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Background: Stone nomogram by Micali et al., able topredict treatment failure of shock-wave lithotripsy (SWL), retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) in the management of single 1-2 cm renal stones, was developed on 2605 patients and showed a high predictive accuracy, with an area under ROC curve of 0.793 at internal validation. The aim of the present study is to externally validate the model to assess whether it displayed a satisfactory predictive performance if applied to different populations., Methods: External validation was retrospectively performed on 3025 patients who underwent an active stone treatment from December 2010 to June 2021 in 26 centers from four countries (Italy, USA, Spain, Argentina). Collected variables included: age, gender, previous renal surgery, preoperative urine culture, hydronephrosis, stone side, site, density, skin-to-stone distance. Treatment failure was the defined outcome (residual fragments >4 mm at three months CT-scan)., Results: Model discrimination in external validation datasets showed an area under ROC curve of 0.66 (95% 0.59-0.68) with adequate calibration. The retrospective fashion of the study and the lack of generalizability of the tool towards populations from Asia, Africa or Oceania represent limitations of the current analysis., Conclusions: According to the current findings, Micali's nomogram can be used for treatment prediction after SWL, RIRS and PNL; however, a lower discrimination performance than the one at internal validation should be acknowledged, reflecting geographical, temporal and domain limitation of external validation studies. Further prospective evaluation is required to refine and improve the nomogram findings and to validate its clinical value.

Background: Recently, the European Association of Urology Guidelines Panel updated the prognostic factor risk groups model for non-muscle-invasive bladder cancer (NMIBC) with the introduction of a new group of patients at very high risk (VHR). Furthermore, three additional clinical risk factors (i.e., age>70 years, multiple papillary tumors; tumor diameter >3 cm) were proposed. However, the new scoring model was created by analyzing data from patients who did not receive BCG intravesical therapy., Methods: This is a retrospective multicenter study analyzing data of 920 patients with HGT1 NMIBC that underwent ReTUR e following BCG intravesical therapy. Patients were stratified into risk groups according to the 2021 new EAU NMIBC prognostic factor risk groups model. This study aimed to identify variables related to disease progression in a large cohort of HGT1 NMIBC patients who underwent both Re-TURB and BCG intravesical immunotherapy., Results: Median follow-up was 51 months (IQR 41-75), according to EAU NMIBC 2021 scoring model 179 (19.5%) patients were at VHR. Progression-free survival at 5 years was 68.2% and 59.9% for the whole sample and the VHR group, respectively. At multivariable regression model size >3 cm, multifocal tumor, concomitant CIS and LVI were identified as independently associated with disease progression., Conclusions: Although patients at VHR are more likely to experience disease progression during follow-up, the European Association of Urology (EAU) NMIBC 2021 scoring model appears to be suboptimal in patients who underwent ReTUR and intravesical BCG therapy.

Background: Ablative techniques emerged as effective alternative to nephron-sparing surgery for treatment of small renal masses. Radiofrequency ablation (RFA) and cryoablation (CRYO) are the two guidelines-recommended techniques. Microwave ablation (MWA) represents a newer technology, less described. The aim of the study was to compare outcomes of MWA to those of CRYO and RFA., Methods: Retrospective investigation of patients who underwent MWA, CRYO, or RFA from seven high-volume US and European centers was performed. The first group included patients who underwent CRYO or RFA; the second MWA. We collected baseline characteristics, clinical, intraoperative, and postoperative data. Oncological data included technical success, local recurrence, and progression to metastasis. Multivariate analysis was performed to find predictors for postoperative complications. A composite outcome of "trifecta" was used to assess surgical, functional, and oncological outcomes., Results: 739 patients underwent CRYO or RFA and 50 MWA. CRYO/RFA group had significantly longer operative time (P<0.001), but no difference in LOS, postprocedural Hb mean, intraprocedural complications (P=0.180), overall postprocedural complication rates (P=0.126), and in the 30-day re-admission rate (P=0.853) were detected. No predictive parameter of postprocedural complications was found. Concerning functional outcome, no differences were detected in terms of eGFR at 1 year (P=0.182), ΔeGFR at 1 year (P=0.825) and eGFR at latest follow-up (P=0.070). "Technical success" was achieved in 98.6% of the cases (MWA=100%, CRYO/RFA=98.5%; P=0.775), and there was no significant difference in terms of 2-year recurrence rate (P=0.114) and metastatic progression (P=0.203). Trifecta was achieved in 73.0% of CRYO/RFA vs. 69.6% of MWA cases (P=0.719)., Conclusions: MWA is a safe and effective treatment option for small renal masses. Compared with CRYO/RFA, it seems to offer low complication rates, shorter operation time, and equivalent surgical and functional outcomes.

Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) remains a challenging clinical condition to manage. Here, we evaluate the efficacy and tolerability of a new treatment option (suppositories) containing pollen extract in combination with hyaluronic acid and vitamins in the management of patients with CP/CPPS., Methods: In this prospective, randomized, controlled, single-blinded, phase-III study we enrolled CP/CPPS patients between March and December 2019. Participants were randomized (1:1) to the following treatment groups: 1) pollen extract suppositories 1 daily for 10 days; or 2) ibuprofen 600 mg 1 tablet in the morning for 10 days. At the enrolment time and at the follow-up evaluations (3, 6 months), all patients completed baseline questionnaires ([National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI] and Quality of Well-Being [QoL]) and underwent urological examination and microbiological evaluation. The primary endpoint was the quality-of-life assessment with Patients' Reported Outcomes (PROs)., Results: One hundred and eighty-seven patients were screened. Finally, one hundred and twenty-four patients (mean age 34.6±3.9 years) were randomly allocated to the new pollen extract treatment (N.=63) or ibuprofen (N.=61) groups. At the end of follow-up examinations 56/63 group 1 patients (88.8%) showed a significant reduction of the NIH-CPSI total score, compared with 17/61 (27.8%) in group 2 (P<0.0001). Group 1 patients also reported a higher improvement in terms of PROs, when compared with the control group and group 1 patients reported a significant reduction of leucocyte count at the Meares-Stamey Test (-12; -4; P<0.001). Only mild adverse events were reported in the two groups and adverse events were less frequent in the pollen extract suppositories group., Conclusions: The combination of pollen extract with hyaluronic acid and vitamins is more effective than ibuprofen in improving symptoms and Quality of Life in patients affected with CP/CPPS and has less side effects.

Background: Intermediate risk prostate cancer (IR PCa) may exhibit a wide array of phenotypes, from favorable to unfavorable. NCCN criteria help distinguishing between favorable versus unfavorable subgroups. We studied and attempted to improve this classification., Methods: Within the SEER database 2010-2016, we identified 19,193 IR PCa patients treated with radical prostatectomy. A multivariable logistic regression model predicting unfavorable IR PCa was developed and externally validated, in addition to a head-to-head comparison with NCCN IR PCa stratification., Results: Model development (development cohort N.=13,436: 3585 unfavorable versus 9851 favorable) rested on age, PSA, clinical T stage, biopsy Gleason Grade Group (GGG) and percentage of positive cores. All were independent predictors of unfavorable IR PCa. In external validation cohort (N.=5757: 1652 unfavorable versus 4105 favorable), NCCN stratification was 61.8% accurate in discriminating between favorable versus unfavorable, compared to 67.6% for nomogram, which exhibited excellent calibration, less pronounced departures from ideal prediction and greater net-benefit in decision curve analyses (DCA) than NCCN stratification. The optimal nomogram cutoff misclassified 312 of 1976 patients (15.8%) versus 598 of 2877 (20.8%) for NCCN stratification. Of NCCN misclassified patients, 90.0% harbored pT3-4 stages versus 84.6% of nomogram., Conclusions: The newly developed, externally validated nomogram discriminates better between favorable versus unfavorable IR PCa, according to overall accuracy, calibration, DCA, and actual numbers and stage distribution of misclassified patients.

