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.

Comparison of Efficacy of Different Surgical Techniques for Benign Prostatic Obstruction / 대한배뇨장애요실금학회지

Purpose@#We compared success rates of 3 surgical techniques (holmium laser enucleation of the prostate [HoLEP], transurethral resection of the prostate [TURP], and photoselective laser vaporization prostatectomy [PVP]) for treatment of benign prostatic obstruction (BPO). We aimed to identify preoperative clinical variables and urodynamic parameters that predict surgical success. @*Methods@#A total of 483 patients who underwent surgical treatment for BPO at Samsung Medical Center between 2006 and 2017 were retrospectively analyzed; of these 361, 81, and 41 patients underwent HoLEP, TURP, and PVP, respectively. Prostate-specific antigen, prostate volume, urodynamic parameters, and International Prostate Symptom Score (IPSS)/quality of life (QoL) index were evaluated preoperatively; uroflowmetry, postvoid residual urine, and IPSS/QoL index were measured 6 months postoperatively. Surgical success was defined based on IPSS, maximum flow rate, and QoL index and predictive factors were identified using multiple logistic regression analyses. @*Results@#Success rates of HoLEP, TURP, and PVP were 67.6%, 65.4%, and 34.1%, respectively, and the HoLEP and TURP groups were not significantly different. Regression analysis revealed prostate volume ≥50 mL and bladder outlet obstruction index (BOOI) ≥40 to be independent factors predicting HoLEP success. Only high preoperative QoL could predict the success of TURP, whereas other urodynamic parameters remained unrelated. @*Conclusions@#Patients treated with HoLEP and TURP displayed equivalent efficacies, but PVP was relatively less efficient than both. Preoperative variables of prostate volume ≥50 mL and BOOI ≥40 were independent predictive factors for the success of HoLEP but not of TURP.

Comparison of Efficacy of Different Surgical Techniques for Benign Prostatic Obstruction / 대한배뇨장애요실금학회지

Purpose@#We compared success rates of 3 surgical techniques (holmium laser enucleation of the prostate [HoLEP], transurethral resection of the prostate [TURP], and photoselective laser vaporization prostatectomy [PVP]) for treatment of benign prostatic obstruction (BPO). We aimed to identify preoperative clinical variables and urodynamic parameters that predict surgical success. @*Methods@#A total of 483 patients who underwent surgical treatment for BPO at Samsung Medical Center between 2006 and 2017 were retrospectively analyzed; of these 361, 81, and 41 patients underwent HoLEP, TURP, and PVP, respectively. Prostate-specific antigen, prostate volume, urodynamic parameters, and International Prostate Symptom Score (IPSS)/quality of life (QoL) index were evaluated preoperatively; uroflowmetry, postvoid residual urine, and IPSS/QoL index were measured 6 months postoperatively. Surgical success was defined based on IPSS, maximum flow rate, and QoL index and predictive factors were identified using multiple logistic regression analyses. @*Results@#Success rates of HoLEP, TURP, and PVP were 67.6%, 65.4%, and 34.1%, respectively, and the HoLEP and TURP groups were not significantly different. Regression analysis revealed prostate volume ≥50 mL and bladder outlet obstruction index (BOOI) ≥40 to be independent factors predicting HoLEP success. Only high preoperative QoL could predict the success of TURP, whereas other urodynamic parameters remained unrelated. @*Conclusions@#Patients treated with HoLEP and TURP displayed equivalent efficacies, but PVP was relatively less efficient than both. Preoperative variables of prostate volume ≥50 mL and BOOI ≥40 were independent predictive factors for the success of HoLEP but not of TURP.

Robotic Sacrocolpopexy for Treatment of Apical Compartment Prolapse / 대한배뇨장애요실금학회지

Abdominal sacrocolpopexy is the gold-standard treatment for apical compartment prolapse, as it is more effective and durable than the transvaginal approach. In the current era of minimally invasive surgery, laparoscopic sacrocolpopexy techniques have been described, but have not gained popularity due to their complexity and steep learning curves. To overcome this problem, robotic sacrocolpopexy was introduced, and has shown equivalent outcomes and safety compared to open and laparoscopic sacrocolpopexy based on findings that have been accumulated over 15 years.

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.

