Interventions aimed to increase average 24-h systolic blood pressure reduce blood pressure drops in patients with reflex syncope and orthostatic intolerance.

AIMS: Systolic blood pressure (SBP) drops recorded by 24-h ambulatory blood pressure (BP) monitoring (ABPM) identify patients with susceptibility to reflex syncope and orthostatic intolerance. We tested the hypothesis that treatments aimed to increase BP (reassurance, education, and lifestyle measures plus pharmacological strategies) can reduce SBP drops. METHODS AND RESULTS: This was a multicentre, observational proof-of-concept study performed in patients with reflex syncope and/or orthostatic intolerance and with SBP drops on a screening ABPM. Among 144 eligible patients, 111 underwent a second ABPM on average 2.5 months after start of treatment. Overall, mean 24-h SBP increased from 114.1 ± 12.1 to 121.4 ± 14.5 mmHg (P < 0.0001). The number of SBP drops <90 and <100 mmHg decreased by 61%, 46% during daytime, and by 48% and 37% during 24-h period, respectively (P < 0.0001 for all). The dose-response relationship between difference in 24-h average SBP increase and reduction in number of SBP drops reached a plateau around ∼15 mmHg increase of 24-h SBP. The reduction in SBP drop rate was consistent and significant in patients who underwent deprescription of hypotensive medications (n = 44) and in patients who received BP-rising drugs (n = 67). CONCLUSION: In patients with reflex syncope and/or orthostatic intolerance, an increase in average 24-h SBP, regardless of the implemented strategy, significantly reduced the number of SBP drops and symptom burden. A 13 mmHg increase in 24-h SBP appears to represent the optimal goal for aborting the maximal number of SBP drops, representing a possible target for future interventions. ClincalTrials.gov identifier: NCT05729724.

Cardiac comorbidities in McArdle disease: case report and systematic review.

INTRODUCTION AND METHODS: Myophosphorylase deficiency, also known as McArdle disease or Glycogen Storage Disease type V (GSD-V), is an autosomal recessive metabolic myopathy that results in impaired glycogen breakdown in skeletal muscle. Despite being labelled as a "pure myopathy," cardiac involvement has been reported in some cases, including various cardiac abnormalities such as electrocardiographic changes, coronary artery disease, and cardiomyopathy. Here, we present a unique case of a 72-year-old man with GSD-V and both mitral valvulopathy and coronary artery disease, prompting a systematic review to explore the existing literature on cardiac comorbidities in McArdle disease. RESULTS: Our systematic literature revision identified 7 case reports and 1 retrospective cohort study. The case reports described 7 GSD-V patients, averaging 54.3 years in age, mostly male (85.7%). Coronary artery disease was noted in 57.1% of cases, hypertrophic cardiomyopathy in 28.5%, severe aortic stenosis in 14.3%, and genetic dilated cardiomyopathy in one. In the retrospective cohort study, five out of 14 subjects (36%) had coronary artery disease. DISCUSSION AND CONCLUSION: Despite McArdle disease primarily affecting skeletal muscle, cardiac involvement has been observed, especially coronary artery disease, the frequency of which was moreover found to be higher in McArdle patients than in the background population in a previous study from a European registry. Exaggerated cardiovascular responses during exercise and impaired glycolytic metabolism have been speculated as potential contributors. A comprehensive cardiological screening might be recommended for McArdle disease patients to detect and manage cardiac comorbidities. A multidisciplinary approach is crucial to effectively manage both neurological and cardiac aspects of the disease and improve patient outcomes. Further research is required to establish clearer pathophysiological links between McArdle disease and cardiac manifestations in order to clarify the existing findings.

The clinical outcomes of vital intact teeth close to large cystic lesions of endodontic origin: A prospective clinical study.

AIM: To evaluate the indication of the endodontic treatment for vital intact teeth with the root apex involved in large radicular cystic lesions of endodontic origin. METHODOLOGY: This prospective cohort study enrolled healthy participants with radicular cysts of endodontic origin and with the root apex of vital intact teeth involved in the bone defect, as determined by cone beam computed tomography (CBCT). Thirty-two sound vital teeth were analysed by thermal (TPT) and electric pulp tests (EPT) before surgery (T0) and 1 week (T1), 2 weeks (T2), 3 months (T3) and 6 months (T4) post-surgery. Student's t-test (p < .05) was used to compare the EPT values at baseline and T4. anova (p < .05) was used to analyse the EPT variations for all maxillary and mandibular teeth. McNemar test (p < .05) was used to compare the results according to variation in EPT values gathering by variation, no variation and no response. RESULTS: At T1, 75 and 65.7% of teeth responded positively whilst 25 and 34.3% did not respond to EPT and TPT, respectively. The variation of the EPT values between T0 and T1 was observed for 50.0% of teeth, whilst no variation was noticed in 25.0% of teeth. At T4, 90.6 and 87.5% of teeth responded positively whilst 9.4 and 12.5% did not respond to EPT and TPT, respectively. At T4, variation of the EPT values between T0 and T4 was observed for 28.1%, whilst no variation was noticed in 62.5% of teeth. There were no statistical differences in EPT results between T0 and T4 (p > .05), but significant differences were observed for EPT values between T1 and T4 (p < .05), and between mandibular and maxillary teeth. The pulp sensibility of maxillary teeth worsened after surgery, before reverting progressively to T0 values, whilst no statistically significant differences were observed for mandibular teeth at the different time points. CONCLUSIONS: These data support the inconsistence of the prophylactic endodontic treatment in healthy vital teeth with apex involvement in large cystic lesions of endodontic origin. Post-surgery follow-up with TPT and EPT is recommended to assess pulp status.

