A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Efficacy and Safety of Vibegron in Treating Korean Patients With Overactive Bladder / 대한배뇨장애요실금학회지

Purpose@#Vibegron, a novel, potent β3 agonist, has been approved for clinical use in overactive bladder (OAB) treatment in Japan and the Unites States. We performed a bridging study to investigate the efficacy and safety of a daily 50-mg vibegron (code name JLP-2002) dose in Korean patients with OAB. @*Methods@#A multicenter, randomized, double-blind, placebo-controlled study was conducted from September 2020 to August 2021. Adult patients with OAB with a symptom duration of more than 6 months entered a 2-week placebo run-in phase. Eligibility was assessed at the end of this phase and selected patients entered a double-blind treatment phase after 1:1 randomization to either the placebo or vibegron (50 mg) group. The study drug was administered once daily for 12 weeks and follow-up visits were scheduled at weeks 4, 8, and 12. The primary endpoint was the change in mean daily micturition at the end of treatment. The secondary endpoints included changes in OAB symptoms (daily micturition, nocturia, urgency, urgency incontinence, and incontinence episodes, and mean voided volume per micturition) and safety. A constrained longitudinal data model was used for statistical analysis. @*Results@#Patients who took daily vibegron had significant improvements over the placebo group in both primary and secondary endpoints, except for daily nocturia episodes. The proportions of patients with normalized micturition and resolution of urgency incontinence and incontinence episodes were significantly higher in vibegron group than in the placebo. Vibegron also improved the patients’ quality of life with higher satisfaction rates. The incidence of adverse events in the vibegron and placebo groups was similar with no serious, unexpected adverse drug reactions. No abnormality in electrocardiographs was observed as well as no significant increase in postvoid residual volume. @*Conclusions@#Once daily vibegron (50 mg) for 12 weeks was effective, safe, and well-tolerated in Korean patients with OAB.

Effect of Diabetes Mellitus on Symptomatic Improvement After Surgery for Benign Prostatic Hyperplasia in Patients With Lower Urinary Tract Symptom and its Relations With Prostatic Urethral Angulation / 대한배뇨장애요실금학회지

Purpose@#To compare improvement of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia in diabetic versus nondiabetic patients after transurethral resection of the prostate (TURP) or holmium laser enucleation of the prostate (HoLEP). @*Methods@#The medical records of 437 patients who underwent TURP or HoLEP at a tertiary referral center from January 2006 to January 2022 were retrospectively analyzed. Among them, 71 patients had type 2 diabetes. Patients in the diabetic mellitus (DM) and non-DM groups were matched 1:1 according to age, baseline International Prostate Symptom Score (IPSS), and ultrasound measured prostate volume. Changes in LUTS were assessed at 3 months after surgery using IPSS and evaluated by categorizing patients according to prostatic urethral angulation (PUA; <50° vs. ≥50°). Medication-free survival after surgery was also investigated. @*Results@#No significant differences were noted between the DM and non-DM groups in baseline characteristics except for comorbidities (i.e., hypertension, cerebrovascular disease, and ischemic heart disease, P=0.021, P=0.002, and P=0.017, respectively) and postvoid residual urine volume (115±98 mL vs. 76±105 mL, P=0.028). Non-DM patients showed significant symptomatic improvement regardless of PUA, while DM patients demonstrated improvement in obstructive symptoms only in those with large PUA (≥51°). Among patients with small PUA, DM patients had worse medication-free survival after surgery compared to controls (P=0.044) and DM was an independent predictor of medication reuse (hazard ratio, 1.422; 95% confidence interval, 1.285–2.373; P=0.038). @*Conclusions@#DM patients experienced symptomatic improvement after surgery only in those with large PUA. Among patients with small PUA, DM patients were more likely to reuse medication after surgery.

