Virtual reality as an adjunct to traditional patient counseling in patients with newly-diagnosed localized prostate cancer.

OBJECTIVES: To determine the utility of a virtual reality (VR) model constructed using patient-derived clinical imaging to improve patient understanding of localized prostate cancer (PCa) diagnosis and surgical plan. METHODS: Patients undergoing robotic radical prostatectomy were selected and demographic data recorded. Patients completed a questionnaire to assess baseline knowledge of their diagnosis after consultation and shared-decision making with their surgeon. A trained non-clinical staff member then guided the patient through a VR experience to view patient-specific anatomy in a 3-dimensional space. Patients then completed the same questionnaire, followed by an additional post-VR questionnaire evaluating patient satisfaction. Questions 1-7 (patient understanding of prostate cancer and treatment plan) and 11-17 (patient opinion of VR) used a standard Likert scale and Questions 8-10 were multiple choice with 1 correct answer. RESULTS: In total, 15 patients were included with an average age of 64.1 years. 6 of 7 questions showed an improvement after VR (p<0.001). The percentage of correct responses on Questions 8-10 were higher after VR but not statistically significant (p>0.13). Mean responses range from 4.3 to 4.8 (Likert scale, 1 through 5) for the post-VR questionnaire, with a mean total of 31.9 out of 35. CONCLUSION: This small preliminary investigation of a novel technology to improve the patient experience showed potential as an adjunct to traditional patient counseling. However, due the small sample size and study design, further research is needed to determine the value VR adds to prostate cancer surgical counselling.

Intravesical hexyl-aminolevulinate used to detect upper tract carcinoma in situ during surveillance ureteroscopy: A case report and review.

Blue-light cystoscopy with intravesical hexyl-aminolevulinate has been shown to improve identification of bladder carcinoma. The application of photodynamic techniques in the upper tract has not been well studied. We present a patient with a patulous ureteral orifice allowing for dwelling of photodynamic reagent and cystoscopic evaluation of the distal ureter. This case was significant for blue light fluorescent, biopsy proven upper tract carcinoma in situ that otherwise would have been a benign examination using traditional white light technique. Future work should be done to study the use of photodynamic techniques in the evaluation of upper tract malignancies.

Trifecta Outcomes After Use of 3-Dimensional Digital Models for Planning of Robotic Prostatectomy: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Planning complex operations such as robotic-assisted laparoscopic radical prostatectomy (RALP) requires surgeons to review 2-dimensional magnetic resonance imaging (MRI) scans to understand 3-dimensional (3D) patient anatomy. Three-dimensional digital models for planning RALP may allow better understanding of patient anatomy and may lead to better patient outcomes, although data are currently limited. Objective: To determine surgical outcomes after RALP when surgeons reviewed 3D digital models during operative planning. Design, Setting, and Participants: This study was a planned secondary analysis of a multicenter, single-blind, randomized clinical trial conducted at 6 large teaching hospitals in the US. The study was conducted between January 1, 2019, and December 31, 2022, and included patients undergoing RALP. Patients were assessed and recruited at the time of surgical consultation. Final data analysis was conducted between August and December 2023. Intervention: Patients were randomized to either a control group undergoing usual preoperative planning with prostate biopsy results and multiparametric MRI only or to an intervention group in which imaging and biopsy results were supplemented with a 3D digital model. This model was viewed on the surgeon's mobile phone in 3D format and picture-in-picture on the robotic console screen. Main Outcomes and Measures: The primary outcome measure for the overall study was oncologic outcomes after RALP, measured as prostate-specific antigen (PSA) detectability. Secondary outcomes were sexual function and urinary function, measured with Sexual Health Inventory for Men (SHIM) scores and rates of urinary incontinence, respectively, as well as use of salvage or adjuvant radiation therapy (RT) or androgen deprivation therapy (ADT). Trifecta outcomes were defined as undetectable PSA without RT or ADT, SHIM score categorically the same or greater than preoperatively, and complete continence. Univariate analysis was performed to compare outcomes between groups. Results: This trial included 92 patients undergoing RALP (51 in the control group and 41 in the intervention group). Their mean (SD) age was 62 (7.4) years; 10 patients (10.9%) were Black and 67 (72.8%) were White. At 18 months postsurgery, the intervention group had lower rates of biochemical recurrence (PSA level >0.1 ng/mL, 0 vs 7 [17.9%]; absolute difference, 17.9% [95% CI, 1.8% to 31.8%]; P = .01) and were significantly less likely to undergo adjuvant or salvage RT (1 [3.1%] vs 12 [31.6%]; absolute difference, 28.5% [95% CI, 10.1% to 46.7%]; P = .002) compared with the control group. Sexual function at 18 months postsurgery was significantly better in the intervention group (mean [SD] SHIM score, 16.8 [8.7] vs 9.8 [7.7]; absolute difference, 7.0 [95% CI, 2.6 to 11.4]; P = .002) and urinary function was unchanged (total continence, 22 [78.6%] vs 29 [80.6%]; absolute difference, 2.0% [95% CI, -17.9% to 21.9%]; P = .84) compared with the control group. Trifecta outcomes were achieved for 12 (48.0%) patients in the intervention group and 3 patients (10.0%) in the control group (absolute difference, 38.0% [95% CI, 14.4% to 61.6%]; P = .002). Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, patients whose surgical planning of RALP involved 3D digital models had better oncologic and functional outcomes. Further work should assess the effect of 3D models in a broader set of patients, physicians, and hospital settings. Trial Registration: ClinicalTrials.gov Identifier: NCT03943368.