A Korean Postmarketing Study Assessing the Effectiveness of OnabotulinumtoxinA for the Treatment of Neurogenic Detrusor Overactivity or Idiopathic Overactive Bladder Using a Validated Patient-Reported Outcome Measure / 대한배뇨장애요실금학회지

PURPOSE: OnabotulinumtoxinA has demonstrated efficacy and safety in the treatment of urinary incontinence (UI) associated with neurogenic detrusor overactivity (NDO) and idiopathic overactive bladder (OAB); however, real-world evidence is limited. This postmarketing surveillance study aimed to assess the effectiveness and safety of onabotulinumtoxinA in Korean patients with UI associated with NDO or OAB with an inadequate response or intolerance to anticholinergics. METHODS: Patients received 200 U (NDO) or 100 U (OAB) of onabotulinumtoxinA. Effectiveness (assessed using the validated International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]) and safety were assessed for 1–4 months after onabotulinumtoxinA administration. RESULTS: Overall, 686 patients (NDO, 161; OAB, 525) comprised the safety population; of these, 612 patients were analyzed for effectiveness. There was a significant decrease (P5 points from baseline in the ICIQ-SF score was observed in 64.9% and 47.3% of patients in the NDO and OAB groups, respectively. Following treatment, 59.9% in the NDO group and 43.0% in the OAB group were dry. There was no effect of age on effectiveness in either group. Only 10 adverse drug reactions (ADRs) were reported in 5.6% of NDO patients and 20 ADRs in 3.2% of OAB patients. Most ADRs in both groups were related to the lower urinary tract such as dysuria (NDO, 1.2%; OAB, 0.6%) and urinary retention (NDO, 0.6%; OAB, 1.5%). CONCLUSIONS: Effectiveness and safety of onabotulinumtoxinA in Korea in a real-world setting was demonstrated.

Recent Patient Health Monitoring Platforms Incorporating Internet of Things-Enabled Smart Devices / 대한배뇨장애요실금학회지

Synergistic integration of the Internet of Things (IoT), cloud computing, and big data technologies in healthcare have led to the notion of “smart health.” Smart health is an emerging concept that refers to the provision of healthcare services for prevention, diagnosis, treatment, and follow-up management at any time or any place by connecting information technologies and healthcare. As a significant breakthrough in smart healthcare development, IoT-enabled smart devices allow medical centers to carry out preventive care, diagnosis, and treatment more competently. This review focuses on recently developed patient health monitoring platforms based on IoT-enabled smart devices that can collect real-time patient data and transfer information for assessment by healthcare providers, including doctors, hospitals, and clinics, or for self-management. We aimed to summarize the available information about recently approved devices and state-of-the-art developments through a comprehensive, systematic literature review. In this review, we also discuss possible future directions for the integration of cloud computing and blockchain, which may offer unprecedented breakthroughs in on-demand medical services. The combination of IoT with real-time, remote patient monitoring empowers patients to assert more control over their care, thereby allowing them to actively monitor their particular health conditions.

Innovative Distribution Priorities for the Medical Devices Industry in the Fourth Industrial Revolution / 대한배뇨장애요실금학회지

PURPOSE: This study aimed to set priorities for improving the medical device distribution structure and to suggest an innovative improvement plan for the distribution structure using the analytic hierarchy process (AHP) method, focusing on stakeholders in the medical device industry. METHODS: This study conducted a survey with 35 specialists using the AHP method, which is a multiple-criteria decisionmaking methodology, in order to set priorities for improvement plans to address the problems faced by the medical device distribution structure. RESULTS: The AHP analysis showed that supply stability was the most important factor, followed by greater transparency, efficiency, smart supply, and cost reduction. CONCLUSIONS: It is necessary to establish a stable supply system and manage crises through supply stability, as well as to provide opportunities for fair trade through greater transparency. As steps towards those goals, we propose establishing a unique device identification system, an information disclosure system, online distribution, and a group purchasing organization system in Korea.

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.

Detecting Bladder Biomarkers for Closed-Loop Neuromodulation: A Technological Review / 대한배뇨장애요실금학회지

Neuromodulation was introduced for patients with poor outcomes from the existing traditional treatment approaches. It is well-established as an alternative, novel treatment option for voiding dysfunction. The current system of neuromodulation uses an open-loop system that only delivers continuous stimulation without considering the patient’s state changes. Though the conventional open-loop system has shown positive clinical results, it can cause problems such as decreased efficacy over time due to neural habituation, higher risk of tissue damage, and lower battery life. Therefore, there is a need for a closed-loop system to overcome the disadvantages of existing systems. The closed-loop neuromodulation includes a system to monitor and stimulate micturition reflex pathways from the lower urinary tract, as well as the central nervous system. In this paper, we reviewed the current technological status to measure biomarker for closed-loop neuromodulation systems for voiding dysfunction.

Recent Patient Health Monitoring Platforms Incorporating Internet of Things-Enabled Smart Devices / 대한배뇨장애요실금학회지

Due to a mistake in reference by the author submission in this article, an erroneous grant number had been published.

