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Background: The first interim analysis of the KEYNOTE-564 study showed improved disease-free survival with adjuvant pembrolizumab compared with placebo after surgery in patients with clear cell renal cell carcinoma at an increased risk of recurrence. The analysis reported here, with an additional 6 months of follow-up, was designed to assess longer-term efficacy and safety of pembrolizumab versus placebo, as well as additional secondary and exploratory endpoints. Methods: In the multicentre, randomised, double-blind, placebo-controlled, phase 3 KEYNOTE-564 trial, adults aged 18 years or older with clear cell renal cell carcinoma with an increased risk of recurrence were enrolled at 213 hospitals and cancer centres in North America, South America, Europe, Asia, and Australia. Eligible participants had an Eastern Cooperative Oncology Group performance status of 0 or 1, had undergone nephrectomy 12 weeks or less before randomisation, and had not received previous systemic therapy for advanced renal cell carcinoma. Participants were randomly assigned (1:1) via central permuted block randomisation (block size of four) to receive pembrolizumab 200 mg or placebo intravenously every 3 weeks for up to 17 cycles. Randomisation was stratified by metastatic disease status (M0 vs M1), and the M0 group was further stratified by ECOG performance status and geographical region. All participants and investigators involved in study treatment administration were masked to the treatment group assignment. The primary endpoint was disease-free survival by investigator assessment in the intention-to-treat population (all participants randomly assigned to a treatment). Safety was assessed in the safety population, comprising all participants who received at least one dose of pembrolizumab or placebo. As the primary endpoint was met at the first interim analysis, updated data are reported without p values. This study is ongoing, but no longer recruiting, and is registered with ClinicalTrials.gov, NCT03142334. Findings: Between June 30, 2017, and Sept 20, 2019, 994 participants were assigned to receive pembrolizumab (n=496) or placebo (n=498). Median follow-up, defined as the time from randomisation to data cutoff (June 14, 2021), was 30·1 months (IQR 25·7–36·7). Disease-free survival was better with pembrolizumab compared with placebo (HR 0·63 [95% CI 0·50–0·80]). Median disease-free survival was not reached in either group. The most common all-cause grade 3–4 adverse events were hypertension (in 14 [3%] of 496 participants) and increased alanine aminotransferase (in 11 [2%]) in the pembrolizumab group, and hypertension (in 13 [3%] of 498 participants) in the placebo group. Serious adverse events attributed to study treatment occurred in 59 (12%) participants in the pembrolizumab group and one (

TPS583 Background: Treatment options are limited for pts with NMIBC and MIBC who experience disease recurrence or who are ineligible for or refuse standard of care. Erda, an oral selective pan-FGFR tyrosine kinase inhibitor, is approved in adults with locally advanced or metastatic urothelial cancer with select FGFR3/2 alterations ( alt) who have progressed during or after ≥1 line of platinum-containing chemotherapy. FGFRalt are among the most common oncogenic drivers detected in NMIBC and MIBC, and are more prevalent in NMIBC. TAR-210 is an intravesical drug delivery system designed to provide local, continuous release of erda within the bladder, thus limiting systemic toxicity. This study evaluates the safety, pharmacokinetics (PK), and efficacy of TAR-210 in pts with NMIBC or MIBC with select FGFRalt. Methods: Open-label, multicenter phase 1 study of TAR-210 in pts with recurrent NMIBC or MIBC (NCT05316155). Eligible pts are aged ≥18 yrs with adequate organ function and tumors with select FGFRalt. A flexible molecular eligibility strategy is used to allow for local or central fresh/archival tissue-based FGFR testing by next-generation sequencing (NGS) or PCR, or urine cell-free DNA NGS testing. Four cohorts will be enrolled: pts with recurrent, bacillus Calmette-Guerin (BCG)-experienced papillary-only high-risk (HR) NMIBC (high-grade Ta/T1) refusing or ineligible for radical cystectomy (RC) (Cohort 1) or scheduled for RC (Cohort 2); pts with recurrent, intermediate-risk NMIBC (Ta/T1) with a history of low-grade disease (Cohort 3); pts with cT2-T3a MIBC scheduled for RC refusing or ineligible for neoadjuvant cisplatin (Cohort 4). Pts in Cohorts 1 and 2 will have TURBT with resection of all visible disease prior to dosing, whereas pts in Cohort 3 must have visible disease prior to dosing. The primary end point is safety (adverse events, including dose-limiting toxicity). Secondary end points include PK, recurrence-free survival (Cohorts 1 and 2), complete response (CR) rate and duration of CR (Cohort 3), and pathologic CR rate, pT0 rate, and rate of downstaging to