Site-specific concordance of targeted and systematic biopsy cores at the index lesion on multiparametric magnetic resonance: can we spare the double-tap?

PURPOSE: To define the impact of systematic biopsy (SB) cores directed in the same area of index lesion in patients undergoing targeted biopsy (TB) and SB for prostate cancer (PCa) suspicion. METHODS: We retrospectively analyzed data of biopsy-naïve patients with one single suspicious lesion at mpMRI who underwent TB plus SB at our institution between January 2015 and September 2021. A convenient sample of 336 patients was available for our analyses. The primary outcome was to evaluate the impact of overlapping SB cores directed to the index lesion at mpMRI. The secondary outcome was to evaluate the SB cores concordance in terms of highest Gleason Score Detection with TB cores. RESULTS: 56% of patients were found to have site-specific concordance. SB cores determined disease upgrade in 22.1% patients. Thirty-one (16.4%) site-concordant patients experienced upgrade through overlapping SB cores, while 149 (79.3%) had no benefit by SB cores, and 8 (4.3%) patients had the worst ISUP at TB cores. 50% of the patients with negative-TB were upgraded to insignificant PCa, and 17.5% was upgraded from negative to unfavorable-intermediate- or high-risk PCa. Overall, 14 (19.4%) patients were also upgraded from ISUP 1 on TB to csPCa, with 28.5% of these harboring high-risk PCa. In csPCas at TB, 9 (12.5%) patients were upgraded from intermediate- to high-risk disease by SB. CONCLUSIONS: TB alone consents to identify worst ISUP PCa in vast majority of patients scheduled for biopsy. A non-negligible number of patients are upgraded via-SB cores, including also index lesion overlapping cores. Omitting these cores might lead to a suboptimal patient management.

Twenty Years' Experience in Retroperitoneal Lymph Node Dissection for Testicular Cancer in a Tertiary Referral Center.

Background and Objectives: The aim of this article is to present a single-surgeon, open retroperitoneal lymph node dissection (RPLND) series for testicular cancer in a high-volume center. Materials and Methods: We reviewed data from patients who underwent RPLND performed by an experienced surgeon at our institution between 2000 and 2019. We evaluated surgical and perioperative outcomes, complications, Recurrence-Free Survival (RFS), Overall Survival (OS), and Cancer-Specific Survival (CSS). Results: RPLND was performed in primary and secondary settings in 21 (32%) and 44 (68%) patients, respectively. Median operative time was 180 min. Median hospital stay was 6 days. Complications occurred in 23 (35%) patients, with 9 (14%) events reported as Clavien grade ≥ 3. Patients in the primary RPLND group were significantly younger, more likely to have NSGCT, had higher clinical N0 and M0, and had higher nerve-sparing RPLND (all p ≤ 0.04) compared to those in the secondary RPLND group. In the median follow-up of 120 (56-180) months, 10 (15%) patients experienced recurrence. Finally, 20-year OS, CSS, and RFS were 89%, 92%, and 85%, respectively, with no significant difference in survival rates between primary vs. secondary RPLND subgroups (p = 0.64, p = 0.7, and p = 0.31, respectively). Conclusions: Open RPLND performed by an experienced high-volume surgeon achieves excellent oncological and functional outcomes supporting the centralization of these complex procedures.

Long-term outcomes of Holmium laser enucleation of prostate and predictive model for symptom recurrence.

