Trend of ambulatory benign prostatic obstruction surgeries during COVID-19 pandemic.

INTRODUCTION: Benign prostatic obstruction (BPO) is one of the most common causes of male lower urinary tract symptoms. Some institutions routinely perform BPO surgeries in ambulatory setting, while others elect for overnight hospitalization. With the COVID-19 pandemic limiting resources and hospital space for elective surgery, we investigated the time trend of ambulatory BPO procedures performed around the COVID-19 outbreak. METHODS: We identified BPO surgeries from the California State Inpatient and State Ambulatory Surgery Databases between 2018 and 2020. Our primary outcome was the proportion of procedures performed in ambulatory settings with a length of stay of zero days. Univariable and multivariable analyses were performed to analyze factors associated with ambulatory surgery around the COVID-19 outbreak. Spline regression with a knot at the pandemic outbreak was performed to compare time trends pre- and post-pandemic. RESULTS: Among 37,148 patients who underwent BPO procedures, 30,067 (80.9%) were ambulatory. Before COVID-19, 80.1% BPO procedures were performed ambulatory, which increased to 83.4% after COVID-19 outbreak (p < 0.001). In multivariable model, BPO procedures performed after COVID-19 outbreak were 1.26 times more likely to be ambulatory (OR 1.26, 95% CI 1.14-1.40, p < 0.0001). Spline curve analysis indicated significantly different trend of change pre- and post-pandemic (p = 0.006). CONCLUSIONS: We observed a rising trend of BPO surgeries performed in ambulatory setting post-pandemic. It remains to be seen if the observed ambulatory transition remains as we continue to recover from the pandemic.

Evaluation of the new cobas® HCV genotyping test based on real-time PCRs of three different HCV genome regions.

BACKGROUND: Determination of the hepatitis C virus (HCV) genotype and discrimination between HCV subtypes 1a and 1b is still mandatory prior to anti-HCV treatment initiation. The aim of this study was to evaluate the performance of the recently introduced cobas® HCV GT assay (Roche) and to compare it to two comparator assays. METHODS: The cobas® HCV GT assay is based on primer-specific real-time polymerase chain reaction (PCR). For comparison, the TRUGENE® HCV 5'NC Genotyping Kit (Siemens) and the VERSANT® HCV Genotype 2.0 Assay (Siemens) were employed. Accuracy of the new assay was determined using proficiency panels. For clinical evaluation, 183 residual clinical samples obtained from patients with chronic hepatitis C infection were included. RESULTS: When accuracy was tested, panel members containing HCV subtypes 1a, 1b, and 3a were identified as expected; however, the new assay failed to identify low titer panel members containing HCV subtype 5a correctly. Of 183 clinical samples, 160 gave concordant results. For seven samples, an indeterminate result was reported with the cobas® HCV GT assay and the remaining 16 samples were found discordant with one of the comparator assays. When time-to-results of the assays were compared, the new assay showed shorter total time and similar hands-on time per sample. CONCLUSIONS: The cobas® HCV GT assay showed a good performance and proved to be suitable for use in the routine diagnostic laboratory. Due to the high level of automation, fast and reliable results are obtained with short hands-on time.

Real-World Safety of Prostate Cancer Focal Therapy: MAUDE Database Analysis.

Objective: The aim of this study was to assess the real-world safety profile of medical devices used in focal prostate cancer treatment utilizing the Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The MAUDE database was searched for reports on high-intensity focused ultrasound (HIFU), cryoablation, laser ablation, and irreversible electroporation (IRE) devices used in prostate cancer treatment from 1993 to 2023. Adverse events were identified and categorized. Results: We identified 175 reports for HIFU, 1362 for cryoablation, 615 for laser ablation, and 135 for IRE devices, with 28, 284, 126, and 2 respective reports, directly related to prostate cancer treatment. The aggregated data revealed the majority of complications were minor, with 82.5% (n = 363 out of 440 total complications) classified as Clavien-Dindo grade 1 or 2. Common minor complications included erectile dysfunction and urinary retention. Severe complications such as rectal fistulas were noted in HIFU and IRE treatments, along with singular mortality due to pulmonary embolism in cryoablation. Conclusions: Our analyses from MAUDE reveal that devices used in focal therapy for prostate cancer are predominantly associated with minor complications, underscoring their overall real-world safety profile. However, the occurrence of severe adverse events emphasizes the critical importance of rigorous patient selection and meticulous procedural planning. These findings provide valuable insights into the safety profile of focal therapy devices and contribute to the growing body of evidence on their use in prostate cancer treatment.

