Quality-of-life outcomes of the ROBOtic-assisted versus Conventional Open Partial nephrectomy (ROBOCOP) II trial.

OBJECTIVES: To comprehensively compare quality-of-life (QoL) outcomes between open partial nephrectomy (OPN) and robot-assisted PN (RAPN) from the randomised ROBOtic-assisted versus Conventional Open Partial nephrectomy (ROBOCOP) II trial, as QoL data comparing OPN and RAPN are virtually non-existent, especially not from randomised controlled trials (RCTs). PATIENTS AND METHODS: The ROBOCOP II was a single-centre, open-label RCT between OPN and RAPN. The pre-planned analyses of QoL outcomes are presented. Data were analysed descriptively in a modified intention-to-treat population. RESULTS: A total of 50 patients underwent surgery. At postoperative Day 90 (POD90), there was no significant difference for the Kidney Disease Quality of Life-Short Form questionnaire score (mean [sd] OPN 72 [20] vs RAPN 76 [15], P = 0.850), while there were advantages for RAPN in the subdomains of 'Pain' (P = 0.006) and 'Physical functioning' (P = 0.011) immediately after surgery. For the European Organisation for Research and Treatment of Cancer quality of life questionnaire 30-item core there were overall advantages directly after surgery (mean [sd] score OPN 63 [20] vs RAPN 75 [17], P = 0.031), as well as for the subdomains 'Fatigue' (P = 0.026), 'Pain' (P = 0.002) and 'Constipation' (P = 0.045) but no differences at POD90. There were no differences for the EuroQoL five Dimensions five Levels questionnaire at POD90 (mean [sd] score OPN 70 [22] vs RAPN 72 [17], P = 1.0) or at any other time point. Finally, no significant differences were found for the overall Convalescence and Recovery Evaluation questionnaire score at POD90 (mean [sd] OPN 84 [13] vs RAPN 86 [10], P = 0.818) but less pain in the RAPN group (P = 0.017) directly after surgery. CONCLUSIONS: Pain and physical functioning as subdomains of QoL are improved after RAPN compared to OPN in the early postoperative course, while there are no differences anymore after 3 months.

Pubic bone osteomyelitis and fistulas after radiation therapy of the pelvic region: patient-reported outcomes and urological management of a rare but serious complication.

PURPOSE: This study investigated late urinary adverse events (UAEs) in patients who underwent pelvic radiation therapy, with a focus on occurrence, diagnostic characteristics and the impact of subsequent extirpative surgery with the need of urinary diversion on quality of life. METHODS: A retrospective analysis of 20 patients after pelvic radiotherapy (2016-2022) was conducted. Data included demographics, perioperative details, oncological parameters, and patient-reported outcomes. Imaging (CT, MRI) was examined for early manifestations of late UAEs. RESULTS: In the study cohort, prostate cancer was the primary malignancy in 85% with a mean radiation dose of 84 Gray over 35 days. Time to diagnosis of late UAEs was 4.0 years post-radiation. Radiological assessment demonstrated a progressive increase in typical CT and MRI features of pubic bone osteomyelitis over time. Surgical interventions, mainly cystectomy, were required with variable outcomes in patient-reported post-surgery quality of life. CONCLUSION: Diagnosing and managing late UAEs after pelvic radiation necessitate an understanding of their occurrence, diagnostic features and appropriate management strategies. Early imaging, particularly MRI, is crucial for timely diagnosis and treatment planning. Variable post-surgery quality of life underscores the importance of a multidisciplinary approach in managing late UAEs. The study contributes to understanding these complications and emphasizes their consideration in post-radiation follow-up care.

Cyclin A2 Expression as Predictive Biomarker in Muscle-Invasive Upper Tract Urothelial Carcinoma.