INTRODUCTION AND OBJECTIVES: Holmium laser enucleation of prostate (HoLEP) represents one of the most studied surgical techniques for benign prostatic hyperplasia (BPH). Its efficacy in symptom relief has been widely depicted. However, few evidence is available regarding the possible predictors of symptom recurrence. We aimed to evaluate long-term outcomes, symptom recurrence rate, and predictors in patients that underwent HoLEP. MATERIALS AND METHODS: We retrospectively analyzed data from patients that consecutively underwent HoLEP for BPH from 2012 to 2015 at two tertiary referral centers. Functional outcomes were evaluated by uroflowmetry parameters and International Prostate Symptom Score (IPSS) questionnaire administration at follow-up visits at 12, 24, and 60 months. The primary outcome was the symptomatic patients' rate presenting lower urinary tract symptoms (LUTS) after 60 months from surgery, defined as in case of one or more of the following: IPSS more than 7, post voidal residue (PVR) more than 20 ml, need for medical therapy for LUTS or redo surgery for bladder outlet obstruction. Multivariable logistic regression analyses evaluated predictors for being symptomatic at follow-up. Covariates consisted of: preoperative peak flow rate (PFR), PVR, and IPSS, prostate volume, age (all as continuous), and surgical technique. RESULTS: A total of 567 patients were available for our analyses. Median prostate volume was 80cc, with a median PFR of 8 ml/s and median PVR of 100cc. One hundred and twenty-five (22%) patients were found to be symptomatic at follow-up. Redo surgery was needed for 25 (4.4%) patients. After adjusting for possible confounders, an increase in preoperative PVR (odds ratio [OR] 1.005) and IPSS (OR 1.12) resulted as independent predictors for symptom recurrence (all p < 0.001). CONCLUSIONS: HoLEP can provide durable symptom relief regardless of the chosen technique. Patients with an important preoperative symptom burden or a high PVR should be carefully counseled on the risk of symptom recurrence.

Patients' perceptions of quality of care delivery by urology residents: A nationwide study.

OBJECTIVE: To present the results of a nationwide survey among urological patients to evaluate their perception of the quality of care provided by residents. METHODS: An anonymous survey was distributed to patients who were referred to 22 Italian academic institutions. The survey aimed to investigate the professional figure of the urology resident as perceived by the patient. RESULTS: A total of 2587 patients were enrolled in this study. In all, 51.6% of patients were able to correctly identify a urology resident; however, almost 40% of respondents discriminated residents from fully trained urologists based exclusively on their young age. Overall, 98.2% patients rated the service provided by the resident as at least sufficient. Urology trainees were considered by more than 50% of the patients interviewed to have good communication skills, expertise and willingness. Overall, patients showed an excellent willingness to be managed by urology residents. The percentage of patients not available for this purpose showed an increasing trend that directly correlated with the difficulty of the procedure. Approximately 5-10% of patients were not willing to be managed by residents for simple procedures such as clinical visits, cystoscopy or sonography, and up to a third of patients were not prepared to undergo any surgical procedure performed by residents during steps in major surgery, even if the residents were adequately tutored. CONCLUSIONS: Our data showed that patients have a good willingness to be managed by residents during their training, especially for medium- to low-difficulty procedures. Furthermore, the majority of patients interviewed rated the residents' care delivery as sufficient. Urology trainees were considered to have good communication skills, expertise and willingness.

Changes in renal function after nephroureterectomy for upper urinary tract carcinoma: analysis of a large multicenter cohort (Radical Nephroureterectomy Outcomes (RaNeO) Research Consortium).

PURPOSE: To investigate prevalence and predictors of renal function variation in a multicenter cohort treated with radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC). METHODS: Patients from 17 tertiary centers were included. Renal function variation was evaluated at postoperative day (POD)-1, 6 and 12 months. Timepoints differences were Δ1 = POD-1 eGFR - baseline eGFR; Δ2 = 6 months eGFR - POD-1 eGFR; Δ3 = 12 months eGFR - 6 months eGFR. We defined POD-1 acute kidney injury (AKI) as an increase in serum creatinine by ≥ 0.3 mg/dl or a 1.5 1.9-fold from baseline. Additionally, a cutoff of 60 ml/min in eGFR was considered to define renal function decline at 6 and 12 months. Logistic regression (LR) and linear mixed (LM) models were used to evaluate the association between clinical factors and eGFR decline and their interaction with follow-up. RESULTS: A total of 576 were included, of these 409(71.0%) and 403(70.0%) had an eGFR < 60 ml/min at 6 and 12 months, respectively, and 239(41.5%) developed POD-1 AKI. In multivariable LR analysis, age (Odds Ratio, OR 1.05, p < 0.001), male gender (OR 0.44, p = 0.003), POD-1 AKI (OR 2.88, p < 0.001) and preoperative eGFR < 60 ml/min (OR 7.58, p < 0.001) were predictors of renal function decline at 6 months. Age (OR 1.06, p < 0.001), coronary artery disease (OR 2.68, p = 0.007), POD-1 AKI (OR 1.83, p = 0.02), and preoperative eGFR < 60 ml/min (OR 7.80, p < 0.001) were predictors of renal function decline at 12 months. In LM models, age (p = 0.019), hydronephrosis (p < 0.001), POD-1 AKI (p < 0.001) and pT-stage (p = 0.001) influenced renal function variation (ß 9.2 ± 0.7, p < 0.001) during follow-up. CONCLUSION: Age, preoperative eGFR and POD-1 AKI are independent predictors of 6 and 12 months renal function decline after RNU for UTUC.

