents determined as having PE, 42.6% responded that they were inclined to receive treatment. Results from this study suggest that the prevalence of PE diagnosed by the respondent on his own was approximately 27.5% in young and middle-aged men in Korea. PE-related stress had a significant effect on the stress, sexual activity and quality of life of the respondent and his sexual partner.

Efficacy and safety of mirodenafil in men taking antihypertensive medications.

INTRODUCTION: Mirodenafil is a recently developed oral phosphodiesterase type 5 inhibitor, which was observed to significantly improve erectile function and was well tolerated in men with broad-spectrum erectile dysfunction (ED). AIM: To investigate the efficacy and safety of mirodenafil treatment compared with placebo in men taking at least one antihypertensive medication. METHODS: A multicenter, double-blind, placebo-controlled, parallel group, fixed-dose study was conducted with 109 subjects who were randomized to placebo or mirodenafil 100 mg for 12 weeks on an "as needed" basis. MAIN OUTCOME MEASURES: The primary efficacy measures were the changes from baseline in sum of scores on International Index of Erectile Function-erectile function domain (IIEF-EF) questions 1 to 5 and 15 with treatment. The secondary efficacy measures included scores on IIEF question 3 and 4 (Q3 and Q4), all domain scores of IIEF, and Sexual Encounter Profile Question 2 and 3 (SEP2 and SEP3) along with responses to Global Assessment Question (GAQ) and Life Satisfaction Checklist (LSC). The safety assessments included laboratory tests, vital signs, 12-lead electrocardiogram recordings, and patients' reporting of adverse events. RESULTS: The mirodenafil group showed significantly greater increase in IIEF-EF scores at 12 weeks compared with the placebo group (9.35 ± 6.86 vs. 2.66 ± 6.44, P<0.001). The mirodenafil group also demonstrated significantly greater improvement in scores of IIEF Q3 and Q4, other four domains of IIEF, SEP2, SEP3, and LSC along with percentages of patients responding positively to GAQ compared with the placebo group. During the study, no clinically significant changes were observed regarding blood pressure, heart rate, electrocardiographic findings, or laboratory values. Facial flushing and headache were the most common treatment-associated adverse events, which were mild or moderate in severity, resolving spontaneously. CONCLUSIONS: Mirodenafil was effective and safe in men with ED concomitantly taking antihypertensive medications.

A prospective multicenter randomized comparative study between the U- and H-type methods of the TVT SECUR procedure for the treatment of female stress urinary incontinence: 1-year follow-up.

BACKGROUND: No studies have been published comparing the U- and H-type methods of the TVT SECUR (TVT-S) procedure. OBJECTIVE: Our aim was to compare the efficacy and safety of the two types of TVT-S for female stress urinary incontinence (SUI). DESIGN, SETTING, AND PARTICIPANTS: Women with urodynamic SUI were enrolled in this 12-mo multicenter randomized study. INTERVENTION: Subjects were randomly allocated to either the U- or H-type method of TVT-S. MEASUREMENTS: Pre- and postoperative evaluations included a standing stress test, the Sandvik questionnaire, the Incontinence Quality of Life (I-QOL) questionnaire, and the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). Patients' satisfaction and complications were evaluated. Objective and subjective cures were defined as no leakage on the stress test and responses on the Sandvik questionnaire, respectively. We compared the surgical outcomes between the two methods. RESULTS AND LIMITATIONS: Of 285 women, 144 had the U-type method and 141 had the H-type method. Objective cure rates were 87.5% for the U-type method and 80.1% for the H-type method (p=0.091). Subjective cure rates were 77.1% for the U-type method and 75.7% for the H-type method (p=0.786). Improvement in I-QOL and domain scores of the ICIQ-FLUTS (filling and incontinence sum, QOL score), and patients' satisfaction favored the U-type method. There were three cases of intraoperative vaginal wall perforation, one case of increased bleeding, and three cases of temporary postoperative retention. A power calculation was not performed, and some baseline characteristics were not balanced between the two methods. CONCLUSIONS: Both methods of TVT-S provided comparable cure rates for female SUI. However, QOL and treatment satisfaction favored the U-type method. TRIAL REGISTRATION: The protocol of this study was not registered.

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.

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.

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.