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Sacituzumab govitecan (SG) is an antibody-drug conjugate (ADC) targeting TROP2, which has recently been approved for treatment-refractory metastatic urothelial cancer (UC). However, the variability of TROP2 expression across different bladder cancer (BC) subtypes, as well as after enfortumab vedotin (EV) exposure, remains unknown. Using gene expression data from four clinical cohorts with1400 patient samples of muscle-invasive BC and a BC tissue microarray, we found that TROP2 mRNA and protein are highly expressed across basal, luminal, and stroma-rich subtypes, but depleted in the neuroendocrine subtype. In addition, TROP2 mRNA levels are correlated with NECTIN4 mRNA but are more highly expressed than NECTIN4 mRNA in patient cohorts and BC cell lines. Moreover, CRISPR/Cas9-mediated knockdown of TROP2 demonstrates that its expression is one factor governing SG sensitivity. After prolonged EV exposure, cells can downregulate NECTIN4, leading to EV resistance, but retain TROP2 expression and remain sensitive to SG, suggesting nonoverlapping resistance mechanisms to these ADCs. While our findings warrant further validation, they have significant implications for biomarker development, patient selection, and treatment sequencing in the clinic as well as clinical trial design and stratification for metastatic BC patients. PATIENT SUMMARY: In this report, we investigated the expression levels of the drug target TROP2 across different molecular subtypes of bladder cancer in multiple patient cohorts and cell lines. We found high levels of TROP2 in most subtypes except in the neuroendocrine subtype. Overall, TROP2 gene expression is higher than NECTIN4 gene expression, and cells resistant to enfortumab vedotin (EV), a NECTIN4-targeting antibody-drug conjugate, remain sensitive to sacituzumab govitecan (SG). Our findings suggest that SG may be effective across most bladder cancer subtypes, including the bladder cancers previously treated with EV.

Introduction:Excessive trainee debt continues to be a problem. Little is known about how debt influences future practice decisions. We sought to examine the correlation between educational ...

Coronavirus disease (COVID-19) has profoundly impacted residency training and education. To date, there has not been any broad assessment of urological surgery residency changes and concerns during the COVID-19 pandemic.The Society of Academic Urologists distributed a questionnaire to urology residency program directors on March 30, 2020 exploring residency program changes related to the COVID-19 pandemic. Descriptive statistics are presented. A qualitative analysis of free response questions was undertaken. A post hoc analysis of differences related to local COVID-19 incidence is described.The survey was distributed to 144 residency programs with 65 responses for a 45% response rate. Reserve staffing had started in 80% of programs. Patient contact time had decreased significantly from 4.7 to 2.1 days per week (p0.001). Redeployment was reported by 26% of programs. Sixty percent of programs reported concern that residents will not meet case minimums due to COVID-19. Wellness activities centered on increased communication. All programs had begun to use videoconferencing and the majority planned to continue. Programs in states with a higher incidence of COVID-19 were more likely to report resident redeployment (48% vs 11%, p=0.002) and exposure to COVID-19 positive patients (70% vs 40%, p=0.03), and were less likely to report concerns regarding exposure (78% vs 97%, p=0.02) and personal protective equipment availability (62% vs 89%, p=0.02).As of April 1, 2020 the COVID-19 pandemic had resulted in significant changes in urology residency programs. These findings inform a rapidly changing landscape and aid in the development of best practices.

Objective To determine whether patient-reported health status, more so than comorbidity, influences treatment in men with localized prostate cancer. Methods Using Surveillance, Epidemiology, and End Results data linked with Medicare claims and CAHPS surveys, we identified men aged 65-84 diagnosed with localized prostate cancer from 2004 to 2013 and ascertained their National Cancer Institute (NCI) comorbidity score and patient-reported health status. Adjusting for demographics and cancer risk, we examined the relationship between these measures and treatment for the overall cohort, low-risk men aged 65-74, intermediate/high-risk men aged 65-74, and men aged 75-84. Results Among 2724 men, 43.0% rated their overall health as Excellent/Very Good, while 62.7% had a comorbidity score of 0. Beyond age and cancer risk, patient-reported health status was significantly associated with treatment. Compared to men reporting Excellent/Very Good health, men in Poor/Fair health less often received treatment (odds ratio [OR] 0.71, 95% confidence interval [CI] 0.56-0.90). Younger men with intermediate/high-risk cancer in Good (OR 0.60, 95% CI 0.41-0.88) or Fair/Poor (OR 0.49, 95% CI 0.30-0.79) health less often underwent prostatectomy vs radiation compared to men in Excellent/Very Good health. In contrast, men with NCI comorbidity score of 1 more often received treatment (OR 1.37, 95% CI 1.11-1.70) compared to men with NCI comorbidity score of 0. Conclusion Patient-reported health status drives treatment for prostate cancer in an appropriate direction whereas comorbidity has an inconsistent relationship. Greater understanding of this interplay between subjective and empiric assessments may facilitate more shared decision-making in prostate cancer care.