Perioperative Outcomes of Holmium Laser Enucleation of the Prostate: A Systematic Review.

INTRODUCTION: The aim of the study was to systematically review the literature and describe perioperative complications of holmium laser enucleation of the prostate (HoLEP), including the Clavien-Dindo classification of surgical complications. METHODS: All English language publications on HoLEP were evaluated. We followed the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analyses) guidelines to evaluate PubMed®, Scopus®, and Web of Science™ databases from January 1, 1998, to June 1, 2020. RESULTS: Fifty-seven studies were included, for a total of 10,371 procedures. We distinguished between intra-, peri-, and postoperative complications. Overall, the rate of complications is 0-7%. Intraoperative complications include incomplete morcellation (2.3%), capsular perforation (2.2%), bladder (2.4%), and ureteric orifice (0.4%) injuries. Perioperative complications include postoperative urinary retention (0.2%), hematuria and clot retention (2.6%), and cystoscopy for clot evacuation (0.7%). Postoperative complications include dysuria (7.5%), stress (4.0%), urge (1.8%), transient (7%) and permanent (1.3%) urinary incontinence, urethral stricture (2%) and bladder neck contracture (1%). CONCLUSIONS: HoLEP is a safe procedure, with a satisfactory low complication rate. The most common reported perioperative complications are not severe (Clavien-Dindo classification grades 1-2). Further randomized studies are certainly warranted to fully determine the predictor of surgical complications in order to prevent them and improve this technique.

Percutaneous ablation or minimally invasive partial nephrectomy for cT1a renal masses? A propensity score-matched analysis.

OBJECTIVE: Local tumor ablation to treat small renal mass is increasing. The aim of the present study was to compare oncologic outcomes among patients with T1 renal mass treated with partial nephrectomy and local tumor ablation. METHODS: To reduce the inherent differences between patients undergoing laparoscopic or robot-assisted partial nephrectomy (n = 405) and local tumor ablation (n = 137), we used a 1:1 propensity score-matched analysis. Local tumor ablation consisted of radiofrequency ablation and cryoablation. Disease-free survival, overall survival and other causes mortality-free survival rates were estimated using the Kaplan-Meier method. Multivariable logistic regression and competing-risk regression models were used to identify predictors of complications, recurrence and other causes mortality, respectively. RESULTS: Partial nephrectomy had higher disease-free survival estimates, as compared with local tumor ablation (92.8% vs 80.4% at 5 years, P = 0.02), with no significant difference between radiofrequency ablation and cryoablation (P = 0.9). Ablation showed comparable overall survival estimates to partial nephrectomy (91% vs 95.8% at 5 years, P = 0.6). The 5-year recurrence rates were 7.9% versus 23.8% for patients aged ≤70 years, and 2.5% versus 11.9% for patients aged >70 years treated with partial nephrectomy and ablation, respectively; the 5-year other causes mortality rates were 0% and 2.2% for patients treated with partial nephrectomy and ablation aged ≤70 years, and 3% versus 10.9% for patients aged >70 years treated with partial nephrectomy and ablation, respectively. At multivariable analysis, ablation was associated with fewer complications (odds ratio 0.41; P = 0.01). At competing risks analysis, age (hazard ratio 0.96) and ablation (hazard ratio 4.56) were independent predictors of disease recurrence (all P ≤ 0.008). CONCLUSIONS: Local tumor ablation showed a higher risk of recurrence and lower risk of complications compared with partial nephrectomy, with comparable overall survival rates.

The impact of multiparametric MRI features to identify the presence of prevalent cribriform pattern in the peripheral zone tumors.

PURPOSE: To assess the role of the multiparametric Magnetic Resonance Imaging (mpMRI) in predicting the cribriform pattern in both the peripheral and transition zones (PZ and TZ) clinically significant prostate cancers (csPCas). MATERIAL AND METHODS: We retrospectively evaluated 150 patients who underwent radical prostatectomy for csPCa and preoperative mpMRI. Patients with negative (n = 25) and positive (n = 125) mpMRI, stratified according to the presence of prevalent cribriform pattern (PCP, ≥ 50%) and non-PCP (< 50%) at specimen, were included. Difference between the two groups were evaluated. Multivariate logistic regression was used to identify predictors of PCP among mpMRI parameters. The receiver operating characteristic (ROC) analysis was performed to evaluate the area under the curve (AUC) of apparent diffusion coefficient (ADC) and ADC ratio in detecting lesions harboring PCP. RESULTS: Considering 135 positive lesions at the mpMRI, 30 (22.2%) and 105 (77.8%) harbored PCP and non-PCP PCa. The PCP lesions had more frequently nodular morphology (83.3% vs 62.9%; p = 0.04) and significantly lower mean ADC value (0.87 ± 0.16 vs 0.95 ± 0.18; p = 0.03) and ADC ratio (0.52 ± 0.09 vs 0.60 ± 0.14; p = 0.003) when compared with non-PCP lesions. At univariate and multivariate analyses, mean ADC and ADC ratio resulted as independent predictors of the presence of the PCP of the PZ tumors(OR: 0.025; p = 0.03 and OR: 0.001; p = 0.004, respectively). At the ROC analysis, the AUC of mean ADC and ADC ratio to predict the presence of PCP in patients with PZ suspicious lesion at the mpMRI were 0.69 (95% CI 0.56-0.81P, p = 0.003) and 0.72 (95% CI 0.62-0.82P, p = 0.001), respectively. CONCLUSIONS: The mpMRI may correctly identify PCP tumors of the PZ and the mean ADC value and ADC ratio can predict the presence of the cribriform pattern in the PCa.