Background: Prostate cancer (PCa) is the second most common neoplasm in male patients. To date, there's no certain indication about the maximum waiting time (WT) acceptable for treatment beginning and the impact on oncological and functional outcomes has not been well established., Methods: Data from the National Research Council PCa monitoring multicenter project in Italy (Pros-IT CNR) were prospectively collected and analyzed. WT was defined as the time from the bioptical diagnosis of PCa to the first treatment received. Patients were divided in two groups, using a time frame of 90 days. Quality of life was measured through the Italian version of the University of California Los Angeles-Prostate Cancer Index (UCLA-PCI) and of the Short-Form Health Survey (SF-12). The occurrence of upgrading, upstaging, presence of lymph node metastasis and positive surgical margins at the final histopathological diagnosis, and PSA at 12 months follow-up were evaluated., Results: The overall median WT was 93 days. The logistic multivariable model confirmed that age, being resident in Southern regions of Italy and T staging at diagnosis were significantly associated with a WT>90 days. At 6 months from diagnosis the mean SF-12 score for the emotional-psychological component was significantly lower in WT≥90 days group (P=0.0428). Among patients treated with surgical approach, no significant differences in oncological outcomes were found in the two groups., Conclusions: In our study age, clinical T stage and provenance from Southern regions of Italy are associated with a WT>90 days. WT might have no impact on functional and oncological outcome.

Background: This study analyzes patient health-related quality of life (QoL) 24-month after prostate cancer (PCa) diagnosis within the PROState cancer monitoring in ITaly from the National Research Council (Pros-IT CNR) study., Methods: Pros-IT CNR is an ongoing, longitudinal and observational study, considering a convenience sample of patients enrolled at PCa diagnosis and followed at 6, 12, 24, 36, 48 and 60 months from the diagnosis. Patients were grouped according to the treatment received: nerve sparing radical prostatectomy (NSRP), non-nerve sparing radical prostatectomy (NNSRP), radiotherapy (RT), RT plus androgen deprivation (RT plus ADT) and active surveillance (AS). QoL was measured through the Italian versions of SF-12 and UCLA-PCI questionnaires at diagnosis and at 6-12 and 24-month. The minimal clinically important difference (MCID) was defined as half a standard deviation of the baseline domain., Results: Overall, 1537 patients were included in the study. The decline in urinary function exceeded the MCID at each timepoint only in the NSRP and NNSRP groups (at 24 months -14.7, P<0.001 and -19.7, P<0.001, respectively). The decline in bowel function exceeded the MCID only in the RT (-9.1, P=0.02) and RT plus ADT groups at 12 months (-10.3, P=0.001); after 24 months, most patients seem to recover their bowel complaints. The decline in sexual function exceeded the MCID at each timepoint in the NNSRP, NSRP and RT plus ADT groups (at 6 months -28.7, P<0.001, -37.8, P<0.001, -20.4, P<0.001, respectively)., Conclusions: Although all the treatments were relatively well-tolerated over the 24 month period following PCa diagnosis, each had a different impact on QoL.