Racial, ethnic, and socioeconomic disparities in rates of stage IV prostate cancer after USPSTF category "D" recommendation against prostate-specific antigen screening: a retrospective cohort study.

Background: In 2012 the United States Preventative Services Task Force (USPSTF) changed its prostate-specific antigen (PSA) screening recommendation to a category "D". The purpose of this study is to examine racial, ethnic, and socioeconomic differences in risk of presentation with metastatic prostate cancer (mPCa) at time of diagnosis before and after the 2012 USPSTF category "D" recommendation. Methods: This is a population-based cohort study. We identified patients with mPCa at diagnosis within the National Cancer Database from 2004-2017. Logistic regression models were used to examine associations of mPCa with age, race, ethnicity, geographic location, education level, income, and insurance status. Linear regression models assuming underlying binomial distribution were fitted to annual percentage of mPCa at diagnosis for years 2012-2017 to evaluate the post category "D" recommendation era. Results: From 2004 to 2017, 88,987 patients presented with mPCa. A higher percentage of mPCa was noted post-USPSTF category "D" recommendation, with a disproportionately greater increase observed among Hispanics and non-Hispanic Blacks [Δslope/year: Hispanics (0.0092), non-Hispanic Blacks (0.0073) and non-Hispanic Whites (0.0070)]. Insurance status impacts race/ethnicity differently: uninsured Hispanics were 3.66 times more likely to present with mPCa than insured Hispanics, while uninsured non-Hispanic Blacks were 2.62 times more likely to present with mPCa than insured non-Hispanic Blacks. Household income appears to be associated with differences in mPCa, particularly among non-Hispanic Blacks. Those earning <$30,000 were more likely to present with mPCa compared to higher income brackets. Conclusions: Since the USPSTF grade "D" recommendation against PSA screening, the percentage of mPCa at diagnosis has increased, with a higher rate of increase among Hispanic and non-Hispanic Blacks compared to non-Hispanic Whites.

Initial Experience With Inpatient Hospital Care at Home for Urologic Disease.

INTRODUCTION: In 2020, Mayo Clinic launched Advanced Care at Home (ACH), a hospital-at-home program that cares for high-acuity inpatients via remote monitoring and in-person care. Herein, we describe our initial experience utilizing ACH for patients with urologic problems. METHODS: We identified ACH patients treated at Mayo Clinic Florida from July 2020 to August 2022. Records were reviewed to identify those with urologic problems, defined as genitourinary infections, urinary tract obstruction, bleeding, or complications following urologic surgery within 90 days of admission. Demographics, Charlson Comorbidity Index, ACH interventions, length of stay, and hospital readmission were assessed. RESULTS: We identified 563 ACH admissions involving 537 patients, of whom 51 (9%) had illnesses with urologic etiology and 3 (0.6%) were admitted for nonurologic postoperative complications following urologic surgery. Admitting diagnoses included pyelonephritis (n = 51, 91%) and epididymoorchitis (n = 2, 4%). Postoperative diagnoses included cellulitis (n = 1, 2%), congestive heart failure (n = 1, 2%), and diverticulitis (n = 1, 2%). Median Charlson Comorbidity Index of admitted patients was 4 (interquartile range: 3-6.8). Twenty-five patients (46%) underwent 38 urologic procedures within 90 days of admission. Interventions included IV antibiotics (n = 51, 91%), IV fluids (n = 12, 21%), IV antifungals (n = 2, 4%), and oral diuretic therapy (n = 1, 2%). Median length of stay was 3 days (interquartile range: 2-4), and 9 patients (16%) were readmitted within 30 days. A total of 216 inpatient hospital days were saved by utilizing ACH. CONCLUSIONS: ACH appeared to be a feasible alternative to brick-and-mortar inpatient care for patients with genitourinary infections requiring IV antimicrobials.

