Stoma complications and quality of life in patients with Indiana pouch versus appendico/neo-appendico-umbilicostomy urinary diversions.

OBJECTIVES: To evaluate three subtypes of continent-cutaneous urinary diversion (CCUD); Indiana pouch (IP), right colon pouch with appendico-umbilicostomy (AU), and right colon pouch with neo-appendico-umbilicostomy (NAU), by investigating diversion-specific complications and quality-of-life outcomes. MATERIALS AND METHODS: A retrospective review of an IRB-approved database was conducted for perioperative and outcome data. The EORTC QLQ-C30 questionnaire was used to assess quality of life; all responses were obtained > 6 months after diversion. RESULTS: Fifty-eight patients who underwent a CCUD at our institution from 2010 to 2016 (33 IP by two surgeons, 15 AU and ten NAU by third surgeon) were identified for this study. Higher age and Charlson Comorbidity Index (CCI) ≥ 3 were seen in the AU cohort when compared to the IP cohort (P = 0.02 and 0.02, respectively). NAU group were also older when compared to the IP group (P = 0.02). After a median follow-up of 21 months (range: 0.8-81.0), more high-grade diversion-related complications were reported for AU and NAU patients comparing to the IP group (P < 0.01 and P = 0.02, respectively). More stoma complications were also reported for the NAU cohort than the IP cohort (70% vs 30%, P = 0.03). In all groups, > 60% of stoma complications occurred at the skin or fascia level. In the 90-day postoperative period, a higher continence rate was reported for the IP cohort, and this difference was significant when compared to the NAU cohort (P = 0.04). Length of stay after surgery and revision rates were not significantly different. For all groups, the majority of patients reported little-to-no disturbance of daily functions and rated overall quality of life as good-to-excellent. CONCLUSION: Urinary diversion using the Indiana pouch and right colon pouch with appendico/neo-appendico-umbilicostomy are all associated with high rates of continence and patient satisfaction. When compared to IP, AU and NAU patients had higher rates of high-grade diversion-related complications and NAU patients had a higher stoma complications with lower 90-day continence rate.

Management of extraretroperitoneal masses in germ cell tumor.

PURPOSE OF REVIEW: Management of extraretroperitoneal (ERP) germ cell tumor (GCT) is a complex clinical scenario faced by urologic oncologists. This article reviews the indications and approach to management of ERP GCT masses. RECENT FINDINGS: ERP GCT management starts with chemotherapy, and for any residual masses, a careful consideration of surgical intervention versus salvage chemotherapy. Decision-making regarding residual ERP masses hinges on tumor markers, and also the anatomical location. These factors should be contextualized by the patient's risk for teratoma or active GCT, which will impact outcome and thus weigh on decision-making conversations with patients who have advanced disease. Technical challenges of surgical management in the postchemotherapy setting also apply in ERP mass resection. The risks of surgical management in the lung and liver, in particular, add special considerations for morbidity. Surgical resection is often the only recourse for a patient who may have chemoresistant disease and may be an important step in achieving cure. SUMMARY: Surgical management of ERP GCT requires multidisciplinary input, and the urologic oncologist can help guide management with particular emphasis on the indication, timing, and approach to surgical resection.

Telementoring and Telesurgery for Minimally Invasive Procedures.

PURPOSE: Tremendous interest and need lie at the intersection of telemedicine and minimally invasive surgery. Robotics provides an ideal environment for surgical telementoring and telesurgery given its endoscopic optics and mechanized instrument movement. We review the present status, current challenges and future promise of telemedicine in endoscopic and minimally invasive surgery with a focus on urological applications. MATERIALS AND METHODS: Two paired investigators screened PubMed®, Scopus® and Web of Science® databases for all full text English language articles published between 1995 and 2016 using the key words "telemedicine," "minimally invasive surgical procedure," "robotic surgical procedure," "education" and "distance." We categorized and included studies of level of interaction between proctors and trainees. Research design, special equipment, telecommunication network bandwidth and research outcomes of each study were ascertained and analyzed. RESULTS: Of 65 identified reports 38 peer-reviewed studies qualified for inclusion. Series were categorized into 4 advancing levels, ie verbal guidance, guidance with telestration, guidance with tele-assist and telesurgery. More advanced levels of surgical telementoring provide more effective and experiential teaching but are associated with increased telecommunication network bandwidth requirements and expenses. Concerns regarding patient safety and legal, financial, economic and ethical issues remain to be reconciled. CONCLUSIONS: Telementoring and telesurgery in minimally invasive surgery are becoming more practical and cost effective in facilitating teaching of advanced surgical skills worldwide and delivery of surgical care to underserved areas, yet many challenges remain. Maturity of these modalities depends on financial incentives, favorable legislation and collaboration with cybersecurity experts to ensure safety and cost-effectiveness.

