Treatment Patterns with Mirabegron and Antimuscarinics for Overactive Bladder: A Prospective, Registry Study in Taiwan and South Korea (FAITH).

INTRODUCTION: This study aimed to assess overactive bladder (OAB) treatment patterns and factors associated with effectiveness and persistence. METHODS: A prospective, longitudinal, observational registry study of adults starting OAB therapy with mirabegron or antimuscarinics was undertaken. Primary endpoints were time from treatment initiation to discontinuation/switching; proportion who discontinued/switched; and reasons for discontinuation/switching. Secondary endpoints included OAB Symptom Score (OABSS), OAB Questionnaire: Short Form, and OAB Bladder Assessment Tool scores; factors associated with effectiveness and persistence; and safety. RESULTS: In total, 556 patients initiating mirabegron and 250 initiating antimuscarinics were enrolled. There was no treatment switch, change, or discontinuation in 68.5% of the mirabegron initiator group and median time to treatment change was not reached. Mean initial treatment duration was 130.8 days. In multivariable models, baseline OABSS was the only variable significantly associated with change from baseline in OABSS, and patients with mild and moderate OAB had significantly better persistence with mirabegron than those with severe OAB. Urinary tract infection was the most common adverse event with mirabegron. There was no treatment switch, change, or discontinuation in 60.4% of the antimuscarinics initiator group and median time to treatment change was not reached. Solifenacin was the most frequent initial treatment (66.0%). Mean treatment duration was 122.2 days. In multivariable models, baseline OABSS was the only variable significantly associated with change from baseline in OABSS, while patients with OAB medication in the 12 months before enrollment had significantly better persistence with antimuscarinics than those with no previous OAB medication. Dry mouth was the most common adverse event with antimuscarinics. CONCLUSIONS: Mirabegron and solifenacin were commonly prescribed as first-line OAB medications. There was no treatment switch, change, or discontinuation in more than 60% of the mirabegron initiator and antimuscarinics initiator groups. Mean initial treatment duration was 130.8 days and 122.2 days for mirabegron and antimuscarinics, respectively. Graphical Abstract available for this article. TRIAL REGISTRATION: ClinicalTrials.gov NCT03572231.

Potential Role of Macrophage Polarization in the Progression of Hunner-Type Interstitial Cystitis.

BACKGROUND: Hunner-type interstitial cystitis (HIC) is a chronic inflammatory condition of the bladder. However, it remains unclear whether there is a causal relationship between the presence of Hunner lesions and seemingly normal-appearing areas in the bladder (non-Hunner lesions). This study aimed to investigate the fundamental aspects of HIC by examining potential genetic differences between Hunner and non-Hunner lesions and elucidate their role as potential markers in the progression and suppression of the disease. METHODS: This cross-sectional study enrolled patients with HIC (n = 10) who underwent supratrigonal cystectomy along with augmentation cystoplasty. Full-thickness bladder tissue was collected from Hunner and non-Hunner lesions in the same patient. Normal bladder tissue biopsies were also obtained as controls. Whole transcriptome analysis was performed to analyze the gene expression patterns and immune cell populations. RESULTS: The mucosal layers of patients exhibited similar pathway dysregulation across Hunner and non-Hunner lesions, with immunerelated pathways being prominently affected. In the mucosal layer, genes related to anti-inflammatory and immune suppression were downregulated in Hunner lesions compared to non-Hunner lesions. Moreover, in Hunner lesions, genes related to macrophage differentiation and polarization, such as VSIG4, CD68, MAFB, and LIRB4, were downregulated. The cell fraction of M2 macrophages was found to decrease in Hunner lesions. Immunohistochemical staining revealed an elevated fraction of M1 macrophages and a reduced fraction of M2 macrophages in Hunner lesions compared to those in non-Hunner lesions. In the muscular layer, transcriptomic evidence of muscle thickness was observed in both Hunner and non-Hunner lesions; however, the difference was not significant. CONCLUSION: Hunner lesions showed a reduced expression of anti-inflammatory and immunosuppressive factors compared to non-Hunner lesions, along with alterations in immune cell populations. This study suggests the possibility that macrophage polarization is related to the progression from non-Hunner lesions to Hunner lesions, suggesting its relevance to the characteristics of autoimmune diseases.

