OBJECTIVES:Positive surgical margins (PSMs) after robot-assisted radical prostatectomy (RARP) increase the risk of prostate cancer recurrence, often requiring salvage treatments that may compromise functional recovery. Intraoperative frozen section can detect PSM but is not feasible as a routine approach in most settings. Ex vivo fluorescence confocal microscopy (FCM) provides a rapid, real-time alternative, though evidence remains limited and knowledge gaps persist. This international Delphi consensus aimed to define expert recommendations on the clinical application of and workflow and research priorities for the safe integration of FCM during RARP. MATERIAL AND METHODS:A modified Delphi process was conducted following the RAND/UCLA Appropriateness Method and reported according to the ACCORD checklist. In total, 32 international experts in urology and pathology participated in a hybrid consensus meeting after structured literature review and preparatory online sessions. Forty-four evidence-based multiple-choice items across patient selection, image acquisition, and surgical management domains were developed and anonymously voted on via a secure online platform. Consensus was predefined as ≥80% agreement among respondents. RESULTS:Consensus was achieved for 24 of 44 items (55%). Key agreements included a risk-adapted use of FCM (97%), its role as an adjunct to magnetic resonance imaging for nerve-sparing decisions (87%), adoption of en-face imaging as the preferred FCM technique (82%), and a maximum reporting time of 30 min (85%). The panel endorsed formal certification for image interpretation (83%), standardized reporting of positive margin length (82%), and feasibility of remote intra-institutional reporting (84%). Larger (>3 mm) PSM in high-risk cases warranted complete neurovascular bundle resection (96%). CONCLUSIONS:This consensus provides a structured framework for the intraoperative use of FCM during RARP, defining its indications, workflow standards, and training requirements. Future multicentre studies are needed to assess its oncological and functional impact and to establish standardized implementation pathways.
BACKGROUND:Work-related musculoskeletal disorders are a growing concern in surgical practice, particularly in the context of robot-assisted surgery. Physical strain can significantly impact the well-being and performance of surgeons and surgical staff. This study aimed to evaluate the prevalence and severity of surgical strain among urologists using different available surgical platforms. METHODS:An anonymized, web-based survey was conducted between March and October 2024 using the REDCap platform. Distributed via professional networks and social media, the survey collected data on demographics, surgical experience, platform usage, and self-reported physical discomfort. Statistical analysis included Mann-Whitney U and Chi-squared tests, with P<0.05 considered significant. RESULTS:A total of 427 urologists participated. Most console surgeons (up to 83% for one robotic system variant) reported some level of physical discomfort. Discomfort was also reported by 83% of open surgeons and 80% of bedside assistants, the latter of whom had the highest incidence of injury (53%) from robotic arms. A noteworthy subset of survey respondents required physiotherapy (13-15%), medical (6-11%), or surgical (2-3.8%) interventions due to physical strain. No significant differences were observed by age or sex among console users. CONCLUSIONS:Ergonomic strain is prevalent among urologic surgeons, regardless of surgical platform, with bedside assistants particularly vulnerable. These findings underscore the need for ergonomic training, physical conditioning, and design improvements in surgical systems to safeguard surgeon health and maintain procedural efficacy.
Background For nearly two decades, the Phoenix criteria (a rise of 2ng/mL above the nadir PSA following radiotherapy) have served as the universal standard for defining recurrence in prostate cancer (PCa) patients after definitive treatment with radiotherapy. However, the advent of prostate-specific membrane antigen positron emission tomography (PSMA-PET) has redefined the diagnostic landscape, challenging the adequacy of PSA-only thresholds and enabling earlier and more price detection of disease relapse. Objective This review evaluates the literature regarding PSMA-PET positivity across PSA levels—including those below the Phoenix criteria threshold—and correlates them with diagnoses of biochemical recurrence (BCR) in men with PCa treated with radiotherapy, aiming to challenge the framework for defining PCa recurrence in this population. Methods We conducted a narrative review of recent prospective trials, cohort studies, and systematic reviews/meta-analyses assessing PSMA-PET-guided detection of BCR, summarising reported detection rates across PSA strata and key effect estimates from the existing literature. Detection rates were evaluated according to PSA levels, risk stratification systems, and guideline recommendations. Results The eleven studies reviewed revealed that PSMA PET had significant relapse detection rates at multiple PSA strata below the Phoenix threshold, with detection rates of 54% (PSA 0.2–0.49 ng/mL), 80% (PSA 0.5–0.99 ng/mL), and 88% (PSA 1–1.99 ng/mL), and pooled rates reaching 99% at PSA 2–5 ng/mL. A review of the latest international guidelines demonstrated widespread endorsement of routine PSMA-PET use in the diagnostic pathway of men with BCR following radiotherapy, underscoring its value for earlier disease relapse detection, precise localisation, and expedient intervention. Conclusions Post-radiotherapy, the Phoenix definition for BCR appears increasingly misaligned with contemporary clinical practice, given that up to 90% of men show PSMA-PET evidence of recurrence before reaching its PSA threshold of 2 ng/mL. Furthermore, PSMA-PET has undoubtedly improved the detection, management, and therapeutic outcomes of men with biochemical relapse subsequent to radiotherapy. Our findings support a shift toward recurrence definitions that integrate PSA kinetics with PSMA-PET as precise and timely tool to diagnose disease relapse and improve prostate cancer care following radiotherapy.
