In Gab Jeong

Purpose: To evaluate the pilot clinical feasibility of an automatic urinary suction device in mobility-limited older adults, focusing on usability, functional performance, and perceived safety, and a secondary exploratory assessment of agreement between device-collected and reference urine specimens.Methods: A 2-cohort clinical evaluation was conducted. The primary usability cohort assessed functional performance, perceived safety, and user satisfaction using structured 5-point Likert-scale questionnaires administered before and after device implementation. A secondary diagnostic cohort compared paired urine samples obtained using the automated suction device and standard-of-care reference urine collection methods to assess bacterial detection agreement, species concordance, and urine pH agreement. Paired statistical analyses with nonparametric sensitivity testing were used for usability outcomes, and diagnostic metrics were calculated with Wilson confidence intervals and Bland-Altman analysis.Results: Seven participants completed paired usability assessments. Significant improvements were observed in operation and functionality (2.97±0.52 vs. 3.83±0.18, P=0.007) and ease of use (2.14±0.48 vs. 3.71±0.39, P=0.001), suggesting improved practicality of urinary management. Scores in the infection/skin complication domain decreased significantly. Product safety and overall satisfaction showed favorable but nonsignificant trends. In a secondary exploratory diagnostic analysis of 12 paired urine samples, bacterial detection agreement was acceptable at the presence/absence level (sensitivity 80.0%, specificity 100.0%, accuracy 91.7%), whereas species-level concordance was limited (40.0%), indicating restricted microbiologic reliability. Urine pH showed close numerical agreement. However, these findings should be interpreted cautiously, as key preanalytical variables were not controlled, and therefore should be regarded as exploratory rather than confirmatory.Conclusions: This pilot study suggests that the automated urinary suction device may improve usability and functional handling in mobility-limited older adults. Skin-related findings remain preliminary, and the diagnostic applicability of device-collected urine should be interpreted cautiously pending further validation.

DNA methylation is one of the most extensively characterized epigenetic alterations in cancer and provides a biologically stable, analytically tractable foundation for biomarker development. In genitourinary (GU) oncology, the early occurrence, clonal maintenance, and chemical stability of aberrant cytosine-phosphate-guanine methylation enable reliable detection in tissue, urine, and plasma, supporting its use in liquid biopsybased diagnostics and surveillance. Recent advances have enabled clinical evaluation of DNA methylation assays across multiple GU malignancies. Among these, urothelial carcinoma has progressed furthest toward clinical translation: urine-based methylation tests have demonstrated high diagnostic accuracy and reproducibility and, in selected settings, have achieved regulatory approval or guideline incorporation for surveillance. In renal cell carcinoma, genome-wide plasma and urine methylome profiling has shown feasibility for early detection and prognostic stratification, although clinical implementation remains investigational. In prostate cancer, tissue-based methylation assays support repeat-biopsy decision-making, whereas urine- and plasma-based tests contribute to detection of clinically significant disease, molecular subtyping, and treatment-response monitoring. Despite strong analytical performance, broad clinical adoption of DNA methylation biomarkers remains constrained by limited prospective validation, interlaboratory variability, and incomplete evidence of cost-effectiveness in real-world care pathways. Economic modeling suggests that these assays could reduce invasive procedures and surveillance costs, but these findings require confirmation in prospective studies. Given the accessibility of urine as a noninvasive biospecimen and ongoing integration with machine-learning and multiomic frameworks, DNA methylation profiling is well positioned to complement conventional diagnostics and advance precision detection, surveillance, and prognostication in GU cancers.

Purpose: This study evaluated the feasibility of radical nephrectomy and thrombectomy without cardiopulmonary bypass (CPB) in patients with renal cell carcinoma (RCC) and level IV venous tumor thrombus, compared with CPB-assisted surgery.Materials and Methods: This retrospective cohort study analyzed patients with RCC and level IV venous tumor thrombus who underwent surgery at a single center between 2014 and 2020. Feasibility of non-CPB surgery was assessed by comparing perioperative safety-related outcomes, overall survival (OS), and progression-free survival (PFS) between the non-CPB and CPB groups. Perioperative outcomes included operative time, blood loss, severe complications (Clavien-Dindo classification grade ≥III), intensive care unit (ICU) stay, and mortality. Kaplan-Meier analysis and generalized Wilcoxon tests were used to compare survival outcomes.Results: A total of 16 patients met eligibility criteria: 5 underwent surgery without CPB, and 11 underwent CPB-assisted surgery. Median operative time was similar between the CPB and non-CPB groups (490 minutes vs. 480 minutes, p=0.650). Compared with the CPB group, blood loss was lower in the non-CPB group (4000 mL vs. 1080 mL, p=0.333). Severe complications occurred in 36.4% of CPB patients and 0% of non-CPB patients (p=0.245). ICU stay was comparable between the non-CPB and CPB groups (2 days vs. 3 days, p=0.356). OS did not differ significantly between groups (p=0.180), whereas PFS was longer in the non-CPB group (p=0.041).Conclusions: Radical nephrectomy and thrombectomy without CPB appears feasible and may be associated with lower perioperative morbidity and blood loss without compromising oncologic outcomes. Non-CPB surgery should be considered in selected patients with level IV venous tumor thrombus when technically feasible.

