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.

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.

A Multicenter, Open-Label, Observational Study Evaluating the Quality of Life After Using a Hydrophilic-Coated Catheter (SpeediCath) With Self-Intermittent Catheterization / 대한배뇨장애요실금학회지

Purpose@#We evaluated the change in patient quality of life after the use of a hydrophilic-coated catheter (SpeediCath) in adults requiring intermittent catheterization (IC). @*Methods@#This was a multicenter, open-label, observational study using the Patient Perception of Intermittent Catheterization (PPIC) questionnaire and the Intermittent Self-Catheterization questionnaire (ISC-Q) and safety at 12 and 24 weeks in adult patients who had already used other type of catheters prior to switching to SpeediCath or in patients undergoing self-IC for the first time for any reason. @*Results@#Among a total of 360 subjects, 215 (59.7%) were women, and the mean age was 62.0±13.2 years. At 24 weeks, the satisfaction rate after using SpeediCath was 84.1%, and 80% of patients responded that they could easily perform IC. In total, 81.6% of patients were willing to continue using SpeediCath. The mean ISC-Q score was 54.90±18.65 at 24 weeks. Men found less interference in their daily life by performing IC than women and found it easier to handle the catheter before it was inserted into the urethra. At week 12, the mean change in ISC-Q was significantly greater in patients <65 years (20.24±23.55) than in those ≥65 years (7.57±27.70, P=0.049), but there was no difference at 24 weeks. The most common adverse events were urinary tract infection in 9.72%, gross hematuria in 2.78%, and urethral pain in 1.39%. @*Conclusions@#The use of a SpeediCath provided good quality of life for patients who needed self-IC regardless of age or sex.

Efficacy and Safety of Naftopidil in Patients With Neurogenic Lower Urinary Tract Dysfunction: An 8-Week, Active-Controlled, Stratified-Randomized, Double-Blind, Double-Dummy, Parallel Group, Noninferiority, Multicenter Design / 대한배뇨장애요실금학회지

Purpose@#The aim of this study was to evaluate the efficacy and safety of naftopidil compared with tamsulosin in patients with neurogenic lower urinary tract dysfunction (LUTD). @*Methods@#This study was conducted as an 8-week, active-controlled, stratified-randomized, double-blind, double-dummy, parallel group, noninferiority, and multicenter clinical trial. After 2 weeks of screening, eligible subjects were randomly assigned to receive naftopidil (25 mg for 1 week followed by 75 mg for 7 weeks) or tamsulosin (0.2 mg for 8 weeks). Primary endpoint was a change of International Prostatic Symptom Score (IPSS) total score after 8 weeks of treatment. @*Results@#One hundred ninety-four subjects with neurogenic LUTD were included into this trial. There were no differences between the 2 groups in baseline characteristics, including urodynamic study results, subtype of LUTD, pretreatment and concomitant medication, and causes of neurogenic bladder. The medication compliance rate was 94.0% (naftopidil, 93.6%; tamsulosin, 94.4%). There was a statistically significant decrease of IPSS total score at 8 weeks versus baseline in both the naftopidil (-5.64±0.66) and tamsulosin (-6.53±0.65) groups (P<0.0001 each). The mean difference between both groups was 0.89 (upper limit of 95% confidential interval, 2.72), which was lower than the noninferiority limit of 3 points. A subgroup analysis of neurologic lesions and sex found no mean difference of IPSS total score in each group. There was also no difference in safety profiles, including treatment emergent adverse events. @*Conclusions@#Naftopidil was not inferior to tamsulosin as a therapeutic drug for patients with neurogenic LUTD and had a similar safety profile.