Surgeons' dominant surgical modality: Impacts on wellbeing, burnout, and interventions for neuromusculoskeletal disorders.

BACKGROUND: This study investigated the impact of surgical modalities on surgeon wellbeing with a focus on burnout, job satisfaction, and interventions used to address neuromusculoskeletal disorders (NMSDs). METHODS: An electronic survey was sent to surgeons across an academic integrated multihospital system. The survey consisted of 47 questions investigating different aspects of surgeons' wellbeing. RESULTS: Out of 245 thoracic and abdominopelvic surgeons, 79 surgeons (32.2 â€‹%) responded, and 65 surgeons (82 â€‹%) were able to be categorized as having a dominant surgical modality. Compared to robotic surgeons, laparoscopic (p â€‹= â€‹0.042) and open (p â€‹= â€‹0.012) surgeons reported more frequent feelings of burnout. The number of surgeons who used any treatment/intervention to minimize the operative discomfort/pain was lower for robotic surgeons than the other three modalities (all p â€‹< â€‹0.05). CONCLUSIONS: NMSDs affect different aspects of surgeons' lives and occupations. Robotic surgery was associated with decreased feelings of burnout than the other modalities.

Creation of a Novel, Race-Adjusted, and Risk-Adapted Scoring System to Predict Positive Surgical Margins and Prolonged Operative Time During Robotic Radical Prostatectomy.

Objectives: To compare racial differences and pelvis dimensions between Caucasians and African Americans (AAs) and to develop a risk calculator and scoring system to predict the risk of prolonged operative time and presence of positive surgical margins (PSM) based on these dimensions. Materials and Methods: A retrospective review of 88 consecutive patients undergoing robot-assisted laparoscopic prostatectomy with a preoperative prostate MRI conducted. Data extraction included demographic, perioperative, and postoperative oncologic outcomes. Prostate-specific antigen (PSA) was obtained within 3 months postsurgery. Wilcoxon rank sum and Fisher's exact tests were used to compare continuous and categorical data, respectively. Single and multivariable regression analysis were used to determine contribution of each factor to the composite outcomes. A risk score was created based on this analysis for predicting the composite outcome. Results: We identified 88 consecutive patients with localized prostate cancer that underwent a preoperative prostate MRI. No statistically significant differences were found with respect to age, body mass index, or any postoperative outcome. PSA was lower at diagnosis (6.49 vs 9.72, p = 0.006) and operative times were shorter in Caucasians. Rates of PSM (13 vs 14, p = 0.35), biochemical recurrence (4 vs 2, p = 0.69), and complications did not vary between the groups. Caucasians had wider/shallower pelvis dimensions. Based on these variables, we found that the log (odds of OR time >3 hours or PSM) = -5.333 + 1.158 (if AA) +0.105 × PSA +0.076 × F -0.035 × G with an area under the receiver operating characteristic curve = 0.73. Using the predefined variables, patients can be risk stratified for PSM or prolonged operative times. Conclusions: Several pelvis dimensions were found to be shorter/narrower in AAs and were associated with longer operative times. The presented risk calculator and stratification system may be used to predict prolonged operative time or having PSM.

Novel laser therapies and new technologies in the endoscopic management of upper tract urothelial carcinoma: a narrative review.

