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Surrogate endpoints (SEs), such as progression-free survival (PFS) and objective response rate (ORR), are frequently used in clinical trials. The relationship between SEs and overall survival (OS) has not been well described in metastatic urothelial cancer (MUC).We evaluated trial-level data to assess the relationship between SEs and OS. We hypothesize a moderate surrogacy relationship between both PFS and ORR with OS.We systematically reviewed phase 2/3 trials in MUC with two or more treatment arms, and report PFS and/or ORR, and OS.Linear regression was performed, and the coefficient of determination (ROf 3791 search results, 59 trials and 62 comparisons met the inclusion criteria. Of the 53 trials that reported PFS, 31 (58%) reported proportional hazard regression for PFS and OS. Linear regression across trials demonstrated an RPFS provides only a moderate level of surrogacy for OS; An HRWe examined the relationship between surrogate endpoints, common outcomes in clinical trials, with survival in urothelial cancer trials. Progression-free survival is moderately correlated, while objective response rate had a poor correlation with survival and should be de-emphasized as a primary endpoint.

BACKGROUND: Bladder cancer treatments may variably impact health-related quality of life (QOL). OBJECTIVE: To characterize the quality of life of patients with bladder cancer at various time points across the continuum of bladder cancer care from non-muscle-invasive disease to metastatic bladder cancer and develop utility scores to inform cost-effective analyses. METHODS: We performed a cross-sectional survey of bladder cancer patients in the Bladder Cancer Advocacy Network Patient Survey Network. Participants were classified into mutually exclusive health states based upon non-muscle invasive (NMIBC), muscle-invasive (MIBC), or metastatic bladder cancer and completed surveys of generic cancer and bladder cancer-specific quality of life, financial toxicity, and work impairment. We constructed generalized linear mixed models to identify patient, clinical, and treatment factors associated with quality of life over time and derived health state utilities. RESULTS: Among 911 self-identified patients with bladder cancer, overall QOL scores and function domains were worse among those with advanced cancer. Financial toxicity was similar among non-metastatic disease states. Work and activity impairment increased with advancing disease (13%and 12%among non-recurrent NMIBC to 63%and 31%for metastatic disease respectively; p

OBJECTIVE To convene a multi-disciplinary panel to develop a pathway for Emergency Department (ED) patients with suspected nephrolithiasis and then prospectively evaluate its effect on patient care. MATERIALS AND METHODS The STONE Pathway was developed and linked to order sets within our Electronic Health Record in April 2019. Records were prospectively reviewed for ED patients who underwent ultrasound or Computerized Tomography (CT) to evaluate suspected nephrolithiasis between January 2019 and August 2019 within our institution. The primary outcome measure was the proportion of patients whose ED CT was low dose (

The NCCN Guidelines for Kidney Cancer focus on the screening, diagnosis, staging, treatment, and management of renal cell carcinoma (RCC). Patients with relapsed or stage IV RCC typically undergo surgery and/or receive systemic therapy. Tumor histology and risk stratification of patients is important in therapy selection. The NCCN Guidelines for Kidney Cancer stratify treatment recommendations by histology; recommendations for first-line treatment of ccRCC are also stratified by risk group. To further guide management of advanced RCC, the NCCN Kidney Cancer Panel has categorized all systemic kidney cancer therapy regimens as “Preferred,” “Other Recommended Regimens,” or “Useful in Certain Circumstances.” This categorization provides guidance on treatment selection by considering the efficacy, safety, evidence, and other factors that play a role in treatment selection. These factors include pre-existing comorbidities, nature of the disease, and in some cases consideration of access to agents. This article summarizes surgical and systemic therapy recommendations for patients with relapsed or stage IV RCC.