The Therapeutic Effect of Human Embryonic Stem Cell-Derived Multipotent Mesenchymal Stem Cells on Chemical-Induced Cystitis in Rats / 대한배뇨장애요실금학회지

PURPOSE: To evaluate the therapeutic effect of human embryonic stem cell (hESC)-derived multipotent mesenchymal stem cells (M-MSCs) on ketamine-induced cystitis (KC) in rats. METHODS: To induce KC, 10-week-old female rats were injected with 25-mg/kg ketamine hydrochloride twice weekly for 12 weeks. In the sham group, phosphate buffered saline (PBS) was injected instead of ketamine. One week after the final injection of ketamine, the indicated doses (0.25, 0.5, and 1×106 cells) of M-MSCs (KC+M-MSC group) or PBS vehicle (KC group) were directly injected into the bladder wall. One week after M-MSC injection, the therapeutic outcomes were evaluated via cystometry, histological analyses, and measurement of gene expression. Next, we compared the efficacy of M-MSCs at a low dose (1×105 cells) to that of an identical dose of adult bone marrow (BM)-derived MSCs. RESULTS: Rats in the KC group exhibited increased voiding frequency and reduced bladder capacity compared to rats of the sham group. However, these parameters recovered after transplantation of M-MSCs at all doses tested. KC bladders exhibited markedly increased mast cell infiltration, apoptosis, and tissue fibrosis. Administration of M-MSCs significantly reversed these characteristic histological alterations. Gene expression analyses indicated that several genes associated with tissue fibrosis were markedly upregulated in KC bladders. However the expression of these genes was significantly suppressed by the administration of M-MSCs. Importantly, M-MSCs ameliorated bladder deterioration in KC rats after injection of a low dose (1×105) of cells, at which point BM-derived MSCs did not substantially improve bladder function. CONCLUSIONS: This study demonstrates for the first time the therapeutic efficacy of hESC-derived M-MSCs on KC in rats. M-MSCs restored bladder function more effectively than did BM-derived MSCs, protecting against abnormal changes including mast cell infiltration, apoptosis and fibrotic damage.

Is It Possible to Prevent Symptom Recurrence After Transurethral Resection for Hunner Lesion? / 대한배뇨장애요실금학회지

No abstract available.

Efficacy of an Alpha-Blocker for the Treatment of Nonneurogenic Voiding Dysfunction in Women: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Trial / 대한배뇨장애요실금학회지

PURPOSE: To evaluate the efficacy of an alpha-1 adrenergic receptor (α1-AR) blocker for the treatment of female voiding dysfunction (FVD) through a pressure-flow study. METHODS: This was a randomized, double-blind, placebo-controlled trial. Women aged ≥18 years with voiding symptoms, as defined by an American Urological Association symptom score (AUA-SS) ≥15 and a maximum flow rate (Qmax) 100 mL and/or a postvoid residual (PVR) volume >150 mL, were randomly allocated to either the alfuzosin or placebo group. After 8 weeks of treatment, changes in the AUA-SS, Bristol female lower urinary tract symptoms (BFLUTS) questionnaire, Qmax/PVR, and voiding diary were compared between groups. Patients’ satisfaction with the treatment was compared. Patients were categorized into 3 groups according to the Blaivas-Groutz bladder outlet obstruction (BOO) nomogram: none, mild, and moderate to severe. Subgroup comparisons were also made. RESULTS: Of a total of 187 women, 154 (79 alfuzosin, 75 placebo) were included in the analysis. After 8 weeks of treatment, the AUA-SS decreased by 7.0 in the alfuzosin group and by 8.0 in the placebo group. Changes in AUA-SS subscores, BFLUTS (except the I-sum), the voiding diary, and Qmax/PVR were not significantly different between groups. Approximately 54% of the alfuzosin group and 62% of the placebo group were satisfied with the treatment. No significant difference was observed between groups according to the presence or grade of BOO. CONCLUSIONS: Alfuzosin might not be more effective than placebo for treating FVD. The presence or the grade of BOO did not affect the results. A further study with sufficient power is needed to determine the efficacy of α1-AR blockers for the treatment of FVD.