528 Background: Novel therapies are required for BCG-unresponsive, high risk non-muscle invasive bladder cancer. We report the interim results of a Phase II Clinical Study of Intravesical Photo Dynamic Therapy (PDT) in patients with BCG-Unresponsive Carcinoma In-Situ (CIS) with or without papillary disease. Methods: Out of a planned 125 patients, 42 patients have been enrolled and treated with two Study Treatments (Day 0 and Day 180) consisting of an intravesical instillation of the photosensitizer TLD-1433 (0.70 mg/cm2) followed by activation with a 520 nm intravesical laser under general anesthesia (Study Device TLC-3200) to a total of 90 J/cm2 of laser light. The primary outcome assessed was efficacy, evaluated by Complete Response (CR), at any point in time. The secondary outcome was duration of CR at 12 months, post initial CR. A tertiary objective is safety, evaluated by the incidence and severity of Adverse Events, Grade 4 or higher that do not resolve within 450 days post treatment. Patients with a negative cystoscopy and positive cytology have been defined as indeterminate response (IR), as these patients remain under investigation for lower and upper tract urothelial carcinoma. Results: Interim analyses included the first 42 patients, along with 3 patients treated in a preceding Phase Ib NMIBC clinical study assessing the safety of TLD-1433 PDT who weretreated at the same parameters, for a total of 45 patients. Data for the primary and secondary outcomes are listed in the table.The interim clinical data demonstrates a 90 day CR of 50% and a duration of response at 360 and 450 days of 35% and 21%, respectively.There have been eight Serious Adverse Events (SAE) identified (2 Grade II (tachycardia, hematuria), 3 Grade III (acute kidney injury, cellulitis), 2 Grade IV (urosepsis, depression/anxiety) and 1 Grade V). None of the SAEs were deemed to be directly related to the PDT. Conclusions: The interim data support that treatment with Photo Dynamic Therapy provides a viable treatment option for patients with BCG unresponsive CIS (+/- papillary disease) with an acceptable ongoing safety profile. Clinical trial information: NCT03945162 . [Table: see text]

INTRODUCTION AND OBJECTIVE:Pathogenic/likely pathogenic (P/LP) germline genetic variants occur in ∼10-15% of all prostate cancer (PCa) patients. However, complicated and restrictive testing guideli...

TPS580 Background: Radical surgery is the mainstay of treatment for muscle-invasive upper tract urothelial cancer (UTUC) and urothelial bladder cancer (UBC). However, even when surgery is combined with cisplatin‐based (neo)adjuvant chemotherapy, recurrence rates are high. Many patients (pts) are ineligible for, do not respond to, or refuse cisplatin-based chemotherapy because of toxicity concerns. Fibroblast growth factor receptor 3 ( FGFR3) genetic alterations occur in 21–38% of muscle-invasive UTUC, and in approx. 20% of invasive UBC. Infigratinib (BGJ398) is an ATP-competitive FGFR1–3 selective oral tyrosine kinase inhibitor that has clinical activity and tolerability in pts with advanced/metastatic urothelial carcinoma (UC) harboring susceptible FGFR3 alterations. PROOF 302 was designed to investigate the efficacy and safety of adjuvant infigratinib in pts with high-risk, muscle-invasive UC (85% UTUC) and susceptible FGFR3 alterations. Methods: PROOF 302 is a global, multicenter, randomized, double-blind, placebo-controlled, phase 3 trial (NCT04197986). Eligible pts have high-risk, muscle-invasive UTUC (85%) or UBC (15%) with susceptible FGFR3 alterations (mutations, gene fusions or rearrangements) confirmed by FoundationOne CDx test, and are ≤120 days following nephroureterectomy, distal ureterectomy, or cystectomy. The study protocol was amended to include pts with carcinoma in situ at surgical margins and those who refuse cisplatin-based chemotherapy (in addition to pts allowed to enroll if ineligible for perioperative cisplatin-based chemotherapy). Eligible pts are M0 and have either disease stage ≥ypT2 and/or yN+ after cisplatin-based neoadjuvant chemotherapy or ≥pT2 pN0–2 or pN+ (UTUC); and ≥pT3 or pN+ (UBC) if not treated with cisplatin-based neoadjuvant chemotherapy. Pts are randomized 1:1 to receive oral infigratinib 125 mg or placebo QD on days 1–21 of a 28-day cycle for up to 52 weeks (13 cycles) or until recurrence, unacceptable toxicity, or death. Primary endpoint: centrally reviewed disease-free survival (DFS) analyzed via stratified log-rank test and Cox model (hazard ratio). Secondary endpoints: investigator-reviewed DFS, metastasis-free survival, overall survival, safety/tolerability. Exploratory endpoints: quality of life, pharmacokinetics, determination of the prevalence of genomic alterations and correlation with features of UC, genomic and proteomic assessment of tumor tissue and cell-free DNA samples from baseline and at recurrence to identify the predictive/prognostic value of biomarkers. PROOF 302 is actively enrolling as of Sep 2021. A second Data Monitoring Committee meeting is planned for Dec 2021. The last pt is expected to complete treatment in 2024. Clinical trial information: NCT04197986.

10504 Background: Pathogenic/likely pathogenic (P/LP) germline genetic variants are estimated to occur in 10-15% of all prostate cancer (PCa) patients. However, genetic testing for PCa patients is underutilized, partially due to complicated and restrictive testing guidelines developed at a time when the cost of testing was high. We conducted a study based in community urology clinics to determine the incidence of P/LP variants in PCa patients who met and did not meet the NCCN 2019 PCa germline genetic testing criteria. Methods: An IRB-approved, multicenter, prospective registry was initiated with 15 community and academic urologists nationwide. Eligibility criteria included patients with a PCa diagnosis unselected for personal or family history, stage or histology who had not been previously tested. Consecutive patients ages 18-90 were consented and underwent an 84-gene germline panel test. HIPAA-compliant electronic case report forms distributed to clinician collected information on patient diagnoses, NCCN testing criteria, and results-based recommendations. Results: To date, 640 enrolled patients have genetic testing results available. Overall, 69 (10.8%) patients had 72 P/LP variants detected, 15% of which were in BRCA1/2. Of the 532 patients for whom we have clinician-reported data, 293 (55%) met NCCN criteria and 239 (45%) did not. Median age was 70 (range 44-90). Overall, 11.1% (59/532) of patients with clinician-reported data had a P/LP variant. 36 (12.3%) of patients who met NCCN criteria and 23 (9.6%) of patients who did not meet criteria had a P/LP variant. The difference in P/LP rate between the two groups was not statistically significant (p=0.33). If only a conservative 12-gene PCa panel was considered, P/LP yield was 5.5% (29/532), with 8 (28%) of these patients missed by guidelines. Stratification by self-reported ethnicity was: 76% White/Caucasian (52 patients w/ P/LP), 18% Black/African American (2 patients w/ P/LP), and