Background and Objective: Upper tract urothelial carcinoma (UTUC) is a rare disease. The gold standard treatment is radical nephroureterectomy (RNU). Endoscopic management of UTUC has emerged as an alternative therapy that aims to preserve kidney function while providing effective oncologic control. Over the years, this has become an increasingly important alternative to RNU for treating UTUC in patients with localized disease. Advancements in lasers and endoscopic technology have continued to expand the applications of endoscopic nephron-sparing treatment. This review aims to provide an overview of the available lasers and ureteroscopic technologies used in treating UTUC with a focus on their clinical applications and outcomes. Methods: A comprehensive literature review was completed using PubMed to create this narrative mini review. Publications from peer-reviewed journals written in English between 1987 to 2022 were evaluated by the authors for inclusion. Key Content and Findings: Improvements in ureteroscopic technology have led to improved visualization and tumor detection. Laser ablation using different laser energies including the holmium/yttrium-aluminum-garnet, neodymium/YAG, and thulium/YAG has demonstrated promising oncologic outcomes. However, accurate staging and risk-stratification remain limitations to the role of laser ablation for the treatment of UTUC. This review also highlights appropriate patient selection as a critical component of successful endoscopic management. Conclusions: The continued evolution of endoscopic management will rely on the development of new technologies to improve risk stratification and oncologic outcomes. Overall, this review provides insights into the available laser therapies and ureteroscopic technologies for the endoscopic management of UTUC.

Impact of preferred surgical modality on surgeon wellness: a survey of workload, physical pain/discomfort, and neuromusculoskeletal disorders.

BACKGROUND: We compared surgeons' workload, physical discomfort, and neuromusculoskeletal disorders (NMSDs) across four surgical modalities: endoscopic, laparoscopic, open, and robot-assisted (da Vinci Surgical Systems). METHODS: An electronic survey was sent to the surgeons across an academic hospital system. The survey consisted of 47 questions including: (I) Demographics and anthropometrics; (II) The percentage of the procedural time that the surgeon spent on performing each surgical modality; (III) Physical and mental demand and physical discomfort; (IV) Neuromusculoskeletal symptoms including body part pain and NMSDs. RESULTS: Seventy-nine out of 245 surgeons completed the survey (32.2%) and 65 surgeons (82.2%) had a dominant surgical modality: 10 endoscopic, 15 laparoscopic, 26 open, and 14 robotic surgeons. Physical demand was the highest for open surgery and the lowest for endoscopic and robotic surgeries, (all p < 0.05). Open and robotic surgeries required the highest levels of mental workload followed by laparoscopic and endoscopic surgeries, respectively (all p < 0.05 except for the difference between robotic and laparoscopic that was not significant). Body part discomfort or pain (immediately after surgery) were lower in the shoulder for robotic surgeons compared to laparoscopic and open surgeons and in left fingers for robotic surgeons compared to endoscopic surgeons (all p < 0.05). The prevalence of NMSD was significantly lower in robotic surgeons (7%) compared to the other surgical modalities (between 60 and 67%) (all p < 0.05). CONCLUSIONS: The distribution of NMSDs, workload, and physical discomfort varied significantly based on preferred surgical approach. Although robotic surgeons had fewer overall complaints, improvement in ergonomics of surgery are still warranted.

Oncological outcomes of visibly complete transurethral resection prior to neoadjuvant chemotherapy for bladder cancer

ABSTRACT Purpose: To evaluate the potential oncologic benefit of a visibly complete transurethral resection of a bladder tumor (TURBT) prior to neoadjuvant chemotherapy (NAC) and radical cystectomy (RC). Materials and Methods: We identified patients who received NAC and RC between 2011-2021. Records were reviewed to assess TURBT completeness. The primary outcome was pathologic downstaging (<ypT2N0), with complete pathologic response (ypT0N0) and survival as secondary endpoints. Logistic regression and Cox proportional hazards models were utilized. Results: We identified 153 patients, including 116 (76%) with a complete TURBT. Sixty-four (42%) achieved <ypT2N0 and 43 (28%) achieved ypT0N0. When comparing those with and without a complete TURBT, there was no significant difference in the proportion with <ypT2N0 (43% vs 38%, P=0.57) or ypT0N0 (28% vs 27%, P=0.87). After median follow-up of 3.6 years (IQR 1.5-5.1), 86 patients died, 37 died from bladder cancer, and 61 had recurrence. We did not observe a statistically significant association of complete TURBT with cancer-specific or recurrence-free survival (p≥0.20), although the hazard of death from any cause was significantly higher among those with incomplete TURBT even after adjusting for ECOG and pathologic T stage, HR 1.77 (95% CI 1.04-3.00, P=.034). Conclusions: A visibly complete TURBT was not associated with pathologic downstaging, cancer-specific or recurrence-free survival following NAC and RC. These data do not support the need for repeat TURBT to achieve a visibly complete resection if NAC and RC are planned.

