International consensus panel for transurethral resection of bladder tumours metrics: assessment of face and content validity.

OBJECTIVE: To develop performance metrics that objectively define a reference approach to a transurethral resection of bladder tumours (TURBT) procedure, seek consensus on the performance metrics from a group of international experts. METHODS: The characterisation of a reference approach to a TURBT procedure was performed by identifying phases and explicitly defined procedure events (i.e., steps, errors, and critical errors). An international panel of experienced urologists (i.e., Delphi panel) was then assembled to scrutinise the metrics using a modified Delphi process. Based on the panel's feedback, the proposed metrics could be edited, supplemented, or deleted. A voting process was conducted to establish the consensus level on the metrics. Consensus was defined as the panel majority (i.e., >80%) agreeing that the metric definitions were accurate and acceptable. The number of metric units before and after the Delphi meeting were presented. RESULTS: A core metrics group (i.e., characterisation group) deconstructed the TURBT procedure. The reference case was identified as an elective TURBT on a male patient, diagnosed after full diagnostic evaluation with three or fewer bladder tumours of ≤3 cm. The characterisation group identified six procedure phases, 60 procedure steps, 43 errors, and 40 critical errors. The metrics were presented to the Delphi panel which included 15 experts from six countries. After the Delphi, six procedure phases, 63 procedure steps, 47 errors, and 41 critical errors were identified. The Delphi panel achieved a 100% consensus. CONCLUSION: Performance metrics to characterise a reference approach to TURBT were developed and an international panel of experts reached 100% consensus on them. This consensus supports their face and content validity. The metrics can now be used for a proficiency-based progression training curriculum for TURBT.

Disposable grasper-integrated flexible cystoscope for ureteral stent removal in transplanted patients; focus on feasibility, safety, and patient experience. Results and micro-cost analysis from a tertiary referral center.

INTRODUCTION & OBJECTIVES: To evaluate ureteral stent removal (SR) using a grasper-integrated disposable flexible cystoscope (giFC-Isiris ®, Coloplast ®) after kidney transplantation (KT), with a focus on feasibility, safety, patient experience, and costs. MATERIAL AND METHODS: All consecutive KT undergoing SR through giFC were prospectively enrolled from January 2020 to June 2023. Patient characteristics, KT and SR details, urine culture results, antimicrobial prescriptions, and the incidence of urinary tract infections (UTI) within 1 month were recorded. A micro-cost analysis was conducted, making a comparison with the costs of SR with a reusable FC and grasper. RESULTS: A total of 136 KT patients were enrolled, including both single and double KT, with 148 stents removed in total. The median indwelling time was 34 days [26, 47]. SR was successfully performed in all cases. The median preparation and procedure times were 4 min [3,5]. and 45 s[30, 60], respectively. The median Visual Analog Scale (VAS) score was 3 [1, 5], and 98.2% of patients expressed willingness to undergo the procedure again. Only one episode of UTI involving the graft (0.7%) was recorded. Overall, the estimated cost per SR procedure with Isiris ® and the reusable FC was 289.2€ and 151,4€, respectively. CONCLUSIONS: This prospective series evaluated the use of Isiris ® for SR in a cohort of KT patients, demonstrating feasibility and high tolerance. The UTI incidence was 0.7% within 1 month. Based on the micro-cost analysis, estimated cost per procedure favored the reusable FC.

Single-use digital flexible cystoscope for double J removal versus reusable instruments: a prospective, comparative study of functionality, risk of infection, and costs.

BACKGROUND: The removal of ureteral stent can be performed with disposable or reusable flexible cystoscopes, but limited comparative data are available on functionality, risk of infections, and costs. METHODS: We performed a multicentric, prospective, observational study on patients undergoing in-office ureteral stent removal with Isiris-α® or a reusable Storz™ flexible cystoscope. Study endpoints were the functionality and effectiveness of the devices, the rate of postoperative bacteriuria and UTIs, and the costs of the procedure. RESULTS: A total of 135 patients were included, 80 (59.2%) treated with reusable cystoscopes and 55 (40.8%) with Isiris-α®. No significant baseline differences between groups were detected. Isiris-α® outperformed the reusable device in terms of quality of vision (p 0.001), manoeuvrability (p 0.001), grasper functionality (p < 0.001), and quality of the procedure (p 0.01). Mean procedure time was shorter with Isiris-α® (p < 0.001) due to a shorter instrument preparation time (p < 0.001). No differences were found in terms of perceived patient pain (p 0.34), nor postoperative bacteriuria or symptomatic UTIs. According to our cost analysis, the in-office procedure performed with Isiris-α® was more expensive (+ 137.8€) but was independent from instrument turnover or disinfection. Among limitations of study we acknowledge the lack of randomization, the use of antibiotic prophylaxis in several patients, and the high rate of missing preoperative urine cultures. CONCLUSIONS: Isiris-α® outperforms reusable cystoscopes for in-office ureteral stent removal in terms of total operative time and quality of the procedure, at the cost of being more expensive. No significant differences in postoperative bacteriuria or symptomatic UTIs were found.