Recurrence after postoperative intravesical instillation therapy in Hunner type interstitial cystitis.

We performed a prospective, single-arm study comparing outcomes between transurethral ablation plus postoperative instillation of hyaluronic acid and chondroitin sulfate (HACS group) and transurethral ablation only in patients with Hunner type interstitial cystitis (historical control group). A total of 78 patients were enrolled, and 51 were included in the per-protocol analysis set. The 2-year recurrence rate was 47.1% (95% CI, 32.9-61.5) in the HACS group, which was significantly lower than that in the control group (86.2%; 95% CI, 74.6-93.9, P < 0.001). After instillation therapy, the hazard ratio for recurrence was 0.38 (95% CI, 0.23-0.65, P < 0.001). The HACS group had an increased recurrence-free survival with the median interval not being reached, while it was 11.4 months in the control group (95% CI, 8.8-13.8, P < 0.001). Regardless of the instillation treatment, there were significant improvements in all symptom questionnaire scores and pain compared to the baseline. However, in the instillation group, improvement was stable even after 12 months. In patients with Hunner type interstitial cystitis, intravesical instillation of hyaluronic acid and chondroitin sulfate after transurethral ablation significantly reduced the recurrence rate and maintained symptom improvement for more than 1 year.

Optimal endoscopic treatment and partial cystectomy with or without bladder augmentation for Hunner-type interstitial cystitis.

Interstitial cystitis/bladder pain syndrome (IC/BPS) presents a significant challenge for urologists in terms of management, owing to its chronic nature and adverse impact on patient quality of life. Given the potential distinction between two disease entities within IC/BPS, namely Hunner-type IC and BPS without Hunner lesion, there is a need for an optimal therapeutic approach that focuses on the bladder lesions in Hunner-type IC. In cases where Hunner lesions are observed, complete transurethral ablation of these lesions should be prioritized as the initial intervention, as it has demonstrated effectiveness in symptom control. However, recurrence remains a limitation of this intervention. The techniques of resection and coagulation are equally effective in terms of symptom relief and recurrence prevention. Reconstructive surgery becomes necessary in cases of end-stage IC/BPS where various therapeutic approaches have failed. Patient selection is crucial in reconstructive surgery, particularly for patients with clear Hunner lesions and small bladder capacity who have not responded to previous treatments. Furthermore, it is vital to consider the patients' expectations and preferences adequately. Based on a comprehensive review of the literature and our own clinical experiences, subtotal cystectomy followed by bladder augmentation is considered a safe and effective surgical option. This stepwise and tailored therapeutic approach aims to optimize patients' quality of life by specifically targeting Hunner-type IC.

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

PURPOSE: Vibegron, a novel, potent ß3 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. CONCLUSION: Once daily vibegron (50 mg) for 12 weeks was effective, safe, and well-tolerated in Korean patients with OAB.

A treatment prediction strategy for overactive bladder using a machine learning algorithm that utilized data from the FAITH study.