OBJECTIVE:To assess adherence of self-labelled proficiency-based progression (PBP) studies to evidence-based PBP criteria and examine associations with training outcomes. METHODS:A systematic review and meta-analysis were conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered in the International Prospective Register of Systematic Reviews. PubMed, CENTRAL, EMBASE, MEDLINE, and Scopus were searched from inception to 1 March 2023. Prospective English-language studies on healthcare procedural training reporting objective performance outcomes were included; non-prospective, non-quantitative, non-procedural, non-English studies, and reviews were excluded. Pre-specified outcomes included adherence to 18 evidence-based PBP criteria and objective performance metrics (errors, steps, time); secondary outcomes included proficiency benchmark achievement and Likert ratings. Data extraction was performed independently by multiple reviewers. Study quality was assessed using the Medical Education Research Study Quality Instrument and risk of bias by two investigators. Effect sizes were pooled using random-effects models (DerSimonian-Laird), expressed as the ratio of means (ROM) for continuous outcomes and bias-corrected odds ratios for dichotomous outcomes. RESULTS:Of 646 studies identified 175 met inclusion criteria. In the PBP studies (n = 18), 94% fulfilled minimum criteria (use of a proficiency benchmark, its quantitative definition, and requirement for demonstration prior to progression) vs 36% of non-PBP studies (n = 157). If all PBP criteria were included, 83% of PBP studies used these criteria vs only 2% of non-PBP-studies. In quantitative analysis (27 randomised clinical studies, 761 participants), ROM results showed that PBP training reduced the number of performance errors by 58% (P < 0.001) and procedural time by 28% (P = 0.006), increasing number of steps performed by 22% (P = 0.03). When stratified based on number of criteria fulfilled, meta-regression demonstrated that increasing the number of PBP criteria fulfilled was associated with progressive and systematic trainee performance improvement. CONCLUSIONS:The more training methodologies adhere to established PBP criteria, the better training outcome will be.
BACKGROUND:Minimally invasive surgical techniques (MISTs) are becoming an increasingly popular outpatient treatment option for lower urinary tract symptoms. Although generally well-tolerated, MISTs may cause periprocedural discomfort. Virtual reality devices (VRDs) have been shown to reduce patient-reported pain during several procedures. This study aims to evaluate whether the use of VRD during MISTs could improve perioperative endovenous sedation needs of a VRD during MISTs in a case-control design. METHODS:We retrospectively analyzed patient data from MISTs performed between January 2024 and July 2025 at a single referral center (ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy). Procedures were conducted with or without a VRD (HypnoVR®, Strasbourg, France), based on patient preference and device availability. Patients were grouped into MISTs without VRD (group 1) and MISTs with VRD (group 2). Periprocedural data, endovenous sedation needs, Visual Analogue Scale (VAS) score for pain, use of additional painkiller drugs after the procedure, and complication rate have been addressed. RESULTS:Twenty-one procedures with VRD and 66 control procedures were analyzed. Groups were comparable in age, prostate volume, PSA, indwelling catheter presence, and type of MIST. Median (IQR) prostate volume was 41 (30-56) mL in group 1 and 36 (30-45) mL in group 2. MIST distribution was similar, though iTIND procedures were more frequent with VRD. Endovenous sedation rate was higher in group 1 (86.4 vs. 38.1%, p < 0.001). Median (IQR) VAS scores were 2 (1-2) in group 1 and 1.5 (1-2.75) in group 2. No VRD-related side effects or procedure interruptions occurred. CONCLUSION:This is the first study demonstrating the safety, feasibility, and tolerability of VRD use during MISTs. Although VRD did not significantly reduce pain scores, it markedly decreased endovenous sedation use, potentially facilitating faster recovery and discharge. VRD may be considered for patients undergoing MISTs where available.