Antibiotic prophylaxis with intravenous ceftriaxone and fluoroquinolone reduces infectious complications after transrectal ultrasound-guided prostatic biopsy

PURPOSE: To assess the rates of infectious complications before and after the change of prophylactic antibiotic regimens in prostate needle biopsy. MATERIALS AND METHODS: The records of 5,577 patients who underwent prostate needle biopsy at Asan Medical Center between August 2005 and July 2012 were retrospectively reviewed. Group 1 (n=1,743) included patients treated between 2005 and 2009 with fluoroquinolone for 3 days, group 2 (n=2,723) included those treated between 2009 and 2012 with ceftriaxone once before the biopsy and fluoroquinolone before biopsy and continue therapy for 3 days, and group 3 (n=1,111) received the same treatment for more than 7 days after the biopsy. Univariable and multivariable logistic regression models addressed risk factors associated with infectious complication after prostate needle biopsy. RESULTS: Infectious complication after prostate needle biopsy developed in 18 (group 1), seven (group 2), and two patients (group 3) (p=0.001). In group 1, seven patients with infectious complication had positive blood cultures and harbored fluoroquinolone-resistant Escherichia coli, four had ceftriaxone susceptible isolates, and three had extended spectrum beta-lactamase-positive E. coli. Two patients in group 1 required intensive care because of septic shock. In multivariable analysis, the patients with combination of fluoroquinolone and ceftriaxone had significantly lower infectious complication rate than the fluoroquinolon alone (p=0.003). CONCLUSIONS: Antibiotic prophylaxis with ceftriaxone and fluoroquinolone before prostate needle biopsy decreased the risk of potentially serious infectious complications.

A Case of Complete Remission of Mucosa-associated Lymphoid Tissue Lymphoma of the Urinary Bladder after Eradication of Helicobacter Pylori / 대한내과학회지

Primary lymphoma of the urinary bladder is rare, comprising 0.2% of extranodal lymphomas. The predominant subtype of mucosa-associated lymphoid tissue (MALT) is extranodal marginal zone lymphoma. We report a case of MALT lymphoma of the urinary bladder in a 53-year-old female patient presenting with a five-year history of persistent hematuria and urinary frequency. A cystoscopy revealed multiple nodular lesions at the posterior wall and trigone of the bladder. The tissue obtained by cold-cup biopsy revealed lymphoid infiltration consistent with low-grade MALT lymphoma. Image studies revealed that the tumor originated from the urinary bladder and there was no evidence of metastases. The patient was positive for a rapid urease test. Because of the relationship between gastric MALT lymphoma and Helicobacter pylori, the patient was treated with antibiotics to eradicate Helicobacter pylori. The lymphoma subsequently disappeared and the patient has remained in persistent complete remission for eight years.

Clinical Factors Associated With Dose Escalation of Solifenacin for the Treatment of Overactive Bladder in Real Life Practice / 대한배뇨장애요실금학회지

PURPOSE: To determine the baseline clinical characteristics associated with dose escalation of solifenacin in patients with overactive bladder (OAB). METHODS: We analyzed the data of patients with OAB (micturition frequency > or =8/day and urgency > or =1/day) who were treated with solifenacin and followed up for 24 weeks. According to our department protocol, all the patients kept voiding diaries, and OAB symptom scores (OABSS) were monitored at baseline and after 4, 12, and 24 weeks of solifenacin treatment. RESULTS: In total, 68 patients (mean age, 60.8+/-10.0 years) were recruited. The dose escalation rate by the end of the study was 41.2%, from 23.5% at 4 weeks and 17.6% at 12 weeks. At baseline, the dose escalator group had significantly more OAB wet patients (53.6% vs. 20.0%) and higher total OABSS (10.2+/-2.4 vs. 7.9+/-3.5, P=0.032) than the nonescalator group. OAB wet (odds ratio [OR], 4.615; 95% confidence interval [CI], 1.578-13.499; P<0.05) and total OABSS (OR, 1.398; 95% CI, 1.046-1.869; P<0.05) were found to be independently associated with dose escalation. CONCLUSIONS: Patients who have urgency urinary incontinence and high total OABSS have a tendency for dose escalation of solifenacin.