SGLT2 Inhibitor and Urinary Tract Infection in Men at Risk for Voiding Dysfunction: A VigiBase Analysis.

INTRODUCTION: We investigated the risk of UTIs and complex UTIs associated with SGLT2 (sodium-glucose cotransporter-2) inhibitors in men, emphasizing older men at higher risk for voiding dysfunction. METHODS: Utilizing a pharmacovigilance case-noncase design, we analyzed VigiBase reports from 1967 to 2022 among male patients. VigiBase is a comprehensive global database for drug safety. Disproportionality analysis, which compares the frequency of reported adverse events for specific drugs against other drugs, was conducted using reporting odds ratio (ROR) and empirical Bayes estimator (EBE). Age was stratified at 65 years as a threshold for increased susceptibility to male voiding dysfunctions. Sensitivity analyses were performed to compare SGLT2 inhibitor with other diabetes medications and years 2013 to 2022. RESULTS: There were 484 UTIs (ROR 6.75 [95% CI: 6.17-7.39]; EBE 6.78) and 165 complex UTIs (ROR 8.09 [95% CI: 6.94-9.43]; EBE 8.60). In men under 65, there were 178 UTIs (ROR 6.82 [95% CI: 5.88-7.91]; EBE 6.99) and 65 complex UTIs (ROR 7.30 [95% CI: 5.71-9.32]; EBE 7.90). In men 65 and over, we found 153 UTIs (ROR 5.11 [95% CI: 4.35-5.99]; EBE 5.44) and 59 complex UTIs (ROR 8.79 [95% CI: 6.79-11.37]; EBE 9.60). Sensitivity analyses consistently showed significant signals. CONCLUSIONS: This study suggests an elevated risk for both UTIs and complex UTIs in men taking SGLT2 inhibitors, with a more pronounced risk for complex UTI in older men who may have benign prostatic hyperplasia-related voiding dysfunction. These findings highlight the need for a balanced approach in prescribing SGLT2 inhibitors, particularly in populations potentially more susceptible to UTIs.

Identifying Barriers to Timely Follow-up After Elevated PSA Screening: A Retrospective Analysis of a Large Healthcare System.

OBJECTIVE: To examine elevated PSA follow-up within our system and identify areas for improvement in the timely diagnosis of prostate cancer. METHODS: We queried the Mass General Brigham's Enterprise Data Warehouse from 2018-2021, identifying patients with elevated PSA and documented time to follow-up. Timely follow-up was defined as having a urologist appointment, prostate biopsy, or prostate magnetic resonance imaging within 6 months from diagnosis. We stratified the location of elevated PSA diagnosis to academic medical centers versus community sites. Univariable and multivariable analyses were performed to identify factors impacting follow-up. RESULTS: We included 28,346 patients, with 50.30%, 15.02%, and 34.69% receiving timely, untimely, and no follow-up during the study period, respectively. In multivariable analysis, patients seen at academic medical centers were more likely to receive follow-up care (OR=1.39, 95%CI 1.30-1.48). In a sensitivity analysis including 2 of our largest community hospitals as part of academic medical facilities, those following up at our main sites showed even higher odds of timely follow-up (OR=1.61, 95%CI 1.51-1.73). CONCLUSION: Our study observed variations in follow-up rate between our academic medical centers and community sites. This finding highlights the need for efforts to improve consistency and timeliness of prostate cancer follow-up care across all facilities. By addressing interfacility disparities, we can facilitate the delivery of timely care to all patients.

Investigating the pattern of prostate specific antigen screening among E-cigarette smokers within the behavioral risk factor surveillance system.