Potential Biomarkers for Diagnosis of Overactive Bladder Patients: Urinary Nerve Growth Factor, Prostaglandin E2, and Adenosine Triphosphate / 대한배뇨장애요실금학회지

PURPOSE: This study aimed to investigate potential biomarkers for the diagnosis of overactive bladder (OAB). METHODS: A total of 219 subjects were enrolled and divided into 2 groups: OAB subjects (n=189) and controls without OAB symptoms (n=30). Three-day voiding diaries and questionnaires were collected, and urinary levels of nerve growth factor (NGF), prostaglandin E2, and adenosine triphosphate were measured and normalized to urine creatinine (Cr). Baseline characteristics and urinary levels of markers were analyzed. A receiver-operator characteristic (ROC) curve was used to analyze the diagnostic performance of urinary markers. Urinary levels of markers according to subgroup and pathogenesis of OAB were evaluated. Correlation analyses were used to analyze the relationship between urinary levels of markers and voiding diary parameters and questionnaires. RESULTS: There was no difference between the 2 groups with regards to age, sex ratio, or urine Cr (P>0.05). The urinary levels of NGF/Cr were higher in OAB subjects than in controls (P < 0.001). Urinary NGF/Cr was a sensitive biomarker for discriminating OAB patients (area under the curve=0.741; 95% confidence interval, 0.62–0.79; P=0.001) in the ROC curve. The urinary levels of NGF/Cr were significantly higher in OAB subjects than in controls regardless of subgroup or pathogenesis. Correlation analysis demonstrated urinary urgency was significantly related to urinary NGF/Cr level (correlation coefficient, 0.156). Limitations include a relatively wide variation of urinary markers. CONCLUSIONS: Urinary NGF is a potential biomarker that could serve as a basis for adjunct diagnosis of OAB.

Assessing the Readjustable Sling Procedure (Remeex System) for Female Stress Urinary Incontinence With Detrusor Underactivity / 대한배뇨장애요실금학회지

PURPOSE: Many surgeons worry about postoperative voiding problems in patients with stress urinary incontinence (SUI) and detrusor underactivity (DU). This study hypothesized that adjusting the tension after surgery would benefit patients with DU, and therefore researchers evaluated the outcomes and quality of life of women with SUI and DU who underwent the readjustable sling procedure (Remeex). METHODS: The medical records of 27 patients who were treated with the Remeex system for SUI and DU between 2007 and 2013 were retrospectively analyzed. The incontinence visual analogue scale (I-VAS), incontinence quality of life questionnaire (I-QOL) and the Sandvik incontinence severity index (ISI) were used to evaluate the efficacy of the Remeex system both prior to surgery and at the last visit after surgery. The treatment was considered successful if there was no urine leakage based on the Sandvik questionnaire. RESULTS: The mean follow-up period was 38.0 months (range, 1–75 months), and the treatment success rate was 81.5%. Despite no urine leakage, 7 patients wanted the Remeex system to be removed due to persistent postoperative urinary retention within a year of surgery. One patient underwent a long-term adjustment under local anesthesia 6 years after the initial surgery. The I-VAS, ISI and all domains of the I-QOL scores improved significantly postoperatively and the maximum flow rate decreased significantly after the procedure. However, the postvoid residual did not change significantly. CONCLUSIONS: The Remeex system provided a good cure rate and improved the quality of life of women with SUI and DU. Therefore, the Remeex system should be considered as a treatment option for female patients with concomitant SUI and DU.

Biodegradation and Biocompatibility of Poly L-lactic Acid Implantable Mesh / 대한배뇨장애요실금학회지

PURPOSE: The purpose of this study was to evaluate the biodegradation and biocompatibility of poly L-lactic acid (PLLA) implantable mesh under in vitro and in vivo conditions. METHODS: PLLA mesh was examined for changes in weight and tensile strength. The histology of the tissue around the PLLA implant was also evaluated. RESULTS: The weight and tensile strength of the PLLA prosthesis was stable for 180 days. In addition, the surface of the PLLA mesh was not digested under in vitro or in vivo conditions as determined by scanning electron microscope. Histologically, there were no significant changes in the diameters of implanted PLLA mesh and subtype fibers over the course of 180 days. Likewise, there were no significant changes in the number of inflammatory and mast cells after 180 days, nor was there an increase in the percentage of collagen surrounding the PLLA mesh. CONCLUSIONS: The results indicate that PLLA prostheses have good rigidity and biocompatibility in vivo and in vitro.