Oncological outcomes of visibly complete transurethral resection prior to neoadjuvant chemotherapy for bladder cancer.

PURPOSE: To evaluate the potential oncologic benefit of a visibly complete transurethral resection of a bladder tumor (TURBT) prior to neoadjuvant chemotherapy (NAC) and radical cystectomy (RC). MATERIALS AND METHODS: We identified patients who received NAC and RC between 2011-2021. Records were reviewed to assess TURBT completeness. The primary outcome was pathologic downstaging (

Single-port robot-assisted perineal radical prostatectomy with the da Vinci XI system: initial experience and learning curve using the cumulative sum method.

BACKGROUND: To evaluate the early functional and oncological outcomes of single-port robot-assisted perineal radical prostatectomy (sp-pRARP) using the da Vinci XI system and analyze its learning curve using the cumulative sum (CUSUM) method. METHODS: The clinical data of 50 patients who underwent sp-pRARP for localized prostate cancer between May 2020 and May 2022 in our center by a single surgeon were analyzed retrospectively. Demographic information, preoperative and postoperative variables, complications, early functional and oncological outcomes of patients were recorded. The CUSUM method was used to illustrate the learning curve based on operation time. RESULTS: All surgeries were completed without conversion. The median (interquartile range, IQR) operation time was 205.0 (82.5) min, whereas the median (IQR) docking time was 30.0 (15.0) min and the console time was 120.0 (80.5) min. The median (IQR) estimated blood loss (EBL) was 50.0 (137.5) mL. Positive surgical margins were detected in five patients (10.0%). The continence rate was 40.9%, 63.6%, 88.4%, and 97.7% at the 1, 3, 6, and 12 months after surgery. According to the CUSUM plot, the inflection points of the learning curve were 20 cases, splitting the case series into "early phase" and "late phase." In "late phase" cases, there was less time spent on each step of the operation and less EBL. CONCLUSIONS: Sp-pRARP using the da Vinci XI system was verified to be a feasible and reliable surgical approach. According to the CUSUM plot, 20 cases was considered the turning point for surgeons to master the novel technique.

Analysis of fixed and variable operating room (or) time point efficiency in partial nephrectomies: open versus robotic-assisted.

To analyze operating room (OR) efficiency by evaluating fixed and variable OR times for open (OPN) and robotic-assisted partial nephrectomies (RAPN). We analyzed consecutive OPN and RAPN performed by one surgeon over a 24-month period. All patients were placed in the lateral decubitus position and secured with a beanbag regardless of approach. Fixed (non-procedural) OR times were prospectively collected and defined as: in-room to anesthesia-release time (IRAT), anesthesia release to cut time (ARCT), and close to wheels-out time (CTWO). Variable OR time was procedural cut to close time (CTCT). Comparisons of fixed and variable OR time points between OPN and RAPN were performed using the Wilcoxon rank-sum test. 146 RAPN and 31 OPN were evaluated from 2019-2020. Median IRAT was similar for RAPN versus OPN [20 min (IQR: 16-25) vs. 20 min (IQR: 16-26), P = 0.57]. Median ARCT was longer for RAPN than it was for OPN [40 min (IQR: 36-46) vs. 34 min (IQR: 30-39), P < 0.001]. Median CTWO was similar for OPN (12 min, IQR: 9-14) and RAPN (11 min, IQR: 7-15) (P = 0.89). Median CTCT was longer for RAPN (202 min, IQR: 170-236) compared to OPN (164 min, IQR: 154-184) (P < 0.001). In a single surgeon, partial nephrectomy series with the same patient positioning, utilization of robotic technology was associated with longer surgeon operating time as well as less efficient fixed OR times, specifically ARCT.

Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report.