Objectives: To evaluate the efficacy and safety of a fixed‐dose combination (FDC) of dutasteride and tadalafil vs monotherapy in patients with benign prostatic hyperplasia (BPH). Patients and Methods: This phase III trial enrolled 667 patients. After screening and washout, eligible patients were stratified by the baseline International Prostate Symptom Score (IPSS) and randomised (1:1:1) to receive FDC dutasteride 0.5 mg/tadalafil 5 mg (FDC 0.5/5 mg), dutasteride 0.5 mg, or tadalafil 5 mg for 48 weeks. The primary endpoint was the change in total IPSS from baseline to Week 48. Efficacy and safety were assessed at 4, 12, 24, 36, and 48 weeks. Results: In total, 619 patients were analysed for efficacy. The least squares (LS) mean (standard error [ se] ) change in total IPSS at 48 weeks from baseline was −9.49 (0.37) for the FDC 0.5/5 mg group vs –4.40 (0.37) for dutasteride 0.5 mg group (LS mean difference [LSMD] –5.09, 95% confidence interval [CI] −6.13 to −4.50; P < 0.001), and −9.53 (0.36) for the FDC 0.5/5 mg group vs –4.24 (0.37) for tadalafil 5 mg group (LSMD –5.29, 95% CI −6.30 to −4.27; P < 0.001). The FDC 0.5/5 mg group demonstrated the most pronounced improvement in quality of life. Although the maximum urinary flow rate and post‐void residual volume improved in all groups, differences were not statistically significant. In the comparison between the FDC 0.5/5 mg and dutasteride 0.5 mg groups, the LSMD (95% CI) of change from baseline to Week 48 in the international index of erectile function ‐ erectile function (IIEF ‐ EF) total score was 4.03 (2.35 to –5.71) ( P < 0.05). Among the 655 patients analysed for safety, treatment‐emergent adverse events occurred in 32.88% (FDC 0.5/5 mg) vs 21.20% (dutasteride 0.5 mg) and 26.48% (tadalafil 5 mg), with few serious adverse events observed. Conclusions: The FDC 0.5/5 mg demonstrated superior efficacy, and an acceptable safety profile compared with dutasteride and tadalafil monotherapies in patients with BPH.

Lee HY, et al. Investig Clin Urol. 2026 Jan;67(1):15-23. https://doi.org/10.4111/icu.20250385

The methylated PENK gene is known to be highly expressed in the urine of patients with bladder cancer. Recent large-scale multicenter studies have confirmed the robust diagnostic performance of urinary PENK methylation, reporting high sensitivity and specificity for bladder cancer detection. However, its association with other cancers remains unclear. This prospective study aimed to determine the diagnostic accuracy of the urinary PENK methylation test for urothelial carcinoma among patients with 13 different cancer types. Between August 2022 and April 2023, 183 patients were enrolled, including 17 with urothelial carcinoma (eight bladder cancer and nine upper tract urothelial carcinoma) and 166 with other cancers. The urinary PENK methylation test showed an overall sensitivity of 94.1% (87.5% for bladder cancer and 100% for UTUC) and a specificity of 95.8% when patients with non-urothelial cancers were used as the control group. Positive urinary PENK methylation test was obtained for two patients with cervical cancer (25.0%), 2 with colorectal cancer (10.5%), and one patient each with esophageal (4.8%), liver (5.0%), and kidney (5.3%) cancer. These findings confirm the high sensitivity and specificity of the urinary PENK methylation test for detecting urothelial carcinoma and support its potential as a non-invasive biomarker.

Importance: An accurate noninvasive biomarker test is needed for the early diagnosis of bladder cancer.Objective: To evaluate the performance of a urinary DNA methylation test (PENK methylation) and compare its diagnostic accuracy with that of the nuclear matrix protein 22 (NMP22) test or urine cytology test.Design, Setting, and Participants: In this prospective multicenter study at 10 sites in the Republic of Korea, individuals 40 years and older with hematuria undergoing cystoscopy within 3 months between March 11, 2022, and May 30, 2024, participated. The study participants were evaluated for bladder cancer using a urinary DNA methylation test.Exposure: Urinary DNA methylation test, NMP22 test, and urine cytology test.Main Outcomes and Measures: The primary outcomes were the sensitivity and specificity of the urinary DNA methylation test for high-grade or invasive bladder cancer. Secondary objectives included the accuracy of the test for overall bladder cancer (all stages and grades) and the comparison of sensitivities and specificities for bladder cancer between the urinary DNA methylation test and the NMP22 test or urine cytology test.Results: Among the 1099 participants, 614 (55.9%) were male; participants had a mean (SD) age of 65 (10) years. Of the 1099 participants, 219 and 176 participants had bladder cancer and high-grade or invasive bladder cancer, respectively. The urinary DNA methylation test had sensitivity and specificity for high-grade or invasive bladder cancer of 89.2% (95% CI, 84.6%-93.8%) and 87.8% (95% CI, 85.6%-89.9%), respectively. Sensitivity and specificity for overall bladder cancer were 78.1% (95% CI, 72.6%-83.6%) and 88.8% (95% CI, 86.7%-90.8%), respectively. The positive predictive value for high-grade or invasive bladder cancer was 61.3% (95% CI, 55.4%-67.3%), and the negative predictive value was 97.6% (95% CI, 96.6%-98.7%). In comparison with the NMP22 test or urine cytology test, the urinary DNA methylation test showed significantly superior sensitivity for high-grade or invasive bladder cancer and overall bladder cancer.Conclusions and Relevance: In this prospective multicenter study of individuals with hematuria, the urinary DNA methylation test showed 89% sensitivity for detecting high-grade or invasive bladder cancer, outperforming the NMP22 test or urine cytology test with high specificity. While this test had an excellent negative predictive value, its positive predictive value was suboptimal.