INTRODUCTION: The aim was to evaluate the prognostic value of altered Cyclin A2 (CCNA2) gene expression in upper tract urothelial carcinoma (UTUC) and to assess its predictive potential as a prognostic factor for overall survival (OS) and disease-free survival. METHODS: 62 patients who underwent surgical treatment for UTUC were included. Gene expression of CCNA2, MKI67, and p53 was analyzed by quantitative reverse transcriptase polymerase chain reaction. Survival analyses were performed using the Kaplan-Meier method and the log-rank test. For Cox regression analyses, uni- and multivariable hazard ratios were calculated. Spearman correlation was used to analyze correlation of CCNA2 expression with MKI67 and p53. RESULTS: The median age of the cohort was 73 years, and it consisted of 48 males (77.4%) and 14 females (22.6%). Patients with high CCNA2 expression levels showed longer OS (HR 0.33; 95% CI: 0.15-0.74; p = 0.0073). Multivariable Cox regression analyses identified CCNA2 overexpression (HR 0.37; 95% CI: 0.16-0.85; p = 0.0189) and grading G2 (vs. G3) (HR 0.39; 95% CI: 0.17-0.87; p = 0.0168) to be independent predictors for longer OS. CCNA2 expression correlated positively with MKI67 expression (Rho = 0.4376, p = 0.0005). CONCLUSION: Low CCNA2 expression is significantly associated with worse OS. Thus, CCNA2 might serve as a potential biomarker in muscle-invasive UTUC and may be used to characterize a subset of patients having an unfavorable outcome and for future risk assessment scores.

Perioperative Antibiotic Prophylaxis in Radical Prostatectomy: "Single-Shot" versus Multiday Regimen.

INTRODUCTION: Perioperative antibiotic prophylaxis (AP) is common in radical prostatectomy (RP). Yet there is no standard recommendation in international guidelines due to poor evidence. It is of great importance that these perioperative AP are sufficiently checked and systemically validated. The objective of this study was to determine whether a "single-shot" (single-use) perioperative AP yields equivalent results compared to a multiday prophylaxis in RP regarding postoperative wound infections and urinary tract infections. METHODS: 376 patients treated by RP at the University Medical Centre Mannheim, from 2014 to 2016, were included in this retrospective study. RP was performed either in a robotic-assisted or open manner. One group received an intravenous dose of perioperative AP with either ciprofloxacin or levofloxacin, continued by an oral dose of AP with ciprofloxacin or levofloxacin until catheter removal, while the other group received a single-shot intravenous perioperative AP with either ciprofloxacin or cefuroxime. RESULTS: There was no significant difference regarding the occurrence of postoperative infections between both AP regimes (p = 0.5). Age, body mass index, and ASA classification did not differ significantly between both groups (p > 0.25). Except for surgery time (p < 0.05), perioperative parameters, such as the preoperative presence of germ-free urine culture, length of hospital stay, catheter time, drain lay time, Gleason score, and TNM stadium, did not differ significantly. CONCLUSION: The present study shows that perioperative single-shot AP does not entail any disadvantage compared to the multiday AP in terms of postoperative infections after RP.

Predicting Complexity in Transurethral Resection of Bladder Tumours: External Validation and Modification of the Bladder Complexity Score.

INTRODUCTION: First external validation of the Bladder Complexity Score (BCS) for predicting complex transurethral resection of bladder tumours (TURBT). METHODS: For BCS calculation, TURBTs performed at our institution between January 2018 and December 2019 were reviewed for the presence of preoperative characteristics listed in the Bladder Complexity Checklist (BCC). Receiver operating characteristics (ROC) analysis was used for BCS validation. To establish a modified BCS (mBCS) with maximum area under the curve (AUC), multivariable logistic regression (MLR) analysis was performed with all BCC-characteristics for different definitions of complex TURBT. RESULTS: 723 TURBTs were included in statistical analyses. Cohort's mean BCS was 11.2 ± 2.4 points (range: 5.5-22 points). In ROC analysis, BCS could not predict complex TURBT (AUC 0.573 [95% CI: 0.517-0.628]). MLR identified tumour size (OR 2.662, p < 0.001), and tumour number > 10 (OR 6.390, p = 0.032) as sole predictors for the modified endpoint of complex TURBT defined as a procedure meeting > 1 criterion: incomplete resection, surgery > 1 h, intraoperative complication, postoperative complications Clavien-Dindo ≥ III. mBCS increased the prediction to an AUC of 0.770 (95% CI: 0.667-0.874). CONCLUSION: In this first external validation, BCS remained an insufficient predictor of complex TURBT. mBCS requires reduced parameters, is more predictive and easier to apply in clinical practice.

Perinephric Toxic Fat: Impact on Surgical Complexity, Perioperative Outcome, and Surgical Approach in Partial Nephrectomy.