To analyze differences in length of stay, opioid use, and other perioperative outcomes in patients undergoing radical cystectomy with urinary diversion who received either liposomal bupivacaine (LB) or epidural analgesia.This was a single center, retrospective cohort study of patients undergoing open radical cystectomy with urinary diversion from 2015-2019 in the early recovery after surgery (ERAS) pathway. Patients received either LB or epidural catheter analgesia for post-operative pain control. LB was injected at the time of fascial closure to provide up to 72 hours of local analgesia. The primary outcome was post-operative length of stay. Secondary outcomes were post-operative opioid use, time to solid food, time to ambulation, and direct hospitalization costs. Multivariable Cox proportional hazards regression was used to determine associations between analgesia type and discharge.LB use was independently associated with shorter post-operative length of stay compared to epidural use (median (IQR) 4.9 days (3.9-5.8) vs 5.9 days (4.9-7.9), P.001), less total opioid use (mean 188.3 vs 612.2 OME, P.001), earlier diet advancement (mean 1.6 vs 2.4 days, P.001), and decreased overall direct costs ($23,188 vs $29,628, P.001). 45% of patients who received LB were opioid-free after surgery, none in the epidural group. On multivariable Cox proportional hazards regression modeling, LB use was independently associated with earlier discharge (HR 2.1, IQR 1.0-4.5).Use of LB in open radical cystectomy is associated with reduced LOS, less opioid exposure, and earlier diet advancement.

Objective: To assess the feasibility of enrollment and collecting PRO data as part of routine clinical urologic care for bladder and prostate cancer patients and examine overall patterns and racial variations in PRO use and symptom reports over time. Subjects/Patients and Methods: We recruited 76 patients (n=29 Black and n=47 White) with prostate or bladder cancer at a single, comprehensive cancer center. The majority of prostate cancer patients had intermediate risk (57%) disease and underwent either radiation or prostatectomy. Over half (58%) of bladder cancer patients had muscle invasive disease and underwent cystectomy. Patients were asked to complete PRO symptom surveys using their preferred mode [web- or phone-based interactive voice response (IVR)]. Symptom summary reports were shared with providers during visits. Surveys were completed at three time points and assessed urinary, sexual, gastrointestinal, anxiety/depression, and sleep symptoms. Feasibility of enrollment and survey completion were calculated, and linear mixed effects models estimated differences in outcomes by race and time. Results: 63% of study participants completed all PRO measures at all three time points. Black patients were more likely to select IVR as their survey mode (40% vs 13%, p

To explore the relationship between research time during urologic training and career academic success.We included urologists graduating residency between 2002 and 2008 from 36 programs affiliated with a top 50 hospital for urology as ranked by the United States News and World Report, and collected research time during residency, fellowship training, current appointment (private practice, assistant professor, associate professor, professor, chair), national institutes of health (NIH) grant accrual, NIH R01 grant accrual, and current H-index in Scopus database. Publication output during and after residency was identified through the PubMed database.In our cohort of 543 urologists, 66.3% of graduating trainees pursued private practice. Increasing residency research time was associated with increased publication count (P.001), pursuit of professor positions (P.001), and NIH funding (P.001). One year of dedicated research increased the odds of being in the top 10th percentile of publication output during residency (odds ratio [OR]: 5.7, 95% confidence interval [CI]: 2.7-12.1), pursuing a fellowship (OR: 2.0, 95% CI: 1.3-3.1), promotion to professor (OR: 4.9, 95% CI: 2.0-12.2), obtaining a NIH grant (OR: 6.2, 95% CI: 2.3-16.5), and decreased the odds of pursuing private practice (OR: 0.4, 95% CI: 0.3-0.6). As amount of time dedicated to research in urologic residency increased from 3-4 to 6-12 months, OR increased for career academic success metrics.Although a minority of trainees enter academics, dedicated time for research in urologic residency is associated with career academic success, with more research time associated with increased publication output, academic appointments, and grant funding.

Objective Financial toxicity (FT) has been defined as the patient-level impact of the costs of cancer care. Our objective was to better characterize FT among bladder cancer patients as well as oncologic, demographic and insurance characteristics related to FT. Methods We conducted a cross-sectional survey of the Bladder Cancer Advocacy Network Patient Survey Network using the validated COST (COmprehensive Score for financial Toxicity) questionnaire. Our primary outcome was relative degree of FT, with lower COST scores corresponding to worse FT. Wilcoxon rank sum tests and multiple regression were used to evaluate differences in demographic, diagnostic and treatment characteristics as they related to degree of FT. Results Among 226 patients, median age was 68 years with 64% male, 83% married, and 49% with Medicare with supplemental insurance. Respondents reported an average of 65 months since diagnosis, with 62% reporting noninvasive disease. Mean COST was 28.4 (range 0–44). On multivariable analysis, patients who were younger, with a household annual income less than $50,000, not retired, or with insurance that was neither Medicare nor employer paid were significantly more likely to have worse FT. A majority of respondents (63.5%) agreed or strongly agreed that they would be interested in discussing cost in the context of their treatment preferences, independent of COST score (P = 0.24). Conclusions A national cross-sectional survey demonstrated high prevalence of FT which was worse among younger patients with lower incomes, not retired, and without employer-paid or Medicare insurance. Most patients preferred to discuss treatment costs with their bladder cancer provider.