Efficacy and Safety of DA-8010, a Novel M3 Antagonist, in Patients With Overactive Bladder: A Randomized, Double-Blind Phase 2 Study / 대한배뇨장애요실금학회지

Purpose@#DA-8010 is a novel muscarinic M3 receptor antagonist with significant selectivity for bladder over salivary gland in preclinical studies. We evaluated the clinical efficacy and safety of DA-8010 in overactive bladder (OAB) patients. @*Methods@#This phase 2, randomized, double-blind, parallel-group, active reference- and placebo-controlled trial was conducted at 12 centers in South Korea (NCT03566134). Patients aged ≥19 years with OAB symptoms for ≥3 months were enrolled. Three hundred six patients (30.07% male) were randomized to 12 weeks of treatment among 4 groups; 2 experimental groups (DA-8010 2.5 or 5 mg), an active reference group (solifenacin 5 mg), and a placebo group. The change from the baseline of (=∆) 24-hour frequency at 12 weeks (primary endpoint), episodes of urgency, overall/urgency urinary incontinence, average/ maximum voided volume, nocturia, and patients’ subjective responses were analyzed. @*Results@#In the full analysis set, the mean (standard deviation) [median] values for ∆ 24-hour frequency at 12 weeks were -1.01 (2.44) [-1.33] for placebo, -1.22 (2.05) [-1.33] for DA-8010 2.5 mg, and -1.67 (2.25) [-1.67] for DA-8010 5 mg; DA-8010 5 mg showed a significant decrease compared with placebo (P=0.0413). At 4 and 8 weeks, both DA-8010 2.5 mg (P=0.0391 at 4 weeks, P=0.0335 at 8 weeks) and DA-8010 5 mg (P=0.0001 at 4 weeks, P=0.0210 at 8 weeks) showed significant decrease in ∆ 24-hour frequency compared with placebo. DA-8010 5 mg achieved a significant decrease in ∆ number of urgency episodes, compared with placebo at 4 (P=0.0278) and 8 (P=0.0092) weeks. Adverse drug reactions (ADRs) were observed in 3.95% of placebo, 6.67% of DA-8010 2.5 mg, 18.42% of DA-8010 5 mg, and 17.33% of solifenacin 5 mg groups. No serious ADRs were observed in any patient. @*Conclusions@#Both DA-8010 2.5 mg and 5 mg showed therapeutic efficacy for OAB without serious ADRs. Therefore, both dosages of DA-8010 can advance to a subsequent large-scale phase 3 trial.

The Use of Gonadotropin-Releasing Hormone Agonist Does Not Affect the Development of Cardiovascular Disease in Prostate Cancer Patients: a Nationwide Population-Based Cohort Study

The Use of Gonadotropin-Releasing Hormone Agonist Does Not Affect the Development of Cardiovascular Disease in Prostate Cancer Patients: a Nationwide Population-Based Cohort Study

BACKGROUND@#The objective of this study was to investigate whether androgen deprivation therapy (ADT) with gonadotropin-releasing hormone agonist (GnRHa) in prostate cancer (Pca) patients is associated with cardiovascular disease in the cohort based from the entire Korean population.@*METHODS@#Using the Korean National Health Insurance database, we conducted an observational study of 579,377 men who sought treatment for Pca between January 1, 2012 and December 31, 2016. After excluding patients with previously diagnosed cardiovascular disease or who had undergone chemotherapy, we extracted the data from 2,053 patients who started GnRHa (GnRHa users) and 2,654 men who were newly diagnosed with Pca (GnRHa nonusers) between July 1, 2012, and December 31, 2012, with follow-up through December 31, 2016. The primary outcomes were cerebrovascular attack (CVA) and ischemic heart disease (IHD).@*RESULTS@#GnRHa users were older, were more likely to reside in rural areas, had lower socioeconomic status, and had more comorbidities than nonusers (all P < 0.050). Although GnRHa users had an increased incidence of CVA and IHD (P = 0.013 and 0.048, respectively) in univariate analysis, GnRHa use was not associated with the outcomes in multivariate analysis. Furthermore, the cumulative duration of ADT was not associated with the outcomes whereas the associations between age at diagnosis with all diseases were significant.@*CONCLUSION@#Our complete enumeration of the Korean Pca population shows that ADT is not associated with increased risks of cardiovascular disease.