Percutaneous nephrolithotomy (PCNL) is the treatment of choice for patients with complex stone burdens. We performed a study to assess the effect of urologist-specific parameters on the use of PCNL-both the access component of the procedure as well as the stone removal. We also examined trends in PCNL utilization over time.We analyzed self-reported 6-month case logs submitted to The American Board of Urology (ABU) for urologists who certified or recertified between 2004 and 2013. Surgeons performing PCNL were identified by Current Procedural Terminology coding. Urologist-specific data, including fellowship training, practice type, and practice population, were used to further stratify this cohort. Trends were examined over the study period.A total of 7278 urologists submitted case logs to the ABU between 2004 and 2013. The median ages of the initial certification group, first recertification group, and second recertification group were 36.0, 43.7, and 53 years, respectively. A greater proportion of newly certified urologists performed PCNL (53%) compared with urologists in the first (41%) and second (29%) recertification groups; initially certified urologists were also more likely to be high volume (10) PCNL surgeons. Urologists with fellowship training were more likely to use PCNL (66%) and be high-volume surgeons (26.4%). PCNL utilization increased significantly during the study period, with 1330 procedures performed in 2004 and 2888 procedures performed in 2012 (117% increase).Younger and fellowship-trained urologists are the primary users of PCNL; the majority of senior urologists do not perform this operation. Overall, the use of PCNL and urologist-directed access has increased in the previous decade.

Objective To report trends in surgical approach and associations with outcomes in children undergoing extirpative renal surgery in the state of Maryland over a 12-year period. Methods The Maryland Health Services Cost Review Commission (HSCRC) database was queried to identify children undergoing total or partial nephrectomy between 2000 and 2011. Demographic, clinical, hospital, and charge data were compared between children undergoing open and minimally invasive renal surgery. Multivariable logistic regression analysis was performed to identify independent predictors of prolonged length of hospital stay and 30-day readmission. Multivariable linear regression was performed to identify independent predictors of increased hospital charges. Results Of the 346 children undergoing extirpative renal surgery, 289 (83.5%) underwent total nephrectomy and 48 (13.9%) underwent minimally invasive surgery. Utilization of minimally invasive surgery for congenital urinary anomalies has steadily increased from 15% to 35% over the past decade. Children undergoing minimally invasive total nephrectomy were healthier, had shorter hospital stay, and were more likely to have surgery at a high-volume institution. No such differences were noted in patients undergoing open and minimally invasive partial nephrectomy. On multivariable regression analyses, high patient complexity was the main predictor of increased length of stay (OR 16.02, 95% CI 7.06–36.31), 30-day readmission (OR 3.04, 95% CI 1.38–6.70), and total hospital charge ( p Conclusion In Maryland hospitals, most extirpative renal surgeries in children are total nephrectomies performed using an open technique by high-volume surgeons. Although the overall proportion of minimally invasive surgeries has not increased over time, the utilization of MIS in congenital anomaly cases has. Patient complexity and not operative approach dictates postoperative morbidity and hospital charges.

population. Methods: The Surveillance, Epidemiology and End Results-Medicare database (1995– 2007) was queried to identify patients with localized T1a kidney cancer undergoing partial nephrectomy, radical nephrectomy or deferring therapy. We explored independent associations of specific comorbidities with causes of death, and developed a simplified cardiovascular index. Cox proportional hazards, and Fine and Gray competing risks regression were used. Results: Of 7177 Medicare beneficiaries in the study population, 754 (10.5%) deferred therapy, 1849 (25.8%) underwent partial nephrectomy and 4574 (63.7%) underwent radical nephrectomy with none of the selected comorbidities identified in 3682 (51.3%) patients. Congestive heart failure, chronic kidney disease, peripheral vascular disease, chronic obstructive pulmonary disease, diabetes and cerebrovascular disease were associated with decreased overall survival. The cardiovascular index provided good survival risk stratification, and reclassified 1427 (41%) patients with a score ≥1 on the Charlson Comorbidity Index to a 0 on the cardiovascular index with minimal concession of 5-year survival. Conclusions: Congestive heart failure, chronic kidney disease, peripheral vascular disease, chronic obstructive pulmonary disease, diabetes and cerebrovascular disease were associated with decreased overall survival among Medicare beneficiaries with small renal masses. The cardiovascular index could serve as a clinically useful prognostic aid when advising older patients that are borderline candidates for surgery or active surveillance.