PURPOSE: The RAZOR (Randomized Open versus Robotic Cystectomy) trial revealed noninferior 2-year progression-free survival for robotic radical cystectomy. This update was performed with extended followup for 3 years to determine potential differences between the approaches. We also report 3-year overall survival and sought to identify factors predicting recurrence, and progression-free and overall survival. MATERIALS AND METHODS: We analyzed the per protocol population of 302 patients from the RAZOR study. Cumulative recurrence was estimated using nonbladder cancer death as the competing risk event and the Gray test was applied to assess significance in differences. Progression-free survival and overall survival were estimated by the Kaplan-Meier method and compared with the log rank test. Predictors of outcomes were determined by Cox proportional hazard analysis. RESULTS: Estimated progression-free survival at 36 months was 68.4% (95% CI 60.1–75.3) and 65.4% (95% CI 56.8–72.7) in the robotic and open groups, respectively (p=0.600). At 36 months overall survival was 73.9% (95% CI 65.5–80.5) and 68.5% (95% CI 59.8–75.7) in the robotic and open groups, respectively (p=0.334). There was no significant difference in the cumulative incidence rates of recurrence (p=0.802). Patient age greater than 70 years, poor performance status and major complications were significant predictors of 36-month progression-free survival. Stage and positive margins were significant predictors of recurrence, and progression-free and overall survival. Surgical approach was not a significant predictor of any outcome. CONCLUSIONS: This analysis showed no difference in recurrence, 3-year progression-free survival or 3-year overall survival for robotic vs open radical cystectomy. It provides important prospective data on the oncologic efficacy of robotic radical cystectomy and high level data for patient counseling.

Purpose: Costly surveillance and treatment of bladder cancer can lead to financial toxicity, a treatment related financial burden. Our objective was to define the prevalence of financial toxicity among patients with bladder cancer and identify delays in care and its effect on health related quality of life.Materials and Methods: We identified patients with bladder cancer in the University of North Carolina Health Registry/Cancer Survivorship Cohort. Financial toxicity was defined as agreement with having “to pay more for medical care than you can afford.” Health related quality of life was measured using general and cancer specific validated questionnaires. Statistical analyses were performed using the Fisher exact test and the Student t-test.Results: A total of 138 patients with bladder cancer were evaluated. Median age was 66.9 years, 75% of the patients were male and 89% were white. Of the participants 33 (24%) endorsed financial toxicity. Participants who were younger (p = 0.02), black (p = 0.01), rep...

Pressure on physicians to increase productivity is rising in parallel with administrative tasks, regulations, and the use of electronic health records (EHRs). Physician extenders and clinical pathways are already in use to increase productivity and reduce costs and burnout, but other strategies are required. We evaluated whether implementation of medical scribes in an academic urology clinic would affect productivity, revenue, and patient/provider satisfaction. Six academic urologists were assigned scribes for 1 clinic day per week for 3 months. Likert-type patient and provider surveys were developed to evaluate satisfaction with and without scribes. Matched clinic days in the year prior were used to evaluate changes in productivity and physician/hospital charges and revenue. After using scribes for 3 months, providers reported increased efficiency (p value = 0.03) and work satisfaction (p value = 0.03), while seeing a mean 2.15 more patients per session (+ 0.96 return visits, + 0.99 new patients, and + 0.22 procedures), contributing to an additional 2.6 wRVUs, $542 in physician charges, and $861 in hospital charges per clinic session. At a gross collection rate of 36%, actual combined revenue was + $506/session, representing a 26% increase in overall revenue. At a cost of $77/session, the net financial impact was + $429 per clinic session, resulting in a return-to-investment ratio greater than 6:1, while having no effect on patient satisfaction scores. Additionally, with scribes, clinic encounters were closed a mean 8.9 days earlier. Implementing medical scribes in academic urology practices may be useful in increasing productivity, revenue, and provider satisfaction, while maintaining high patient satisfaction.

Introduction In this study we holistically describe and characterize the current state of urology practice by evaluating compensation, workload and practice factors as they relate to our demographic makeup as a specialty. Methods We collaborated with the American Urological Association to query its domestic membership of practicing urologists regarding socioeconomic, workforce and quality of life issues. The survey consisted of 26 questions and took approximately 13 minutes to complete. A total of 733 responders had complete data for the factors statistically analyzed in the study. Results Mean yearly compensation for urologists surveyed was $404,755 and median compensation was $380,000 (IQR $300,000–480,000). Female respondents had a significantly lower median yearly compensation vs males ($318,422 vs $400,000) on univariate and multivariate analysis. Respondents reported a median of 60 work hours per week (IQR 50–60) and the median number of call days per month was 7 (IQR 5–10). Of the respondents 62% indicated that they use advanced practice providers in their practice. In addition, 30% reported employed status, 49% reported self-employed status and 21% reported academic status. Overall 20% of respondents plan to retire within 5 years and 40% within 10 years. Conclusions Higher income was associated with greater job satisfaction and hourly wage appeared to decrease at increased work hours per week. Several workplace and demographic factors drive compensation, number of hours worked per week, number of call days per month and job satisfaction.