The impact of single-use digital flexible cystoscope for double J removal on hospital costs and work organization: A multicentric evaluation.

BACKGROUND: Isiris-α® is a single-use digital flexible cystoscope with an integrated grasper designed for double J (DJ) stent removal. Aim of this study was to conduct a multicentric evaluation of the costs and criticalities of stent removals performed with Isiris®-α in different hospitals and health systems, as compared to other DJ removal procedures. METHODS: After gathering 10 institutions worldwide with experience on Isiris-α®, we performed an analysis of the reported costs of DJ removal with Isiris-α®, as compared to the traditional reusable equipment used in each institution. The cost evaluation included instrument purchase, Endoscopic Room (EnR)/ Operatory Room (OR) occupancy, medical staff, instrument disposal, maintenance, repairs, decontamination or sterilization of reusable devices. RESULTS: The main factor affecting the costs of the procedure was OR/EnR occupancy. Decontamination and sterilization accounted for a less important part of total costs. Isiris-α® was more profitable in institutions where DJ removal is usually performed in the EnR/OR, allowing to transfer the procedure to outpatient clinic, with a significant cost saving and EnR/OR time saving to be allocated to other activities. In the only institution where DJ removal was already performed in outpatient clinics, there is a slight cost difference in favor of reusable instruments in high-volume institutions, given a sufficient number to guarantee the turnover. CONCLUSION: Isiris-α® leads to significant cost benefit in the institutions where DJ removal is routinely performed in EnR/OR, and brings significant improvement in organization, cost impact and turnover.

Outcomes and Cost Evaluation Related to a Single-Use, Disposable Ureteric Stent Removal System: a Systematic Review of the Literature.

PURPOSE OF REVIEW: To present the latest evidence related to the outcomes and cost of single-use, disposable ureteric stent removal system (Isiris). RECENT FINDINGS: Our review suggests that compared to a reusable flexible cystoscope (re-FC), a disposable flexible cystoscope (d-FC) with built-in grasper (Isiris) significantly reduced procedural time and provided a cost benefit when the latter was used in a ward or outpatient clinic-based setting. The use of d-FC also allowed endoscopy slots to be used for other urgent diagnostic procedures. Disposable FCs are effective and safe for ureteric stent removal. They offer greater flexibility and, in most cases, have been demonstrated to be cost-effective compared to re-FCs. They are at their most useful in remote, low-volume centres, in less well-developed countries and in centres where large demand is placed on endoscopy resources.

How uro-oncology has been affected by COVID-19 emergency? Data from Piedmont/Valle d'Aosta Oncological Network, Italy.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) pandemic has dramatically hit all Europe and Northern Italy in particular. The reallocation of medical resources has caused a sharp reduction in the activity of many medical disciplines, including urology. The restricted availability of resources is expected to cause a delay in the treatment of urological cancers and to negatively influence the clinical history of many cancer patients. In this study, we describe COVID-19 impact on uro-oncological management in Piedmont/Valle d'Aosta, estimating its future impact. METHODS: We performed an online survey in 12 urological centers, belonging to the Oncological Network of Piedmont/Valle d'Aosta, to estimate the impact of COVID-19 emergency on their practice. On this basis, we then estimated the medical working capacity needed to absorb all postponed uro-oncological procedures. RESULTS: Most centers (77%) declared to be "much"/"very much" affected by COVID-19 emergency. If uro-oncological consultations for newly diagnosed cancers were often maintained, follow-up consultations were more than halved or even suspended in around two out of three centers. In-office and day-hospital procedures were generally only mildly reduced, whereas major uro-oncological procedures were more than halved or even suspended in 60% of centers. To clear waiting list backlog, the urological working capacity should dramatically increase in the next months; delays greater than 1 month are expected for more than 50% of uro-oncological procedures. CONCLUSIONS: COVID-19 emergency has dramatically slowed down uro-oncological activity in Piedmont and Valle d'Aosta. Ideally, uro-oncological patients should be referred to COVID-19-free tertiary urological centers to ensure a timely management.

The Cancer of the Bladder Risk Assessment (COBRA) score for estimating cancer-specific survival after radical cystectomy: external validation in a large bi-institutional cohort.