Background: We aimed to test the hypothesis that the immune-modulatory effect of statins may improve survival outcomes in patients with non-muscle invasive bladder cancer (NMIBC). We focused on a cohort of patients diagnosed with high risk NMIBC, that were treated with intravesical BCG immunotherapy., Methods: We included patients at first diagnosis of T1 high grade NMIBC after transurethral resection of bladder (TURB). All procedures were performed at 18 different tertiary institutions between January 2002 and December 2012. Univariable and multivariable models were used to test differences in terms of residual tumor, disease recurrence, disease progression and overall mortality (OM) rates., Results: Overall, 1510 patients with T1 high grade NMIBC at TURB were included in our analyses. Of these, 402 (26.6%) were statin users. At multivariable analysis, statin use was associated with a higher rate of high-grade BC at re-TURB (OR: 1.37, 95%CI: 1.04-1.78; P=0.022), while at follow-up it was not independently associated with OM (HR: 0.71, 95%CI: 0.50-1.03; P=0.068) and disease progression rates (HR: 0.97, 95%CI: 0.79-1.19; P=0.753). Conversely, statin use has been shown to be independently associated with a lower risk of recurrence (HR:0.80, 95%CI: 0.67-0.95; P=0.009). The median recurrence-free survival was 47 (95%CI 40-49) months for those classified as non-statin users vs. 53 (95%CI 48-68) months in those classified as statin users., Conclusions: Statin daily intake do not compromise oncological outcomes in high risk NMIBC patients treated with BCG. Moreover, statin may have a beneficial effect on recurrence rates in this cohort of patients.

Introduction: Detrusor underactivity (DUA) and detrusor overactivity (DO) have potential impact on the outcomes of surgery for lower urinary tract symptoms related to benign prostate hyperplasia (LUTS/BPH)., Evidence Acquisition: We performed a literature search including studies on humans enrolling patients with preoperative urodynamic evidence of DO and/or DUA undergoing LUTS/BPH surgery. Factors that may influence the outcomes of surgery in these patients were evaluated., Evidence Synthesis: In patients with DUA mean bladder contractility index improved from +4 to +44.6, mean total International Prostate Symptom Score (IPSS) improved from -3 to -19.5 points, mean maximum urinary flow (Qmax) improved from +1.4 to +11.7 mL/s, and mean postvoid residual volume (PVR) improved from -16.5 to -736 mL. Older age, lack of obstruction, concomitant DO, lower detrusor contractility and use of transurethral resection of the prostate (TURP) or photovaporization (PV) instead of Holmium laser enucleation of the prostate (HoLEP) were associated with worse outcomes. In patients with DO, the percentage of DO resolution ranged from 57.1% to 83.3%. Mean total IPSS, Qmax, and PVR variations ranged from +0.9 to -15.7 points, from -0.2 mL/s to +14 mL/s, and from -19.6 to -202.5 mL, respectively. Older age, lack of obstruction, terminal DO, low maximum cystometric capacity, early and high amplitude DO, and use of transurethral prostate incision instead of TURP or open adenomectomy were associated with worse outcomes., Conclusions: In patients with DUA or DO, surgery for LUTS/BPH provides overall good results. However, a number of factors can affect these outcomes.

The severe acute respiratory syndrome coronavirus 2 and the disease it causes, coronavirus disease 2019 (COVID-19) is generating a rapid and tragic health emergency in Italy due to the need to provide assistance to an overwhelming number of infected patients and, at the same time, treat all the non-deferrable oncological and benign conditions. A panel of Italian urologists has agreed on possible strategies for the reorganization of urological routine practice and on a set of recommendations that should facilitate the process of rescheduling both surgical and outpatient activities during the COVID-19 pandemic and in the subsequent phases. This document could be a valid tool to be used in routine clinical practice and, possibly, a cornerstone for further discussion on the topic also considering the further evolution of the COVID-19 pandemic. It also may provide useful recommendations for national and international urological societies in a condition of emergency.

Background: Evidence about the clinical benefits of Hyperbaric Oxygen Therapy (HBOT) in patients with Fournier's Gangrene (FG) is controversial and inconclusive. We aimed to compare the mortality related to FG between patients undergoing surgical debridement and/or standard antibiotic therapy alone or in combination with HBOT., Methods: We performed a retrospective multi-institutional observational case-control study. All patients admitted with diagnosis of FG from June 2009 to June 2019 were included into the study. Patients received surgical debridement and/or standard antibiotic therapy alone or in combination with HBOT. Factors associated with FG related mortality were assessed with uni-and multivariate analyses. The main outcome measure was FG related mortality., Results: A total of 161 patients with diagnosis of FG were identified. Mean FG Severity Index was 8.6±4.5. All patients had broad-spectrum parenteral antibiotic therapy. An aggressive debridement was performed in 139 (86.3%) patients. A total of 72 patients (44.7%) underwent HBOT. Mortality due to FG was observed in 32 (36.0%) of patients who do not underwent HBOT and in 14 (19.4%) of patients who underwent HBOT (P=0.01). At the multivariate analysis, surgical debridement and HBOT were independent predictors of lower mortality while higher FG Severity Index was independent predictor of higher mortality., Conclusions: HBOT and surgical debridement are independent predictors of reduced FG related mortality.