The Use of Gonadotropin-Releasing Hormone Agonist Does Not Affect the Development of Cardiovascular Disease in Prostate Cancer Patients: a Nationwide Population-Based Cohort Study

BACKGROUND@#The objective of this study was to investigate whether androgen deprivation therapy (ADT) with gonadotropin-releasing hormone agonist (GnRHa) in prostate cancer (Pca) patients is associated with cardiovascular disease in the cohort based from the entire Korean population.@*METHODS@#Using the Korean National Health Insurance database, we conducted an observational study of 579,377 men who sought treatment for Pca between January 1, 2012 and December 31, 2016. After excluding patients with previously diagnosed cardiovascular disease or who had undergone chemotherapy, we extracted the data from 2,053 patients who started GnRHa (GnRHa users) and 2,654 men who were newly diagnosed with Pca (GnRHa nonusers) between July 1, 2012, and December 31, 2012, with follow-up through December 31, 2016. The primary outcomes were cerebrovascular attack (CVA) and ischemic heart disease (IHD).@*RESULTS@#GnRHa users were older, were more likely to reside in rural areas, had lower socioeconomic status, and had more comorbidities than nonusers (all P < 0.050). Although GnRHa users had an increased incidence of CVA and IHD (P = 0.013 and 0.048, respectively) in univariate analysis, GnRHa use was not associated with the outcomes in multivariate analysis. Furthermore, the cumulative duration of ADT was not associated with the outcomes whereas the associations between age at diagnosis with all diseases were significant.@*CONCLUSION@#Our complete enumeration of the Korean Pca population shows that ADT is not associated with increased risks of cardiovascular disease.

Clinical Efficacy of Solifenacin in the Management of Diabetes Mellitus-Associated Versus Idiopathic Overactive Bladder Symptoms: A Multicenter Prospective Study / 대한배뇨장애요실금학회지

PURPOSE: To compare the clinical efficacy of anticholinergics for managing diabetes mellitus-associated overactive bladder (DM OAB) versus idiopathic overactive bladder (OAB) in Korean women. METHODS: We conducted a multicenter, prospective, parallel-group, open-label, 12-week study. Women (20–65 years old) with OAB symptoms for over 3 months were assigned to the DM OAB and idiopathic OAB groups. Changes in the Overactive Bladder Symptom Score (OABSS), urgency, urinary urgency incontinence, nocturia, daytime frequency according to a voiding diary, uroflowmetry, and postvoid residual urine volume (PVR) at the first visit (V1), week 4 (V2), and week 12 (V3) were compared. RESULTS: No significant difference was found between the baseline patient characteristics of the DM OAB and idiopathic OAB groups. Treatment with solifenacin was associated with improvements in urgency, urinary urgency incontinence, nocturia, frequency according to a voiding diary, and the total OABSS between V1 and V2 and between V1 and V3. Moreover, a significant improvement in urgency and urge incontinence was found between V2 and V3 in the DM OAB group. However, no significant changes were found in any other parameters. There were no significant differences between the DM OAB group and the idiopathic OAB group except for urgency and urge incontinence at V2 (3.71 vs. 2.28 and 0.47 vs. 0.32, respectively). CONCLUSIONS: The patients who received solifenacin demonstrated improved urgency, urinary urgency incontinence, nocturia, frequency according to a voiding diary, and total OABSS. Management with solifenacin was equally effective for both DM-related OAB and idiopathic OAB.