INTRODUCTION: To assess influencing factors on perinephric toxic fat (high Mayo Adhesive Probability [MAP] score) and the impact of high MAP scores on surgical complexity, perioperative outcome, and surgical approach in patients with localized renal tumors undergoing open (OPN) and robot-assisted partial nephrectomy (RAPN). METHODS: 698 patients were included in this study. Based on preoperative imaging, adherent perinephric fat (APF) was assessed to define MAP scores. Regression analyses assessed influencing parameters for high MAP scores (≥3), predictors of surgical outcome, and influencing factors on surgical approach. RESULTS: OPN was performed in 331 (47%) patients, and 367 (53%) patients underwent RAPN. Male gender (p < 0.001), age ≥65 (p < 0.001), and BMI ≥27.4 kg/m2 (p < 0.001) showed to be significantly influencing factors for the presence of APF. High MAP scores showed to be an influencing factor for a prolonged surgery duration (OR = 1.68, 95% CI 1.22-2.31, p = 0.002) and a significant predictor to rather undergo OPN than RAPN (OR = 1.5, 95% CI 1.05-2.15, p = 0.027). CONCLUSION: Older, male patients with high BMI scores have a higher risk for APF. The presence of APF increases surgery time and may have an impact on decision making regarding the preferred surgical approach.

Perioperative Outcome of Thulium Laser Enucleation of the Prostate versus Robot-Assisted Simple Prostatectomy: A Propensity Score-Matched Analysis.

INTRODUCTION: The aim of this study was to investigate and compare clinical safety and efficiency of Thulium laser enucleation of the prostate (ThuLEP) and robot-assisted simple prostatectomy (RASP) for the treatment of large gland benign prostatic hyperplasia in a tertiary care center. METHODS: Perioperative data of 39 patients who underwent RASP in our institution from 2015 to 2021 was collected. Propensity score matching using prostate volume, patient age, and body mass index (BMI) was performed from a database of 1,100 Patients treated by ThuLEP from 2009 to 2021. A total of 76 patients were matched. Preoperative parameters such as BMI, age, and prostate volume, as well as intra- and postoperative parameters such as operation time, resection weight, transfusion rate, postoperative catheterization time, length of hospital stay (LoS), hemoglobin drop, postoperative urinary retention (PUR), Clavien-Dindo Classification (CDC), and the Combined Complication Index (CCI), were evaluated. RESULTS: There was no difference in mean hemoglobin drop (2.2 vs. 1.9 g/dL, p = 0.34), yet endoscopic surgery showed superiority in mean operation time (109 vs. 154 min, p < 0.001), mean postoperative catheterization time (3.3 vs. 7.2 days, p < 0.001), and mean LOS (5.4 vs. 8.4 days, p < 0.001). Complication rates evaluated by CDC (p = 0.11) and CCI (p = 0.89) were similar in both groups. Within the documented complications, transfusion rate (0 vs. 3, p = 0.08) and the occurrence of PUR (1 vs. 2, p = 0.5) showed no significant difference. CONCLUSION: ThuLEP and RASP show similar perioperative efficacy and a low rate of complications. ThuLEP had shorter operation times, shorter catheterization time, and a shorter LoS.

Robotic-Assisted Versus Conventional Open Partial Nephrectomy (Robocop): A Propensity Score-Matched Analysis of 249 Patients.

OBJECTIVES: The objective of this study was to compare open partial nephrectomy (OPN) and robotic-assisted PN (RAPN) based on a propensity score-matched sample and to test the Comprehensive Complication Index (CCI) as an end point for complications. METHODS: Patients undergoing PN from 2010 to 2018 at a university care center were included. OPN and RAPN cases were matched in a 2:1 ratio using propensity score-matching with age, gender, BMI, RENAL score, and tumor size as confounders. The primary end point was complications measured with the CCI as continuous score (0-100, 100 indicating death). RESULTS: Data of 570 patients were available. After matching, both cohorts (OPN = 166; RAPN = 83) showed no baseline differences. For the primary end point, CCI, RAPN was superior (RAPN 2.6 ± 7.9 vs. OPN 8.7 ± 13.9; p < 0.001). Additionally, RAPN was superior for length of stay (RAPN 6.5 ± 4.0 vs. OPN 7.4 ± 3.5 days; p < 0.001), hemoglobin drop (RAPN 2.8 ± 1.4 vs. OPN 3.8 ± 1.6 g/dL; p < 0.001), and drop of glomerular filtration rate (RAPN 11.4 ± 14.2 vs. OPN 19.5 ± 14.3 mL/min; p < 0.001). OPN had shorter operating times (RAPN 157 ± 43 vs. OPN 143 ± 45 min; p = 0.014) and less ischemia (RAPN 13% vs. OPN 28%; p = 0.016). CONCLUSIONS: RAPN provides superior short-term results regarding overall complications without compromising renal function for small and less complex tumors. However, OPN remains an important option for more complex and larger tumors.