PURPOSE: Our goal was to evaluate long-term safety and durability of response to UGN-101, a mitomycin-containing reverse thermal gel, as primary chemoablative treatment for low-grade upper tract urothelial carcinoma. MATERIALS AND METHODS: In this open-label, single-arm, multicenter, phase 3 trial (NCT02793128), patients ≥18 years of age with primary or recurrent biopsy-proven low-grade upper tract urothelial carcinoma received 6 once-weekly instillations of UGN-101 via retrograde catheter to the renal pelvis and calyces. Those with complete response (defined as negative ureteroscopic evaluation, negative cytology and negative for-cause biopsy) 4-6 weeks after the last instillation were eligible for up to 11 monthly maintenance instillations and were followed for ≥12 months with quarterly evaluation of response durability. Durability of complete response was determined by ureteroscopic evaluation; duration of response was estimated by the Kaplan-Meier method. Treatment-emergent adverse events (TEAEs) were monitored. RESULTS: Of 71 patients who initiated treatment, 41 (58%) had complete response to induction therapy and consented to long-term followup; 23/41 patients (56%) remained in complete response after 12 months (95% CI 40, 72), comprising 6/12 (50%) who did not receive any maintenance instillations and 17/29 (59%) who received ≥1 maintenance instillation. Kaplan-Meier analysis of durability was estimated as 82% (95% CI 66, 91) at 12 months. Ureteric stenosis was the most frequently reported TEAE (31/71, 44%); an increasing number of instillations appeared to be associated with increased incidence of urinary TEAEs. CONCLUSIONS: Durability of response to UGN-101 with or without maintenance treatment is clinically meaningful, offering a kidney-sparing therapeutic alternative for patients with low-grade disease.

Long-term Success With Diminished Opioid Prescribing After Implementation of Standardized Postoperative Opioid Prescribing Guidelines: An Interrupted Time Series Analysis.

OBJECTIVE: To assess longitudinal prescribing patterns for patients undergoing urologic surgery in the nearly 2-year time frame before and after implementation of an evidence-based opioid prescribing guideline to accurately characterize the impact on postoperative departmental practices. PATIENTS AND METHODS: Historical prescribing data for adults who underwent 21 urologic procedures at 3 academic institutions were used to derive a 4-tiered guideline for postoperative opioid prescribing. The guideline was implemented on January 16, 2018, and prescribing patterns including quantity of opioids prescribed (in oral morphine equivalents [OMEs]) and refill rates were compared for opioid-naïve patients undergoing urologic surgery before (January 1, 2016, through January 15, 2018; N=10,649) and after (January 16, 2018, through September 30, 2019; N=9422) guideline implementation. Univariate analysis was performed using Wilcoxon rank sum and χ2 tests. Cochran-Armitage trend tests and interrupted time series analysis were used to test for significance in the change in OMEs prescribed before vs after guideline implementation. RESULTS: The median quantity of opioids decreased from 150 OMEs (interquartile range, 0-225) before guideline implementation to 0 OMEs (interquartile range, 0-90) after guideline implementation (P<.001). Median OMEs decreased significantly in each tier and each of 21 individual procedures. Overall guideline adherence was 90.7% (n=8547). Despite this decrease in OMEs prescribed, post-guideline implementation patients obtained fewer refills than the pre-guideline implementation group (614 [6.5%] vs 999 [9.4%]; P<.001). CONCLUSION: In a multi-institutional follow-up prospective study of adult urologic surgery-specific evidence-based guidelines for postoperative prescribing, we demonstrate sustained reduction in OMEs prescribed secondary to guideline implementation and adherence by our providers.

Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial.