BACKGROUND: US Black men are twice as likely to die from prostate cancer as men of other races. Lower quality care may contribute to this higher death rate. METHODS: Sociodemographic and clinical data were obtained for men in SEER-Medicare diagnosed with clinically localized prostate cancer (cT1–4N0/xM0/x) and managed primarily by radical prostatectomy (2005–2015). Surgical volume was determined for facility and surgeon. Relationships between race, surgeon/facility volume, and characteristics of treating facility with survival (all-cause and cancer-specific) were assessed using multivariable Cox regression and competing risk analysis. RESULTS: Black men represented 6.7% (n=2,123) of 31,478 cohort. They were younger at diagnosis, had longer time from diagnosis to surgery, lower socioeconomic status, higher PSA, and higher comorbid status compared with men of other races (p

Urologists frequently treat patients for tobacco-related conditions but infrequently engage in evidence-based practices (EBPs) that screen for and treat tobacco use. Improving the use of EBPs will help to identify smokers, promote cessation, and improve patients' health outcomes.A prospective type I hybrid effectiveness-implementation study was performed to test the feasibility and effectiveness of using a multilevel implementation strategy to improve the use of tobacco EBPs. All urology providers at outpatient urology clinics within the Veterans Health Administration Greater Los Angeles and all patients presenting for a new urology consultation were included. The primary outcome was whether a patient was screened for tobacco use at the time of consultation. Secondary outcomes included a patient's willingness to quit, chosen quit strategy, and subsequent engagement in quit attempts.In total, 5706 consecutive veterans were seen for a new consultation during the 30-month study period. Thirty-six percent of all visits were for a tobacco-related urologic diagnosis. The percentage of visits that included tobacco use screening increased from 18% (before implementation) to 57% in the implementation phase and to 60% during the maintenance phase. There was significant provider-level variation in adherence to screening. Of all screened patients, 38% were willing to quit, and most patients chose a "cold turkey" method; 22% of the patients elected referral to a formal smoking cessation clinic, and 24% chose telephone counseling. Among those willing to quit, 39% and 49% made a formal quit attempt by 3 and 6 months, respectively.A strategy that includes provider education and a customized clinical decision support tool can facilitate provider use of tobacco EBPs in a surgery subspecialty clinic.

Background Black men in the United States have markedly higher rates of prostate cancer than the general population. National guidelines for prostate-specific antigen (PSA) screening do not provide clear guidance for this high-risk population. The purpose of this study is to estimate the benefit and harm of intensified PSA screening in Black men. Methods Two microsimulation models of prostate cancer calibrated to incidence from the Surveillance, Epidemiology, and End Results program among Black men project the impact of different screening strategies (varying screening intervals, starting and stopping ages, and biopsy utilization following an abnormal PSA) on disease-specific mortality and overdiagnosis. Each strategy induces a mean lead time (MLT) for detected cases. A longer MLT reduces mortality according to estimates combining the US and European prostate cancer screening trials but increases overdiagnosis. Results Under historical population screening, Black men had similar MLT to men of all races and similar mortality reduction (range between models = 21%-24% vs 20%-24%) but a higher frequency of overdiagnosis (75-86 vs 58-60 per 1000 men). Screening Black men aged 40-84 years annually would increase both mortality reduction (29%-31%) and overdiagnosis (112-129 per 1000). Restricting screening to ages 45-69 years would still achieve substantial mortality reduction (26%-29%) with lower overdiagnosis (51-61 per 1000). Increasing biopsy utilization to 100% of abnormal tests would further reduce mortality but substantially increase overdiagnosis. Conclusions Annual screening in Black men is expected to reduce mortality more than that estimated under historical screening. Limiting screening to men younger than 70 years is expected to help reduce overdiagnosis.

Mutations in the BRCA1 and BRCA2 tumour suppressor genes are associated with prostate cancer risk; however, optimal screening protocols for individuals with these mutations have been a subject of debate. Several prospective studies of prostate cancer incidence and screening among BRCA1/2 mutation carriers have indicated at least a twofold to fourfold increase in prostate cancer risk among carriers of BRCA2 mutations compared with the general population. Moreover, BRCA2 mutations are associated with more aggressive, high-grade disease characteristics at diagnosis, more aggressive clinical behaviour and greater prostate cancer-specific mortality. The risk for BRCA1 mutations seems to be attenuated compared with BRCA2. Prostate-specific antigen (PSA) measurement or prostate magnetic resonance imaging (MRI) alone is an imperfect indicator of clinically significant prostate cancer; therefore, BRCA1/2 mutation carriers might benefit from refined risk stratification strategies. However, the long-term impact of prostate cancer screening is unknown, and the optimal management of BRCA1/2 carriers with prostate cancer has not been defined. Whether timely localized therapy can improve overall survival in the screened population is uncertain. Long-term results of prospective studies are awaited to confirm the optimal screening strategies and benefits of prostate cancer screening among BRCA1/2 mutation carriers, and whether these approaches ultimately have a positive impact on survival and quality of life in these patients.