Association of training level and outcome of software-based image fusion-guided targeted prostate biopsies.

PURPOSE: The aim of this study was to assess the impact of experience on the outcome of image fusion-guided prostate biopsies performed by urologists working at a high-volume medical center. METHODS: The first 210 consecutive fusion biopsies were analyzed following installation of the software-based biopsy platform Artemis™ (Eigen, USA). The impact of training was measured in terms of changes in prostate cancer detection rates and biopsy duration over time. We sought to identify a threshold of experience for urologists, which predicts higher detection rates of targeted biopsies. The influence of various factors on prostate cancer detection rates was evaluated using bi- and multivariate analysis. RESULTS: Twenty-two urologists (n = 9 senior urologists, n = 13 urological residents) performed targeted biopsies followed by systematic 12-core biopsies. Overall, targeted biopsies yielded a positive result in 39.6% of 260 suspicious MRI lesions. A subgroup analysis of the six urologists who performed more than ten biopsies was then conducted, and their level of experience (i.e., performance of more than eight biopsies) was found to be associated with higher detection rates than those with less experience (49.0% and 23.0%, respectively; p < 0.001) in the targeted biopsies. Experience was likewise a significant and independent predictor of a cancer-positive targeted biopsy (p = 0.002). Experienced senior physicians did not outperform residents in their targeted biopsy results. Further, biopsy duration correlated negatively (r = - 0.5931, p < 0.001) with the total number of biopsies performed for all subgroups during the period of assessment. CONCLUSIONS: Experience is an important predictor of the rate of detection in targeted biopsies using software-based biopsy platforms with semi-robotic assistance. Moreover, the performance of just a few procedures appears sufficient to increase biopsy effectiveness significantly. Lastly, supervision by experts is recommended during the training phase.

Maximizing efficiency and ensuring safety: Exploring the outcomes of 2 consecutive open radical cystectomies by the same team within a single surgical day.

BACKGROUND: The purpose of this study was to evaluate the outcomes of performing 2 consecutive open radical cystectomies (RCs) within 1 day by the same surgical team. PATIENTS AND METHODS: A retrospective analysis was conducted on data from patients who underwent RC at a single tertiary care center from January 2015 to February 2023. Patient characteristics, perioperative outcomes and endpoints were analyzed. Univariable and multivariable logistic regression models were created to predict major complications. RESULTS: A total of 657 patients were included in the final cohort, containing 64 paired RCs (32 RC1 and 32 RC2) and 593 single RCs. Major complications occurred in 24.7% of the entire cohort, with no significant differences between single RC vs. RC1 and RC2. Paired RCs showed significantly shorter operative time (OT; p = 0.001) and length of stay (LOS; p = 0.047) compared to single RCs. There were no significant differences in transfusion rates, 30-day readmission, 30-day mortality, or histopathological results between paired and single RCs. Multivariable analysis identified patient characteristics such as age (OR = 1.67, p = 0.03), sex (OR = 0.45, p = 0.008), BMI (OR = 1.98, p = 0.007), ASA-score (OR = 1.61, p = 0.04), and OT (OR = 1.87, p = 0.008) as independent predictors of major complications. CONCLUSION: Performing 2 consecutive open RCs within 1 day by the same surgical team is a safe approach in experienced hands. This strategy optimizes the utilization of surgical resources and addresses the growing demand for urologic care while maintaining high-quality patient care. Preoperative planning should consider patient-specific factors to minimize risks associated with major complications. MICRO ABSTRACT: This study evaluates the outcomes of performing 2 consecutive open radical cystectomies (RC) in a single day by the same surgical team. Data from 657 patients who underwent RC at a single tertiary medical center proved that this approach is safe, with no significant differences in major complications. Preoperative planning should consider patient-specific factors for efficient utilization of surgical resources.

Randomized Controlled Feasibility Trial of Robot-assisted Versus Conventional Open Partial Nephrectomy: The ROBOCOP II Study.