Comparison of Erectile Dysfunction Treatment Efficacy of Mirodenalfil 50mg Once Daily and 100mg On-Demand in Patients with Benign Prostatic Hyperplasia and Erectile Dysfunction: Multicenter, Randomized

PURPOSE: To Compare the improvement of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) as well as the efficacy of mirodenalfil 50mg once daily and 100mg on-demand in patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). MATERIALS AND METHODS: Prospective study was done with 220 patients who had BPH and ED from June 2013 to October 2014. Out of 220 individuals, 260 met inclusion criteria and 204 finished the research. Patients were divided into two groups. Group 1 had mirodenafil 50mg once daily and Group 2 had mirodenafil 100mg on-demand. The five-item version of the International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS), Qmax, and residual urine volume(PVR) were assessed immediately before initiation of treatment (V1) and after four (V2) and twelve weeks of treatment (V3). RESULTS: No difference of IIEF-5, IPSS, Qmax, and PVR between two groups in V1. At V3, both groups had improvements of IPSS and group 1 had better improvements (-5.1+/-4.4 vs. -3.1+/-3.9 p<0.001). And Group 1 had larger improvements than Group 2 in Qmax significantly. No difference in PVR in both groups comparing V1 vs. V2 and V1 vs V3. Group 1 had better improved IIEF-5 than Group 2 (V1 vs. V3: 4.8+/-5.8 vs. 4.4+/-5.1; p=0.032). There was no drop out patients due to cardiovascular problems. CONCLUSIONS: Once daily mirodenafil 50mg was more efficacious in treating both ED and LUTS than on-demand dosing mirodenafil 100mg without any complication of cardiovascular problems.

Factors Influencing the Acceptance of Transrectal Ultrasound-Guided Prostate Biopsies

PURPOSE: This study aimed to improve prostate biopsy compliance by analyzing the factors that influence the acceptance of prostate biopsy by patients to whom transrectal ultrasound (TRUS)-guided prostate biopsy is recommended for suspected prostate cancer. MATERIALS AND METHODS: The subjects of this study were 268 patients to whom TRUS-guided prostate biopsy was recommended from January to June 2011 and who completed a questionnaire. Patients who showed a prostate-specific antigen (PSA) increase to more than 4.0 ng/mL or abnormal findings on a digital rectal examination and TRUS were recommended to undergo prostate biopsy. The questionnaire consisted of 9 questions about the subjects' demographic characteristics and 15 questions that assessed their knowledge of prostate disease. Fisher exact probability test was conducted to assess the influence of the demographic characteristics and levels of knowledge of prostate disease on acceptance of prostate biopsy. RESULTS: The mean age of the subjects was 66.2 years (range, 43-83 years). Of the cohort, 188 patients (70.7%) agreed to the prostate biopsy and 78 patients (29.3%) refused. In terms of demographic characteristics, the patients' acceptance of prostate biopsy was associated only with education level. Patients with relatively lower education levels had a higher acceptance rate for prostate biopsy (80.0% vs. 65.9%, p=0.018). Other demographic factors, as well as the degree of knowledge of prostate disease, had no significant effect on the acceptance rate. CONCLUSIONS: The patients' acceptance of prostate biopsy can be influenced by demographic characteristics, especially education level. Therefore, when prostate biopsy is recommended to patients, their demographic characteristics should be taken into consideration.

Feasibility of the Interferon-gamma Release Assay for the Diagnosis of Genitourinary Tuberculosis in an Endemic Area

PURPOSE: To evaluate the feasibility of the interferon-gamma release assay (IGRA) as a supplementary diagnostic tool for the diagnosis of genitourinary tuberculosis (GUTB). MATERIALS AND METHODS: Fifty-seven patients who were tested with the IGRA to diagnose GUTB were included. All patients had clinical or radiologic features suspicious for GUTB. Signs and symptoms included chronic dysuria with long-standing sterile pyuria, renal calcification with distorted renal calyces and contracted renal pelvis, and chronic epididymitis. Patients who had a history of tuberculosis in other organs were excluded. Tests including IGRA, urine acid-fast bacilli (AFB) stain and culture, urine tuberculosis polymerase chain reaction (UT-PCR), and radiological examinations were performed to confirm GUTB. The medical records of the patients were reviewed retrospectively. RESULTS: The IGRA result was positive in 30 patients (52.6%). The results of the urine AFB stain and culture were positive in 5 patients (8.8%) and 7 patients (12.2%), respectively. The results of UT-PCR were positive in 9 patients (15.8%). The 7 patients who showed positive results in the urine AFB stain and culture also had positive results on the IGRA. A UT-PCR-negative patient was diagnosed with GUTB by positive results on both the IGRA and AFB stain and culture. CONCLUSIONS: The IGRA might feasibly be used as a supplementary or screening tool for the diagnosis of GUTB in addition to urine AFB stain and culture. Further studies for statistical evaluation of its sensitivity, specificity, and efficacy are needed.