Objectives For men with intermediate prostate-specific antigen (PSA) levels (4-10 ng/mL), urine-based biomarkers and multiparametric magnetic resonance imaging (MRI) are increasingly used as reflex tests before prostate biopsy. We assessed the cost effectiveness of these reflex tests in the United States. Methods We used an existing microsimulation model of prostate cancer (PCa) progression and survival to predict lifetime outcomes for a hypothetical cohort of 55-year-old men with intermediate PSA levels. Urine-based biomarkers—PCa antigen (PCA3), TMPRSS2:ERG gene fusion (T2:ERG), and the MyProstateScore (MPS) for any PCa and for high-grade (Gleason score ≥7) PCa (MPShg)—were generated using biomarker data from 1112 men presenting for biopsy at 10 United States institutions. MRI results were based on published sensitivity and specificity for high-grade PCa. Costs and utilities were sourced from literature and Medicare reimbursement schedules. Outcome measures included life years, quality-adjusted life years (QALYs), and lifetime medical costs per patient. Incremental cost-effectiveness ratios were empirically calculated on the basis of simulated life histories under different reflex testing strategies. Results Biopsying all men provided the most life years and QALYs, followed by reflex testing using MPShg, MPS, MRI, T2:ERG, PCA3, and biopsying no men (QALY range across strategies 15.98-16.09). Accounting for costs, MRI and MPShg were dominated by other strategies. PCA3, T2:ERG, and MPS were likely to be the most cost-effective strategy at willingness-to-pay thresholds of $100 000/QALY, $125 000/QALY, and $150 000/QALY, respectively. Conclusions Using PCA3, T2:ERG, or MPS as reflex tests has greater economic value than MRI, biopsying all men, or biopsying no men with intermediate PSA levels.

Objective To describe opioid prescribing patterns for patients undergoing kidney cancer surgery and evaluate associations with medical resource utilization in the postoperative setting. Methods Linked Surveillance, Epidemiology, and End Results - Medicare data were used to identify patients with kidney cancer who underwent partial or radical nephrectomy (open vs. minimally invasive) from 2007 to 2015. Total dose of discharge opioid prescriptions was quantified into 3 exposure groups based on observed tertiles: 1-199 (low), 200-300 (moderate), and >300 (high) oral morphine milligram equivalents. Associations between exposure groups and patient demographics, clinical factors, and hospital volumes were measured using multivariate logistic regression. Additionally, we identified associations with prior opioid exposure and postoperative medical resource utilization. Results Of 4538 patients meeting inclusion criteria, exposure group distributions were 35% (low), 43.5% (moderate) and 21.6% (high). Over one-third of patients (39.5%) received an opioid prescription within 6 months preceding surgery. High opioid prescriptions were associated with prior exposure, younger age, rural residence and open surgery (P Conclusion Prescribing patterns after kidney cancer surgery vary widely. Higher prescribed dose of post-surgical opioids is associated with 90-day hospital readmissions and long-term exposure. Prior opioid exposure conveys a higher risk of medical resource utilization. More judicious opioid prescribing may limit medical resource utilization and help combat the opioid epidemic.

Purpose New federal legislation in the United States grants patients expanded access to their medical records, making it critical that medical records information is understandable to patients. Provision of informational summaries significantly increase patient perceptions of patient-centered care and reduce feelings of uncertainty, yet their use for cancer pathology is limited. Methods Our team developed and piloted patient-centered versions of pathology reports (PCPRs) for four cancer organ sites: prostate, bladder, breast, and colorectal polyp. The objective of this analysis was to identify common barriers and facilitators to support dissemination of PCPRs in care delivery settings. We analyzed quantitative and qualitative data from pilot PCPR implementations, guided by the RE-AIM framework to explore constructs of reach, effectiveness, adoption, implementation, and maintenance. Results We present two case studies of PCPR implementation – breast cancer and colorectal polyps — that showcase diverse workflows for pathology reporting. Cross-pilot learnings emphasize the potential for PCPRs to improve patient satisfaction, knowledge, quality of shared decision-making activities, yet several barriers to dissemination exist. Conclusion While there is promise in expanding patient-centered cancer communication tools, more work is needed to expand the technological capacity for PCPRs and connect PCPRs to opportunities to reduce costs, improve quality, and reduce waste in care delivery systems.