AIMS: To use machine learning algorithms to develop a model to accurately predict treatment responses to mirabegron or antimuscarinic agents in patients with overactive bladder (OAB), using real-world data from the FAITH registry (NCT03572231). METHODS: The FAITH registry data included patients who had been diagnosed with OAB symptoms for at least 3 months and were due to initiate monotherapy with mirabegron or any antimuscarinic. For the development of the machine learning model, data from patients were included if they had completed the 183-day study period, had data for all timepoints and had completed the overactive bladder symptom scores (OABSS) at baseline and end of study. The primary outcome of the study was a composite outcome combining efficacy, persistence, and safety outcomes. Treatment was deemed "more effective" if the composite outcome criteria for "successful," "no treatment change," and "safe" were met, otherwise treatment was deemed "less effective." To explore the composite algorithm, a total of 14 clinical risk factors were included in the initial data set and a 10-fold cross-validation procedure was performed. A range of machine learning models were evaluated to determine the most effective algorithm. RESULTS: In total, data from 396 patients were included (266 [67.2%] treated with mirabegron and 130 [32.8%] treated with an antimuscarinic). Of these, 138 (34.8%) were in the "more effective" group and 258 (65.2%) were in the "less effective" group. The groups were comparable in terms of their characteristic distributions across patient age, sex, body mass index, and Charlson Comorbidity Index. Of the six models initially selected and tested, the decision tree (C5.0) model was chosen for further optimization, and the receiver operating characteristic of the final optimized model had an area under the curve result of 0.70 (95% confidence interval: 0.54-0.85) when 15 was used for the min n parameter. CONCLUSIONS: This study successfully created a simple, rapid, and easy-to-use interface that could be further refined to produce a valuable educational or clinical decision-making aid.

Retrospective Observational Study of Treatment Patterns and Efficacy of onabotulinumtoxinA Therapy in Patients with Refractory Overactive Bladder in Clinical Practice.

This study aimed to evaluate the treatment patterns and long-term efficacy of onabotulinumtoxinA injections in a clinical setting. This single-center retrospective study was conducted on patients with refractory overactive bladder (OAB) aged 18 years or older who received onabotulinumtoxinA 100 IU administered between April 2012 and May 2022. The primary endpoint was the treatment pattern, including the retreatment rate and OAB medication prescription pattern. The duration and effectiveness of onabotulinumtoxinA treatment were analyzed using the overactive bladder symptom score and voiding diaries. A total of 216 patients were enrolled in this study, and the overall patient satisfaction rate was 55.1%. After the first injection, 19.9% received a second treatment, and 6.1% received three or more injections. The median duration until the second injection was 10.7 months. Among the patients, 51.4% resumed OAB medications after 2.96 months. The presence of urodynamic detrusor overactivity was observed only in female patients (odds ratio, 23.65; 95% CI, 1.84 to 304.40), which was associated with a good response. In contrast to clinical trials, the degree of improvement and retreatment rate did not meet expectations. Our findings provide valuable insights into the effectiveness of onabotulinumtoxinA injections in patients with refractory OAB symptoms in real-world practice.

The Anterolateral Approach, Revisited for Benign Jugular Foramen Tumors With Predominant Extracranial Extension: Microsurgical Anatomy and Case Series (SevEN-012).

BACKGROUND AND OBJECTIVES: The anterolateral approach (ALA) enables access to the mid and lower clivus, jugular foramen (JF), craniocervical junction, and cervical spine with added anterior and lateral exposure than the extreme lateral and endoscopic endonasal approach, respectively. We describe the microsurgical anatomy of ALA with cadaveric specimens and report our clinical experience for benign JF tumors with predominant extracranial extension. METHODS: A stepwise and detailed microsurgical neurovascular anatomy of ALA was explored with cadaveric specimens. Then, the clinical results of 7 consecutive patients who underwent ALA for benign JF tumors with predominant extracranial extension were analyzed. RESULTS: A hockey stick skin incision is made along the superior nuchal line to the anterior edge of the sternocleidomastoid muscle (SCM). ALA involves layer-by-layer muscle dissection of SCM, splenius capitis, digastric, longissimus capitis, and superior oblique muscles. The accessory nerve runs beneath SCM and is found at the posterior edge of the digastric muscle. The internal jugular vein (IJV) is lateral to and at the level of the accessory nerve. The occipital artery passes over the longissimus capitis muscle and IJV and into the external carotid artery, which is lateral and superficial to IJV. The internal carotid artery (ICA) is more medial and deeper than external carotid artery and is in the carotid sheath with the vagus nerve and IJV. The hypoglossal and vagus nerves run along the lateral and medial side of ICA, respectively. Prehigh cervical carotid, prejugular, and retrojugular surgical corridors allow deep and extracranial access around JF. In the case series, gross and near-total resections were achieved in 6 (85.7%) patients without newly developed cranial nerve deficits. CONCLUSION: ALA is a traditional and invaluable neurosurgical approach for benign JF tumors with predominant extracranial extension. The anatomic knowledge of ALA increases competency in adding anterior and lateral exposure of extracranial JF.