BACKGROUND: There is no evidence from randomized controlled trials (RCTs) comparing robot-assisted partial nephrectomy (RAPN) and open partial nephrectomy (OPN). OBJECTIVE: To assess the feasibility of trial recruitment and to compare surgical outcomes between RAPN and OPN. DESIGN, SETTING, AND PARTICIPANTS: ROBOCOP II was designed as single-center, open-label, feasibility RCT. Patients with suspected localized renal cell carcinoma referred for PN were randomized at a 1:1 ratio to either RAPN or OPN. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the feasibility of recruitment, assessed as the accrual rate. Secondary outcomes included perioperative and postoperative data. Data were analyzed descriptively in a modified intention-to-treat population consisting of randomized patients who underwent surgery. RESULTS AND LIMITATIONS: A total of 50 patients underwent RAPN or OPN (accrual rate 65%). In comparison to OPN, RAPN had lower blood loss (OPN 361 ml, standard deviation [SD] 238; RAPN 149 ml, SD 122; difference 212 ml, 95% confidence interval [CI] 105-320; p < 0.001), less need for opioids (OPN 46%; RAPN 16%; difference 30%, 95% CI 5-54; p = 0.024), and fewer complications according to the mean Comprehensive Complication Index (OPN 14, SD 16; RAPN 5, SD 15; difference 9, 95% CI 0-18; p = 0.008). OPN has a shorter operative time (OPN 112 min, SD 29; RAPN 130 min, SD 32; difference -18 min, 95% CI -35 to -1; p = 0.046) and warm ischemia time (OPN 8.7 min, SD 7.1; RAPN 15.4 min, SD 7.0; difference 6.7 min, 95% CI -10.7 to -2.7; p = 0.001). There were no differences between RAPN and OPN regarding postoperative kidney function. CONCLUSIONS: This first RCT comparing OPN and RAPN met the primary outcome of the feasibility of recruitment; however, the window for future RCTs is closing. Each approach has advantages over the other, and both remain safe and effective options. PATIENT SUMMARY: For patients with a kidney tumor, open surgery and robot-assisted keyhole surgery are both feasible and safe approaches for partial removal of the affected kidney. Each approach has known advantages. Long-term follow-up will explore differences in quality of life and cancer control outcomes.

Perioperative Outcomes and Complication Rates in Holmium Laser Enucleation of the Prostate Patients After Prior Prostate Biopsy-Does It Really Make a Difference? A Propensity Score Matched Analysis.

Introduction: Before holmium laser enucleation of the prostate (HoLEP), many patients have undergone short-term prostate biopsy (PB) to rule out the presence of prostate cancer. The aim of this study is to determine whether a short-term PB before HoLEP has an impact on the perioperative outcomes or complications of HoLEP. Methods: In total, 734 consecutive patients treated with HoLEP at a tertiary care university hospital between January 2021 and July 2023 were retrospectively enrolled. Patients who had PB within 6 months before HoLEP were matched to patients who underwent PB more than 6 months or had no PB before HoLEP using propensity score matching (PSM) based on age, prostate volume (PV), prostate-specific antigen (PSA), preoperative urinary tract infection (UTI), and surgeon. Perioperative parameters, such as operation time (OT), enucleation efficiency (EF), as well as complications according to the Satava classification, the Clavien-Dindo classification (CDC), and the Comprehensive Complication Index (CCI) were evaluated. Results: In total, 206 patients were matched. Age, PV, PSA, as well as the presence of a preoperative UTI and surgeons did not differ significantly between both groups after PSM. There were no significant differences in mean OT (75 vs. 81 minutes, p = 0.28) and EF (2.13 vs. 2.13 g/min, p = 0.99). No differences were noted regarding intraoperative (16 vs. 25, p = 0.16) or postoperative complications graded by CDC (p = 0.53) and CCI (p = 0.92). Conclusion: PB within 6 months preoperatively before HoLEP showed no effect on perioperative outcomes or intra- and postoperative complications.

A comprehensive molecular characterization of the 8q22.2 region reveals the prognostic relevance of OSR2 mRNA in muscle invasive bladder cancer.