OBJECTIVE: To perform an external validation of the Cancer of the Bladder Risk Assessment (COBRA) score for estimating cancer-specific survival (CSS) after radical cystectomy (RC) in a large bi-institutional cohort of patients. PATIENTS AND METHODS: Patients treated with RC and lymph node dissection (LND) between May 1996 and July 2017 were retrieved from the RC databases of Leuven and Turin. Collected variables were age at RC, tumour stage, lymph node (LN) density, neoadjuvant chemotherapy, the extent of LND, and nodal stage. The primary outcome was CSS visualised using Kaplan-Meier plots. Cox proportional hazard models were used to assess the impact of variables on CSS. We performed a pairwise comparison between the COBRA score levels using a log-rank test corrected by Bonferroni, and developed a simplified COBRA score with three risk categories. To compare models, we assessed concordance indices (C-indices), receiver operating characteristic curves with area under the curve (AUC), calibration plots, and decision curve analysis (DCA). Finally, we compared both COBRA and simplified COBRA models with the established American Joint Committee on Cancer (AJCC) model. RESULTS: A total of 812 patients were included. All COBRA score variables had a significant impact on CSS in a Cox proportional hazard model. However, pairwise comparison of the COBRA subscores could not differentiate significantly between all COBRA score levels. Based on these findings, we developed a simplified COBRA score by introducing three categories within the following COBRA score ranges: low- (0-1) vs intermediate- (2-4) vs high-risk (5-7). A pairwise comparison could discriminate significantly between all COBRA risk categories. When finally comparing COBRA and simplified COBRA models with the AJCC model, AJCC performed better than both. C-indices, AUCs, calibration plots and DCA for AJCC were all better compared with the original and simplified COBRA models. CONCLUSION: We performed an external validation of the COBRA score in a large bi-institutional cohort. We observed that several risk groups had overlapping CSS, demonstrating suboptimal performance of the COBRA score. Therefore, we constructed a simplified model with three COBRA score risk categories. This model resulted in demarcated risk groups with non-overlapping CSS and good predictive accuracy. However, both COBRA score models were outperformed by the AJCC staging system. Therefore, we conclude that the AJCC staging system should remain the current standard for stratifying patients after RC for CSS.

Risk Stratification Tools and Prognostic Models in Non-muscle-invasive Bladder Cancer: A Critical Assessment from the European Association of Urology Non-muscle-invasive Bladder Cancer Guidelines Panel.

CONTEXT: This review focuses on the most widely used risk stratification and prediction tools for non-muscle-invasive bladder cancer (NMIBC). OBJECTIVE: To assess the clinical use and relevance of risk stratification and prediction tools to enhance clinical decision making and counselling of patients with NMIBC. EVIDENCE ACQUISITION: The most frequent, currently used risk stratification tools and prognostic models for NMIBC patients were identified by the members of the European Association of Urology (EAU) Guidelines Panel on NMIBC. EVIDENCE SYNTHESIS: The 2006 European Organization for Research and Treatment of Cancer (EORTC) risk tables are the most widely used and validated tools for risk stratification and prognosis prediction in NMIBC patients. The EAU risk categories constitute a simple alternative to the EORTC risk tables and can be used for comparable risk stratification. In the subgroup of NMIBC patients treated with a short maintenance schedule of bacillus Calmette-Guerin (BCG), the Club Urológico Español de Tratamiento Oncológico (CUETO) scoring model is more accurate than the EORTC risk tables. Both the EORTC risk tables and the CUETO scoring model overestimate the recurrence and progression risks in patients treated according to current guidelines. The new concept of conditional recurrence and progression estimates is very promising during follow-up but should be validated. CONCLUSIONS: Risk stratification and prognostic models enable outcome comparisons and standardisation of treatment and follow-up. At present, none of the available risk stratification and prognostic models reflects current standards of treatment. The EORTC risk tables and CUETO scoring model should be updated with previously unavailable data and recalculated. PATIENT SUMMARY: Non-muscle-invasive bladder cancer is a heterogeneous disease. A risk-based therapeutic approach is recommended. We present available risk stratification and prediction tools and the degree of their validation with the aim to increase their use in everyday clinical practice.

Cell-cycle Progression-score Might Improve the Current Risk Assessment in Newly Diagnosed Prostate Cancer Patients.