Pretreatment Features to Influence Effectiveness of Intravesical Hyaluronic Acid Instillation in Refractory Interstitial Cystitis/Painful Bladder Syndrome / 대한배뇨장애요실금학회지

PURPOSE: To determine the efficacy of intravesical hyaluronic acid (HA) instillation in treating patients with refractory interstitial cystitis/painful bladder syndrome (IC/PBS) and to identify any related factors that influence its therapeutic effect. METHODS: Thirty-three female IC/PBS patients who demonstrated poor or unsatisfactory responses to previous treatments between December 2010 and October 2012 were enrolled. Despite previous treatments, the enrolled patients had visual analogue scale (VAS) pain scores > or =4 and total scores (symptom and bother scores) > or =13 on the pelvic pain and urgency/frequency (PUF) questionnaire and > or =12 on the O'Leary-Sant interstitial cystitis symptoms index (ICSI)/problems index (ICPI). All patients received once weekly intravesical instillations of 40-mg HA diluted in 50-mL saline for 4 weeks. The efficacy of the HA instillation was evaluated by comparing the mean changes in the scores of the VAS and questionnaires from baseline to 4 weeks after treatment. Improvement was defined as a > or =2 decrease in the VAS. Moreover, we investigated the effects of the presence of Hunner's ulcer and previous treatment modalities on the therapeutic outcome of HA instillation. RESULTS: The mean age was 57.0+/-1.8 years (range, 28-75 years). The VAS score significantly decreased from baseline to 4 weeks after treatment (-2.5, P<0.001). The mean changes in the PUF, ICSI, and ICPI from baseline to 4 weeks after the treatment were -3.8 (P<0.001), -2.3 (P<0.001), and -2.7 (P<0.001), respectively. Twenty patients (61%) showed improvements. Previous treatment modalities did not affect the efficacy of HA instillation and the presence of Hunner's ulcer was unrelated to outcomes. No complications were observed. CONCLUSIONS: These results show that intravesical HA instillation is an effective and safe treatment for patients with refractory IC/PBS. Previous treatment modalities and presence of Hunner's ulcer do not affect the efficacy of HA instillation.

Effect of Combined Systematized Behavioral Modification Education Program With Desmopressin in Patients With Nocturia: A Prospective, Multicenter, Randomized, and Parallel Study / 대한배뇨장애요실금학회지

PURPOSE: The aims of this study were to investigate the efficacy of combining the systematized behavioral modification program (SBMP) with desmopressin therapy and to compare this with desmopressin monotherapy in the treatment of nocturnal polyuria (NPU). METHODS: Patients were randomized at 8 centers to receive desmopressin monotherapy (group A) or combination therapy, comprising desmopressin and the SBMP (group B). Nocturia was defined as an average of 2 or more nightly voids. The primary endpoint was a change in the mean number of nocturnal voids from baseline during the 3-month treatment period. The secondary endpoints were changes in the bladder diary parameters and questionnaires scores, and improvements in self-perception for nocturia. RESULTS: A total of 200 patients were screened and 76 were excluded from the study, because they failed the screening process. A total of 124 patients were randomized to receive treatment, with group A comprising 68 patients and group B comprising 56 patients. The patients' characteristics were similar between the groups. Nocturnal voids showed a greater decline in group B (-1.5) compared with group A (-1.2), a difference that was not statistically significant. Significant differences were observed between groups A and B with respect to the NPU index (0.37 vs. 0.29, P=0.028), the change in the maximal bladder capacity (-41.3 mL vs. 13.3 mL, P<0.001), and the rate of patients lost to follow up (10.3% [7/68] vs. 0% [0/56], P=0.016). Self-perception for nocturia significantly improved in both groups. CONCLUSIONS: Combination treatment did not have any additional benefits in relation to reducing nocturnal voids in patients with NPU; however, combination therapy is helpful because it increases the maximal bladder capacity and decreases the NPI. Furthermore, combination therapy increased the persistence of desmopressin in patients with NPU.

Elimination of Hunner's Ulcers by Fulguration in Patients With Interstitial Cystitis: Is It Effective and Long Lasting?