Technological advances in molecular profiling have enabled the comprehensive identification of common regions of gene amplification on chromosomes (amplicons) in muscle invasive bladder cancer (MIBC). One such region is 8q22.2, which is largely unexplored in MIBC and could harbor genes with potential for outcome prediction or targeted therapy. To investigate the prognostic role of 8q22.2 and to compare different amplicon definitions, an in-silico analysis of 357 patients from The Cancer Genome Atlas, who underwent radical cystectomy for MIBC, was performed. Amplicons were generated using the GISTIC2.0 algorithm for copy number alterations (DNA_Amplicon) and z-score normalization for mRNA gene overexpression (RNA_Amplicon). Kaplan-Meier survival analysis, univariable, and multivariable Cox proportional hazard ratios were used to relate amplicons, genes, and clinical parameters to overall (OS) and disease-free survival (DFS). Analyses of the biological functions of 8q22.2 genes and genomic events in MIBC were performed to identify potential targets. Genes with prognostic significance from the in silico analysis were validated using RT-qPCR of MIBC tumor samples (n = 46). High 8q22.2 mRNA expression (RNA-AMP) was associated with lymph node metastases. Furthermore, 8q22.2 DNA and RNA amplified patients were more likely to show a luminal subtype (DNA_Amplicon_core: p = 0.029; RNA_Amplicon_core: p = 0.01). Overexpression of the 8q22.2 gene OSR2 predicted shortened DFS in univariable (HR [CI] 1.97 [1.2; 3.22]; p = 0.01) and multivariable in silico analysis (HR [CI] 1.91 [1.15; 3.16]; p = 0.01) and decreased OS (HR [CI] 6.25 [1.37; 28.38]; p = 0.0177) in RT-qPCR data analysis. Alterations in different levels of the 8q22.2 region are associated with manifestation of different clinical characteristics in MIBC. An in-depth comprehensive molecular characterization of genomic regions involved in cancer should include multiple genetic levels, such as DNA copy number alterations and mRNA gene expression, and could lead to a better molecular understanding. In this study, OSR2 is identified as a potential biomarker for survival prognosis.

Soft Urinary Bladder Phantom for Endoscopic Training.

Bladder cancer (BC) is the main disease in the urinary tract with a high recurrence rate and it is diagnosed by cystoscopy (CY). To train the CY procedures, a realistic bladder phantom with correct anatomy and physiological properties is highly required. Here, we report a soft bladder phantom (FlexBlad) that mimics many important features of a human bladder. Under filling, it shows a large volume expansion of more than 300% with a tunable compliance in the range of 12.2 ± 2.8 - 32.7 ± 5.4 mL cmH2O-1 by engineering the thickness of the bladder wall. By 3D printing and multi-step molding, detailed anatomical structures are represented on the inner bladder wall, including sub-millimeter blood vessels and reconfigurable bladder tumors. Endoscopic inspection and tumor biopsy were successfully performed. A multi-center study was carried out, where two groups of urologists with different experience levels executed consecutive CYs in the phantom and filled in questionnaires. The learning curves reveal that the FlexBlad has a positive effect in the endourological training across different skill levels. The statistical results validate the usability of the phantom as a valuable educational tool, and the dynamic feature expands its use as a versatile endoscopic training platform.

ROBOCOP II (ROBOtic assisted versus conventional open partial nephrectomy) randomised, controlled feasibility trial: clinical trial protocol.

INTRODUCTION: Randomised controlled trials comparing robotic-assisted partial nephrectomy (RAPN) and open PN (OPN) are lacking. Therefore, we aim to report the study protocol and a trial update for a randomised controlled feasibility trial comparing RAPN versus OPN for renal neoplasms. METHODS AND ANALYSIS: The ROBOtic assisted versus conventional Open Partial nephrectomy II trial is designed as a single-centre, randomised, open-label, feasibility trial. Participation will be offered to patients with renal neoplasms and deemed feasible for both, OPN and RAPN. We aim to enrol 50 patients within 15 months using a 1:1 allocation ratio. The primary endpoint of the trial is feasibility of recruitment and will be successful if one third of eligible patients agree to participate. Secondary endpoints include perioperative results, health-related quality of life, inflammatory response as well as surgical ergonomics of the operating team. If the primary outcome, feasibility of recruitment, is successful, the secondary results of the trial will be used for planning a confirmative phase III trial. ETHICS AND DISSEMINATION: Ethical approval was obtained from the local institutional review board (Ethik-Kommission II at Heidelberg University: 2020-542N). Results will be made publicly available in peer-reviewed scientific journals and presented at appropriate congresses and social media. TRIAL REGISTRATION NUMBER: NCT04534998.