Introduction: Males who present with a palpable testis nodule are likely to have malignant germ cell tumor in >90% of cases. Therefore radical orchiectomy remains the standard of care for intratesticular tumors. However, due to the recent developments of high-frequency probes in ultrasonography, the incidence of detecting a small non-palpable testis tumor is higher and higher. These lesions are thought to be benign in more than 60-80% of cases, thus a radical orchiectomy should be considered an overtreatment. In addition to that, radical orchiectomy might cause infertility, psychological issues and endocrine disorders, hence an organ-sparing procedure in such cases should be pursued., Evidence Acquisition: Only fourteen reliable retrospective studies met the inclusion criteria. No prospective randomized trials have appeared in Medline database., Evidence Synthesis: This review of the current literature has confirmed the safety and efficacy of testicular-sparing surgery in selected patients: 1) monorchid patients; 2) bilateral testis masses; 3) normal patients with a small, non-palpable masses detected with US, as long as the dimension of the lesion is up to 3 cm and not greater that 30% of the total volume of the organ., Conclusions: According to the literature, testis sparing surgery is a safe and feasible procedure for patients presenting a benign small testis mass. The enthusiasm found in the literature should however be tempered as the small number of patients reported in the studies coupled with the absence of a prospective trial represent important limits that need to be overtaken. Therefore more robust and well-designed studies are needed.

iXip® (Immune CompleX Predictive Index, Xeptagen, Venice, Italy) is a diagnostic tool which biological bases ground on PSA-IgM complexes. An algorithm merges the data of PSA-IgM and serum total PSA dosage, prostate volume and patient's age, providing as output a numerical value that correlates with the risk of finding prostate cancer (PCa) at biopsy. The present paper reviews the available evidence and explores future perspective on iXip. A few studies consistently showed that iXip offers better diagnostic accuracy in the diagnosis of PCa than every single parameter composing the index. In detail, for values of iXip below 20% prostatic biopsies were invariably negative, between 20% and 30% only one out of 10 patients had cancer, generally Gleason Score 6, whereas for iXiP>30% the detection rate raised up to 35% and comprised the majority of Gleason score >6 cancers. The PROXIMA study is an ongoing prospective trial that should assess the predictive ability of iXip towards the presence of a clinically significant PCa defined at radical prostatectomy, accounting for clinical, multiparametric magnetic resonance and bioptic data. Preliminary data showed that for iXip values <20% prostatic biopsy could be safely omitted and that the diagnosis of Gleason Score >6 PCa is unlikely for values below 30%.

Background: The aim of this study was to analyze the predictive factors of intraoperative complications in patients submitted to PN and the impact of intraoperative complications on postoperative outcomes., Methods: Data of 1055 patients who underwent PN for cortical renal masses were recorded from a multicenter prospective observational study (RECORd1 project)., Results: Overall, 48 (5%) patients experienced 49 intraoperative complications (four medical, 45 surgical). At multivariable analysis, age (OR=1.02, 95% CI: 1.00-1.08, P=0.03), imperative versus elective surgical indication (OR=2.55, 95% CI: 1.12-5.85, P=0.03), open (OR=5.76, 95% CI: 1.05-9.21, P=0.01) and laparoscopic (OR=2.35, 95% CI: 1.11-4.95, P=0.03) versus robotic approaches resulted independent predictive factors of intraoperative complications. Patients experiencing intraoperative complications had a significantly higher rate of overall postoperative complications (41.6% vs. 17.3%, P<0.0001), surgical postoperative complications (29.2% vs. 12.6%, P<0.0001), Clavien 2 surgical postoperative complications (14.6% vs. 7.2%, P=0.05) and a significantly longer length of stay (8 [6-9] vs. 7 [5-8] days, P<0.0001) than those with an uneventful intraoperative course., Conclusions: Efforts should be made to minimize the risk of intraoperative complications during PN, and, in that case, patients should be carefully monitored.