INTRODUCTION AND OBJECTIVES: E-cigarettes use has recently increased, even among older individuals quitting smoking. Though past studies suggest tobacco smokers may avoid cancer screening, the relationship between e-cigarette uses and preventive health behaviors like prostate specific antigen screening is uncertain. We assessed the relationship between self-reported e-cigarette smoking and prostate specific antigen screening utilization among US adults with a history of e-cigarette use. MATERIALS AND METHODS: We included men aged 50-69 years, who provided responses regarding PSA screening receipt and smoking status, from Behavioral Risk Factor Surveillance System 2020 and 2022 surveys. Primary outcome was PSA screening receipt. Multivariable regression model was performed to investigate the association between smoking status (never-smokers, current or former e-cigarette smokers, current or former tobacco smokers) and PSA screening. RESULTS: We included a weighted population of 8.1 million men aged 50-69. 2.3 million (28.3%) received PSA screening. 3.9 million (48.2%) were never-smokers. 1.3 million (16.6%) were from e-cigarettes smokers group, and 2.9 million (35.2%) were from tobacco smokers group. E-cigarettes smokers were less likely to receive PSA screening within last 2 years (0.76 [0.66-0.88]) than never-smokers. No significant difference in PSA screening was detected between never-smokers and tobacco smokers (0.91 [0.82-1.02]). E-cigarette smokers were less likely to receive PSA screening within the selected time frame (0.84 [0.72-0.97]) than tobacco smokers. When examining potential mediation by primary care visits, e-cigarette smokers were less likely to have had a check-up visit in past 2 years than tobacco smokers (0.77 [0.65-0.92]). CONCLUSIONS: E-cigarette smokers were less likely to undergo PSA screening than never-smokers and tobacco smokers, possibly due to reduced use of primary care services.

Trends and Safety of Same-Day Discharge for Robot-Assisted Laparoscopic Prostatectomy: a Comparison between the Pre-Pandemic and Pandemic Periods from the National Cancer Database.

OBJECTIVE: To assess and compare the use of same-day discharge (SDD) for robot-assisted laparoscopic prostatectomy (RALP) between the "Pre-pandemic" and "Pandemic" periods and investigate SDD impact on mortality and readmissions. MATERIALS AND METHODS: We examined data from the National Cancer Database on men receiving RALP in the "Pre-pandemic" (2018-2019) and "Pandemic" (2020) periods. We analyzed the differences in patient and hospital characteristics between SDD and non-SDD patients. Multivariable logistic regression analysis was performed to evaluate the likelihood of SDD during "Pandemic" versus "Pre-pandemic" periods. Inverse probability treatment weighting (IPTW) was utilized to assess the impact of SDD on 30-day mortality, 90-day mortality, and 30-day readmissions, adjusting for patient and hospital characteristics. RESULTS: Out of 111,117 men, 8,997 (8%) received SDD. Patients with more comorbidities, non-private insurance, and high-risk prostate cancer reported lower SDD rates (p<0.001). Higher SDD rates were observed at academic facilities and those in the top RALP volume quartile (p<0.001). Patients who underwent RALP during the "Pandemic" period had increased odds of SDD compared to those receiving RALP in the "Pre-pandemic" period (aOR 1.37; 95%CI 1.31-1.45; p<0.001). When comparing SDD and non-SDD patient outcomes, after IPTW adjustment, there was no difference in the odds of 30-day mortality (aOR 0.98; 95%CI 0.47-2.01; p=0.95), 90-day mortality (aOR 1.09; 95%CI 0.60-1.97; p=0.76), or 30-day readmissions (aOR 0.90; 95%CI 0.76-1.06, p=0.21). CONCLUSION: SDD for RALP increased steadily after pandemic. Identifying factors and necessary resources to standardize SDD for RALP will be crucial for its widespread adoption in the coming years.

Charlson-Deyo Comorbidity Index as a Novel Predictor for Recurrence in Non-Muscle-Invasive Bladder Cancer.