Nephrometry Scores: The Effect of Imaging on Routine Read-out and Prediction of Outcome of Nephron-sparing Surgery.

BACKGROUND/AIM: This study investigated the impact of available preoperative imaging on the reliability and predictive accuracy of RENAL and PADUA nephrometry-scoring systems for renal tumors. PATIENTS AND METHODS: Five urologists determined RENAL and PADUA scores using preoperative imaging data (computed tomography and magnetic resonance imaging) of 100 patients admitted for partial nephrectomy with the following combinations: T0: transverse planes without excretory phase (EP), TC0: transverse and coronal planes without EP, TC1: transverse and coronal planes with EP. Reference standard was obtained by a uro-radiologist. Ischemia time was used as surrogate for surgical complexity. RESULTS: Assignment of EP significantly reduced interobserver-variability among urologists (p<0.0001). Predictive accuracy for surgical complexity or correct assignment to nephrometry risk groups did not depend on image planes or EP. CONCLUSION: Interobserver variability, but not predictive accuracy of nephrometric systems, is affected by additional usage of EP.

Interrupted versus continuous suturing for vesicourethral anastomosis during radical prostatectomy: protocol for a systematic review and meta-analysis.

INTRODUCTION: Radical prostatectomy is the mainstay of treatment for prostate cancer. The vesicourethral anastomosis is a critical step, which most likely impacts urinary continence and urethral stenosis. To date, it still remains unclear whether interrupted and continuous suturing for the anastomosis have different outcomes. Therefore, the aim of this systematic review and meta-analysis is to compare different suture techniques for vesicourethral anastomosis in terms of surgical and functional parameters. METHODS AND ANALYSIS: A comprehensive literature search will be conducted covering MEDLINE, Embase, Web of Science, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov. Studies comparing interrupted versus continuous suturing will be included in the analyses. No language restrictions will be applied. Screening, data extraction, statistical analysis and reporting will be done in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Quality assessment will be performed with the help of the Cochrane Collaboration's tool for assessing risk of bias and the Newcastle-Ottawa Scale for assessing quality of non-randomised studies. The quality of evidence will be evaluated with the Grading of Recommendations Assessment, Development and Evaluation. The primary outcome will be the time until removal of the urinary catheter. Secondary outcomes include rate of extravasation, length of hospital stay, time needed to perform the anastomosis, continence level at defined postoperative intervals and development of urethral strictures. Quantitative analysis will be calculated if meaningful. ETHICS AND DISSEMINATION: In order to meet the highest ethical and methodological standards. we followed the PRISMA Protocol 2015 checklist. Each item was answered appropriately. For systematic reviews the ethical issues are strictly methodological as only data that were published earlier will be used. The full manuscript will be submitted to a peer-reviewed journal. Furthermore, the results will be presented on national and international congresses. TRIAL REGISTRATION NUMBER: International prospective register of systematic reviews PROSPERO CRD42017076126.

Predictive value of molecular subtyping in NMIBC by RT-qPCR of ERBB2, ESR1, PGR and MKI67 from formalin fixed TUR biopsies.

Expression of ESR1, PGR, HER2 and Ki67 is important for risk stratification and therapy in breast cancer. Hormone receptor expression can also be found in MIBC, reflecting luminal and basal subtypes of breast cancer. Thus the purpose was to investigate on the mRNA expression of the aforementioned markers and their prognostic value in pT1 bladder cancer. Retrospective analysis of clinical data and Formalin-Fixed Paraffin-Embedded tissues (FFPE) of patients with stage pT1 NMIBC who underwent transurethral resection of the bladder was performed. mRNA expression was measured by single step RT-qPCR. Relative gene expression was determined by normalization to two housekeeping genes (CALM2, B2M) using the 40-ΔΔCT method. Correlation of mRNA expression with outcome was assessed using Kaplan-Meier analysis and multivariate Cox regression analysis. From overall 302 patients, 255 samples could be analyzed with valid measurements. Subtype distribution was Luminal-A in 11.4%, Luminal-B in 38.8%, triple negative in 36.9% and ERBB2 in 12.9%, respectively. Kaplan-Meier analysis revealed molecular subtyping being statistical significant for RFS (p=0.0408) and PFS (p=0.0039). Luminal-A patients did have the best RFS and PFS. Multivariate analysis revealed molecular subtyping to be significant for PFS (L-R Chi2 of 11.89, p=0.0078). Elevated expression of HER2 was statistically significant for PFS (p=0.0025) and discriminated among G3 tumors a high risk group (60% PFS) from a low risk risk group (90% PFS) after 5 year follow-up (p<0.001). Expression of ESR1, PGR and HER2 has predictive value in stage pT1 NMIBC and reveals potential therapeutic targets.