[18F]-Fluciclovine PET/CT for preoperative nodal staging in high-risk primary prostate cancer: final results of a prospective trial.

PURPOSE: The conventional imaging flowchart for prostate cancer (PCa) staging may fail in correctly detecting lymph node metastases (LNM). Pelvic lymph node dissection (PLND) represents the only reliable method, although invasive. A new amino acid PET compound, [18F]-fluciclovine, was recently authorized in suspected PCa recurrence but not yet included in the standard staging work-up of primary PCa. A prospective monocentric study was designed to evaluate [18F]-fluciclovine PET/CT diagnostic performance for preoperative LN staging in primary high-risk PCa. METHODS: Consecutive patients (pts) with biopsy-proven PCa, standard staging (including [11C]choline PET/CT), eligible for PLND, were enrolled to undergo an investigational [18F]-fluciclovine PET/CT. Nodal uptake higher than surrounding background was reported by at least two readers (blinded to [11C]choline) using a visual 5-point scale (1-2 probably negative; 4-5 probably positive; 3 equivocal); SUVmax, target-to-background (aorta-A; bone marrow-BM) ratios (TBRs), were also calculated. PET results were validated with PLND. [18F]-fluciclovine PET/CT performance using visual score and semi-quantitative indexes was analyzed both per patient and per LN anatomical region, compared to conventional [11C]choline and clinical predictive factors (to note that diagnostic performance of [18F]-fluciclovine was explored for LNM but not examined for intrapelvic or extrapelvic M1 lesions). RESULTS: Overall, 94 pts underwent [18F]-fluciclovine PET/CT; 72/94 (77%) high-risk pts were included in the final analyses (22 pts excluded: 8 limited PLND; 3 intermediate-risk; 2 treated with radiotherapy; 4 found to be M1; 5 neoadjuvant hormonal therapy). Median LNM risk by Briganti nomogram was 19%. LNM confirmed on histology was 25% (18/72 pts). Overall, 1671 LN were retrieved; 45/1671 (3%) LNM detected. Per pt, median no. of removed LN was 22 (mean 23 ± 10; range 8-51), of LNM was 2 (mean 3 ± 2; range 1-10). Median LNM size was 5 mm (mean 5 ± 2.5; range 2-10). On patient-based analyses (n = 72), diagnostic performance for LNM resulted significant with [18F]-fluciclovine (AUC 0.66, p 0.04; 50% sensitivity, 81% specificity, 47% PPV, 83% NPV, 74% accuracy), but not with [11C]choline (AUC 0.60, p 0.2; 50%, 70%, 36%, 81%, and 65% respectively). Briganti nomogram (OR = 1.03, p = 0.04) and [18F]-fluciclovine visual score (≥ 4) (OR = 4.27, p = 0.02) resulted independent predictors of LNM at multivariable analyses. On region-based semi-quantitative analyses (n = 576), PET/CT performed better using TBR parameters (TBR-A similar to TBR-BM; TBR-A fluciclovine AUC 0.61, p 0.35, vs choline AUC 0.57 p 0.54; TBR-BM fluciclovine AUC 0.61, p 0.36, vs choline AUC 0.58, p 0.52) rather than using absolute LN SUVmax (fluciclovine AUC 0.51, p 0.91, vs choline AUC 0.51, p 0.94). However, in all cases, diagnostic performance was not statistically significant for LNM detection, although slightly in favor of the experimental tracer [18F]-fluciclovine for each parameter. On the contrary, visual interpretation significantly outperformed PET semi-quantitative parameters (choline and fluciclovine: AUC 0.65 and 0.64 respectively; p 0.03) and represents an independent predictive factor of LNM with both tracers, in particular [18F]-fluciclovine (OR = 8.70, p 0.002, vs OR = 3.98, p = 0.03). CONCLUSION: In high-risk primary PCa, [18F]-fluciclovine demonstrates some advantages compared with [11C]choline but sensitivity for metastatic LN detection is still inadequate compared to PLND. Visual (combined morphological and functional), compared to semi-quantitative assessment, is promising but relies mainly on readers' experience rather than on unquestionable LN avidity. TRIAL REGISTRATION: EudraCT number: 2014-003,165-15.