We report the results of a prospective trial aimed at describing the feasibility and accuracy of prostate-specific membrane antigen (PSMA) radio-guided surgery (RGS) during robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND) in patients with prostate cancer (PCa). This was a phase 2 study (NCT04832958) that enrolled 82 patients with localized PCa and a lymph node invasion (LNI) risk >5%. All patients underwent preoperative PSMA positron emission tomography (PET). [99mTc]Tc-PSMA-I&S was administered intravenously the day before surgery, followed by single-photon emission computed tomography/computed tomography. Side effects, perioperative outcomes, and the performance characteristics of PSMA-RGS for LNI detection were measured. A total of 62 patients completed all study procedures and were included in the final analyses. Median blood loss and length of stay were 50 ml and 4 d, respectively. No adverse events after tracer administration or intraoperative complications were recorded. Four patients experienced a Clavien-Dindo grade 3 complication within 30 d. Overall, PSMA-RGS identified two additional patients with high-risk PCa and pathologically node-positive (pN1) disease compared with preoperative PSMA PET, exhibiting a lower positive predictive value (PPV) and a similar negative predictive value (NPV) in the per-patient analysis (PPV: 50% vs 70%; NPV: 83% vs 83%). The PPV and NPV at per-region analysis in patients with molecular imaging node-positive (miN1) disease were higher for PSMA-RGS than for PSMA PET (PPV: 55% vs 42%; NPV: 85% vs 81%). In conclusion, PSMA-RGS identifies additional patients with pN1 disease missed by preoperative PSMA-PET among men with high-risk PCa, and extends the ePLND template in patients with miN1 disease, in whom PSMA PET underestimates the nodal burden. However, its NPV is suboptimal for avoiding ePLND in patients with PCa who have a LNI risk >5% and negative PSMA-RGS findings during RARP.
BACKGROUND AND OBJECTIVE:Flexible cystoscopy is one of the most frequently performed diagnostic procedures in urology. Despite its routine nature, significant variability exists in how it is performed across institutions and countries, reflecting a lack of procedural standardization. Metric-based approaches have been effectively used in other surgical domains to characterize and objectively assess performance, but no such framework has previously been established for cystoscopy. The aim of the current study is to develop and achieve expert consensus on performance metrics for flexible cystoscopy through a modified Delphi consensus. METHODS:The study followed a validated methodological framework of metric-based performance analysis previously applied to an image-guided procedure. The study consisted of two phases: (1) procedure characterization and metrics development and (2) face and content validation through an in-person modified Delphi panel of 13 urologists, held at ORSI Academy (Melle, Belgium) on September 25, 2025. The preliminary metrics, comprising six procedural phases, 24 steps, 24 errors, and 16 critical errors (CEs), were developed through literature review, video analysis, and expert discussion. During the Delphi meeting, 14 international experts (urologists and one behavioral scientist) reviewed, discussed, and refined each metric element until ≥80% agreement was achieved. RESULTS:Consensus was unanimous (100%) for all procedural components. After editing, the final metrics include six phases, 24 steps, 25 errors, and 16 CEs. Beyond metric modifications and language refinements, discussions addressed the role of antibiotic prophylaxis, preprocedural urine cultures, patient positioning, and irrigation control. CONCLUSION:This Delphi consensus represents the first international, structured effort to define standardized, performance-based metrics for flexible cystoscopy. The resulting metrics provide an objective, reproducible framework for describing optimal and suboptimal performance and will serve as the foundation for future validation, educational implementation, and quality assurance initiatives in endourology.
BACKGROUND AND OBJECTIVE:Prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is increasingly used for prostate cancer staging. However, the diagnostic role of molecular imaging for patients with rising prostate-specific antigen (PSA) levels following radical prostatectomy and postoperative radiation therapy remains unknown. We performed a systematic review and meta-analysis to assess the diagnostic performance and recurrence patterns detected by PSMA PET in this specific setting. METHODS:PubMed/MEDLINE, Cochrane library's Central, EMBASE, and Scopus were searched from database inception to September 1, 2025. Studies reporting PSMA PET findings in men with rising PSA levels after radical prostatectomy and postoperative radiotherapy were included. Pooled detection rates were calculated using random-effects meta-analysis. Site-specific recurrence patterns and PSA-dependent positivity were analyzed. Risk of bias was assessed using Quality Assessment of Diagnostic Accuracy Studies-2, and the certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation. KEY FINDINGS AND LIMITATIONS:A total of eight studies including 940 patients were analyzed. The pooled PSMA PET positivity rate was 83% (95% confidence interval [CI]: 0.75-0.89), with significant heterogeneity. When stratified by site, positivity rates were 7% for local recurrence, 42% for nodal disease, and 31% for distant metastases. PSMA PET positivity increased with PSA level, from approximately 72% at a PSA level of 0.2 ng/ml to >90% at a PSA level of ≥2.0 ng/ml. Interpretation is limited due to heterogeneity, observational designs, and incomplete reporting of key clinical variables. CONCLUSIONS AND CLINICAL IMPLICATIONS:The use of PSMA PET demonstrates high detection rates in men with rising PSA following radical prostatectomy and postoperative radiation therapy, even at low PSA levels. Recurrence is rarely located in the prostatic bed and more commonly involves nodal or distant sites. Despite limitations in evidence certainty, these findings support PSMA PET as a valuable restaging tool in this setting and underscore the need for further studies to optimize its timing and integration into salvage treatment strategies. PATIENT SUMMARY:In this study we explored how well the PSMA PET works as a diagnostic tool in the setting of a PSA increase after radical prostatectomy plus radiotherapy. We found that PSMA PET was informative about the location of recurrence at an early stage, even at low PSA levels. These results may help clinicians in the early diagnosis of recurrent prostate cancer and in potential salvage treatments.