Contemporary rates of postoperative hemorrhage after partial nephrectomy (PN) are low. Commercially available hemostatic agents are commonly used during this surgery to reduce this risk despite a paucity of data supporting the practice. We assessed the impact of fibrin sealant hemostatic agents, a costly addition to surgeries, during robot-assisted partial nephrectomy (RAPN).Between 2007 and 2011, 114 consecutive patients underwent RAPN by a single surgeon (MEA). Evicel fibrin sealant was used in the first 74 patients during renorraphy. The last 40 patients had renorraphy performed without the use of any hemostatic agents. Clinicopathologic, operative, and complication data were compared between groups. Multivariate and univariate logistic regression analysis was performed to test the association between the use of fibrin sealants and operative outcomes.Patient demographic data and clinical tumor characteristics were similar between groups. The use of fibrin sealant did not increase operative time (166.3 vs 176.1 minutes, P=0.28), warm ischemia time (WIT) (14.4 vs 16.1 minutes, P=0.18), or length of hospital stay (2.6 vs 2.4 days, P=0.35). The omission of these agents did not increase estimated blood loss (116.6 vs 176.1 mL, P=0.8) or postoperative blood transfusion (0% vs 2.5%, P=0.17). Univariate analysis demonstrated no association between use of fibrin sealants and increased complications (P0.05). Multivariable logistic regression showed no statistically significant predictive value of omission of hemostatic agents for perioperative outcomes (P0.05).Perioperative hemorrhage and other major complications after contemporary RAPN are rare in experienced hands. In our study, the use of fibrin sealants during RAPN does not decrease the rate of complications, blood loss, or hospital stay. Furthermore, no impact is seen on operative time, WIT, or other negative outcomes. Omitting these agents during RAPN could be a safe, effective, cost-saving measure.

Objectives To evaluate the feasibility and report our initial experience with Robotic-Assisted Laparoscopic Mitrofanoff Appendicovesicostomy (RALMA) in patients with prune belly syndrome. The Mitrofanoff appendicovesicostomy procedure uses the appendix to create an easily accessible continent, catheterizable channel into the urinary bladder. Historically, the procedure is performed by an open surgical approach in prune belly patients. We describe our initial experience herein. Materials and methods Between October 2008 and February 2010 three patients with prune belly syndrome underwent RALMA. The appendicovesicostomy anastomosis was performed on the anterior bladder wall and the stoma was brought to the umbilical site or right lower quadrant. At least 4 cm of detrusor backing was ensured. The appendicovesicostomy stent was left in place for 4 weeks postoperatively before initiation of catheterization. Results Mean age at surgery was 9.7 years (range 5-14 years). Blood loss volume was 20 mL in each case. Overall mean operative time was 352 min (range 319-402 min). There were no intraoperative complications and no open conversions. There was one postoperative complication in the form of wound infection. All patients are catheterizing their stomas and are continent at an average follow-up of 14.7 months (range 5-21 months). Conclusion In our initial experience, RALMA is a feasible option with encouraging early experience for creating a continent catheterizable channel into the urinary bladder in patients with prune belly syndrome.

Objectives To present outcomes of a contemporary series of patients undergoing radical cystectomy (RC) for bladder cancer after previous treatment for localized cancer of the prostate (CaP). Methods A retrospective review of more than 1000 RCs performed for bladder cancer between 1995 and 2008 identified 49 patients previously treated for localized CaP. Patients were stratified according to the type of primary therapy received for CaP: any form of primary or adjuvant radiotherapy (brachytherapy or external beam radiotherapy) versus radical prostatectomy (RP) monotherapy. Perioperative data were analyzed and compared between the 2 groups. Results Of 49 patients, 40 (82%) underwent primary or adjuvant radiotherapy and 9 (18%) RP alone. Eleven (22%) patients received a continent diversion. Mean estimated blood loss (EBL) and hospital stay were 979 mL and 12 days, respectively. Extravesical disease (≥pT3a) was present in 23 patients (57.5%) in the radiotherapy group and in 2 patients (22%) in the RP group. Ten patients (all in the radiotherapy group) had a positive margin, 9 (90%) of whom had pathologic T4 disease. The overall major perioperative complication rate was 41%. Of the 6 patients with an ONB (all after RP), 4 had severe incontinence. Conclusions Patients undergoing RC after previous treatment for localized CaP are at increased risk for perioperative morbidity. Patients should be counseled that orthotopic diversion after RP may be associated with significant incontinence. Extravesical disease is more prevalent in patients treated with previous radiation. We observed a high rate of positive margins associated with pathologic T4 disease in this cohort.

Objective: The optimal management of vaginal mesh extrusion placed during incontinence and prolapse repairs has not been well defined. We reviewed our experience with these patients

To describe our technique for robot-assisted radical nephrectomy (RARN) with inferior vena cava (IVC) tumor thrombectomy and to present initial results for our first two patients.Two patients with renal masses with infrahepatic IVC extension underwent RARN with IVC tumor thrombectomy using a four-arm configuration. Both cases were right-sided tumors. Vascular control was obtained with complete cross-clamping of the vena cava with robotic bulldog clamps. Intraoperative ultrasound was used to delineate extent of tumor extension. Specimens were removed en-bloc, and the IVC was closed with 2-layers of 4-0 Prolene. The specimen is extracted through a lower midline incision.Two robotic IVC thrombectomies were successfully completed. There were no conversions, intraoperative or postoperative complications. Median operative time was 243 minutes with a median estimated blood loss of 150 mL. Both patients were able to ambulate independently free of intravenous opioids on postoperate day 1. Median length of stay was 4.5 (range 3-6) days. Final pathology revealed clear cell RCC in both cases with negative surgical margins.Robotic technology may facilitate RN and IVC thrombectomy in the well selected patient and appears to be a safe and feasible approach.