Protocol of the Italian Radical Cystectomy Registry (RIC): a non-randomized, 24-month, multicenter study comparing robotic-assisted, laparoscopic, and open surgery for radical cystectomy in bladder cancer.

BACKGROUND: Bladder cancer is the ninth most common type of cancer worldwide. In the past, radical cystectomy via open surgery has been considered the gold-standard treatment for muscle invasive bladder cancer. However, in recent years there has been a progressive increase in the use of robot-assisted laparoscopic radical cystectomy. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence. METHODS: We describe a protocol for an observational, prospective, multicenter, cohort study to assess patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion. The Italian Radical Cystectomy Registry is an electronic registry to prospectively collect the data of patients undergoing radical cystectomy conducted with any technique (open, laparoscopic, robotic-assisted). Twenty-eight urology departments across Italy will provide data for the study, with the recruitment phase between 1st January 2017-31st October 2020. Information is collected from the patients at the moment of surgical intervention and during follow-up (3, 6, 12, and 24 months after radical cystectomy). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerve sparing and lymphadenectomy. Follow-up data collection includes histological information (e.g., post-op staging, grading, and tumor histology), short- and long-term outcomes (e.g., mortality, post-op complications, hospital readmission, sexual potency, continence etc). DISCUSSION: The current protocol aims to contribute additional data to the field concerning the short- and long-term outcomes of three different radical cystectomy surgical techniques for patients with bladder cancer, including open, laparoscopic, and robot-assisted. This is a comparative-effectiveness trial that takes into account a complex range of factors and decision making by both physicians and patients that affect their choice of surgical technique. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04228198 . Registered 14th January 2020- Retrospectively registered.

Prognostic performance of magnetic resonance imaging-guided biopsy in defining prostate cancer anterior lesions.

PURPOSE: Diagnosis of anterior prostate cancer (PCa) can be quite challenging, often leading to delay in treatment. mpMRI-guided biopsy (GB) has been introduced aiming to increase the number of diagnoses of clinically significant PCa with fewer cores. The aim of our study is to compare pathological findings of prostate biopsy, In-bore or Fusion technique, with histopathological evaluation of radical prostatectomy. METHODS: We prospectively collected data from 90 consecutive patients who underwent either In-bore or Fusion biopsy following the detection of an index suspicious lesion at mpMRI in the anterior part of the prostatic gland. Bioptical pathological findings were compared with pathological findings reported after robot-assisted radical prostatectomy. RESULTS: Patients who underwent In-bore GB had a higher rate of previous negative prostate biopsies (19% vs 44%, p = 0.02). Median number of bioptic cores taken (13 vs 2) and number of positive cores (3 vs 2) were significantly superior in the Fusion group compared to the In-bore group (p < 0.001 and p = 0.002, respectively), whilst clinical International Society of Urological Pathology (ISUP) grade was homogeneous within groups. The concordance between anterior lesions detected at biopsy and those reported in the histopathological finding of radical prostatectomy was very high, without statistically significant difference between groups. CONCLUSION: Both Fusion and In-bore GB are accurate in detecting anterior PCa, with enhanced precision detecting clinically significant tumours, as evidenced by pathologic examinations which confirmed the presence of index anterior PCa in > 50% of patients overall. Additional sextant biopsy is still required, especially among biopsy-näive patients, to avoid missing clinically significant PCa.

Testis Sparing Surgery of Small Testicular Masses: Retrospective Analysis of a Multicenter Cohort.

PURPOSE: We evaluated possible factors predicting testicular cancer in patients undergoing testis sparing surgery. MATERIALS AND METHODS: We retrospectively analyzed the records of all patients who underwent testis sparing surgery for a small testicular mass at a total of 5 centers. All patients with 1 solitary lesion 2 cm or less on preoperative ultrasound were enrolled in the study. Testis sparing surgery consisted of tumor enucleation for frozen section examination. Immediate radical orchiectomy was performed in all cases of malignancy at frozen section examination but otherwise the testes were spared. Univariate and multivariate analysis were performed and ROC curves were produced to evaluate preoperative factors predicting testicular cancer. RESULTS: Overall 147 patients were included in the study. No patient had elevated serum tumor markers. Overall 21 of the 147 men (14%) presented with testicular cancer. On multivariate analysis the preoperative ultrasound diameter of the lesion was a predictor of malignancy (OR 6.62, 95% CI 2.26-19.39, p=0.01). On ROC analysis lesion diameter had an AUC of 0.75 (95% CI 0.63-0.86, p=0.01) to predict testicular cancer. At the best cutoff of 0.85 the diameter of the lesion had 81% sensitivity, 58% specificity, 24% positive predictive value and 95% negative predictive value. CONCLUSIONS: Our study confirms that small testicular masses are often benign and do not always require radical orchiectomy. Preoperative ultrasound can assess lesion size and the smaller the nodule, the less likely that it is malignant. Therefore, we suggest a stepwise approach to small testicular masses, including tumorectomy, frozen section examination and radical orchiectomy or testis sparing surgery according to frozen section examination results.