Preoperative Clinical Factors for Diagnosis of Incidental Prostate Cancer in the Era of Tissue-Ablative Surgery for Benign Prostatic Hyperplasia: A Korean Multi-Center Review

PURPOSE: To identify potential predictive factors of incidental prostate cancer (IPca) in patients considering tissue-ablation treatment for benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: From the 11 centers, 1,613 men who underwent transurethral resection of the prostate (TURP) or open prostatectomy were included. Before surgery, prostate biopsy was performed in all patients with prostate-specific antigen (PSA) > or =4.0 ng/ml or with abnormal digital rectal examination (DRE) findings. The patients with prostate cancer preoperatively or with PSA >20 ng/ml were excluded. As predictive factors of IPca, age, body mass index, PSA, DRE, and transrectal ultrasonography (TRUS) findings, including total prostate volume (TPV), transition zone volume (TZV), and the presence of hypoechoic lesions, were reviewed. PSA density (PSAD) and PSAD in the transition zone (PSAD-TZV) were calculated. RESULTS: IPca was diagnosed in 78 patients (4.8%). DRE findings, PSA, and TZV were independent predictive factors in the multivariate analysis. In the receiver operating characteristic curve analysis of PSA, PSAD, and PSAD-TZV, the area under the curve (AUC) was the largest for PSAD-TZV (AUC, 0.685). CONCLUSIONS: IPca was detected in 4.8% of the population studied. In addition to DRE findings, the combination of TZV and PSA can be useful predictive factors of IPca in patients considering tissue-ablation treatment as well as TURP.

Current Status of Transurethral Prostatectomy: A Korean Multicenter Study

PURPOSE: We aimed to verify the current status of transurethral resection of the prostate (TURP) in Korea. MATERIALS AND METHODS: The medical records of 1,341 men who underwent TURP in 9 Korean medical centers between 2004 and 2008 were reviewed. The patients were divided into two groups according to time periods: 2004-2005 (group 1) and 2006-2008 (group 2). To verify differences in the two patient groups, age, prostate volume, indications for TURP, preoperative International Prostate Symptom Score (IPSS), and resected tissue weight were evaluated. RESULTS: The mean age of the patients was 71.2 years and the mean IPSS was 22.7. The patients' characteristics were not significantly different between the two groups. The annual cases of TURP increased over the study period. The proportion of lower urinary tract symptoms (LUTS) as an indication for TURP increased up to 58.3% in group 2 compared with 51.6% in group 1 (p=0.019). However, the proportion of patients who presented with acute urinary retention decreased from 35.5% to 30.3% with marginal statistical significance (p=0.051). Other indications such as hematuria, bladder stone, recurrent urinary tract infection, and hydronephrosis were not significantly different between the groups. The mean resected weights of the prostate were similar (17.5 g in group 1 and 18.3 g in group 2, respectively; p>0.05). CONCLUSIONS: TURP has been steadily performed in patients with benign prostatic hyperplasia and it is expected to remain constant. LUTS was the most common indication for TURP in recent years.