Metabolic Syndrome Negatively Impacts the Outcome of Localized Renal Cell Carcinoma.

The aim of this study was to analyze the impact of metabolic syndrome (MetS) on outcome of patients with localized renal cell carcinoma (RCC). A retrospective database was compiled consisting of 646 patients who underwent surgery for localized RCC between 2005 and 2014. A total of 439 patients were eligible for final analysis. For diagnosis of MetS, the WHO criteria of 1998 were used. Median follow-up was 32 months (ranging from 2 to 119). Kaplan-Meier and log-rank analyses were performed to compare patients with and without MetS or its components. Univariate and multivariate logistic regression identified prognostic factors for progression-free survival (PFS), cancer-specific survival (CSS), and overall survival (OS). In our cohort, 9.8% (n = 43) of patients were diagnosed with MetS. There were no differences between patients with and without MetS regarding clinicopathological parameters with the exception of patients' age (p = 0.002). Kaplan-Meier and log-rank analyses revealed a shorter PFS for patients with MetS (p = 0.018), whereas no differences were found for each of the single components of MetS, namely, diabetes mellitus (DM) (p = 0.332), BMI >30 kg/m2 (p = 0.753), hypertension (p = 0.451), and hypertriglyceridemia (p = 0.891). Logistic regression identified age (HR = 1.92, p = 0.03), tumor stage (HR = 4.37, p < 0.001), grading (HR = 4.57, p < 0.001), nodal status (HR = 3.73, p = 0.04), surgical margin (HR = 1.96, p = 0.04), concomitant sarcomatoid differentiation (HR = 5.06, p < 0.001), and MetS (HR = 1.98, p = 0.04) as independent factors for PFS. For CSS, only age (HR = 2.62, p = 0.035), tumor stage (HR = 3.06, p < 0.02), and grading (HR = 6.83, p < 0.001) were significant. In conclusion, patients with localized RCC and MetS show significantly reduced PFS and might profit from specific consultation and follow-up.

ESR1, ERBB2, and Ki67 mRNA expression predicts stage and grade of non-muscle-invasive bladder carcinoma (NMIBC).

Pathological staging and grading are crucial for risk assessment in non-muscle-invasive bladder cancer (NMIBC). Molecular grading might support pathological evaluation and minimize interobserver variability. In this study, the well-established breast cancer markers ESR1, PGR, ERBB2, and MKI67 were evaluated as potential molecular markers to support grading and staging in NMIBC. We retrospectively analyzed clinical data and formalin-fixed paraffin-embedded tissues (FFPE) of patients with NMIBC. Messenger RNA (mRNA) expression of the aforementioned markers was measured by single-step reverse transcription quantitative real-time polymerase chain reaction (RT-qPCR) using RNA-specific TaqMan assays. Relative gene expression was determined by normalization to two reference genes (CALM2 and B2M) using the 40-ΔΔCT method and correlated to histopathological stage and grade. Pathological assessment was performed by an experienced uropathologist. Statistical analysis was performed using the SAS software JMP 9.0.0 version and GraphPad Prism 5.04. Of 381 cases of NMIBC, samples of 100 pTa and 255 pT1 cases were included in the final study. Spearman rank correlation revealed significant correlations between grade and expression of MKI67 (r = 0.52, p < 0.0001), ESR1 (r = 0.25, p < 0.0001), and ERBB2 (r = 0.18, p = 0.0008). In Mann-Whitney tests, MKI67 was significantly different between all grades (p < 0.0001), while ESR1 (p = 0.0006) and ERBB2 (p = 0.027) were significantly different between G2 and G3. Higher expression of MKI67 (r = 0.49; p < 0.0001), ERBB2 (r = 0.22; p < 0.0001), and ESR1 (r = 0.18; p = 0.0009) mRNA was positively correlated with higher stage. MKI67 (p < 0.0001), ERBB2 (p = 0.0058), and PGR (p = 0.0007) were significantly different between pTa and pT1. In NMIBC expression of ESR1, ERBB2 and MKI67 are significantly different between stage and grade. This potentially provides objective parameters for pathological evaluation.