Wireless, Fully Implantable and Expandable Electronic System for Bidirectional Electrical Neuromodulation of the Urinary Bladder.

Current standard clinical options for patients with detrusor underactivity (DUA) or underactive bladder─the inability to release urine naturally─include the use of medications, voiding techniques, and intermittent catheterization, for which the patient inserts a tube directly into the urethra to eliminate urine. Although those are life-saving techniques, there are still unfavorable side effects, including urinary tract infection (UTI), urethritis, irritation, and discomfort. Here, we report a wireless, fully implantable, and expandable electronic complex that enables elaborate management of abnormal bladder function via seamless integrations with the urinary bladder. Such electronics can not only record multiple physiological parameters simultaneously but also provide direct electrical stimulation based on a feedback control system. Uniform distribution of multiple stimulation electrodes via mesh-type geometry realizes low-impedance characteristics, which improves voiding/urination efficiency at the desired times. In vivo evaluations using live, free-moving animal models demonstrate system-level functionality.

Current and Emerging Pharmacological Targets and Treatments of Urinary Incontinence and Related Disorders.

Overactive bladder syndrome with and without urinary incontinence and related conditions, signs, and disorders such as detrusor overactivity, neurogenic lower urinary tract dysfunction, underactive bladder, stress urinary incontinence, and nocturia are common in the general population and have a major impact on the quality of life of the affected patients and their partners. Based on the deliberations of the subcommittee on pharmacological treatments of the 7th International Consultation on Incontinence, we present a comprehensive review of established drug targets in the treatment of overactive bladder syndrome and the aforementioned related conditions and the approved drugs used in its treatment. Investigational drug targets and compounds are also reviewed. We conclude that, despite a range of available medical treatment options, a considerable medical need continues to exist. This is largely because the existing treatments are symptomatic and have limited efficacy and/or tolerability, which leads to poor long-term adherence. SIGNIFICANCE STATEMENT: Urinary incontinence and related disorders are prevalent in the general population. While many treatments have been approved, few patients stay on long-term treatment despite none of them being curative. This paper provides a comprehensive discussion of existing and emerging treatment options for various types of incontinence and related disorders.

The Asia-Pacific AMS800 artificial urinary sphincter consensus statement.

This Asia-Pacific (AP) AMS 800™ artificial urinary sphincter (AUS) consensus statement aims to provide a set of practical recommendations to assist surgeons with the AMS 800 device surgery. The AP consensus committee consisted of key opinion leaders with extensive experience with AMS 800 surgery across several AP countries. The panel reviewed and discussed relevant findings with emphasis on locoregional and specific clinical challenges relevant to the AP region. Recommendations were made in key areas namely (1) patient selection and informed consent process; (2) preoperative assessment; (3) dealing with co-existing urological disorders; (4) surgical principles and intraoperative troubleshooting; (5) postoperative care; (6) special populations; and (7) cost analysis and comparative review. The AMS 800 device should be offered to males with moderate to severe stress urinary incontinence (SUI). Full informed consent should be undertaken, and emphasis is placed on surgical contraindications and high-risk candidates. The presence of a surgical mentor or referral to experts is recommended in complex AUS candidates. Preoperative cystoscopy with or without multichannel urodynamic study is necessary and patients with pre-existing urological disorders should be treated adequately and clinically stable before surgery. Adherence to strict patient selection and safe surgical principles are critical to ensure excellent clinical outcomes and minimize complications. Given that InhibiZone-coated device is not available in many AP countries, the use of prophylactic antibiotics pre-and post-operatively are recommended. The AMS 800 device should be prepared according to the manufacturer's guidelines and remains a cost-effective treatment for male SUI. The AMS 800 device remains the surgical benchmark for male SUI but is associated with certain mechanical limitations and a unique set of complications.