Introduction Projections suggest a significant shortage of urologists coupled with an increasing burden of urological disease due to an aging population. To meet this need, urologists have increasingly partnered with advanced practice providers. However, to this point the advanced practice provider workforce has not been comprehensively evaluated. Understanding the impact of advanced practice providers on the urology workforce is essential to maximize collaborative care as we strive for value and quality in evolving delivery models. Methods A 29-item, web based survey was administered to advanced practice providers identified by the AUA (American Urological Association), UAPA (Urological Association of Physician Assistants) and SUNA (Society of Urologic Nurses and Associates), querying many aspects of their practice. Results A total of 296 advanced practice providers completed the survey. Advanced practice nurses comprised 62% of respondents while physician assistants comprised the remaining 38%. More than two-thirds of the respondents were female and median age was 46 years. Only 6% reported having participated in formal postgraduate urological training. Advanced practice providers were evenly divided between institutional and private practice settings, and overwhelmingly in urban or suburban environments. The majority of advanced practice providers practice in the ambulatory setting (74%) and characterize their practice as general urology (72%). Overall 81% reported performing procedures independently, with 63% performing some procedures considered to be of moderate or high complexity. Conclusions Advanced practice providers are active in the provision of urological care in many roles, including complex procedures. Given future workforce needs, advanced practice providers will likely assume additional responsibilities. As roles shift we must ensure we have the necessary educational and training opportunities to equip this vital part of our workforce.

INTRODUCTION AND OBJECTIVES:The advantage of health-related quality of life (HRQoL) in continent (C) urinary diversions (UD) over non-continent (NC) UD remains controversial. We compared outcomes b...

INTRODUCTION AND OBJECTIVES:Health-related quality of life (HRQoL) can be significantly affected following radical cystectomy (RC) and factors affecting it have not been well studied in this popula...

Objectives: To study the effect of lymph node dissection (LND) at the time of nephrectomy and tumor thrombectomy on oncological outcomes in patients with renal cell carcinoma (RCC) and tumor thrombus. Patients and methods: The records of 1,978 patients with RCC and tumor thrombus who underwent radical nephrectomy and tumor thrombectomy from 1985 to 2014 at 24 centers were analyzed. None of the patients had distant metastases. Extent and pathologic results of LND were compared with respect to cancer-specific survival (CSS). Multivariable Cox regression models were used to quantify the effect of multiple covariates. Results: LND was performed in 1,026 patients. In multivariable analysis, the presence of LN metastasis, the number of positive LNs, and LN density were independently associated with cancer-specific mortality (CSM). Clinical node-negative (cN-) disease was documented in 573 patients, 447 of them underwent LND with 43 cN- patients (9.6%) revealing positive LNs at pathology. LN positive cN- patients showed significantly better CSS when compared to LN positive cN+ patients. In multivariable analysis, positive cN status in LN positive patients was a significant predictor of CSM (HR, 2.923; P = 0.015). Conclusions: The number of positive nodes harvested during LND and LN density was strong prognostic indicators of CSS, while number of removed LNs did not have a significant effect on CSS. The rate of pN1 patients among clinically node-negative patients was relatively high, and LND in these patients suggested a survival benefit. However, only a randomized trial can determine the absolute benefit of LND in this setting. Copyright (C) 2018 Elsevier Inc. All rights reserved.

Context Gender-specific functional and health-related quality of life (HRQOL) outcomes following radical cystectomy (RC) for bladder cancer (BCa) remain unclear, with many studies excluding women from the study population. Objective To better characterize female-specific functional outcomes following RC and urinary diversion for BCa. Evidence acquisition We performed a critical review of PubMed/Medline and Embase in August 2015 according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. Outcomes of interest included urinary function (for orthotopic neobladder), sexual function, bowel function, and quality of life. Excluded were nonbladder malignancies, RCs performed for neurogenic bladder dysfunction, and patients with exposure to radiation therapy prior to surgery. Forty-five publications were selected for inclusion in this analysis. Evidence synthesis Included reports addressed urinary function (34 studies), sexual function (11 studies), and HRQOL (9 studies). All studies had a high risk of bias and ranged significantly in sample size, inclusion criteria, and follow-up time, precluding meaningful meta-analysis. Daytime incontinence approximated 20%, nighttime incontinence 20%, and hypercontinence 10–20%. Sexual function appeared to be better among those patients undergoing genitalia-sparing RC, but generally poor outcomes were noted among those undergoing routine RC. Only 40% of studies assessed sexual function using standardized instruments. HRQOL differences between diversion types appeared to be minimal, whereas comparisons with the general population revealed significant differences in emotional problems, role functioning, fatigue, and appetite. Conclusions Functional outcomes among women undergoing RC for BCa are poorly studied with limitations regarding use of validated questionnaires, heterogeneous patient populations, and small sample sizes. Collaborative efforts will be needed to better define functional outcomes among this poorly studied patient population. Patient summary We reviewed functional outcomes following cystectomy among women with bladder cancer. We found that urinary, sexual, and bowel function and quality of life are poorly studied among women, with function ranging significantly across studies.