IMPORTANCE: Genital gender-affirming surgery (GAS) is safe and offers substantial benefits to patients. Geographic accessibility and high out-of-pocket (OOP) costs reportedly hinder access; however, to date, this has not been thoroughly investigated at the national level. OBJECTIVE: To estimate OOP and total costs for GAS among commercially insured beneficiaries and assess whether costs differed between surgical procedures conducted in and outside the patient’s state of residence. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used previously collected insurance data from the MarketScan Commercial Database (129 million patients) from January 1, 2007, to December 31, 2019. Vaginoplasties and phalloplasties were identified using diagnosis and procedure codes among patients aged 18 to 64 years. Out-of-state surgical procedures were identified based on residence at enrollment and place of service of the surgery. Data analysis took place from July 1 to September 31, 2021. EXPOSURES: Vaginoplasty and phalloplasty. MAIN OUTCOMES AND MEASURES: The main outcomes were differences in OOP and total costs by out-of-state designation, census region, age, and insurance type for surgical procedures, estimated using multivariable linear regression models. RESULTS: The study included 771 patients who underwent GAS. A total of 609 underwent vaginoplasty, of whom 249 (41%) underwent surgery in their state of residence (mean [SD] age, 38.7 [13.1] years) and 340 (56%) underwent surgery outside their state (mean [SD] age, 38.1 [13.0] years), and 162 underwent phalloplasty, of whom 66 (41%) underwent surgery in their state of residence (mean [SD] age, of 39.7 [11.6] years) and 81 (50%) underwent surgery outside their state (mean [SD] age, 35.8 [10.9] years); 20 vaginoplasties (3%) and 15 phalloplasties (9%) could not be classified as in or out of state owing to missing data about the facility or residence. Procedures outside the state were associated with 49% (95% CI, 19%-85%) higher OOP costs compared with procedures done in the state of residence. CONCLUSIONS AND RELEVANCE: In this cross-sectional study, 56% of patients who underwent vaginoplasty and 50% of patients who underwent phalloplasty underwent the procedure outside their state of residence. Patients who underwent these procedures outside their state also experienced higher OOP costs than did those who underwent these procedures in their state. Improving geographic access and understanding patient preferences for surgical care may help reduce the cost burden for those planning to undergo GAS.

PURPOSE: Prior studies of mixed insurance populations have demonstrated poor adherence to surgical standard of care (SOC) for penile cancer. We used data from the Surveillance, Epidemiology and End Results (SEER) cancer registry linked to Medicare to calculate SOC adherence to surgical treatment of penile cancer in insured men over the age of 65, focusing on potential social and racial disparities. METHODS: This is an observational analysis of patients with T2–4 penile cancer of any histologic subtype without metastasis in the SEER-Medicare database (2004–2015). SOC was defined as penectomy (partial or radical) with bilateral inguinal lymph node dissection (ILND) based on the National Comprehensive Cancer Network guidelines. We calculated proportions of those receiving SOC and constructed multivariate models to identify factors associated with receiving SOC. RESULTS: A total of 447 men were included. Of these men, 22.1% (99/447) received SOC while 18.8% (84/447) received no treatment at all. Only 23.3% (104/447) had ILND while 80.9% (362/447) underwent total or partial penectomy. Race and socioeconomic status (SES) were not associated with decreased SOC. Increasing age (OR 0.93, 95%CI:0.89–0.96), Charlson Comorbidity Index score ≥ 2 (OR 0.53, 95%CI:0.29–0.97), and T3-T4 disease (OR 0.34, 95%CI:0.18–0.65) were associated with not receiving SOC on adjusted analysis. CONCLUSIONS: Rates of SOC are low among insured men 65 years of age or older with invasive penile cancer, regardless of race or SES. This finding is largely driven by low rates of ILND. Strategies are needed to overcome barriers to SOC treatment for men with invasive penile cancer.