Background: The aim of this study was to evaluate the outcomes in laparoscopic radical prostatectomy (LRP) in patients who had undergone prior prostate surgery (PPS)., Methods: In this study 946 consecutive LR P patients were included and a retrospective comparison between those patients who had received PPS (group A) and those who had not received PPS (group B) was carried out. The preoperative, intraoperative and postoperative data was collected in a prospectively-maintained database. All complications occurring ≤30 days after surgery were recorded and defined according to the Dindo-modification of the Clavien system., Results: Longer operative time, greater blood loss, longer catheterization time, higher incidence of lymphocele, rectal injury and anastomotic stricture were found to be more frequent in group A. No statistically significant difference was noted between the two groups in terms of positive surgical margin rate and Biochemical recurrence free survival (BCRFS). Complete urinary continence rate resulted significantly higher in group B patients at both 1-year and 2-year follow-up. Potency rate resulted better in group B patients even if a statistically significant difference for both unilateral and bilateral nerve sparing techniques was not reached., Conclusions: LRP procedure can be safely performed on patients who have previously undergone PPS without compromising oncologic safety whereas a negative impact on functional outcome in terms of achieving a complete urinary continence rate and sexual potency should be expected.

Lymphadenectomy in germinal tumors of the testis, in spite of the immediate morbility (postoperative complications) and of the permanent morbility (unejaculation), is still, as regards the group of non-seminoma neoplasms, the most suitable for survival. However, groups of oncologists are seeking the possibility of avoiding this technique at stage I and II of the lesions, with the help, of course, of careful observation by CT, NMR, markers. The use of combined therapies (chemotherapy and radius therapy) has increased survival and the patients' life, allowing a highly satisfying percentage of recovery also in the non-initial stages.

The therapeutic efficacy and tolerance of a new 150,000 U (40 mg) formulation of mepartricin (to be administered once-a-day in the evening) were evaluated during a double-blind study against placebo in 2 groups of uncomplicated BPH patients treated for 60 days. The data obtained disclosed a positive pharmaco-therapeutic effect of this new formulation coupled with excellent local and systemic tolerance. At the end of trial the various objective and subjective parameters considered showed marked improvement in the group treated with mepartricin, with statistically significant differences from the placebo-treated group. The treatment efficacy was judged positive in 74-78% of cases by patients and physicians in the mepartricin group and in 36.4% of cases in the placebo group.

A group of 25 patients with uncomplicated BPH was treated mepartricin 150,000 U (40 mg) once in the evening for 60 days and the results were compared with those obtained in 25 patients treated with mepartricin 50,000 U (13 mg) t.d.s. Efficacy and tolerance of both treatment schemes were good. In the group treated with on single dose at night some symptoms such as nocturia and pollakiuria regressed more rapidly.

For many years diagnosis and management of prostatic adenocarcinoma were straightforward. However, with the advent of medical and less invasive therapies for the treatment of prostatic cancer, it has become necessary to know more about the etiology and pathophysiology of the disease. For example, hormonal factors, growth factors, stromal-epithelial interactions and aging have all been implicated in the etiology of the disease. The pathology of the disease demonstrates heterogeneity in the ratio of the stroma to the epithelium in any given patient, and the pathophysiology varies. Recognizing this heterogeneity in the disease, it is clear that no one form of medical or interventional therapy should be expected to result in a complete response.