Use of Automated Performance Metrics to Measure Surgeon Performance during Robotic Vesicourethral Anastomosis and Methodical Development of a Training Tutorial.

PURPOSE: We sought to develop and validate automated performance metrics to measure surgeon performance of vesicourethral anastomosis during robotic assisted radical prostatectomy. Furthermore, we sought to methodically develop a standardized training tutorial for robotic vesicourethral anastomosis. MATERIALS AND METHODS: We captured automated performance metrics for motion tracking and system events data, and synchronized surgical video during robotic assisted radical prostatectomy. Nonautomated performance metrics were manually annotated by video review. Automated and nonautomated performance metrics were compared between experts with 100 or more console cases and novices with fewer than 100 cases. Needle driving gestures were classified and compared. We then applied task deconstruction, cognitive task analysis and Delphi methodology to develop a standardized robotic vesicourethral anastomosis tutorial. RESULTS: We analyzed 70 vesicourethral anastomoses with a total of 1,745 stitches. For automated performance metrics experts outperformed novices in completion time (p <0.01), EndoWrist® articulation (p <0.03), instrument movement efficiency (p <0.02) and camera manipulation (p <0.01). For nonautomated performance metrics experts had more optimal needle to needle driver positioning, fewer needle driving attempts, a more optimal needle entry angle and less tissue trauma (each p <0.01). We identified 14 common robotic needle driving gestures. Random gestures were associated with lower efficiency (p <0.01), more attempts (p <0.04) and more trauma (p <0.01). The finalized tutorial contained 66 statements and figures. Consensus among 8 expert surgeons was achieved after 2 rounds, including among 58 (88%) after round 1 and 8 (12%) after round 2. CONCLUSIONS: Automated performance metrics can distinguish surgeon expertise during vesicourethral anastomosis. The expert vesicourethral anastomosis technique was associated with more efficient movement and less tissue trauma. Standardizing robotic vesicourethral anastomosis and using a methodically developed tutorial may help improve robotic surgical training.

Advanced chronic kidney disease; A comparison between nephroureterectomy and nephron-sparing surgery for upper tract urothelial carcinoma.

PURPOSE: Renal function outcomes between radical nephroureterectomy (RNU) and nephron-sparing surgery (NSS) for upper tract urothelial carcinoma (UTUC) patients are not well established. We sought to compare the incidence and factors associated with development of advanced chronic kidney disease (CKD) between RNU and NSS and examine the role of acute kidney injury (AKI) on renal function outcomes. METHODS: We retrospectively analyzed an institutional database for patients who underwent either RNU or NSS for UTUC. Cumulative incidence of postoperative advanced CKD, defined as eGFR < 30 ml/min/1.73 m2, was compared between groups. Fine-Gray competing risk regression was used to identify predictors of advanced CKD. Locally weight scatterplot smoothing was used to assess postoperative eGFR trends. AKI events were counted, staged, and assessed for influence of progression to advanced CKD. RESULTS: Four hundred and twenty-six patients were included in analysis, with a median follow up of 6.68 years (IQR 3.4-12.2). Median preoperative eGFR was similar between the groups (NSS: 68 ml/min/1.73 m2, RNU: 65 ml/min/1.73 m2,P = 0.220). Cumulative incidence of advanced CKD was significantly lower in the NSS cohort (P = 0.009). Factors associated with advanced CKD included age, diabetes, recurrent AKI and RNU. Percent of patients with an AKI event differed between the groups (51.5% NSS, 72.7% RNU, P = <0.001), there was no between group difference in percentage of patients with recurrent AKI (25.6% NSS, 25.9% RNU, P =1). CONCLUSION: NSS provides a renal function benefit in UTUC. AKI is common among UTUC patients and recurrent AKI is a risk factor for development of advanced CKD.