Factors associated with quality of life in patients with benign prostatic hyperplasia, 2009-2016.

This study analyzed the factors affecting the health-related quality of life of patients with benign prostatic hyperplasia (BPH) according to age. We also aimed to determine appropriate strategies to improve their quality of life. Data from the Korea Health Panel Survey (2009-2016) were used in this study. A total of 3806 patients with BPH were divided into 2 groups: younger adults (aged under 65 years) and older adults (aged over 65 years). In addition, a logistic regression analysis was conducted to identify factors affecting the quality of life of young and older patients with BPH. In younger adult patients with BPH, the higher the level of education, the higher the quality of life by a factor of 1.379, and the more intense the physical activity, the lower the quality of life by a factor of 0.791. Also, the longer the sitting time, the lower the quality of life by a factor of 0.765. In contrast, for older adult patients with BPH, the quality of life improved by factors of 1.601 and 2.921, respectively, for health insurance and higher income level. In addition, it was found that the quality of life decreased by a factor of 0.754 in patients who drink alcohol. In order to improve the quality of life of the middle-aged adult population with BPH, it is necessary to reduce sitting time through constant physical activity. Moreover, the cost of medical care should be reduced and the quality of life increased through reductions in surgical treatment, as the burden of medical expenses will degrade the quality of life for older adults.

The impact of Hunner lesion-type interstitial cystitis/bladder pain syndrome on health-related quality of life and the effects of transurethral ablation.

PURPOSE: Interstitial cystitis/bladder pain syndrome (IC/BPS) has a negative impact on quality of life. We compared health-related quality of life (HRQoL) of patients with IC/BPS with patients having other diseases using the EuroQol five-dimension (EQ-5D) and evaluated whether the HRQoL is improved after surgery. METHODS: We compared EQ-5D of patients with Hunner lesion type IC/BPS with patients who had other diseases that cause chronic and severe pain including arthritis and cancer from a cross-sectional analysis of responses to the 2012-2016 Korea National Health and Nutrition Examination Survey. Changes in EQ-5D after transurethral coagulation (TUC) or resection (TUR) were measured in the IC/BPS participants. RESULTS: Compared to the EQ-5D index of normal population, patients with arthritis, cancer and IC/BPS had - 0.07 (95% CI - 0.07, - 0.06), - 0.01 (95% CI - 0.02, - 0.01), and - 0.21 (95% CI - 0.23, - 0.20) lower scores, respectively. Patients with IC/BPS were 35.9, 9.24, and 9.05 times more likely to have "extreme problem" in pain/discomfort, anxiety/depression, and usual activities EQ-5D domains, respectively, than patients without arthritis/cancer. After TUC or TUR, EQ-5D index was 0.90 in the TUC group and 0.92 in the TUR group. CONCLUSION: IC/BPS patients have worse HRQoL than healthy individuals. However, after surgical treatment, HRQoL is restored to a level close to normal.

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

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. CONCLUSION: 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 Prospective Observational Study of the Recurrence Characteristics of Hunner Lesion After Repeated Transurethral Ablation in Patients With Interstitial Cystitis/Bladder Pain Syndrome.