Men with clinically localized prostate cancer face an archetypal "preference sensitive" treatment decision. A shared decision making process incorporating patient values and preferences is paramount. We evaluated the benefit of a novel decision making application, and investigated associations between patient preferences and treatment choice.We used a novel, web based application that provides education, preference measurement and personalized decision analysis for patients with newly diagnosed prostate cancer. Preferences are measured using conjoint analysis. The application ranks treatment options according to their "fit" (expected value) based on clinical factors and personal preferences, and serves as the basis for shared decision making during the consultation. We administered the decisional conflict scale before and after completion of the application. Additionally, we compared post-visit perceptions of shared decision making between a baseline "usual care" cohort and a cohort seen after the application was integrated into clinical practice.A total of 109 men completed the application before their consultation, and had decisional conflict measured before and after use. Overall decisional conflict decreased by 37% (p0.0001). Analysis of the decisional conflict subscales revealed statistically significant improvements in all 5 domains. Patients completing the decision making application (33) felt more included in (88% vs 57%, p=0.01) and jointly responsible for (94% vs 52%, p0.0001) the decision about further treatment compared to those receiving usual care (24). More patients who completed the application strongly agreed that different treatment options were discussed (94% vs 74%, p=0.02).Implementation of this web based intervention was associated with decreased decisional conflict and enhanced elements of shared decision making.

Introduction There is little information on job satisfaction in the extant literature in urology. The purpose of this study is to examine 1) the current state of job satisfaction among urologists in the United States, and 2) the demographic and work place factors that have the greatest influence on satisfaction. Methods We collaborated with AUA (American Urological Association) to query its domestic membership of practicing urologists regarding socioeconomic, work force and quality of life issues. A total of 848 responses were collected for a total response rate of 13%. Linear regression models were used to evaluate bivariable and multivariable associations with job satisfaction scores on a 1 to 5 scale. Results Of providers 70% reported being satisfied, 63% reported that they would choose medicine again and 83% would choose urology again. Age and job satisfaction did not demonstrate a linear association on statistical analysis but rather a U-shaped relationship. On bivariate analysis significant factors associated with higher job satisfaction included younger and older age, higher income (p = 0.047), fewer call days (p = 0.006), fellowship training (p = 0.006) and academic practice (overall p = 0.002). On multivariate analysis age (younger and older ages) and academic practice remained significant predictors of job satisfaction (p = 0.01) as did higher income (p = 0.038). Conclusions The current study helps describe the current state of job satisfaction among American urologists and examined work place factors that influence satisfaction. Income, hours worked, academic practice and age each have a significant impact on job satisfaction for the practicing urologist. Keeping abreast of the drivers of job satisfaction is critical to ensure that urologists continue to care for patients, perform research, educate future physicians and provide service to their communities.

Introduction: Computed tomography (CT) has limited diagnostic accuracy for staging of muscle-invasive bladder cancer (MIBC). [18F] Fluorodeoxyglucose positron emission tomography (FDG-PET)/magnetic resonance imaging (MRI) is a novel imaging modality incorporating functional imaging with improved soft tissue characterization. This pilot study evaluated the use of preoperative FDG-PET/MRI for staging of MIBC. Patients and Methods: Twenty-one patients with MIBC with planned radical cystectomy were enrolled. Two teams of radiologists reviewed FDG-PET/MRI scans to determine: (1) presence of primary bladder tumor; and (2) lymph node involvement and distant metastases. FDG-PET/MRI was compared with cystectomy pathology and computed tomography (CT). Results: Eighteen patients were included in the final analysis, most (72.2%) of whom received neoadjuvant chemotherapy. Final pathology revealed 10 (56%) patients with muscle invasion and only 3 (17%) patients with lymph node involvement. Clustered analysis of FDG-PET/MRI radiology team reads revealed a sensitivity of 0.80 and a specificity of 0.56 for detection of the primary tumor with a sensitivity of 0 and a specificity of 1.00 for detection of lymph node involvement when compared with cystectomy pathology. CT imaging demonstrated similar rates in evaluation of the primary tumor (sensitivity, 0.91; specificity, 0.43) and lymph node involvement (sensitivity, 0; specificity, 0.93) when compared with pathology. Conclusions: This pilot single-institution experience of FDG-PET/MRI for preoperative staging of MIBC performed similar to CT for the detection of the primary tumor; however, the determination of lymph node status was limited by few patients with true pathologic lymph node involvement. Further studies are needed to evaluate the potential role for FDG-PET/MRI in the staging of MIBC. © 2020 Elsevier Inc.In this pilot study, preoperative staging with [18F] fluorodeoxyglucose-positron emission tomography/magnetic resonance imaging in muscle-invasive bladder cancer detected the primary bladder tumor; however, the determination of lymph node status was limited by few patients with pathologic lymph node involvement. Additional studies are needed to evaluate the potential role for [18F] fluorodeoxyglucose-positron emission tomography/magnetic resonance imaging in the staging of bladder cancer.