Surgical Outcomes and Safety of Robotic Sacrocolpopexy in Women With Apical Pelvic Organ Prolapse / 대한배뇨장애요실금학회지

PURPOSE: This study aimed to investigate the surgical outcomes and safety of robotic sacrocolpopexy (RSC) in patients with uterine/vaginal vault prolapse. METHODS: Between January 2009 and June 2015, 16 women with apical prolapse underwent RSC. Pelvic organ prolapse quantification (POP-Q) examination was performed, and treatment success was defined as the presence of grade 0 or I apical prolapse upon POP-Q examination at the final follow-up. Pelvic floor distress inventory-short form 20 (PFDI-SF 20) was administered at every follow-up. A treatment satisfaction questionnaire was administered by telephone to evaluate patient satisfaction with the operation. RESULTS: Median age was 65 years (interquartile range [IQR], 56–68 years), and follow-up duration was 25.3 months (IQR, 5.4–34.0 months). Thirteen women (81.3%) had ≥grade III apical prolapse. Operation time was 251 minutes (IQR, 236–288 minutes), and blood loss was 75 mL (IQR, 50–150 mL). Median hospital stay was 4 days (IQR, 3–5 days). At the final follow-up, treatment success was reported in all patients, who presented grade 0 (n=8, 57.1%) and grade I (n=6, 42.9%) apical prolapse. Dramatic improvements in PFDI-SF 20 scores were noted after RSC (from 39 to 4; P=0.001). Most patients (12 of 13) were satisfied with RSC. An intraoperative complication (sacral venous plexus injury) was reported in 1 patient, and there was no conversion to open surgery. Mesh erosion was not reported. CONCLUSIONS: RSC is an efficient and safe surgical option for apical prolapse repair. Most patients were satisfied with RSC. Thus, RSC might be one of the best treatment options for apical prolapse in women.

Urinary Nerve Growth Factor as a Potential Biomarker of Treatment Outcomes in Overactive Bladder Patients / 대한배뇨장애요실금학회지

PURPOSE: The aim of this study was to investigate urinary nerve growth factor (NGF) as a biomarker of treatment efficacy and recurrence in overactive bladder (OAB) patients. METHODS: We enrolled 189 OAB subjects who visited our outpatient clinic from February 2010 to February 2015. All subjects with OAB received antimuscarinic treatment. A 3-day voiding diary and questionnaire were collected from each patient. Urinary levels of NGF were evaluated at baseline, the beginning of antimuscarinic treatment, and the end of antimuscarinic treatment. Urinary NGF was normalized to urine creatinine (Cr). Between-group comparisons of baseline characteristics were made using the Mann-Whitney U-test. Multivariate logistic regression analyses were used to predict responses to anticholinergic treatment and recurrence. The Wilcoxon signed-rank test with the Bonferroni correction was used for intragroup comparisons. A receiver operating characteristic curve was used to analyze the utility of this biomarker. RESULTS: Urinary levels of NGF/Cr tended to decrease in patients who responded to treatment (n=62), but this was not significant (P=0.260). Urinary NGF levels were higher at baseline in patients who did not experience recurrence than in those who did (P=0.047). In those who did not experience recurrence (n=29), urinary NGF/Cr decreased at the end of treatment compared to baseline, and this reduction was maintained at 12 weeks after the end of treatment (P < 0.05). CONCLUSIONS: Urinary NGF is a potential biomarker for predicting the outcome of antimuscarinic treatment in OAB patients. This may provide useful information when deciding to stop antimuscarinic treatment in responders.

New pharmacotherapy for treating overactive bladder: mirabegron and botulinum toxin

Overactive bladder (OAB) is a symptom-driven condition characterized by urinary urgency with or without urinary incontinence and a common problem that can significantly affect quality of life. Drugs that prevent acetylcholine-mediated involuntary detrusor contractions are the mainstay of OAB treatment, but several alternative therapeutic options have become established treatments for OAB. Mirabegron (a β3-adrenoceptor agonist) has a different mechanism of action from antimuscarinic agents. Recently published randomized controlled trials have shown that mirabegron is an effective and safe drug for the symptomatic treatment of OAB patients. Mirabegron represents a valid option both for patients with OAB who are antimuscarinics treatment-naïve, as well as for those who are unresponsive or intolerant to antimuscarinics. Intravesical injection of botulinum toxin A is an effective treatment for OAB that is refractory to antimuscarinics. Treatment with botulinum toxin A showed clinically relevant improvement in all OAB symptoms and health-related quality of life. It was generally well tolerated by most patients, and most treatment-related complications were acceptable. However, increased risk of a larger volume of post-void residual urine was noted in several patients and the possibility of chronic catheterization requires careful evaluation before treatment. In sum, recent options for management of OAB, mirabegron and intravesical injection of botulinum toxin A, expand the treatment options for the optimal treatment of each patient.

Surgical Treatment for Falcotentorial Meningiomas

Among intracranial meningiomas, falcotentorial meningiomas, occurring at the junction of the falx cerebri and tentorial dural folds, are extremely rare. Because of their deep location, they are surrounded by critical structures, and have been regarded as one of the most challenging lesions for surgical treatment. In this study, we describe our surgical strategy for falcotentorial meningiomas and provide a review of our experience.