INTRODUCTION AND OBJECTIVES: Percutaneous nephrolithotomy (PNL) is a specialized surgical procedure utilized for patients with complex stone burdens. Our understanding of factors affecting the utilization of this procedure is limited. We studied the impact of urologist training and practice parameters on the utilization of PNL and urologist-directed access over time. METHODS: We analyzed self-reported 6 month case logs submitted to The American Board of Urology (ABU) for urologists certifying or re-certifying between 2004 and 2013. Surgeons performing PNL were identified by CPT coding: 50080 and 50081; percutaneous access was identified by CPT 50395. Urologist-specific data, including fellowship training, practice type, and practice population, were used to further stratify the cohort performing these procedures. RESULTS: A total of 7,278 urologists submitted case logs to the ABU between 2004-2013. The median ages of the initial certification group, first recertifying group and second recertifying group were 36.0, 43.7 and 53 years, respectively. A greater proportion of newly certified urologists performed PNL (53%) compared to urologists in the 1st (41%) and 2nd (29%) recertification groups; newly certified urologists were also more likely to be high volume (> 10) PNL surgeons. Urologists with fellowship training in stones were much more likely to utilize PNL (66%) and be high-volume surgeons (26.4%). Non-private and heavily populated (>1,000,000) practice settings also had significantly more high-volume PNL surgeons. PNL utilization increased significantly during the study period, with 1,330 procedures performed in 2004 and 2,888 procedures performed in 2012 (117% increase). Older urologists’ utilization of PNL increased over time. Urologist access concordantly increased over time, with 14.5% of PNL cases utilizing urologist access in 2004 and 20.4% in 2012, a 29% increase (see figure 1). Certification status did not correlate with urologist access. CONCLUSIONS: Younger and fellowship-trained urologists are the primary utilizers of PNL, and the majority of senior urologists do not perform this operation. Overall, the use of PNL and urologist-directed access has increased in the previous decade. Our findings can serve to inform future discussions on the regionalization of specialized urologic care.

INTRODUCTION AND OBJECTIVES: Time to recovery of continence after robotic-assisted radical prostatectomy (RARP) remains the most bothersome complaint by patients. Many techniques have been described to shorten recovery to continence, none have thus far been validated. We propose a technique that creates a “hammock” around the urethra at the time of vesico-urethral anastomosis. We believe that this may lead to very early (

The objectives of the present study were analyze specific comorbidities associated with survival and actual causes of death for patients with small renal masses, and to suggest a simplified measure associated with decreased overall survival specific to this population.The Surveillance, Epidemiology and End Results-Medicare database (1995-2007) was queried to identify patients with localized T1a kidney cancer undergoing partial nephrectomy, radical nephrectomy or deferring therapy. We explored independent associations of specific comorbidities with causes of death, and developed a simplified cardiovascular index. Cox proportional hazards, and Fine and Gray competing risks regression were used.Of 7177 Medicare beneficiaries in the study population, 754 (10.5%) deferred therapy, 1849 (25.8%) underwent partial nephrectomy and 4574 (63.7%) underwent radical nephrectomy with none of the selected comorbidities identified in 3682 (51.3%) patients. Congestive heart failure, chronic kidney disease, peripheral vascular disease, chronic obstructive pulmonary disease, diabetes and cerebrovascular disease were associated with decreased overall survival. The cardiovascular index provided good survival risk stratification, and reclassified 1427 (41%) patients with a score ≥1 on the Charlson Comorbidity Index to a 0 on the cardiovascular index with minimal concession of 5-year survival.Congestive heart failure, chronic kidney disease, peripheral vascular disease, chronic obstructive pulmonary disease, diabetes and cerebrovascular disease were associated with decreased overall survival among Medicare beneficiaries with small renal masses. The cardiovascular index could serve as a clinically useful prognostic aid when advising older patients that are borderline candidates for surgery or active surveillance.

Obesity is an important medical problem that is rapidly approaching epidemic status. As diet and lifestyle changes can be ineffective at producing long-term weight loss, bariatric surgical procedures have become increasingly applicable to the management of obesity. Recent evidence suggests that certain types of bariatric procedures will induce lithogenic metabolic changes, and have been associated with increased risk of kidney stone formation. Specifically, Roux-en-Y gastric bypass procedures appear most likely to increase risk of urinary stone disease. In these patients, identification of metabolic abnormalities is important to therapeutically modify these risk factors. In doing so, the likelihood of stone formation may be reduced.

Robotic surgeons are faced with an increasing array of complex clinical scenarios in the management of localized prostate cancer. With appropriate preparation and resource utilization, many of these “difficult cases” can be handled safely and efficiently. Securing obese patients adequately to the operating table and preventing port slippage is important in minimizing long case times and complications in these patients. In patients with large prostates, a well-developed posterior plane prior to bladder neck transection minimizes risk of injuring nearby structures. Use of a retraction suture or the fourth arm to elevate a median lobe can assist in patients with significant intravesical prostatic lobes. Bladder neck reconstruction may be necessary, and however be easily performed with lateral figure-of-eight stitches, which can also internalize the ureteral orifices. RARP can safely be performed in patients with prior bladder outlet, hernia, or multiple abdominal operations, although patients with prior TURP may have an increased risk of postoperative incontinence. An extended lymphadenectomy can be efficiently performed robotically, and increases prognostic and therapeutic yield of the operation without significantly increasing morbidity.