Objective To present an evidence-based review of the perioperative management of the radical cystectomy (RC) patient in the context of a care redesign initiative. Methods A comprehensive review of the key factors associated with perioperative management of the RC patient was completed. PubMed, Medline, and the Cochrane databases were queried via a computerized search. Specific topics were reviewed within the scope of the three major phases of perioperative management: preoperative, intraoperative, and postoperative. Preference was given to evidence from prospective randomized trials, meta-analyses, and systematic reviews. Results Preoperative considerations to improve care in the RC patient should include multi-disciplinary medical optimization, patient education, and formal coordination of care. Efforts to mitigate the risk of malnutrition and reduce postoperative gastrointestinal complications may include carbohydrate loading, protein nutrition supplementation, and avoiding bowel preparation. Intraoperatively, a fluid and opioid sparing protocol may reduce fluid shifts and avoid complications from paralytic ileus. Finally, enhanced recovery protocols including novel medications, early feeding, and multi-modal analgesia approaches are associated with earlier postoperative convalescence. Conclusion RC is a complex and morbid procedure that may benefit from care redesign. Evidence based quality improvement is integral to this process. We hope that this review will help guide further improvement initiatives for RC.

Context Urine-based tumor markers are not routinely used in the diagnosis and surveillance of bladder cancer. The main limitation of urinary markers has been a lack of clarity regarding clinical benefit. Objective To review the indications for urinary marker use, barriers to marker utilization, and clinical trial designs for markers available for detection (hematuria populations) and surveillance (bladder cancer populations). The study aim was to facilitate an optimal trial design that could change clinical practice. Evidence acquisition A PubMed search was conducted on February 17, 2018, using the MeSH search terms “Urinary Bladder Neoplasms” [Mesh] AND “Biomarkers” [Mesh] AND “Urine” [Mesh] yielded 127 articles, of which only two also fulfilled the search term “Randomized Controlled Trial” [Publication Type]. Neither of these two articles examined clinical outcomes for patients but rather focused on the performance characteristics of the urinary marker. For the search terms “Hematuria” [Mesh] AND “Randomized Controlled Trial” [Publication Type] AND “Urinary Bladder Neoplasms” [Mesh] yielded 12 articles, none of which used randomization with the outcome of interest being a clinical endpoint. Evidence synthesis Several potential designs for urinary marker trials were developed for detection and surveillance of bladder cancer. A marker-based approach compared to usual care for evaluation of hematuria in a primary care setting could reduce unnecessary cystoscopy in patients with low risk and expedite care in patients with higher risk. For bladder cancer surveillance, marker-based approaches could reduce cystoscopy for patients with low-grade disease and potentially improve detection for patients with high risk. Conclusions Urinary markers are not currently routinely used owing to the absence of level 1 evidence supporting incorporation of urinary markers into protocols for detection or surveillance of bladder cancer. This review provides practical designs for studies that could demonstrate superiority of marker-based approaches over current clinical care. The sample sizes required for these studies are no greater than many of those accrued for previous urinary marker studies, but the proposed trial concepts require planning and a willingness to risk failure of the marker to demonstrate the desired benefits. Patient summary In this review we discuss current limitations in the use of urinary markers for detection and surveillance of bladder cancer. We identify potential studies that could demonstrate a clinical benefit of the use of markers in improving detection of bladder cancer by reducing evaluation of patients unlikely to have cancer or expediting identification of cancer. For surveillance, a marker trial could improve identification of bladder cancer or reduce cystoscopy in patients with low risk.

The purpose of the RAZOR (randomized open vs robotic cystectomy) study is to compare open radical cystectomy (ORC) vs robot-assisted RC (RARC), pelvic lymph node dissection (PLND) and urinary diversion for oncological outcomes, complications and health-related quality of life (HRQL) measures with a primary endpoint of 2-year progression-free survival (PFS). RAZOR is a multi-institutional, randomized, non-inferior, phase III trial that will enrol at least 320 patients with T1–T4, N0–N1, M0 bladder cancer with ≈160 patients in both the RARC and ORC arms at 15 participating institutions. Data will be collected prospectively at each institution for cancer outcomes, complications of surgery and HRQL measures, and then submitted to trial data management services Cancer Research and Biostatistics (CRAB) for final analyses. To date, 306 patients have been randomized and accrual to the RAZOR trial is expected to conclude in 2014. In this study, we report the RAZOR trial experimental design, objectives, data safety, and monitoring, and accrual update. The RAZOR trial is a landmark study in urological oncology, randomizing T1–T4, N0–N1, M0 patients with bladder cancer to ORC vs RARC, PLND and urinary diversion. RAZOR is a multi-institutional, non-inferiority trial evaluating cancer outcomes, surgical complications and HRQL measures of ORC vs RARC with a primary endpoint of 2-year PFS. Full data from the RAZOR trial are not expected until 2016–2017.

Patient selection and preoperative counseling are critical aspects of determining which urinary diversion to perform and should be emphasized at each stage of preoperative planning. The surgeon must have a thorough understanding of the patient's disease process, functional and psycho-emotional status, and social support network so that they can set appropriate expectations. It is also crucial to have a multidisciplinary team of individuals who are experienced with all aspects of urinary diversion care, including ostomy nurses, nurse navigators, and urologic surgeons skilled at teaching and trouble-shooting self-catheterization for continent cutaneous diversion and orthotopic diversion in the setting of hypercontinence.