OBJECTIVE: To assess whether cell-cycle progression (CCP)-score (Prolaris) can improve the current risk assessment in newly diagnosed prostate cancer (PCa) patients. CCP-score is a well-validated prognostic assay predictive of PCa death, biochemical recurrence, and progression. METHODS: We evaluated CCP-score at biopsy in 52 patients newly diagnosed with PCa who underwent radical prostatectomy. CCP-score was calculated as average RNA expression of 31 CCP genes, normalized to 15 housekeeping genes. The predictive ability of CCP-score was assessed in univariate and multivariate analyses, and compared to that of Ki-67 levels and traditional clinical variables including prostate-specific antigen, Gleason score, stage, and percentage of positive cores at biopsy. RESULTS: In spite of an overall good accuracy in attributing the correct risk class, 7 high-risk and 13 intermediate-risk patients were misclassified by the Prolaris test. On analysis of variance, mean CCP-score significantly differed across different risk classes based on pathologic results (-1.2 in low risk, -0.444 in intermediate risk, 0.208 in high risk). CCP-score was a significant predictor of high-risk PCa both on univariate and multivariate analyses, after adjusting for clinical variables. Combining CCP-score and the European Association of Urology clinical risk assessment improved the accuracy of risk attribution by around 10%, up to 87.8%. CCP-score was a significant predictor of biochemical recurrence, but only on univariate analysis. CONCLUSION: The CCP-score might provide important new information to risk assessment of newly diagnosed PCa in addition to traditional clinical variables. A correct risk attribution is essential to tailor the best treatment for each patient.

Clinical and cost effectiveness of hexaminolevulinate-guided blue-light cystoscopy: evidence review and updated expert recommendations.

CONTEXT: Non-muscle-invasive bladder cancer (NMIBC) is associated with a high recurrence risk, partly because of the persistence of lesions following transurethral resection of bladder tumour (TURBT) due to the presence of multiple lesions and the difficulty in identifying the exact extent and location of tumours using standard white-light cystoscopy (WLC). Hexaminolevulinate (HAL) is an optical-imaging agent used with blue-light cystoscopy (BLC) in NMIBC diagnosis. Increasing evidence from long-term follow-up confirms the benefits of BLC over WLC in terms of increased detection and reduced recurrence rates. OBJECTIVE: To provide updated expert guidance on the optimal use of HAL-guided cystoscopy in clinical practice to improve management of patients with NMIBC, based on a review of the most recent data on clinical and cost effectiveness and expert input. EVIDENCE ACQUISITION: PubMed and conference searches, supplemented by personal experience. EVIDENCE SYNTHESIS: Based on published data, it is recommended that BLC be used for all patients at initial TURBT to increase lesion detection and improve resection quality, thereby reducing recurrence and improving outcomes for patients. BLC is particularly useful in patients with abnormal urine cytology but no evidence of lesions on WLC, as it can detect carcinoma in situ that is difficult to visualise on WLC. In addition, personal experience of the authors indicates that HAL-guided BLC can be used as part of routine inpatient cystoscopic assessment following initial TURBT to confirm the efficacy of treatment and to identify any previously missed or recurrent tumours. Health economic modelling indicates that the use of HAL to assist primary TURBT is no more expensive than WLC alone and will result in improved quality-adjusted life-years and reduced costs over time. CONCLUSIONS: HAL-guided BLC is a clinically effective and cost-effective tool for improving NMIBC detection and management, thereby reducing the burden of disease for patients and the health care system. PATIENT SUMMARY: Blue-light cystoscopy (BLC) helps the urologist identify bladder tumours that may be difficult to see using standard white-light cystoscopy (WLC). As a result, the amount of tumour that is surgically removed is increased, and the risk of tumour recurrence is reduced. Although use of BLC means that the initial operation costs more than it would if only WLC were used, over time the total costs of managing bladder cancer are reduced because patients do not need as many additional operations for recurrent tumours.

Costs in surgical techniques for radical prostatectomy: a review of the current state.

INTRODUCTION: We carried out a mini-review of the literature in order to obtain a snapshot of the present state of the art of surgical techniques costs available for radical prostatectomy. MATERIALS AND METHODS: We developed a MEDLINE search strategy and one economist assessed the included studies using the NHS EED guidelines for reviewers. RESULTS: When observing costs by the author, it is possible to trace up a trend line of increasing costs which starts off with RPP, passes through RRP and LRP and ends up with robot-assisted radical prostatectomy. Two studies do not agree with this. One author claims that LRP is less costly than radical retropubic prostatectomy whereas another one agrees on radical perineal prostatectomy and radical retropubic prostatectomy but does not on RAP, which he claims to be less costly. CONCLUSIONS: The data shown in our study outline a situation by which the observed studies highlight: different costs of the techniques and incapability to achieve a conclusion about the technique with less average costs. These results can be considered in an explorative way and cannot be generalized. They maintain a strictly approximate value in local realities having only an informative purpose.