PURPOSE: To evaluate the outcome of fulguration of Hunner's ulcers (HUs) in painful bladder syndrome/interstitial cystitis (PBS/IC) that is refractory to conservative treatment. MATERIALS AND METHODS: Patients diagnosed with refractory PBS/IC and treated with fulguration between 2011 and 2013 were identified through screening of medical records. To evaluate treatment outcomes, voiding diaries, the visual analogue scale (VAS) for pain, and two IC symptom questionnaires (pelvic pain and urgency/frequency scale [PUF] and O'Leary-Sant IC symptom index and IC problem index [OS]) were used. Fulguration was deemed to be successful if the VAS score was <2 or less than half of the preoperative VAS score. RESULTS: In total, 27 patients with PBS/IC in whom conservative treatments had failed were enrolled. Two months after fulguration, decreases were observed in the mean 24-hour urinary frequency (from 16.0 to 10.2), 24-hour urgency episodes (8.0 to 1.8), and the VAS (5.8 to 1.2), PUF symptom (15.1 to 7.0), PUF bother (8.4 to 2.7), OS symptom (15.1 to 7.2), and OS problem (13.8 to 6.0) scores. At 5 and 10 months, all variables had worsened. At 2, 5, and 10 months, the success rates were 94.1%, 70.0%, and 33.3%, respectively. Four patients underwent one repeat fulguration on average 11.3 months after the first fulguration. Repeat fulguration was not significantly associated with any clinical characteristics. CONCLUSIONS: In PBS/IC that was refractory to medication or other conservative treatments, HU elimination by fulguration effectively improved symptoms. However, this effect decreased gradually over time.

Effectiveness of Retropubic Tension-Free Vaginal Tape and Transobturator Inside-Out Tape Procedures in Women With Overactive Bladder and Stress Urinary Incontinence / 대한배뇨장애요실금학회지

PURPOSE: We compared the effectiveness of the retropubic tension-free vaginal tape (TVT) and the transobturator inside-out tape (TVT-O) in treating symptoms of overactive bladder (OAB) in women with stress urinary incontinence (SUI). METHODS: Women with urodynamic SUI and OAB (mean urgency episodes > or =1 and frequency > or =8/24 hours on a 3-day voiding diary) were assigned to the TVT or TVT-O group. Preoperative measures were based on a urodynamic study, 3-day voiding diary, the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS(SF)), and the urgency perception scale (UPS). At 12 postoperative months, the 3-day voiding diary, symptoms questionnaire, patient satisfaction, and standing stress test were assessed. The primary endpoint was change in the number of urgency episodes/24 hours from baseline to 12 months. RESULTS: In this group of 132 women, 42 received TVT and 90 received TVT-O. The mean urgency episodes/24 hours decreased from 6.3+/-5.5 to 1.6+/-3.2 in the TVT group and from 5.1+/-4.4 to 1.8+/-3.0 in the TVT-O group. The mean percent change was significantly greater after TVT than after TVT-O (73% vs. 60%, P=0.049). All subscales of BFLUTS(SF) and UPS were significantly improved using either method, with significantly greater improvement seen in the quality of life (QoL) domain after TVT (P=0.002). There were no significant differences in the cure and satisfaction rates between the two groups. CONCLUSIONS: Intervention with the TVT or the TVT-O significantly improved symptoms of OAB in women with SUI and OAB. Urgency and QoL significantly improved after TVT compared with that after TVT-O.

Psychometric Properties of the Korean Version of the Overactive Bladder Questionnaire (OAB-q) in a Korean Population / 대한배뇨장애요실금학회지

PURPOSE: Psychometric properties of the overactive bladder questionnaire (OAB-q) were recently examined. However, since the cross-cultural adaptation of a non-English version of the OAB-q has never been demonstrated, we evaluated the psychometric properties of a Korean version of the OAB-q in a Korean population with OAB. METHODS: A prospective cohort study involving 116 women with 58 OAB and 58 control subjects was performed and convergent validity was assessed. Total and subscale OAB-q scores of the control and OAB groups were compared to their sensitivity to score changes before and after administering anti-cholinergic medication for 12 weeks. Short form 36 and King's health questionnaire (KHQ) were also used for comparison or correlation. RESULTS: Assessment of face validity showed that the Korean version of the OAB-q was reasonable with OAB-q subscale scores being significantly different between the control and patient groups. Significant correlation (range, -0.29 to -0.81) was found between the OAB-q scores and KHQ results for the OAB patients. Cronbach's alpha coefficients (range, 0.77 to 0.95) indicated excellent internal consistency and test-retest analysis involving 35 OAB patients showed that each questions as well as subscale scores were reproducible. Each score of OAB-q also showed statistically significant sensitivity to changes following anti-muscarinic treatment for OAB (n=27, P<0.001 except for social, P=0.059). CONCLUSIONS: The Korean version of the OAB-q is a valid and reliable instrument to measure outcomes in Korean patients with OAB.