PURPOSE: To test the association between the Charlson-Deyo Comorbidity Index (CCI) and the recurrence of non-muscle-invasive bladder cancer (NMIBC). METHODS: NMIBC (Ta, T1, TIS) patients who underwent transurethral resection of bladder tumor (TURB) between 2010 and 2018 were identified within a retrospective data repository of a large university hospital. Kaplan-Meier estimates and uni- and multivariable Cox regression models tested for differences in risk of recurrence according to low vs. high comorbidity burden (CCI ≤ 4 vs. >4) and continuously coded CCI. RESULTS: A total of 1072 NMIBC patients were identified. The median follow-up time of the study population was 55 months (IQR 29.6-79.0). Of all 1072 NMIBC patients, 423 (39%) harbored a low comorbidity burden vs. 649 (61%) with a high comorbidity burden. Overall, the rate of recurrence was 10% at the 12-month follow-up vs. 22% at the 72-month follow-up. In low vs. high comorbidity burden groups, rates of recurrence were 6 vs. 12% at 12 months and 18 vs. 25% at 72 months of follow-up (p = 0.02). After multivariable adjustment, a high comorbidity burden (CCI > 4) independently predicted a higher risk of recurrence (HR 1.42, 95% confidence interval (CI) 1.06-1.92, p = 0.018). After multivariable adjustment, the hazard of recurrence increased by 5% per each one-unit increase on the CCI scale (HR 1.05, 95% CI 1.00-1.10, p = 0.04). CONCLUSIONS: Comorbidities in NMIBC patients are common. Our data suggest that patients with higher CCI have an increased risk of BC recurrence. As a consequence, patients with a high comorbidity burden should be particularly encouraged to adhere to NMIBC guidelines and conform to follow-up protocols.

Combining targeted and systematic prostate biopsy improves prostate cancer detection and correlation with the whole mount histopathology in biopsy naïve and previous negative biopsy patients.

Objective: Guidelines for previous negative biopsy (PNB) cohorts with a suspicion of prostate cancer (PCa) after positive multiparametric (mp) magnetic-resonance-imaging (MRI) often favour the fusion-guided targeted prostate-biopsy (TB) only approach for Prostate Imaging-Reporting and Data System (PI-RADS) ≥3 lesions. However, recommendations lack direct biopsy performance comparison within biopsy naïve (BN) vs. PNB patients and its prognostication of the whole mount pathology report (WMPR), respectively. We suppose, that the combination of TB and concomitant TRUS-systematic biopsy (SB) improves the PCa detection rate of PI-RADS 2, 3, 4 or 5 lesions and the International Society of Urological Pathology (ISUP)-grade predictability of the WMPR in BN- and PNB patients. Methods: Patients with suspicious mpMRI, elevated prostate-specific-antigen and/or abnormal digital rectal examination were included. All PI-RADS reports were intramurally reviewed for biopsy planning. We compared the PI-RADS score substratified TB, SB or combined approach (TB/SB) associated BN- and PNB-PCa detection rate. Furthermore, we assessed the ISUP-grade variability between biopsy cores and the WMPR. Results: According to BN (n = 499) vs. PNB (n = 314) patients, clinically significant (cs) PCa was detected more frequently by the TB/SB approach (62 vs. 43%) than with the TB (54 vs. 34%) or SB (57 vs. 34%) (all p < 0.0001) alone. Furthermore, we observed that the TB/SB strategy detects a significantly higher number of csPCa within PI-RADS 3, 4 or 5 reports, both in BN and PNB men. In contrast, applied biopsy techniques were equally effective to detect csPCa within PI-RADS 2 lesions. In case of csPCa diagnosis the TB approach was more often false-negative in PNB patients (BN 11% vs. PNB 19%; p = 0.02). The TB/SB technique showed in general significantly less upgrading, whereas a higher agreement was only observed for the total and BN patient cohort. Conclusion: Despite csPCa is more frequently found in BN patients, the TB/SB method always detected a significantly higher number of csPCa within PI-RADS 3, 4 or 5 reports of our BN and PNB group. The TB/SB strategy predicts the ISUP-grade best in the total and BN cohort and in general shows the lowest upgrading rates, emphasizing its value not only in BN but also PNB patients.