BACKGROUND:Robot-assisted partial nephrectomy (RAPN) with the novel Da Vinci® Single Port can be performed either in a standard flank position (flank approach) or in an innovative supine decubitus (namely, Supine Anterior Retroperitoneal Access [SARA]). Based on low quality retrospective data, the latter is advocated to provide crucial advantages in the quality of care. OBJECTIVE:To demonstrate that the SARA approach compared to the lateral approach portends lower intra-operative adverse events (anesthesiologic and surgical), faster postoperative patient recovery (lower pain, shorter time to first walk, feed and canalization) without jeopardizing oncological safety (positive surgical margins). DESIGN, SETTING, AND PARTICIPANTS:The K-3 study is a single-center, patient-blinded, randomized clinical trial aiming to recruit 124 patients candidate to RAPN for clinically T1 single renal masses. A 1:1 randomization will yield two equally sized arms of study (namely, lateral approach [n = 62] vs SARA approach [n = 62]). The trial has received ethical approval (CETL 3 n°5448) and is registered on ClinicalTrials.gov as NCT07234409. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:The primary end point of the trial is the rate of achievement of a trifecta composed by 1). Absence of intraoperative adverse events graded according to Intraoperative Adverse Incident Classification (EAUiaiC) proposed by the European Association of Urology; 2). Negative surgical margins; 3). Hospital discharge within 24 h from surgery. CONCLUSIONS:K-3 trial will provide the first, most unbiased, highest-quality, real-World data concerning a topic of paramount importance in both anesthesiologic and urological field, potentially able to change the how RAPN is conceived, planned and performed. PATIENT SUMMARY:Partial nephrectomy for localized renal masses, with the Da Vinci® Single Port system, in supine decubitus might enhance intraoperative anaesthesiologic assistance, minimize postoperative pain and reduce hospital stay without threatening oncological safety, compared to the standard flank position.
INTRODUCTION:Bacillus Calmette-Guérin (BCG) immunotherapy remains the standard treatment for high-risk non-muscle-invasive bladder cancer (NMIBC). While the European Association of Urology (EAU) guidelines recommend initiating BCG treatment no later than 4-6 weeks following transurethral resection of bladder tumors (TURBT), delays in BCG administration are not uncommon due to factors such as pathological assessment timelines, patient-related issues, healthcare system limitations, and drug shortages. This systematic review aims to evaluate the impact of delayed BCG therapy or unconventional schedules on oncological outcomes, trying to establish the best treatment option for these patients. EVIDENCE ACQUISITION:A comprehensive literature search was conducted across multiple databases (PubMed, Scopus, Web of Science) for studies published from January 2010 to the present. After screening 262 publications, relevant prospective and retrospective studies, systematic reviews, and meta-analyses were included. EVIDENCE SYNTHESIS:We retrieved 14 manuscripts evaluating different BCG schedule or doses. Only two papers specifically referred to the delay in the treatment of high risk NMIBC. The findings highlight that the delays in initiating the BCG therapy beyond 6 weeks are associated with worse recurrence-free survival (RFS), progression-free survival (PFS), and cancer-specific survival (CSS) rates. However, evidence on the progression to MIBC or metastatic disease remains inconclusive, with only a few studies suggesting a potential impact. Despite these delays, even reduced dose or shortened BCG regimens appear to offer some level of protection against disease progression. CONCLUSIONS:This review emphasizes the importance of adhering to standard BCG treatment schedules to minimize the risk of recurrence and suggests that, in cases of unavoidable delay, strict endoscopic follow-up is crucial and an optimal treatment in case of cancer relapse must be offered. Further prospective studies are needed to conclusively determine the long-term effects of delayed therapy.