Renal failure can be divided into acute kidney injury and chronic kidney disease. Both are common and result in increased patient morbidity and mortality. The etiology is multifactorial and differentiation of acute kidney injury from chronic kidney disease includes clinical evaluation, laboratory tests, and imaging. The main role of imaging is to detect treatable causes of renal failure such as ureteral obstruction or renovascular disease and to evaluate renal size and morphology. Ultrasound is the modality of choice for initial imaging, with duplex Doppler reserved for suspected renal artery stenosis or thrombosis. CT and MRI may be appropriate, particularly for urinary tract obstruction. However, the use of iodinated and gadolinium-based contrast should be evaluated critically depending on specific patient factors and cost-benefit ratio. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

BACKGROUND: The unique burden of treatment and survivorship of patients with bladder cancer can negatively impact caregiver experience and their use of supportive care resources. OBJECTIVE: To assess caregivers’ well-being and their perception of potential supportive resources. METHODS: In this cross-sectional survey, caregivers of patients with bladder cancer (N = 630) were recruited through the nationwide Bladder Cancer Advocacy Network Patient Survey Network. We used stakeholder-developed questionnaires to examine caregiver well-being (i.e., physical well-being, tiredness, fear, worry, sadness), the perceived helpfulness of potential resources (i.e., web-based and print-based information, specialized support, personal stories of other caregivers, phone-call and online chat with other caregivers), and influencing factors. RESULTS: Caregivers more frequently reported emotional well-being as a moderate to serious problem (67% for fear, 78% for worry, 66% for sadness) compared with physical well-being (30%) and tiredness (47%). Decreased well-being was associated with female gender of the caregiver, higher than high school education, or caring for a patient with advanced (versus non-invasive) bladder cancer. Of six potential resources, “web-based information” was perceived as “very helpful” among 79% of respondents, followed by “personal stories from other caregivers” (62%). Caregiver preferences for “web-based information” was not associated with any specific demographic or clinical factors. CONCLUSIONS: Caregivers reported moderate to serious problems with emotional and physical well-being. Web-based platforms were perceived as beneficial supportive resources for bladder cancer caregivers. Future intervention research should target the influencing factors identified in this study to optimize the health outcomes of caregivers and enhance the supportive care resources for improving their well-being.

Introduction:Low grade upper tract urothelial cancer is an uncommon urothelial tumor for which treatment involves multiple ureteroscopic interventions and potentially radical nephroureterec...

Objective For patients with a new cancer diagnosis, the pathology report is a critical tool to support diagnosis and decision-making, yet they are designed for providers, not patients. We sought to qualitatively explore patients’ experiences receiving and interpreting pathology reports for breast and colorectal cancers. Methods We conducted four focus groups with patients (n = 23) who had received diagnostic or surgical pathology reports for breast cancer, colorectal cancer or polypectomy. Focus groups discussed patients’ experiences with pathology reports and recommendations for improving the patient-centeredness of report design. Focus groups were transcribed and thematic analysis was used to explore patient perspectives. Results Participants described experiences with pathology reports that were fraught with confusion and variability. Three central themes were identified related to how 1) the experience receiving the pathology report, 2) the pathology report language, and 3) the format of pathology reports all influence patient understanding and ability to engage in treatment decision-making. Conclusion Due to their complex medical language and challenging framing, traditional pathology reports can contribute to the confusion and uncertainty patients experience as they navigate a new cancer diagnosis.