We sought to investigate the prevalence and variables associated with early oncologic failure.We retrospectively reviewed the IRCC (International Radical Cystectomy Consortium) database of patients who underwent robot-assisted radical cystectomy since 2003. The final cohort comprised a total of 1,894 patients from 23 institutions in 11 countries. Early oncologic failure was defined as any disease relapse within 3 months of robot-assisted radical cystectomy. All institutions were surveyed for the pneumoperitoneum pressure used, breach of oncologic surgical principles, and techniques of specimen and lymph node removal. A multivariate model was fit to evaluate predictors of early oncologic failure. The Kaplan-Meier method was applied to depict disease specific and overall survival, and Cox proportional regression analysis was used to evaluate predictors of disease specific and overall survival.A total of 305 patients (22%) experienced disease relapse, which was distant in 220 (16%), local recurrence in 154 (11%), peritoneal carcinomatosis in 17 (1%) and port site recurrence in 5 (0.4%). Early oncologic failure developed in 71 patients (5%) at a total of 10 institutions. The incidence of early oncologic failure decreased from 10% in 2006 to 6% in 2015. On multivariate analysis the presence of any complication (OR 2.87, 95% CI 1.38-5.96, p = 0.004), pT3 or greater disease (OR 3.73, 95% CI 2.00-6.97, p0.001) and nodal involvement (OR 2.14, 95% CI 1.21-3.80, p = 0.008) was a significant predictor of early oncologic failure. Patients with early oncologic failure demonstrated worse disease specific and overall survival (23% and 13%, respectively) at 1 and 3 years compared to patients who experienced later or no recurrences (log rank p0.001).The incidence of early oncologic failure following robot-assisted radical cystectomy has decreased with time. Disease related rather than technical related factors have a major role in early oncologic failure after robot-assisted radical cystectomy.

Item does not contain fulltext Hexaminolevulinate (HAL) is a tumour photosensitizer that is used in combination with blue-light cystoscopy (BLC) as an adjunct to white-light cystoscopy (WLC) in the diagnosis and management of non-muscle-invasive bladder cancer (NMIBC). Since being licensed in Europe in 2005, HAL has been used in >200,000 procedures, with consistent evidence that it improves detection compared with WLC alone. Current data support an additional role in the reduction of recurrence of NMIBC. Since the approval of HAL by the FDA in 2010, experience of HAL-BLC in the USA continues to expand. To define areas of need and to identify the benefits of HAL-BLC in clinical practice, a focus group of expert urologists specializing in the management of patients with bladder cancer convened to review the clinical evidence, share their experiences and reach a consensus regarding the optimal use of HAL-BLC in the USA. The focus group concluded that HAL-BLC should be considered for initial assessment of NMIBC, surveillance for recurrent tumours, diagnosis in patients with positive urine cytology but negative WLC findings, and for tumour staging.

Objective To characterise the surgical feasibility and outcomes of robot-assisted radical cystectomy (RARC) for pathological T4 bladder cancer. Patients and Methods Retrospective evaluation of a prospectively maintained International Radical Cystectomy Consortium database was conducted for 1118 patients who underwent RARC between 2003 and 2012. We dichotomised patients based on pathological stage (≤pT3 vs pT4) and evaluated demographic, operative and pathological variables in relation to morbidity and mortality. Results In all, 1000 ≤pT3 and 118 pT4 patients were evaluated. The pT4 patients were older than the ≤pT3 patients (P = 0.001). The median operating time and blood loss were 386 min and 350 mL vs 396 min and 350 mL for p T4 and ≤pT3, respectively. The complication rate was similar (54% vs 58%; P = 0.64) among ≤pT3 and pT4 patients, respectively. The overall 30- and 90-day mortality rate was 0.4% and 1.8% vs 4.2% and 8.5% for ≤pT3 vs pT4 patients (P < 0.001), respectively. The body mass index (BMI), American Society of Anesthesiology score, length of hospital stay (LOS) >10 days, and 90-day readmission were significantly associated with complications in pT4 patients. Meanwhile, BMI, LOS >10 days, grade 3–5 complications, 90-day readmission, smoking, previous abdominal surgery and neoadjuvant chemotherapy were significantly associated with mortality in pT4 patients. On multivariate analysis, BMI was an independent predictor of complications in pT4 patients, but not for mortality. Conclusions RARC for pT4 bladder cancer is surgically feasible but entails significant morbidity and mortality. BMI was independent predictor of complications in pT4 patients.

Objective To elucidate whether metabolic syndrome (MS) has an effect on outcomes after nephrectomy, prostatectomy, or cystectomy. Methods Using the American College of Surgeons National Surgical Quality Improvement Program's database, patients undergoing cystectomy, nephrectomy, or prostatectomy between 2005 and 2011 were reviewed to assess for the presence of MS and a variety of perioperative complications. Results The overall complication rate for cystectomy, nephrectomy, and prostatectomy was 52.4%, 20.2%, and 8.7%, respectively. On multivariate analysis controlling for age, sex, body mass index, cardiac comorbidity, functional status, surgical approach (prostatectomy and nephrectomy), and surgery within 30 days, MS was not associated with perioperative complications in patients undergoing cystectomy (odds ratio [OR], 0.760; 95% confidence interval [CI], 0.476-1.213). On multivariate analysis, the presence of MS was a significant predictor of perioperative complications after radical nephrectomy (adjusted OR, 1.489; 95% CI, 1.146-1.934). With regards to prostatectomy, MS was not a significant predictor of complications (OR, 1.065; 95% CI, 0.739-1.535). Conclusion Patients in this cohort with MS undergoing cystectomy or prostatectomy did not experience a higher rate of complications compared with patients without MS, although patients with MS undergoing nephrectomy had a higher complication rate. It may be warranted to preoperatively counsel patients with MS undergoing nephrectomy that complication rates may be higher.