Clinical Significance of a Large Difference (> or = 2 points) between Biopsy and Post-prostatectomy Pathological Gleason Scores in Patients with Prostate Cancer

We investigated the clinical significance of large difference (> or = 2 points) between biopsy-derived (bGS) and post-prostatectomy Gleason scores (pGS). At 14 medical centers in Korea, 1,582 men who underwent radical prostatectomy for prostate cancer were included. According to the difference between bGS and pGS, the patients were divided into three groups: A (decreased in pGS > or = 2, n = 30), B (changed in pGS or = 2, n = 55). We evaluated various clinicopathological factors of prostate cancer and hazards for biochemical failure. Group A showed significantly higher mean maximal percentage of cancer in the positive cores (max%) and pathological T stage than control. In group C, the number of biopsy core was significantly smaller, however, tumor volume and max% were significantly higher and more positive biopsy cores were presented than control. Worse pathological stage and more margin-positive were observed in group A and C than in control. Hazard ratio for biochemical failure was also higher in group A and C (P = 0.001). However, the groups were not independent factors in multivariate analysis. In conclusion, large difference between bGS and pGS shows poor prognosis even in the decreased group. However it is not an independent prognostic factor for biochemical failure.

Korean Urologist's View of Practice Patterns in Diagnosis and Management of Benign Prostatic Hyperplasia: A Nationwide Survey

PURPOSE: In Korea, there was no specific guidelines for the management of benign prostatic hyperplasia (BPH). We reviewed the practice patterns of Korean urologists in the management of BPH and aimed to describe the need to develop specific guidelines. MATERIALS AND METHODS: A probability sample was taken from the Korean Urological Association Registry of Physicians, and a structured questionnaire, that explored practice patterns in the management of BPH, was mailed to a random sample of 251 Korean urologists. RESULTS: For the initial evaluation of BPH, most urologists routinely performed prostatic specific antigen (PSA) (96.4%), digital rectal exam (94.4%), international prostate symptom score (IPSS) (83.2%) and transrectal ultrasound (79.2%). Symptom assessment (36.4%) followed by transrectal ultrasound of prostate (TRUS) (20.0%) was considered as the most important diagnostic examination affecting the decision about individual treatment options. Almost all urologists (92.2%) chose medical treatment as the first-line treatment option for uncomplicated BPH with moderate symptoms. Of the respondents, 57.2% had prescribed alpha blocker and 41.6% alpha blocker plus 5-alpha reductase inhibitors as the medical treatment option for BPH. The prescription of 5-ARIs was dependent on the size of the prostate and the severity of symptoms. CONCLUSION: The results of our current survey provide useful insight into variations in the clinical practice of Korean urologists. They also indicate the need to develop further practical guidelines based on solid clinical data and to ensure that these guidelines are widely promoted and accepted by the urological community.

Stent Position Is More Important than alpha-Blockers or Anticholinergics for Stent-Related Lower Urinary Tract Symptoms after Ureteroscopic Ureterolithotomy: A Prospective Randomized Study

PURPOSE: To evaluate the clinical factors that impact ureteral stent-related lower urinary tract symptoms (LUTS) after ureteroscopic ureterolithotomy, including the stent position and medication. MATERIALS AND METHODS: Fifty-three patients who underwent ureteroscopic ureterolithotomy with indwelling a stent were distributed into three groups. On demand analgesics were given to the group 1 (n=18). Daily tamsulosin 0.2 mg was added for group 2 (n=15) and daily tamsulosin 0.2 mg and tolterodine 4 mg was added for group 3 (n=20). The patients were also subclassified into appropriate or inappropriate group according to stent position. All the patients completed a visual analogue scale (VAS) and International Prostate Symptom Score (IPSS) on the 1st and 7th postoperative days. The VAS and IPSS were analyzed according to the medication groups and the stent position. RESULTS: In the appropriate stent potion group, only the storage symptom scores of groups 2 and 3 on the 1st postoperative day were significantly lower than those of the group 1 (p=0.001). This medication effect on LUTS was not observed in the inappropriate stent position group. In this group, total IPSS (p=0.015) and storage symptom scores (p=0.002) were higher than in the appropriate stent position group on the 7th postoperative day. CONCLUSIONS: Correct placement of the stent was more important than medication for lessening stent-related storage symptoms.