Clinical trial of high dose hyperthermic intravesical mitomycin C for intermediate and high-risk non-muscle invasive bladder cancer during BCG shortage.

PURPOSE: Intravesical Bacillus Calmette-Guérin (BCG) is the gold standard for intermediate and high-risk non-muscle invasive bladder cancer (NMIBC), but availability is limited by global shortages. We present the first North American clinical experience using intravesical hyperthermia (HIVEC) with high-dose mitomycin C (MMC) during BCG shortage. MATERIALS AND METHODS: Single arm intermediate size expanded access protocol for high dose HIVEC MMC in patients with intermediate and high-risk NMIBC during BCG shortage. Patients received 120 mg intravesical MMC using the Combat BRS to achieve 43°C HIVEC. Primary outcome was a safety assessment of adverse events, with recurrence-free survival and a descriptive analysis of hematologic impacts as secondary outcomes. RESULTS: Fourteen patients were treated from May 2019 to June 2020, 4 (29%) intermediate and 10 (71%) high risk. The cohort is heavily pretreated, only 2 (14%) BCG naïve and median 6 BCG instillations (IQR 5.25, 8.25), with median 3.5 recurrences per patient (IQR 1.00, 5.25) 67% with >1 per year. Patients underwent a median 6 instillations (IQR 3.25, 9.25) which were well tolerated in 11/14 (79%). Seven patients (50%) experienced 10 adverse events, all grades 1 or 2. Most common was MMC allergy (4/14, 29%), followed by bladder spasm (3/14, 21%). Two had recurrences at median 11 months follow up, but both discontinued HIVEC after only 2 treatments. CONCLUSIONS: High dose MMC HIVEC is a safe and well-tolerated substitute for BCG during global shortages. The higher rate of systemic effects implies increased drug delivery, which may improve efficacy.

Overview of Taris GemRIS, a Novel Drug Delivery System for Bladder Cancer.

GemRIS, an implantable drug delivery system from Taris Biomedical that delivers continuous intravesical gemcitabine, shows potential for use in multiple bladder cancer settings. Ongoing and recently completed phase 1 trials in non-muscle-invasive as well as muscle-invasive bladder cancer are yielding promising preliminary results.

Hyperthermia Improves Solubility of Intravesical Chemotherapeutic Agents.

BACKGROUND: Nearly 70% of all new cases of bladder cancer are non-muscle invasive disease, the treatment for which includes transurethral resection followed by intravesical therapy. Unfortunately, recurrence rates approach 50% in part due to poor intravesical drug delivery. Hyperthermia is frequently used as an adjunct to intravesical chemotherapy to improve drug delivery and response to treatment. OBJECTIVE: To assess the solubility profile of intravesical chemotherapies under varying conditions of pH and temperature. METHODS: Using microplate laser nephelometry we measured the solubility of three intravesical chemotherapy agents (mitomycin C, gemcitabine, and cisplatin) at varying physical conditions. Drugs were assessed at room temperature (23°C), body temperature (37°C), and 43°C, the temperature used for hyperthermic intravesical treatments. To account for variations in urine pH, solubility was also investigated at pH 4.00, 6.00, and 8.00. RESULTS: Heat incrementally increased the solubility of all three drugs studied. Conversely, pH largely did not impact solubility aside for gemcitabine which showed slightly reduced solubility at pH 8.00 versus 6.00 or 4.00. Mitomycin C at the commonly used 2.0 mg/mL was insoluble at room temperature, but soluble at both 37 and 43°C. CONCLUSIONS: Hyperthermia as an adjunct to intravesical treatment would improve drug solubility, and likely drug delivery as some current regimens are insoluble without heat. Improvements in solubility also allow for testing of alternative administration regimens to improve drug delivery or tolerability. Further studies are needed to confirm that improvements in solubility result in increased drug delivery.

Assessments of frailty in bladder cancer.