Objective To evaluate the association between patterns of care and patient survival for the treatment of muscle-invasive bladder cancer (MIBC) using a large, national database. Patients and Methods We identified a cohort of 36 469 patients with MIBC (stage II) from 1998 to 2010 from the National Cancer Data Base. Patients were stratified into four treatment groups: radical cystectomy, chemo-radiation, other therapy, or no treatment. Overall survival (OS) among the groups was evaluated using Kaplan–Meier analysis and the log rank test. A multivariable Cox proportional hazards model was fit to evaluate the association between treatment groups and OS. Results In all, 27% of patients received radical cystectomy, 10% chemo-radiation, 61% other therapy and 2% no treatment. Unadjusted Kaplan–Meier analysis showed significant differences by treatment group, with cystectomy having the greatest median OS (48 months) followed by chemo-radiation (28 months), other therapy (20 months), and no treatment (5 months). When controlling for multiple covariates, the OS for cystectomy was similar to that for chemo-radiation (hazard ratio [HR] 1.05, 95% confidence interval [CI] 0.98, 1.12), but superior to other therapy (HR 1.42; 95% CI 1.35, 1.48), and no treatment (HR 2.40; 95% CI 2.12, 2.72). The OS time for chemo-radiation was superior to other therapy and no treatment. Conclusions Radical cystectomy and chemo-radiation are significantly underused despite a substantial survival benefit compared with other therapies or no treatment. Future studies are needed to optimise care delivery and improve outcomes for patients with MIBC.

Objective To determine whether neoadjuvant chemotherapy (NAC) is a predictor of postoperative complications, length of stay (LOS), or operating time after radical cystectomy (RC) for bladder cancer. Patients and Methods A retrospective review of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database was performed to identify patients receiving NAC before RC from 2005 to 2011. Bivariable and multivariable analyses were used to determine whether NAC was associated with 30-day perioperative outcomes, e.g. complications, LOS, and operating time. Results Of the 878 patients who underwent RC for bladder cancer in our study, 78 (8.9%) received NAC. Excluding those patients who were ineligible for NAC due to renal insufficiency, 78/642 (12.1%) received NAC. In all, 457 of the 878 patients (52.1%) undergoing RC had at least one complication ≤30 days of RC, including 43 of 78 patients (55.1%) who received NAC and 414 of 800 patients (51.8%) who did not (P = 0.58). On multivariable logistic regression, NAC was not a predictor of complications (P = 0.87), re-operation (P = 0.16), wound infection (P = 0.32), or wound dehiscence (P = 0.32). Using multiple linear regression, NAC was not a predictor of increased operating time (P = 0.24), and patients undergoing NAC had a decreased LOS (P = 0.02). Conclusions Our study is the first large multi-institutional analysis specifically comparing complications after RC with and without NAC. Using a nationally validated, prospectively maintained database specifically designed to measure perioperative outcomes, we found no increase in perioperative complications or surgical morbidity with NAC. Considering these findings and the well-established overall survival benefit over surgery alone, efforts are needed to improve the uptake of NAC.

OBJECTIVE To define the relationship between urology relative value units (RVUs) and measures of surgical complexity and physician workload. Secondary objectives include: (1) identifying procedures with outlying RVU values for their measures of surgical complexity and workload; and (2) calculating projected RVU values for these procedures. METHODS We obtained surgical case data for 71 urology current procedural terminology (CPT) codes from the 2017 American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. Pearson correlation coefficients were calculated to measure the association between mean total work RVU and operative time, length of hospital stay, serious adverse events, readmissions, and mortality. We developed a multivariable regression model to predict mean total work RVU from these measures. Studentized residuals were used to identify outlying CPT codes for both bivariable and multivariable regression models, and empirically derived RVU values from complexity and work effort metrics were estimated. RESULTS We analyzed 71 urology CPT codes encompassing 55,068 cases. RVUs correlated well with median length of hospital stay (R = 0.81), median operative time (R = 0.92), serious adverse events (R = 0.83), and readmissions (R = 0.74). RVUs were poorly correlated with mortality (R = 0.34). Outlying procedures identified using the multivariable model were retroperitoneal lymph node dissection (projected +21.09 RVUs), laparoscopic ureteroneocystotomy (projected −12.34 RVUs), and cystectomy with bilateral pelvic lymphadenectomy (projected +9.37 RVUs). CONCLUSION Urology work RVUs correlate more with operative time than other measures of surgical complexity and physician workload. There exist several significant outlying procedures for various work measures. Incorporating objective work data may improve RVU assignments in the future.