Purpose. Intravesical Bacillus Calmette-Guerin (BCG) immunotherapy is indicated for high-grade nonmuscle-invasive bladder cancer (NMIBC). The efficacy of BCG in patients with a history of previous pelvic radiotherapy (RT) may be diminished. We evaluated the outcomes of radical cystectomy for BCG-treated recurrent bladder cancer in patients with a history of RT for prostate cancer (PC). Methods. A retrospective chart review was performed to identify patients with primary NMIBC. We compared the outcomes of three groups of patients who underwent radical cystectomy for BCG-refractory NMIBC: those with a history of RT for PC, those who previously underwent radical prostatectomy (RP), and a cohort without PC or RT exposure. Results. From 1996 to 2008, 53 patients underwent radical cystectomy for recurrent NMIBC despite BCG. Those with previous pelvic RT were more likely to have a higher pathologic stage and decreased recurrence-free survival compared to the groups without prior RT exposure. Conclusion. Response rates for intravesical BCG therapy may be impaired in those with prior prostate radiotherapy. Patients with a history of RT who undergo radical cystectomy after failed BCG are more likely to be pathologically upstaged and have decreased recurrence-free survival. Earlier consideration of radical cystectomy may be warranted for those with NMIBC who previously received RT for PC.

Underuse of partial vs radical nephrectomy for renal tumors was noted in recent population based analyses. An explanation is the learning curve associated with laparoscopic partial nephrectomy. We analyzed state trends in renal surgery and their relationship to the introduction of robotic technology.We used the Maryland HSCRC (Health Services Cost Review Commission) database to identify patients who underwent radical or partial nephrectomy, or renal ablation from 2000 to 2011. Utilization trends, and associated patient and hospital factors were analyzed using multivariate logistic regression. ICD-9 robotic modifier codes were established in October 2008.Of the 14,260 patients included in analysis 11,271 (79.0%), 2,622 (18.4%) and 367 (2.6%) underwent radical and partial nephrectomy, and renal ablation, respectively. Partial nephrectomy increased from 8.6% in 2000 to 27% in 2011. Open radical nephrectomy decreased by 33%, while minimally invasive radical nephrectomy increased by 15%. Robot-assisted laparoscopic partial nephrectomy increased from 2008 to 2011, attaining a 14% rate at university and 10% at nonuniversity hospitals (p = 0.03). It was associated with increased partial nephrectomy (OR 9.67, p0.001). Younger age, male gender and low patient complexity predicted partial nephrectomy on overall analysis, while higher hospital volume and university status were predictors only in earlier years.Partial nephrectomy use increased in Maryland from 2001 to 2011, which was facilitated by robotic technology. Associations with hospital factors decreased with time. These data suggest that robotic technology may enable surgeons across practice settings to more frequently perform nephron sparing surgery.

Objective To evaluate the anthropometric measurements of body mass index, outer-abdominal fat (OAF) and intra-abdominal fat (IAF) for their utility in predicting perioperative complications following minimally invasive partial nephrectomy. Methods We retrospectively reviewed the clinical data of patients who underwent a laparoscopic or robotic partial nephrectomy between August 2006 and July 2012 by a single surgeon. Measurements of OAF and IAF were obtained from preoperative cross-sectional imaging available through our institution's imaging archive. Preoperative clinical parameters, including BMI, OAF and IAF, were evaluated for associations with postoperative complications, operative time and length of hospital stay. Results In total, 257 patients underwent a minimally invasive partial nephrectomy during the study period. Of these patients, 195 (75.9%) had preoperative scans available for analysis of OAF and IAF. A total of 52 (26.7%) patients experienced a Clavien grade I-IV complication within 30 days of surgery, 18 (34.6%) of which were grade III-IV. No patient experienced a grade V complication. On multivariate analysis, only increasing IAF (OR 1.05 [95% CI 1.02-1.09], P = .005) was associated with grade I-IV complications, while IAF (OR 1.05 [95% CI 1.00-1.10], P = .04) and intermediate to high tumor complexity (OR 5.31 [95% CI 1.47-19.17], P = .01) were associated with grade III-IV complications. BMI, OAF and IAF were not found to be independently associated with operative time or length of hospital stay. Conclusion IAF is independently associated with complications following minimally invasive partial nephrectomy. With further validation, this measurement may prove useful in the preoperative risk stratification of patients with small renal masses.