Efficacy and Safety of Tamsulosin for Treating Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled, Open-Label Non-Inferiority Study

PURPOSE: To compare the efficacy and safety of Sulosin D (PACIFICPHARMA, Korea) and Harnal D (ASTELLAS PHARMA KOREA, Korea) in treating patients with lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: This randomized, controlled, open-label, multicenter non-inferiority study was conducted at four sites in Korea. We randomly assigned 123 patients with an International Prostate Symptom Score (IPSS) > or =12 to receive either Sulosin D or Harnal D treatment for 8 weeks. The primary outcome was the mean change in IPSS from baseline to endpoint. Secondary outcomes were the mean change from baseline to endpoint in IPSS quality of life subscores, maximum uroflowmetry (Qmax), and post-voiding residuals (PVR). RESULTS: In all, 123 patients were randomly assigned (60 Sulosin D and 63 Harnal D). The changes in the total IPSS from baseline in the Sulosin D- and Harnal D-treated groups were -4.97 and -4.03, respectively. There were significant decreases compared with baseline in both groups. The mean difference (Sulosin D - Harnal D) was -0.91 (with a two-sided 90% confidence interval), inferring that Sulosin D was not inferior to Harnal D. The mean changes in the IPSS subscore, Qmax, and PVR from baseline were comparable between the groups (both p>0.05). During the treatment periods, the incidence of adverse events was 23.33% and 34.92% in the Sulosin D and Harnal D groups, respectively (p=0.1580). CONCLUSIONS: We demonstrate the non-inferiority of Sulosin D to Harnal D in patients with lower urinary tract symptoms associated with BPH.

Drug treatment for lower urinary tract symptoms

Lower urinary tract symptoms (LUTS) are classified into three groups: storage, voiding, and post-micturition symptoms. The most popular causes of LUTS are benign prostatic hyperplasia (BPH) and overactive bladder (OAB). Although BPH is a pathologic term, clinically, we use this when patients have LUTS due to benign prostatic enlargement and obstruction. OAB is defined as urgency, with or without urge incontinence, usually with frequency and nocturia. Currently alpha1-adrenoceptor antagonists are the most common drug treatment for BPH, and are thought to act by relaxing the prostatic smooth muscle. They are all effective for the treatment of LUTS/BPH. 5alpha-reductase inhibitors, such as fiansteride and dutasteride, are another treatment option for BPH symptoms, which reduce the prostatic volume by inducing epithelial atrophy. Long-term combination therapy with alpha-1-blockers and 5alpha-reductase inhibitors reduces the risk of the overall clinical progression of BPH significantly more than does treatment with either drug alone. Antimuscarinics are the mainstay for the treatment of OAB. Antimuscarinics competitively block muscarinic receptors of all subtypes but with variations in selectivity for the different subtypes. When they are used for the treatment of OAB, they are active during the storage phase of the bladder, with little or no effect on voiding contractions. Desmopressin acetate is a synthetic analogue of Arginin vasopressin, which has been proven effective for the treatment of nocturnal polyuria in LUTS.