PURPOSE: The aim of this study was to investigate the rate and pattern of recurrence for patients with Hunner lesion (HL) type interstitial cystitis/bladder pain syndrome (IC/BPS) after transurethral ablation. METHODS: This prospective study included 210 patients with HL type IC/BPS. The primary outcomes were the recurrence rate according to 3 patterns of recurrence: pattern A (according to the relationship with the previous surgical site), pattern B (according to the bladder zone), and pattern C (according to the number of lesions). The secondary outcomes were recurrencefree time after treatment according to pattern A and pattern C. RESULTS: The pattern A recurrence rate was 50.8% in the same site (A1), 6.7% at a new site (A2), and 42.5% at mixed sites (A3). The pattern B recurrence rate was 10.5% for the anterior wall, 59.0% for the posterior wall, 69.5% for the lateral wall, and 69.0% for the dome area. Multiple lesions recurred as multiple lesions in 75.8% of cases. The pattern C recurrence rate was 10.8% for C1 (single → single), 6.7% for C2 (single → multiple), 6.7% for C3 (multiple → single), and 75.8% for C4 (multiple → multiple). The recurrence-free time in pattern A was 13 months for A1, 12.5 months for A2, and 8 months for A3, with a significant difference between A1 and A3 (P=0.008). There was no significant difference in recurrence-free time in pattern C, either with single or multiple HLs. CONCLUSION: The distinct recurrence characteristics of HLs was not predictable despite repeated ablations. Complete remission should not be expected because the whole bladder was to have the potential to develop the HLs even after repeated transurethral ablation.

Regrowth factors of WHO grade I skull base meningiomas following incomplete resection.

OBJECTIVE: The role of adjuvant radiation therapy following incomplete resection of WHO grade I skull base meningiomas (SBMs) is controversial, and little is known regarding the behavior of residual tumors. The authors investigated the factors that influence regrowth of residual WHO grade I SBMs following incomplete resection. METHODS: From 2005 to 2019, a total of 710 patients underwent surgery for newly diagnosed WHO grade I SBMs. The data of 115 patients (16.2%) with incomplete resection and without any adjuvant radiotherapy were retrospectively assessed during a mean follow-up of 78 months (range 27-198 months). Pre-, intra-, and postoperative clinical and molecular factors were analyzed for relevance to regrowth-free survival (RFS). RESULTS: Eighty patients were eligible for analysis, excluding those who were lost to follow-up (n = 10) or had adjuvant radiotherapy (n = 25). Regrowth occurred in 39 patients (48.7%), with a mean RFS of 50 months (range 3-191 months). Significant predictors of regrowth were Ki-67 proliferative index (PI) ≥ 4% (p = 0.017), Simpson resection grades IV and V (p = 0.005), and invasion of the cavernous sinus (p = 0.027) and Meckel's cave (p = 0.027). After Cox regression analysis, only Ki-67 PI ≥ 4% (hazard ratio [HR] 9.39, p = 0.003) and Simpson grades IV and V (HR 8.65, p = 0.001) showed significant deterioration of RFS. When stratified into 4 scoring groups, the mean RFSs were 110, 70, 38, and 9 months for scores 1 (Ki-67 PI < 4% and Simpson grade III), 2 (Ki-67 PI < 4% and Simpson grades IV and V), 3 (Ki-67 PI ≥ 4% and Simpson grade III), and 4 (Ki-67 PI ≥ 4% and Simpson grades IV and V), respectively. RFS was significantly longer for score 1 versus scores 2-4 (p < 0.01). Tumor consistency, histology, location, peritumoral edema, vascular encasement, and telomerase reverse transcriptase promoter mutation had no impact on regrowth. CONCLUSIONS: Ki-67 PI and Simpson resection grade showed significant associations with RFS for WHO grade I SBMs following incomplete resection. Ki-67 PI and Simpson resection grade could be utilized to stratify the level of risk for regrowth.

Feasibility of a deep learning-based diagnostic platform to evaluate lower urinary tract disorders in men using simple uroflowmetry.