BACKGROUND AND AIMS: The incidence of frailty is increasing as the population ages, which has important clinical implications given the associations between frailty and poor outcomes in the bladder cancer population. Due to a multi-organ system decline and decreased physiologic reserve, frail patients are vulnerable to stressors of disease and have poorer mortality and morbidity rates than their nonfrail peers. The association between frailty and poor outcomes has been documented across multiple populations, including radical cystectomy, creating a need for frailty assessments to be used preoperatively for risk stratification. We aim to provide a review of the common frailty assessments and their relevance to radical cystectomy patients. FINDINGS: A variety of assessments for frailty exist, from short screening items to comprehensive geriatric assessments. The syndrome spans multiple organ systems, as do the potential diagnostic instruments. Some instruments are less practical for use in clinical practice by urologists, such as the Canadian Study of Health and Aging Frailty Index and Comprehensive Geriatric Assessment. The tool most studied in radical cystectomy is the modified Frailty Index, associated with high grade complications and 30-days mortality. Frailty often coexists with malnutrition and sarcopenia, stressing the importance of screening for and addressing these syndromes to improve patient's perioperative outcomes. CONCLUSIONS: There is no universally agreed upon frailty assessment, but the most studied in radical cystectomy is the modified Frailty Index, providing valuable data with which to counsel patients preoperatively. Alterations in immune phenotypes provide potential future diagnostic biomarkers for frailty.

Factors influencing ICU admission and associated outcome in patients undergoing radical cystectomy with enhanced recovery pathway.

PURPOSE: To characterize drivers of ICU admission during index hospitalization after Radical Cystectomy (RC) with Enhanced Recovery After Surgery (ERAS) protocol, as well as corresponding outcomes. METHODS: A retrospective review of an IRB-approved cystectomy database was conducted. All patients who underwent RC with ERAS protocol from 2012 to 2017 were included. EXCLUSION CRITERIA: adjunct nephrectomy or urethrectomy. RESULTS: A total of 512 patients were identified. ICU admission in index hospitalization was reported in 33 patients (6.4%), 26 with unplanned ICU transfer after initial non-ICU level of care and 7 with planned direct postoperative ICU admission. Higher age and Charlson Comorbidity Index ≥3 were significant risk factors for unplanned ICU admission. On multivariate analysis, age remained associated (odds ratio 1.05, 95% confidence interval 1.008, 1.1, P = 0.02) and Charlson Comorbidity Index ≥3 kept the trend (odds ratio 2.16, 95% confidence interval 0.86 - 5.07, P = 0.08) with this increased risk of ICU admission. Patients in the unplanned ICU group spent a median of 3 days (range: 0-32) at non-ICU level of care before ICU transfer; cardiac indications were the most common reason for transfer (52%). Patients who required unplanned ICU transfer had a median length of stay of 11.5 days, compared to a length of stay of 5 days (P < 0.01) for non-ICU patients. Ninety-day readmission and mortality rates were higher in the planned ICU cohort when compared to the unplanned ICU cohort. A low rate of ICU admission (2.7%) in the corresponding 90-day postoperative period was reported for the group not requiring ICU admission during index hospitalization. CONCLUSION: ICU admission is uncommon following RC with ERAS protocol. Advanced age and comorbidity index are significantly associated with unplanned ICU transfer. Planned ICU admissions are not shown to be associated with improved outcomes compared to unplanned ICU admissions. Further efforts to elucidate the role of ICU care in the context of the ERAS protocol is important for targeted care optimization and appropriate postoperative planning.

Enhanced Recovery After Surgery Pathways: Role and Outcomes in the Management of Muscle Invasive Bladder Cancer.

Radical cystectomy remains the gold standard therapy for the treatment of muscle-invasive urothelial carcinoma, yet is accompanied by significant rates of perioperative complications and readmission. Enhanced recovery protocols aim to apply evidence-based principles of care to ameliorate the morbidity of this procedure by enabling better tolerance of and recovery from radical cystectomy. Multiple patient series have demonstrated the capacity for enhanced-recovery-after-surgery (ERAS) principles to improve outcomes among patients undergoing radical cystectomy through decreased incidence of gastrointestinal complications and decreased length of hospitalization without increased readmissions or overall morbidity. Opportunities remain for adoption of established ERAS principles.