BACKGROUND: Most patients with low-grade upper tract urothelial cancer are treated by radical nephroureterectomy. We aimed to assess the safety and activity of a non-surgical treatment using instillation of UGN-101, a mitomycin-containing reverse thermal gel. METHODS: In this open-label, single-arm, phase 3 trial, participants were recruited from 24 academic sites in the USA and Israel. Patients (aged ≥18 years) with primary or recurrent biopsy-proven, low-grade upper tract urothelial cancer (measuring 5-15 mm in maximum diameter) and an Eastern Cooperative Oncology Group performance status score of less than 3 (Karnofsky Performance Status score >40) were registered to receive six instillations of once-weekly UGN-101 (mitomycin 4 mg per mL; dosed according to volume of patient's renal pelvis and calyces, maximum 60 mg per instillation) via retrograde catheter to the renal pelvis and calyces. All patients had a planned primary disease evaluation 4-6 weeks after the completion of initial therapy, in which the primary outcome of complete response was assessed, defined as negative 3-month ureteroscopic evaluation, negative cytology, and negative for-cause biopsy. Activity (complete response, expected to occur in >15% of patients) and safety were assessed by the investigator in all patients who received at least one dose of UGN-101. Data presented are from the data cutoff on May 22, 2019. This study is registered with ClinicalTrials.gov, NCT02793128. FINDINGS: Between April 6, 2017, and Nov 26, 2018, 71 (96%) of 74 enrolled patients received at least one dose of UGN-101. 42 (59%, 95% CI 47-71; p<0·0001) patients had a complete response at the primary disease evaluation visit. The median follow-up for patients with a complete response was 11·0 months (IQR 5·1-12·4). The most frequently reported all-cause adverse events were ureteric stenosis in 31 (44%) of 71 patients, urinary tract infection in 23 (32%), haematuria in 22 (31%), flank pain in 21 (30%), and nausea in 17 (24%). 19 (27%) of 71 patients had study drug-related or procedure-related serious adverse events. No deaths were regarded as related to treatment. INTERPRETATION: Primary chemoablation of low-grade upper tract urothelial cancer with intracavitary UGN-101 results in clinically significant disease eradication and might offer a kidney-sparing treatment alternative for these patients. FUNDING: UroGen Pharma.

Comparison of prescribing patterns before and after implementation of evidence-based opioid prescribing guidelines for the postoperative urologic surgery patient.

BACKGROUND: We developed evidence-based guidelines for postoperative opioid prescribing after urologic surgery and assessed changes in prescribing after implementation. METHODS: Prescribing data for adults who underwent 21 urologic procedures were used to derive a four-tiered guideline for postoperative opioid prescribing. This was implemented on January 1, 2018, and prescribing patterns including quantity of opioids prescribed (oral morphine equivalents; OME) and refill rates were compared between patients undergoing surgery prior to (January-April, 2017; n equals 1732) and after (January-April, 2018; n equals1376) implementation. RESULTS: The median OME (IQR) prescribed was significantly lower for 2018 compared with 2017 [100 (0; 175) versus 150 (60; 225); p < .0001]. The median prescribed OME decreased in 14/21 procedures (67%). The refill rates did not significantly change. Guideline adherence rates after implementation, based on individual procedures, ranged from 33 to 95%. CONCLUSIONS: Fewer opioids were prescribed after implementing a prescribing guideline. Additional study is required to assess patient opioid utilization.

Wide Variation in Opioid Prescribing After Urological Surgery in Tertiary Care Centers.

OBJECTIVE: To describe postoperative opioid prescribing practices in a large cohort of patients undergoing urological surgery. PATIENTS AND METHODS: We identified 11,829 patients who underwent 21 urological surgical procedures at 3 associated facilities from January 1, 2015, through December 31, 2016. After converting opioids to oral morphine equivalents (OMEs), prescribing patterns were compared within and across procedures. Subgroup analysis for opioid-naive patients (those without a history of long-term opioid use) was performed. Statistical analysis was utilized to evaluate variations based on demographic and perioperative/postoperative variables. RESULTS: Of the 11,829 patients, 9229 (78.0%) were prescribed an opioid at discharge, and the median (interquartile range [IQR]) OME prescribed was 188 (150-225). The remaining 9253 patients (78.2%) were considered opioid naive. Striking variation in prescribing patterns was observed within and across surgical procedures. For instance, IQR ranges of 150 or greater were observed for open cystectomy (median, 300; IQR, 210-375], open radical nephrectomy (median, 300; IQR, 225-375), retroperitoneal node dissection (median, 300; IQR, 225-375), hand-assisted laparoscopic nephrectomy (median, 225; IQR, 150-300), and penile prosthesis (median, 225; IQR, 150-315). On multivariate analysis, younger age, cancer diagnosis, and inpatient hospitalization were associated with higher likelihood of receiving a highest-quartile OME prescription for opioid naive patients. Thirty-day refill rates varied from 1.6% to 25.9%. Interestingly, refill rates were higher in patients receiving more opioids at discharge. CONCLUSION: The United States is facing an opioid epidemic, and physicians must take action. In this study, we found considerable variation in opioid prescribing patterns within and across surgical procedures. These data provide support for the development of standardized opioid prescribing guidelines for postoperative analgesia.