Cytoreductive nephrectomy (CN) for the treatment of metastatic renal cell carcinoma (mRCC) was called into question following the publication of the CARMENA trial. While previous retrospective studies have supported CN alongside targeted therapies, there is minimal research establishing its role in conjunction with immune checkpoint inhibitor (ICI) therapy.To evaluate the association between CN and oncological outcomes in patients with mRCC treated with immunotherapy.A multicenter retrospective cohort study of patients diagnosed with mRCC between 2000 and 2020 who were treated at the Seattle Cancer Care Alliance and The Ohio State University and who were treated with ICI systemic therapy (ST) at any point in their disease course. Overall survival (OS) was estimated using Kaplan Meier analyses. Multivariable Cox proportional hazards models evaluated associations with mortality.The study cohort consisted of 367 patients (CN+ST n = 232, ST alone n = 135). Among patients undergoing CN, 30 were deferred. Median survivor follow-up was 28.4 months. ICI therapy was first-line in 28.1%, second-line in 17.4%, and third or subsequent line (3L+) in 54.5% of patients. Overall, patients who underwent CN+ST had longer median OS (56.3 months IQR 50.2-79.8) compared to the ST alone group (19.1 months IQR 12.8-23.8). Multivariable analyses demonstrated a 67% reduction in risk of all-cause mortality in patients who received CN+ST vs. ST alone (P0.0001). Similar results were noted when first-line ICI therapy recipients were examined as a subgroup. Upfront and deferred CN did not demonstrate significant differences in OS.CN was independently associated with longer OS in patients with mRCC treated with ICI in any line of therapy. Our data support consideration of CN in well selected patients with mRCC undergoing treatment with ICI.

Research priorities are often set by expert clinicians and researchers. We sought to apply an established process in patient-centered research to engage survivors and their caregivers in prioritizing research topics in prostate cancer.A prostate cancer patient survey network, formed in partnership with Us TOO and the National Alliance of State Prostate Cancer Coalitions, engaged in a series of mixed-methods studies to prioritize comparative effectiveness research questions. This was accomplished through an iterative process that included 2 survey rounds and multidisciplinary working groups.There were 591 and 706 survey respondents in the first and second rounds, respectively, with most having had localized prostate cancer (58.1%). Survey participants represented 45 states in the U.S. Five of the top 11 prioritized research questions related to treatment decision making and/or survivorship care. The following had the highest overall importance ratings: What is the comparative effectiveness of different 1) strategies to improve counseling regarding the side effects of prostate cancer treatment, 2) tools for decision making in localized prostate cancer and 3) sequences of treatments for metastatic prostate cancer?We present a unique, patient-centered list of prioritized research questions among prostate cancer patients and their caregivers. These research questions may inform funding decisions for organizations that support research, and should be considered as priorities for clinicians, researchers and institutions conducting prostate cancer research. Prostate cancer is a common disease that affects 1 in 9 men over their lifetime. Researchers usually identify questions to study without asking men with prostate cancer. We asked survivors of prostate cancer and their caregivers to help us. They identified research questions and topics that are important to them. Researchers can focus on this list of questions to help men with prostate cancer. Groups who pay for research studies can make these questions their priority.

BACKGROUND Smoking, the most common risk factor for bladder cancer (BC), is associated with increased complications after radical cystectomy (RC), poorer oncologic outcomes, and higher mortality. The authors hypothesized that the effect of smoking on the probability of major complications increases with increasing age among patients who undergo RC. METHODS The authors analyzed the American College of Surgeons National Surgical Quality Improvement Program database (2011-2017), identified all patients undergoing RC using Current Procedural Terminology codes, and formed two groups according to smoking status (active smoker and nonsmoker [included former and never-smokers]). Patient characteristics and 30-day postoperative complications using the Clavien-Dindo Classification (CDC) were assessed. A multivariable logistic regression model was constructed that included age, sex, race, body mass index, operative time, comorbidities, chemotherapy status, and type of diversion with major complications (CDC ≥III) as the outcome variable, and explored the interaction between age and smoking status. RESULTS A total of 10,528 patients underwent RC, including 22.8% who were active smokers. The authors identified an interaction between age and smoking status (P = .045). Older patients were found to experience a stronger smoking effect than younger patients with regard to the probability of major complications. The risk of a major complication was the same for 50-year-old nonsmokers and smokers, but it increased from 17.8% to 21.7% for 70-year-old nonsmokers and smokers, respectively (P < .001). CONCLUSIONS Up to 20% of patients who undergo RC are active smokers, and these individuals have an increased risk of major complications. The effect of smoking is stronger with increasing age; the difference with regard to complications for smokers versus nonsmokers was found to increase substantially, wherein older smokers are at an especially high risk of complications.

Introduction:The overprescribing of opioids after urological surgery places patients at risk for opioid overuse and dependency. However, few guidelines exist to help urologists consistently...