Prediction nomogram for 68Ga-PSMA-11 PET/CT in different clinical settings of PSA failure after radical treatment for prostate cancer.

OBJECTIVE: The objective of this study was to develop a clinical nomogram to predict gallium-68 prostate-specific membrane antigen positron emission tomography/computed tomography (68Ga-PSMA-11-PET/CT) positivity in different clinical settings of PSA failure. MATERIALS AND METHODS: Seven hundred three (n = 703) prostate cancer (PCa) patients with confirmed PSA failure after radical therapy were enrolled. Patients were stratified according to different clinical settings (first-time biochemical recurrence [BCR]: group 1; BCR after salvage therapy: group 2; biochemical persistence after radical prostatectomy [BCP]: group 3; advanced-stage PCa before second-line systemic therapies: group 4). First, we assessed 68Ga-PSMA-11-PET/CT positivity rate. Second, multivariable logistic regression analyses were used to determine predictors of positive scan. Third, regression-based coefficients were used to develop a nomogram predicting positive 68Ga-PSMA-11-PET/CT result and 200 bootstrap resamples were used for internal validation. Fourth, receiver operating characteristic (ROC) analysis was used to identify the most informative nomogram's derived cutoff. Decision curve analysis (DCA) was implemented to quantify nomogram's clinical benefit. RESULTS: 68Ga-PSMA-11-PET/CT overall positivity rate was 51.2%, while it was 40.3% in group 1, 54% in group 2, 60.5% in group 3, and 86.9% in group 4 (p < 0.001). At multivariable analyses, ISUP grade, PSA, PSA doubling time, and clinical setting were independent predictors of a positive scan (all p ≤ 0.04). A nomogram based on covariates included in the multivariate model demonstrated a bootstrap-corrected accuracy of 82%. The nomogram-derived best cutoff value was 40%. In DCA, the nomogram revealed clinical net benefit of > 10%. CONCLUSIONS: This novel nomogram proved its good accuracy in predicting a positive scan, with values ≥ 40% providing the most informative cutoff in counselling patients to 68Ga-PSMA-11-PET/CT. This tool might be important as a guide to clinicians in the best use of PSMA-based PET imaging.

Predictive accuracy and clinical benefit of a nomogram aimed to predict 68Ga-PSMA PET/CT positivity in patients with prostate cancer recurrence and PSA < 1 ng/ml external validation on a single institution database.

PURPOSE: To perform an external validation of a recently published nomogram aimed to predict positive 68Ga-PSMA-11 PET/CT in patients with biochemical recurrence (BCR) after radical prostatectomy (RP) by Rauscher et al. (Eur Urol 73(5):656-661, 2018). METHODS: Overall, 413 PCa patients with BCR after RP (two consecutive PSA ≥ 0.2 ng/ml) and PSA value between 0.2 and 1 ng/ml were included. A multivariable logistic regression model was produced to assess the predictors of positive 68Ga-PSMA-11 PET/CT results. The performance characteristics of the model were assessed by quantifying the predictive accuracy, according to model calibration. Yuden's index was used to find the best nomogram's cut-off. Finally, decision curve analysis (DCA) was implemented to quantify the nomogram's clinical value. RESULTS: In the external cohort, the overall detection rate of 68Ga-PSMA-11 PET/CT was 44% vs. 64.7% in the original population. At multivariate analysis, PSA at 68Ga-PSMA-11 PET/CT (OR: 7.06, p < 0.001) and ongoing ADT at time of 68Ga-PSMA-11 PET/CT (OR: 2.07, p = 0.03) were the only independent predictors of PET/CT positivity. The predictive accuracy of nomogram was suboptimal and comparable to that reported in the original model (64% vs. 67%, respectively). The calibration plot indicated suboptimal concordance. The best nomogram's cut-off to predict positive 68Ga-PSMA-11 PET/CT was 35% (AUC = 0.61). In DCA, the nomogram revealed clinical net benefit when the threshold probabilities of positive 68Ga-PSMA-11 PET/CT is > 35%. CONCLUSION: We assessed similar suboptimal predictive accuracies in the external cohort compared to the original one. PSA and ongoing ADT were confirmed as positive predictors, and the most informative nomogram cut-off resulted 35%.