Efficacy and Safety of Alfuzosin 10 mg Once Daily in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: A 6-Months Study in Real Life Practice

PURPOSE: The aim of the study was to evaluate the long-term safety profile and efficacy of Alfuzosin 10 mg once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH), under daily practice conditions in Korea. MATERIALS AND METHODS: In this 6-months, open-label, multicenter, noncomparative, observational study, 511 men were enrolled. International Prostate Symptom Score (IPSS), IPSS 8th question (bother score), maximum flow rate (Qmax), Danish Prostate Symptom Score (DAN-PSS) were evaluated at baseline and after 3, 6 months of treatment. Safety was analyzed in all patients exposed to alfuzosin (n=480). Analysis was performed at end-point in the intent to treat population (n=368). RESULTS: Of the 511 enrolled patients in the study, 218 patients (42.7%) dropped out. With alfuzosin, IPSS and bother score significantly improved from baseline by -6.7+/-6.4 (-31.9%, p<0.001) and -1.2+/-1.2 (-29.3%, p<0.001), respectively. Nocturia also significantly improved from 2.3+/-1.3 at baseline to 1.8+/-1.0 at end-point (-0.6+/-1.1, p<0.001). In the subgroup of patients likely to be obstructed (Qmax <10 ml/sec at baseline), Qmax improved from 8.3+/-1.2 at baseline to 13.7+/-6.1 at end-point (+5.4+/-5.8, p=0.001). In patients with pain/discomfort on ejaculation, weighted score significantly improved from 2.4+/-2.2 at baseline to 1.5+/-1.9 at end-point (-31%, p=0.002). There were no clinically relevant changes in sitting systolic BP and diastolic BP at endpoint. CONCLUSIONS: Alfuzosin 10 mg once daily administered for 6-months is effective in improving LUTS and quality of life, and is well tolerated from a sexual and cardiovascular perspective, including in elderly men and those receiving anti-hypertensive co-medication.

The Analysis of Clinical Efficacy of Phosphodiesterase 5 Inhibitors for Erectile Dysfunction using SS-Penogram / 대한남성과학회지

PURPOSE: As the first-line pharmacotherapy for erectile dysfunction (ED), phosphodiesterase type 5 (PDE5) inhibitors are widely used and their clinical efficacy is well established. But up to now, most of these comparative studies have been based on questionnaires, and Udenafil and Mirodenafil, which have recently been developed in South Korea, have not yet to be compared in clinical studies. We compared and analyzed the efficacy of five PDE5 inhibitors using the sexual stimulated (SS)-Penogram. MATERIALS AND METHODS: A total of 347 patients taking PDE5 inhibitors for the treatment of ED and underwent SS-Penogram was enrolled in this study. AUC (area under the curve) of SS-Penogram was compared in each PDE5 inhibitors. Differences in AUC according to age, combined disorders, serum testostereone and prolactin, cholesterol and IIEF were also analysed using Chi-square and Kruskal-Wallis test. P-value less than 0.05 was considered as statistically insignificant. RESULTS: Ratios of Type I curves in medication groups with normal erection were not statistically different before and after medication. Ratios of the excellent response (>50 % increase in area under the curve) and non-response groups (no increase or even decrease in area under the curve) in each medication group were not statistically different. CONCLUSIONS: In this clinical comparative study of the efficacy of PDE5 inhibitors using the SS-Penogram, there were no definite differences in efficacy among PDE5 inhibitors.

Prostate-Specific Antigen Test Interval according to Baseline Prostate-Specific Antigen and Age