Joung JY, et al. Investig Clin Urol. 2025 Sep;66(5):416-430. https://doi.org/10.4111/icu.20250147

Background: Diapers are commonly used by older patients with urination disorders. A smart diaper system (SDS) may be able to estimate the weight of urine comparably to conventional measurements made by weighing diapers. Objective: The aim of the current research is to determine the degree of accuracy of an SDS technology specifically designed for the management of urination routines and the use of incontinence pads in older adults. Methods: From January to December 2022, 97 older patients with at least 1 chronic disease from 3 nursing homes were included. In this study, the SDS was used for 1 month per patient after obtaining their consent; all patients originally used traditional diapers in the nursing home. The index test measured the change in electrical resistance of the SDS and the reference test measured the change in actual urine weight. When measuring the actual urine weight, the degree of absorption was directly confirmed with the naked eye because the expression value varied according to pressure changes caused by the user’s movement or position. The Pearson correlation was used to determine the correlation between the 2 test methods, the intraclass correlation coefficient (ICC) was used to check the degree of agreement between the evaluators, and the Bland-Altman test was used to confirm whether there was a significant difference between the 2 test methods. Results: The average age of the 97 participants was 86.48 (SD 6.26) years, with 10 men and 87 women. There were 73 patients (75%) with hypertension, 86 patients (88%) with dementia, and 86 patients (88%) with 2 or more comorbidities, accounting for the majority. The Pearson correlation coefficient and ICC were 0.971 and 0.985 (P<.001). In the Bland-Altman figure, the difference in the mean between the 2 tests was evenly scattered without showing a specific pattern, indicating that the SDS and actual urine weight were very consistent. The difference between the mean of the 2 tests was –0.045 of the standardized mean difference, and all measurements were located within the 95% CI, so this confirms that the 2 test methods are equivalent. Conclusions: Our study showed a fairly high correlation coefficient and ICC for all patient groups, which reveals that the 2 tests were very consistent and that the SDS can replace traditional diapers, even in a real clinical setting. This study shows the possibility that heath care professionals could be alerted by the SDS to the need for pad replacement due to incontinence, thus avoiding the development of dermatological complications.

Purpose Pathologic T3b (pT3b) prostate cancer, characterized by seminal vesicle invasion (SVI), exhibits variable oncological outcomes post–radical prostatectomy (RP). Identifying prognostic factors is crucial for patient-specific management. This study investigates the impact of bilateral SVI on prognosis in pT3b prostate cancer.Materials and Methods We evaluated the medical records of a multi-institutional cohort of men who underwent RP for prostate cancer with SVI between 2000 and 2012. Univariate and multivariable analyses were performed using Kaplan-Meier analysis and covariate-adjusted Cox proportional hazard regression for biochemical recurrence (BCR), clinical progression (CP), and cancer-specific survival (CSS).Results Among 770 men who underwent RP without neo-adjuvant treatment, median follow-up was 85.7 months. Patients with bilateral SVI had higher preoperative prostate-specific antigen levels and clinical T category (all p < 0.001). Extracapsular extension, tumor volume, lymph node metastasis (p < 0.001), pathologic Gleason grade group (p < 0.001), and resection margin positivity (p < 0.001) were also higher in patients with bilateral SVI. The 5-, 10-, and 15-year BCR-free survival rates were 23.9%, 11.7%, and 8.5%; CP-free survival rates were 82.8%, 62.5%, and 33.4%; and CSS rates were 96.4%, 88.1%, and 69.5%, respectively. The bilateral SVI group demonstrated significantly lower BCR-free survival rates, CP-free survival rates, and CSS rates (all p < 0.001). Bilateral SVI was independently associated with BCR (hazard ratio, 1.197; 95% confidence interval, p=0.049), CP (p=0.022), and CSS (p=0.038) in covariate-adjusted Cox regression.Conclusion Bilateral SVI is a robust, independent prognostic factor for poor oncological outcomes in pT3b prostate cancer.