The benefit of routine mechanical bowel preparation for patients undergoing radical cystectomy is not well established. We compared postoperative complications in patients who did or did not undergo mechanical bowel preparation before radical cystectomy.In 2008 a single surgeon (GDS) performed open radical cystectomy with an ileal conduit or orthotopic neobladder in 105 consecutive patients with preoperative mechanical bowel preparation consisting of 4 l GoLYTELY®. In 2009 radical cystectomy with an ileal conduit or orthotopic neobladder was performed in 75 consecutive patients without mechanical bowel preparation. A comprehensive database provided clinical, pathological and outcome data.All patients had complete perioperative data available. The 2 groups were similar in age, Charlson comorbidity score, diversion type, receipt of neoadjuvant radiation or chemotherapy, blood loss, hospital stay, time to diet and pathological stage. Postoperative urinary tract infection, wound dehiscence and perioperative death rates were similar in the 2 groups. Clostridium difficile infection developed within 30 days of surgery in 11 of 105 vs 2 of 75 patients with vs without mechanical bowel preparation (p = 0.08). When adjusted for the annual hospital-wide C. difficile rate, the difference remained insignificant (p = 0.21). Clavien grade 3 or greater abdominal and gastrointestinal complications, including fascial dehiscence, abdominal abscess, small bowel obstruction, bowel leak and entero-diversion fistula, developed in 7 of 105 patients with (6.7%) vs 11 of 75 without (14.7%) mechanical bowel preparation (p = 0.08).The use of mechanical bowel preparation for patients undergoing radical cystectomy with an ileal conduit or orthotopic neobladder does not seem to impact the rates of perioperative infectious, wound and bowel complications. Larger series with multiple surgeons are necessary to confirm these findings.

Previous studies have demonstrated differences in surgical outcomes after radical prostatectomy based on ethnicity. We compared sexual and urinary outcomes in African-American (AA) patients 6 and 12 months after robot-assisted radical prostatectomy (RARP) with those of non-AA patients.We reviewed our RARP database at our institution for patients with at least 12 months of follow-up. Erectile function was defined using the University of California, Los Angeles Prostate Cancer Index as erections "firm enough for masturbation and foreplay" or "firm enough for intercourse," while urinary continence was defined as being "pad free." Only patients who were potent and pad free preoperatively were included in the analysis. Multivariate logistic regression was used to compare postoperative potency and urinary pad-free status between AA and non-AA patients while controlling for pertinent demographic, clinical, and pathologic variables.In the urinary continence analysis, 140 AA patients and 576 non-AA patients were included, compared with 105 AAs and 500 non-AA patients who were included in the analysis of sexual function. At 12 months postoperatively, a smaller proportion of AA patients were potent compared with non-AA patients (60% vs 76.4%, P=0.001). Similarly, we found a lower incidence of pad-free status for AA patients at 12 months postoperatively (55.7% vs 69.8%, P=0.039). Similar functional results were found at 6 months postoperatively for both analysis groups.AA men appear to have worse urinary and sexual outcomes at 12 months after RARP compared with non-AA patients. At 6 months, there is no statistically significant difference. Further, longer-term studies are needed to validate these results.

To evaluate the feasibility and report our initial experience with Robotic-Assisted Laparoscopic Mitrofanoff Appendicovesicostomy (RALMA) in patients with prune belly syndrome. The Mitrofanoff appendicovesicostomy procedure uses the appendix to create an easily accessible continent, catheterizable channel into the urinary bladder. Historically, the procedure is performed by an open surgical approach in prune belly patients. We describe our initial experience herein.Between October 2008 and February 2010 three patients with prune belly syndrome underwent RALMA. The appendicovesicostomy anastomosis was performed on the anterior bladder wall and the stoma was brought to the umbilical site or right lower quadrant. At least 4 cm of detrusor backing was ensured. The appendicovesicostomy stent was left in place for 4 weeks postoperatively before initiation of catheterization.Mean age at surgery was 9.7 years (range 5-14 years). Blood loss volume was 20 mL in each case. Overall mean operative time was 352 min (range 319-402 min). There were no intraoperative complications and no open conversions. There was one postoperative complication in the form of wound infection. All patients are catheterizing their stomas and are continent at an average follow-up of 14.7 months (range 5-21 months).In our initial experience, RALMA is a feasible option with encouraging early experience for creating a continent catheterizable channel into the urinary bladder in patients with prune belly syndrome.

Purpose To evaluate outcomes following laparoscopic heminephrectomy (LHN) in duplex kidneys in the pediatric population, focusing on the fate of the remnant moiety. Methods 142 patients underwent laparoscopic heminephrectomy for duplex kidney across 4 different institutions in the U.S. and Europe. Median age at surgery was 11.4 months. A retroperitoneoscopic approach was used in all patients, with 82 (57.7%) patients placed in posterior prone position (PPR), and 60 (42.3%) in lateral retroperitoneal (LRP). Follow up included routine ultrasound, and DMSA was performed in the event of abnormalities in ultrasound or postoperative course. Results Median operative time was 120 min. 11 patients (7.7%) required open conversion, the majority of which (8/11) occurred prior to 2000. Median hospital stay was 2 days and no major complications were observed. 7 patients (4.9%) developed a postoperative urinoma, and 1 patient required ureterectomy for urinary tract infection. With a median follow-up of 4.5 years, 7 children (4.9%) experienced significant loss of function in the remaining moiety, with 3 patients requiring completion nephrectomy. Of patients losing their remaining moiety, median age at surgery was 9 months [4 – 42], and all except 1 (6/7) had an upper pole heminephrectomy. Three patients in this group (42%) experienced an immediate postoperative complication (hematoma, UTI, urinoma). No consistent preoperative or technical factors were consistent in the renal loss group. Conclusions LHN for duplex kidney produces satisfactory outcomes in the pediatric population. With a median follow up of 4.5 years, we demonstrate a non-functioning renal moiety rate of 5%. We did not identify any clinical predictors of this outcome in our series, although upper pole heminephrectomy, patient age, and postoperative complications may be contributing factors.

