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Brief report on the stage I/IIa review to evaluate the safety, tolerability, and also immune result of AGMG0201 in patients with essential high blood pressure levels.
PURPOSE Given the importance of evaluating the severity of overactive bladder (OAB) symptoms and outcomes after treatment, several questionnaires have been developed to evaluate OAB patients. However, only limited questionnaires are available in Korea for use with Korean patients. Therefore, this study aimed to develop Korean versions of OAB questionnaires through a rigorous linguistic validation process. METHODS The Indevus Urgency Severity Scale, Urgency Perception Scale, Urgency Severity Scale, and Patient Perception of Intensity of Urgency Scale underwent translation and linguistic validation. The linguistic validation procedure consisted of permission for translation, forward translations, reconciliation, back-translation, cognitive debriefing, and proofreading. Two independent bilingual translators translated the original version of each questionnaire, and a panel then discussed and reconciled the 2 initial translations. Next, a third independent bilingual translator performed a backward translation of the reconciled version into English. Five Korean patients diagnosed with OAB were interviewed for cognitive debriefing. RESULTS Each item of the questionnaires was translated into 2 Korean versions in the forward translation process. Terms such as 'urgency' and 'wetting' were translated into ordinary language by the translators and adjusted by the panel members to more conceptually equivalent terms in a medical context. In the back-translation process, the panel made a few changes regarding details based on a comparison of the back-translated and original versions. During the cognitive debriefing process, 5 patients provided a few pieces of feedback on the naturalness of the wording of the questionnaires, but generally agreed on the translated terms. CONCLUSION In this study, the panel produced a successful linguistic validation of Korean versions of multiple OAB questionnaires, which can be utilized to evaluate the severity and treatment outcomes of OAB.PURPOSE To evaluate intravesical loss of onabolunumtoxinA (onaBTA) during endoscopic injection into the bladder wall for treatment of neurogenic detrusor overactivity (NDO). The intraluminal loss of onaBTA cannot be determined directly, therefore we added methylene blue (MB) to reconstitute onaBTA. Subsequently we used spectrophotometry to determine the total amount of MB in the irrigation fluid, which allowed us to calculate total intraluminal loss of onaBTA. METHODS The study population was consisted of 48 patients with NDO. The mean age was 36.6±8.9 years. Forty-two patients suffered from NDO due to spinal cord injury and 6 patients suffered from multiple sclerosis. Each patient received 200 units of onaBTA administered by 30 endoscopic injections (1 mL per injection) using a 23-G needle. The entire volume of irrigation fluid was collected and spectrophotometry was used to determine the MB concentration. The total amount of injected onaBTA, total amount of irrigation solution and the known amount of MB used during reconstitution, allowed for the determination of intravesical loss of onaBTA. RESULTS Forty-five patients were included in the final analysis. The mean volume of irrigation fluid was 603.33±400.14 mL. The mean absorbance was 0.14±0.12 with the mean MB concentration 0.19±0.18 mg/L. The mean calculated loss of onaBTA was 4.14±4.11 units. CONCLUSION The endoscopic injection of onaBTA marked by MB into the bladder wall is associated with minimal intravesical loss of the agent, representing less than 3% of the administered dose of MB. This may reflect the amount of the onaBTA detected in the irrigation fluid.PURPOSE The Q-tip test is used to measure urethral hypermobility and can predict surgical outcomes. However, certain factors may affect the reliability of this test. Our aim was to identify independent clinical and urodynamic predictors of the results of the Q-tip test. METHODS Between January 2014 and June 2019, 176 consecutive women with lower urinary tract symptoms who underwent the Q-tip test and urodynamic studies were included in this retrospective study. RESULTS Multivariable regression analysis revealed that age (regression coefficient, -0.55), point Ba (regression coefficient, 4.1), urodynamic stress incontinence (regression coefficient, 9.9), maximum flow rate (Qmax) (regression coefficient, 0.13), pressure transmission ratio (PTR) at maximum urethral pressure (MUP) (regression coefficient, -0.14), and the score on the fifth question of the Incontinence Impact Questionnaire (IIQQ5; "Has urine leakage affected your participation in social activities outside your home?"; regression coefficient, -4.1) were independent predictors of the Q-tip angle, with a constant of 87.0. The following Spearman rank correlation coefficients were found between the Q-tip angle and the following variables age, -0.38; point Ba, 0.34; urodynamic stress incontinence, 0.32; Qmax, 0.28; PTR at MUP, -0.28; and IIQQ5, -0.23. A receiver operating characteristic curve (ROC) analysis for the prediction of urodynamic stress incontinence found that the optimum cutoff for PTR at MUP was less then 81%, with an area under the ROC curve of 0.70. CONCLUSION Age, point Ba, urodynamic stress incontinence, Qmax, PTR at MUP, and IIQQ5 were independent predictors of the Q-tip angle. However, none of these could be used as effective surrogates for the Q-tip test due to their lack of a sufficient correlation.PURPOSE Compared to the microbiome of other body sites, the urinary microbiome remains poorly understood. Although noninvasive voided urine specimens are convenient, contamination by urethral microbiota may confound understanding of the bladder