PURPOSE: The optimal interval at which to repeat prostate-specific antigen (PSA) measurement is controversial. We evaluated the probability of the serum PSA value increasing above specific cutoff values (4.0 ng/ml, 3.0 ng/ml, and 2.5 ng/ml) on annual follow-up visits in men with a lower baseline PSA than each cutoff value. MATERIALS AND METHODS: Between 2002 and 2006, a total of 14,459 men aged 40 to 79 years who underwent serum PSA determinations at least twice during health examinations at 11 medical centers were enrolled in this study. To reduce probable bias, we excluded men with pyuria, those with a baseline or follow-up PSA level of 10.0 ng/ml or more, and those with a history of medication with 5 alpha-reductase inhibitors. Serum PSA underwent logarithmic conversion to work out the normal distribution. The cumulative rate of freedom from increase in PSA above 4.0 ng/ml, 3.0 ng/ml, and 2.5 ng/ml was estimated with the Kaplan-Meier method according to baseline PSA range and age. The significance level was 1%. RESULTS: The rate of increase in PSA was lower in men who had a baseline PSA value in the low range and whose age was in the 40s or 50s. However, the cumulative rate of freedom from increase in PSA decreased as the PSA cutoff value was lowered. The optimal screening interval for men in their 40s and 50s whose baseline serum PSA level was 1.0 ng/ml or lower was 3 years when the significance level for PSA rising above 4.0 ng/ml was 1%. It was 2 years and 1 year, respectively, when the cutoff value was lowered to 3.0 ng/ml or 2.5 ng/ml. An annual PSA screening interval was recommended in men older than their 60s. CONCLUSIONS: The PSA test interval should be individualized according to baseline PSA, age, and PSA cutoff value.

Long-term Follow up of Augmentation Ileocystoplasty with Goodwin's Ileal Cup Patched Bladder / 대한비뇨기과학회지

PURPOSE: We evaluated the long-term outcomes in patients undergoing augmentation ileocystoplasty with Goodwin(')s ileal cup patched bladder. MATERIALS AND METHODS: This was a retrospective study of 72 consecutive patients who underwent augmentation ileocystoplasty because of decreased bladder capacity, vesico-ureteral reflux and urinary incontinence. The outcomes assessed included the continence status, bladder capacity, upper tract status, and significant post-operative complications. RESULTS: The 72 patients studied(61 men and 11 women) were 12 to 62 years old(mean age 35.6). The follow up was 0.3 to 7.9 years(mean 5.4). The preoperative diagnoses were a neurogenic bladder from spinal cord injury in 54 patients, meningomyelocele in 5, pelvic trauma in 3, polymyelitis in 2, GU tuberculosis in 2, cerebrovascular diseases in 2, and disc rupture in 2. The bladder capacity was significantly increased from 168cc to 392cc postoperatively and the maximal bladder capacity was increased along with the decreased number of daily clean intermittent catheterizations. The most common complication related to surgery was a paralytic ileus. While most cases of unilateral reflux disappeared, bilateral or high grade reflux remained during the postoperative follow up period. CONCLUSIONS: Bladder augmentation provided durable clinical and urodynamic improvement for patients with neurogenic and contracted bladders.

Twenty Years of Experience with Artificial Urinary Sphincter Implantation / 대한비뇨기과학회지

PURPOSE: The efficacy of the artificial urinary sphincter(AUS) in treating sphincteric incontinence has been clearly demonstrated. We report on 20 years of experience using artificial sphincter implantation at a single institute. MATERIALS AND METHODS: The follow-up data for 37 patients who received AUS(AMS 800(TM)) implantation between 1987 and 2006 at Yonsei University were available for this study. We investigated various components of the medical records, such as the number of pads used per day, results of pre-operative urodynamic studies, operative and post-operative complications, and revision rate. RESULTS: Mean patient age was 35.6 years(range 15-64 years), and mean follow-up duration was 12.4 years(range 1.4-19.8 years). Of the 37 patients, 21 had neurogenic bladder, and 9 had traumatic injury. Other causes of incontinence included post-operative complications(4 patients) and congenital anomalies(3 patients). The cuffs were placed were in the bladder necks of 21 patients and in the bulbous urethrae of 16 patients. The average number of pads used daily decreased significantly from 6.2 to 1.2 after the operation, and 27 patients(72.9%) were able to maintain 'dry-up status' (number of pads used< or=1). A total of 32 artificial sphincters remained in place(86.4% survival rate), with 8 revisions(21.6%) required secondary to infection, mechanical failure, or urethral stone. CONCLUSIONS: AUS implantation is a safe and durable treatment for urinary incontinence in patients with intrinsic sphincter deficiency from various underlying diseases.