PURPOSE: To diagnose lower urinary tract symptoms (LUTS) in a noninvasive manner, we created a prediction model for bladder outlet obstruction (BOO) and detrusor underactivity (DUA) using simple uroflowmetry. In this study, we used deep learning to analyze simple uroflowmetry. MATERIALS AND METHODS: We performed a retrospective review of 4,835 male patients aged ≥40 years who underwent a urodynamic study at a single center. We excluded patients with a disease or a history of surgery that could affect LUTS. A total of 1,792 patients were included in the study. We extracted a simple uroflowmetry graph automatically using the ABBYY Flexicapture® image capture program (ABBYY, Moscow, Russia). We applied a convolutional neural network (CNN), a deep learning method to predict DUA and BOO. A 5-fold cross-validation average value of the area under the receiver operating characteristic (AUROC) curve was chosen as an evaluation metric. When it comes to binary classification, this metric provides a richer measure of classification performance. Additionally, we provided the corresponding average precision-recall (PR) curves. RESULTS: Among the 1,792 patients, 482 (26.90%) had BOO, and 893 (49.83%) had DUA. The average AUROC scores of DUA and BOO, which were measured using 5-fold cross-validation, were 73.30% (mean average precision [mAP]=0.70) and 72.23% (mAP=0.45), respectively. CONCLUSIONS: Our study suggests that it is possible to differentiate DUA from non-DUA and BOO from non-BOO using a simple uroflowmetry graph with a fine-tuned VGG16, which is a well-known CNN model.

The usefulness of patient-specific 3D nasal silicone implant using 3D design and order form.

PURPOSE: The need for customized implants has continuously increased, but patient-specific silicone implants are not yet commonly used in the plastic surgery market. We sought to validate the effectiveness of a 3D customized nasal implant design in terms of design and lead time compared with a manually customized implant by a surgeon. MATERIALS AND METHODS: Based on the computed tomography (CT) findings of 15 patients who planned rhinoplasty, a surgeon wrote order forms reflecting the surgical plan and subsequently designed implants manually using epoxy on a 3D printed skull. Separately, engineers analyzed the CT findings and designed 3D implants based on the order forms. RESULTS: Epoxy designs were 3D-scanned, converted into a stereolithography format and compared with 3D implant designs to assess which method had a smaller margin of error as per the preoperative order form. Moreover, the lead time in all steps are compared. Nasion thickness, tip thickness, glabella starting point, glabella width, radix width, and total volume were comparatively analyzed. In all parameters, the error rate of the 3D design is relatively lower than that of the epoxy design. The former also had a lower total volume and a faster manufacturing time. CONCLUSION: With novel 3D customized nasal implants, the limitations of ready-made silicone implants are addressed, and it is now possible to preoperatively design implants more accurately, quickly, and conveniently.

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

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%. CONCLUSION: The use of a SpeediCath provided good quality of life for patients who needed self-IC regardless of age or sex.

The role of apparent diffusion coefficient as a predictive factor for tumor recurrence in patients with cerebellopontine angle epidermoid tumor.

Intracranial epidermoid tumors are slowly growing benign tumors, but due to adjacent critical neurovascular structures, surgical resection is challenging, with the risk of recurrence. The apparent diffusion coefficient (ADC) has been used to evaluate the characteristics of brain tumors, but its utility for intracranial epidermoid tumors has not been specifically explored. This study analyzed the utility of preoperative ADC values in predicting tumor recurrence for patients with intracranial epidermoid tumors. Between 2008 and 2019, 21 patients underwent surgery for cerebellopontine angle (CPA) epidermoid tumor, and their preoperative ADC data were analyzed. The patients were divided into two groups: the recurrence group, defined by regrowth of the remnant tumor or newly developed mass after gross total resection on magnetic resonance imaging (MRI); and the stable group, defined by the absence of growth or evidence of tumor on MRI. Receiver operating characteristic (ROC) analysis was used to obtain the ADC cutoff values for predicting tumor recurrence. The prognostic value of the ADC was assessed using Kaplan-Meier curves. The minimum ADC values were significantly lower in the recurrence group than in the stable tumor group (P = 0.020). ROC analysis showed that a minimum ADC value lower than 804.5 × 10-6 mm2/s could be used to predict higher recurrence risk of CPA epidermoid tumors. Non-total resection and mean and minimum ADC values lower than the respective cutoffs were negative predictors of recurrence-free survival. Minimum ADC values could be useful in predicting the recurrence of CPA epidermoid tumors.