A Prospective Multi-center Trial of Escherichia coli Extract for the Prophylactic Treatment of Patients with Chronically Recurrent Cystitis

We have assessed the efficacy and safety of Escherichia coli extract (ECE; Uro-Vaxom(R)) which contains active immunostimulating fractions, in the prophylactic treatment of chronically recurrent cystitis. Forty-two patients with more than 2 episodes of cystitis in the proceeding 6 months were treated for 3 months with one capsule daily of ECE and observed for a further 6 months. The primary efficacy criterion was the number of episodes of recurrent cystitis during the 6 months after treatment compared to those during the 6 months before treatment. At the end of the 9-month trial, 34 patients (all women) were eligible for statistical analysis. Their mean age was 56.4 yr (range, 34-75 yr), and they had experienced recurrent urinary tract infections for 7.2+/-5.2 yr. The number of recurrences was significantly lower during the 6-month follow-up period than during the 6 months preceding the trial (0.35 vs. 4.26, P<0.001). During the follow-up, 28 (82.4%) patients had no recurrences and 4 (11.8%) had 1 each. In patients who relapsed, ECE alleviated cystitis symptoms, including painful voiding, frequency and urgency. There were no serious adverse events related to the study drug. Our study demonstrates the efficacy and safety of ECE in the prophylactic treatment of chronically recurrent cystitis.

Long-Term Study of the Effects of the Tension-Free Vaginal Tape Procedure for Female Stress Urinary Incontinence on Voiding, Storage, and Patient Satisfaction: A Post-Hoc Analysis

PURPOSE: We assessed the long-term effects of the tension-free vaginal tape (TVT) procedure for stress urinary incontinence (SUI) on voiding, storage, and patient satisfaction. MATERIALS AND METHODS: This retrospective study examined the records of 134 patients who had undergone the TVT procedure for SUI and were followed up for more than 5 years. Voiding function was evaluated by measuring maximum urinary flow rate (MFR), post-void residual urine volume (PVR), and storage function by using a voiding diary. Patients were asked to describe their satisfaction with the operation. RESULTS: MFR was lower at 1 month compared with the preoperative level, but had recovered to preoperative levels by 5 years postoperatively. However, some patients with >50%, 25-50%, and 50% at 5 years. PVR increased over the 5 postoperative years. Of the patients with urgency and urgency incontinence, 43.8% and 48.1% showed improvement, respectively, whereas new patients developed postoperatively. Thus, the total number of patients with urgency or urgency incontinence remained similar over the 5 years. In those with a changed voiding pattern, patient satisfaction was negatively affected by de novo urgency and urgency incontinence and decreased MFR. CONCLUSIONS: Any obstructive effect of the TVT procedure diminished over time in most patients, although a decrease in the MFR was sustained in some patients. With regard to overactive bladder symptoms, some patients were cured and some patients complained of de novo symptoms. The most major factor affecting patient satisfaction was de novo urgency.

Anatomical and Functional Outcomes of Posterior Intravaginal Slingplasty for the Treatment of Vaginal Vault or Uterine Prolapse: A Prospective, Multicenter Study

PURPOSE: We aimed to evaluate the anatomical and functional outcomes of posterior intravaginal slingplasty (P-IVS) for the treatment of a vaginal vault or uterine prolapse (VP/UP). MATERIALS AND METHODS: This was a 12-month prospective, multicenter, observational study. Women aged over 30 years who presented with stage II or greater VP/UP underwent P-IVS by four urologists at four university hospitals. Preoperatively, pelvic examination by use of the Pelvic Organ Prolapse Quantification (POP-Q) system, the Pelvic Floor Distress Inventory (PFDI) questionnaire, the 3-day frequency volume chart, and uroflowmetry were completed. At the 12-month follow-up, changes in the POP-Q, PFDI, frequency volume chart, and uroflowmetry parameters were assessed. Cure was defined as VP/UP stage 0 and improvement as stage I. RESULTS: The cure and improvement rates among the 32 women were 65.6% and 34.4%, respectively. All subscale scores of the Urinary Distress Inventory, the general subscale score of the Pelvic Organ Prolapse Distress Inventory, and the rectal prolapse subscale score of the Colo-Rectal-Anal Distress Inventory were significantly improved. There were no significant changes in the frequency volume chart or uroflowmetry parameters. There was one case of surgery-related transfusion. CONCLUSIONS: Trans-vaginal repair by P-IVS is an effective and safe procedure for restoring the anatomical defect and improving the associated pelvic floor symptoms in women with VP/UP.