Urology in the Time of Coronavirus: Reduced Access to Urgent and Emergent Urological Care during the Coronavirus Disease 2019 Outbreak in Italy.

PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic has put a substantial burden on the Italian healthcare system, resulting in the restructuring of hospitals to care for COVID-19 patients. However, this has likely impacted access to care for patients experiencing other conditions. We aimed to quantify the impact of COVID-19 on access to care for patients with urgent/emergent urological conditions throughout Italy. MATERIALS AND METHODS: A questionnaire was sent to 33 urological units in the AGILE consortium, asking clinicians to report on the number of urgent/emergent urological patients seen and/or undergoing surgery over a 3-week period during the peak of the COVID-19 outbreak and a reference week prior to the outbreak. ANOVA and linear regression models were used to quantify these changes. RESULTS: Data from 27 urological centres in Italy showed a decrease from 956 patients/week seen just prior to the outbreak to 291 patients/week seen by the end of the study period. There was a difference in the number of patients with urgent/emergent urological disease seen within/during the different weeks (all p values < 0.05). A significant decrease in the number of patients presenting with haematuria, urinary retention, urinary tract infection, scrotal pain, renal colic, or trauma and urgent/emergent cases that required surgery was reported (all p values < 0.05). CONCLUSION: In Italy, during the COVID-19 outbreak there has been a decrease in patients seeking help for urgent/emergent urological conditions. Restructuring of hospitals and clinics is mandatory to cope with the COVID-19 pandemic; however, the healthcare system should continue to provide adequate levels of care also to patients with other conditions.

Radiomics of peripheral nerves MRI in mild carpal and cubital tunnel syndrome.

OBJECTIVE: To assess the discriminative power of radiomics of peripheral nerves at 1.5T MRI, using common entrapment neuropathies of the upper limb as a model system of focal nerve injury. MATERIALS AND METHODS: Radiomics was retrospectively done on peripheral nerve fascicles on T1-weighted 1.5T MRI of 40 patients with diagnosis of mild carpal (n = 25) and cubital tunnel (n = 15) syndrome and of 200 controls. Z-score normalization and Mann-Whitney U test were used to compare features of normal and pathological peripheral nerves. Receiver operating characteristic analysis was performed. RESULTS: A total of n = 104 radiomics features were computed for each patient and control. Significant differences between normal and pathological median and ulnar nerves were found in n = 23/104 features (p < 0.001). According to features classification, n = 5/23 features were shape-based, n = 7/23 were first-order features, n = 11/23 features were classified as gray level run length matrix. Nine of the selected features showed an AUC higher that 0.7: minimum AUC of 0.74 (95% CI 0.61-0.89) for sum variance and maximum AUC of 0.90 (95% CI 0.82-0.99) for zone entropy. CONCLUSION: Features analysis demonstrated statistically significant differences between normal and pathological nerve. The results suggested that radiomics analysis could assess the median and ulnar nerve inner structure changes due to the loss of the fascicular pattern, intraneural edema, fibrosis or fascicular alterations in mild carpal tunnel and mild cubital tunnel syndromes even when the nerve cross-sectional area does not change.

How does 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography impact the management of patients with prostate cancer recurrence after surgery?

OBJECTIVE: To evaluate the clinical impact of 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography on the planned management of prostate cancer patients with biochemical recurrence after surgery. METHODS: We enrolled 276 prostate cancer patients referred to 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography due to biochemical recurrence after surgery (two consecutive prostate-specific antigen assays ≥0.2 ng/mL). First, the detection rate of 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography was assessed according to different prostate-specific antigen levels. Second, the independent predictors of 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography positive results were assessed. Finally, the intended treatment before revision of 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography was assessed by a multidisciplinary team based on the European Association of Urology guidelines, patient clinical condition and clinical parameters. Then, re-assessment of the treatment plan was prospectively recorded by the same board after revision of 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography. The effective clinical impact of 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography was rated as major (change in therapeutic approach), minor (same treatment, but modified therapeutic strategy) or none. RESULTS: The overall detection rate of 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography was 47.5%. Prostate-specific antigen at 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography (odds ratio 3.52) and prostate-specific antigen doubling time <3 months (odds ratio 3.98) were independent predictors of positive 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography results (all P ≤ 0.03). 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography led to a major treatment change in 177 cases (64.1%), with a minor clinical impact of 2.5%. The overall clinical impact of 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography was 42.4%, 27.7%, 21.2% and 8.7% in men with prostate-specific antigen at 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography of 0.2-0.4, 0.5-1, 1.1-2 and >2 ng/mL, respectively. CONCLUSIONS: 68 Ga-prostate-specific membrane antigen positron emission tomography/computed tomography allows clinicians to radically change the intended treatment approach before imaging evaluation, in roughly two out three individuals.