microbiome. Herein we compared the voiding- versus catheterization-associated urine microbiome of healthy men and women. METHODS An asymptomatic, healthy cohort of 6 women and 14 men underwent midstream urine collection, followed by sterile catheterization of the bladder after bladder refilling. Urine samples underwent urine dipstick testing and conventional microscopy and urine cultures. Samples also underwent Illumina MiSeq-based 16S ribosomal RNA gene amplification and sequencing. RESULTS All organisms identified by urine culture were also identified by 16S amplification; however, next-generation sequencing (NGS) also detected bacteria not identified by cultivation. Lactobacillus and Streptococcus were the most abundant species. Abundances of the 9 predominant bacterial genera differed between the urethra and bladder. Voided and catheterized microbiomes share all dominant (>1%) genera and Operational Taxonomic Units but in similar or different proportions. Hence, urethra and bladder microbiomes do not differ in taxonomic composition, but rather in taxonomic structure. Women had higher abundance of Lactobacillus and Prevotella than men. CONCLUSION Our findings lend credence to the hypothesis that Lactobacilli are important members of the healthy urine microbiome. Our data also suggest that the microbiomes of the urethra and bladder differ from one another. In conclusion, urine collection method results in different 16S-based NGS data, likely due to the sensitivity of NGS methods enabling detection of urethral bacteria present in voided but not catheterized urine specimens.PURPOSE Pioglitazone, an antihyperglycemic drug, is widely used in diabetes mellitus patients with insulin resistance. Although pioglitazone is known to have a potential link to bladder cancer (BC), there have been contradictory results. This present study is designed to understand the regulatory mechanisms that drive the effects of pioglitazone on the bladder epithelial cells. METHODS Labeled liquid chromatography-tandem mass spectrometry-based proteomics profiling characterized the global proteomes of normal human bladder epithelial cells treated with or without pioglitazone. RESULTS This approach detected approximately 5,769 proteins in total. Of those 5,769 proteins, 124 were identified as being differentially expressed due to pioglitazone treatment. Further analysis identified 95 upregulated and 29 downregulated proteins (absolute log2 fold change >0.58 and P-value less then 0.05). The following functional gene enrichment analysis suggested that pioglitazone may be altering a few select biological processes, such as gene/chromatin silencing, by downregulating BMI1 (B lymphoma Mo-MLV insertion region 1 homolog), a polycomb complex protein. Further cell-based assays showed that cell adhesion molecules, epithelial-mesenchymal transition markers, and major signaling pathways were significantly downregulated by pioglitazone treatment. WAY-316606 clinical trial CONCLUSION These experimental results revealed the proteomic and biological alterations that occur in normal bladder cells in response to pioglitazone. These findings provided a landscape how bladder proteome is influenced by pioglitazone, which suggests the potential adverse effects of diabetes drugs and their links to bladder dysfunctions.PURPOSE To investigate the effect of dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, on inflammatory cytokines of urogenital tissue in a rat model of type 2 diabetes (T2DM) to infer pharmaceutical influence of dapagliflozin on genitourinary infection or inflammation. METHODS Study animals were divided into the following 4 groups of 10 animals each (1) the Otsuka Long-Evans Tokushima Fatty (OLETF)-DA group treated with dapagliflozin at 1.0 mg/kg/day, (2) the OLETF-VO group treated with voglibose at 0.6 mg/kg/day, (3) the control group (OLETF-CO) given water, and (4) the Long-Evans Tokushima Otsuka (LETO) rats were included as nondiabetic control group. Changes in blood glucose, 24-hour urine volume, and urine glucose were measured. The interleukin-1β (IL-1β) and interleukin-18 (IL-18) levels in the bladder and the urethra were quantified, respectively. RESULTS The urine glucose level and the 24-hour urine volume at 12 weeks of treatment were significantly higher in the OLETF-DA group than that in any other group (P less then 0.05). The cytokine analysis of the bladder and urethra showed higher IL18 and IL-1β in the OLETF-DA and the OLETF-CO groups than that in the OLETF-VO and LETO groups (P less then 0.05). The cytokine levels did not differ between the OLETF-DA and the OLETF-CO groups, and the level of IL-18 in the OLETF-DA group was higher in the urethra than in the bladder. CONCLUSION This study revealed that dapagliflozin increased the urine glucose concentration, resulting in an inflammatory response remain in the urogenital tract as the untreated diabetic rats. Therefore, when treating patients with T2DM with dapagliflozin, careful attention should be paid to genitourinary infection or inflammation.Increasingly many studies have presented robotic simple prostatectomy (RSP) as a surgical treatment option for large benign prostatic hyperplasia (BPH) weighing 80-100 g or more. In this review, some frequently used RSP techniques are described, along with an analysis of the literature on the efficacy and complications of RSP and differences in treatment results compared with other surgical methods. RSP has the advantage of a short learning curve for surgeons with experience in robotic surgery. Severe complications are rare in patients who undergo RSP, and RSP facilitates the simultaneous treatment of important comorbid diseases such as bladder stones and bladder diverticula. In conclusion, RSP can be recommended as a safe and effective minimally invasive treatment for large BPH.
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