INTRODUCTION AND OBJECTIVES: Patients with T1 highgrade (T1HG) bladder cancer represent a unique subset of urothelial carcinoma patients in whom both conservative and radical therapy may be advocated. Proponents of early cystectomy cite high rates of clinical understaging and eventual disease progression with conservative therapies. The purpose of this study was to identify clinical disease characteristics in a large cohort of patients predictive of final pathologic upstaging. METHODS: We performed a retrospective database review of all patients treated with radical cystectomy at 2 university urology centers from 1997–2007. All patients had histologic confirmation of high-grade urothelial cancer invasive into the lamina propria without muscle invasion prior to undergoing radical cystectomy. Pertinent preand postoperative clnical and pathologic factors were recorded and analyzed. Multivariate analysis was performed using Stata statistical software. RESULTS: Ninety patients undergoing radical cystectomy were clinical stage T1. Median age was 67 years (range: 48–87) and 72 patients (80%) were male. 59% of the cohort had multifocal disease and 37% had associated carcinoma in-situ (CIS) on transurethral resection. 51% of patients received intravesical BCG and 14% had other intravesical treatment prior to cystectomy. Thirty patients (33.3%) demonstrated pathologic upstaging at cystectomy, defined as pT2 and/or lymph node involvement. Seven of 90 patients (7.8%) had lymph node metastases at cystectomy, while 17 (18.9%) had extravesical disease. On multivariate analysis (Table 1) the presence of CIS was the only preoperative factor significantly associated with pathologic upstaging at radical cystectomy (p 0.03, OR 0.24 (0.06–0.89)). CONCLUSIONS: Clinical T1HG bladder cancer is an aggressive malignancy with a substantial risk of disease progression. Our data suggests that up to one-third of these patients were clinically understaged, and the presence of concomitant CIS is significantly associated with this finding. The lower incidence of adverse pathologic outcomes (LN , pT2) in our cohort compared to other T1HG series may be due to the emphasis on early cystectomy prior to progression in these patients.

Epidemiologic studies on testicular cancer have focused primarily on European countries. Global incidence and mortality have been less thoroughly evaluated.Our goal was to gain a better understanding of the most recent global age-standardized incidence and mortality rates for testicular cancer and to use these values to estimate a region's health care quality.Age-standardized incidence rate (ASIR) and age-standardized mortality rate (ASMR) for testicular cancer were obtained for men of all ages in 172 countries by using the GLOBOCAN 2008 database, reflecting the annual rate of cancer incidence and mortality per 100,000 men. These data were evaluated on a regional level to compare incidence and mortality rates. Global plots of these values were constructed to better visualize geographic distributions. Finally, the ratio of ASIR to ASMR was calculated as a method to assess each region's proficiency in diagnosing and effectively treating testicular cancer.ASIR and ASMR were analyzed by region, and each region's ratio of ASIR to ASMR was calculated.Testicular cancer ASIR is highest in Western Europe (7.8%), Northern Europe (6.7%), and Australia (6.5%). Asia and Africa had the lowest incidence (1.0%). ASMR was highest in Central America (0.7%), western Asia (0.6%), and Central and Eastern Europe (0.6%). Mortality was lowest in North America, Northern Europe, and Australia (0.1-0.2%). The ASIR-ASMR ratio was highest in Australia (65.0%) and lowest in western Africa (1.0%). National reporting systems varied by country, and data quality may have fluctuated between regions.Testicular cancer incidence remains highest in developed nations with primarily Caucasian populations. Variable ASIR-ASMR ratios suggest markedly different geographic-specific reporting mechanisms, access to care, and treatment capabilities.

Energy-based hemostasis of the prostatic vascular pedicles (PVP) during robot-assisted radical prostatectomy (RARP) may cause collateral thermal injury to adjacent neural tissue and has been shown to negatively impact sexual function recovery. The unique engineering design of the EnSeal(®) (Ethicon, Cincinnati, OH) has been demonstrated to limit collateral thermal tissue damage to1.0 mm. Use of tissue and instrument cooling before and during device activation may potentially further reduce thermal spread. As such, we sought to evaluate the collateral tissue effects of EnSeal with or without cold saline irrigation (CSI) during PVP control.The EnSeal Trio device was used for PVP control in 20 consecutive men undergoing bilateral, non-nerve-sparing RARP. Ipsilateral vascular pedicles were randomly selected to EnSeal plus CSI (4 °C) application to the tissue before and during device activation or EnSeal alone. The primary end point was the distance of thermal injury from the inked margin using both hematoxylin and eosin (HE) and terminal transferase uridyl nick end-labeling (TUNEL) apoptosis staining. A mean of three measurements was taken for each pedicle. Pathologic analysis was performed by a single, blinded uropathologist.Mean distance of thermal injury from the inked margin using HE staining was 0.31 mm (range 0.15-0.40 mm) and 0.98 mm (range 0.7-1.2 mm) for the EnSeal plus CSI and EnSeal alone, respectively (P0.0001). TUNEL staining also demonstrated lateral tissue damage of 0.39 mm (range 0.2-0.5 mm) and 1.12 mm (range 0.9-1.3 mm), respectively (P0.001). No complications related to hemostasis or postoperative bleeding were observed in the study.The hemostatic properties of EnSeal work effectively when submerged in CSI. Adjacent thermal tissue damage is significantly minimized with the addition of CSI. This may have a beneficial impact on nerve preservation and sexual function outcomes after RARP.