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Objectives The Rotterdam Prostate Cancer Risk calculator (RPCRC) has been validated in the past years. Recently a new version including multiparametric magnetic resonance imaging (mpMRI) data has been released. The aim of our study was to analyze the performance of the mpMRI RPCRC app. Methods A series of men undergoing prostate biopsies were enrolled in eleven Italian centers. Indications for prostate biopsy included: abnormal Prostate specific antigen levels (PSA>4 ng/ml), abnormal DRE and abnormal mpMRI. Patients’ characteristics were recorded. Prostate cancer (PCa) risk and high-grade PCa risk were assessed using the RPCRC app. The performance of the mpMRI RPCRC in the prediction of cancer and high-grade PCa was evaluated using receiver operator characteristics, calibration plots and decision curve analysis. Results Overall, 580 patients were enrolled: 404/580 (70%) presented PCa and out of them 224/404 (55%) presented high-grade PCa. In the prediction of cancer, the RC presented good discrimination (AUC = 0.74), poor calibration (p = 0.01) and a clinical net benefit in the range of probabilities between 50 and 90% for the prediction of PCa (Fig. 1). In the prediction of high-grade PCa, the RC presented good discrimination (AUC = 0.79), good calibration (p = 0.48) and a clinical net benefit in the range of probabilities between 20 and 80% (Fig. 1). Conclusions The Rotterdam prostate cancer risk App accurately predicts the risk of PCa and particularly high-grade cancer. The clinical net benefit is wide for high-grade cancer and therefore its implementation in clinical practice should be encouraged. Further studies should assess its definitive role in clinical practice.

Nocturia is one of the most prevalent and bothersome lower urinary tract symptoms (LUTS) in men, leading to increased morbidity and mortality and a considerable economic burden on healthcare systems. Understanding its natural history, effect of pharmacotherapy, and predictors of failure of pharmacotherapy would allow optimised patient management.To evaluate the prevalence and effect of clinically relevant nocturia (crN) on quality of life in a contemporary cohort of European men aged ≥50 yr in a "real-life" setting, to understand its natural history, to detect any effect of pharmacotherapy, and to identify predictors of pharmacotherapy failure.This is a secondary analysis of the data from the Evolution Registry-a European, multicentre, prospective, observational registry, conducted in five European countries within a sample of general practitioners' and urologists' clinics. A consecutive sample of 2175 men aged ≥50 yr with LUTS in association with benign prostatic enlargement was enrolled between February 2010 and April 2011, and followed up for 2yr. Overall, data from 1838 men were suitable for analysis.The primary outcome was evaluation of the baseline incidence of nocturia in the study population. Secondary outcomes included the impact of nocturia on quality of life, efficacy of pharmacotherapy, and predictive factors associated with persistence of nocturia. Descriptive statistics were used to examine the data. Logistic regressions were used to analyse associations between comorbid conditions and risk factors in men with nocturia.Overall, 1198 men (65%) reported crN (two or more voids per night). This increased age dependently from 59% in the 50-59-yr age group (n=74) to 89% in the 80-99-yr age group (n=25). Overall, the incidence of crN improved in those who commenced pharmacological treatment at study entry, from 69% at baseline to 49% at 24 mo (p0.00001). This was statistically significant only in those80 yr old. A weak correlation was found between the severity of nocturia at baseline and quality-of-life scores on the International Prostate Symptom Score questionnaire (r=0.33, p0.001). Of the patients treated with an alpha-blocker or a 5-alpha reductase inhibitor, 62% still had crN at 24 mo.Almost two-thirds of men in the Evolution Registry reported clinically significant nocturia with increased incidence with age. Despite prostate-targeted treatment, most patients, especially older men, still had persistent or worsening nocturia at 2-yr follow-up, and in this study, it was not possible to identify specific clinical factors that predicted those who could respond well to treatment in this regard.This large study of men from five different European countries has shown that waking up at night to pass urine (nocturia) is very common and becomes more common with older age, and treatments that target the prostate do not significantly improve symptoms over 2yr in most men.

Purpose To compare surgery outcomes and safety of button bipolar enucleation of the prostate vs laparoscopic simple prostatectomy in patients with large prostates (> 80 g) in a two-center cohort study. Methods All patients with lower urinary tract symptoms due to benign prostatic enlargement (Prostate volume > 80 cc) undergoing button bipolar enucleation of the prostate (BTUEP) or laparoscopic simple prostatectomy (LSP) in two centers were enrolled. Data on clinical history, physical examination, urinary symptoms, uroflowmetry and prostate volume were collected at 0, 1, 3 6, 12, 24 and 36 months. Early and long-term complications were recorded. Results Overall, 296 patients were enrolled. Out of them, 167/296 (56%) performed a LSP and 129/296 (44%) performed a BTUEP. In terms of efficacy both procedures showed durable results at three years with a reintervention rate of 8% in the LSP group and of 5% in the BTUEP group. In terms of safety, BTUEP and LSP presented similar safety profiles with a 9% of transfusion rate and no major complications. Conclusion LSP and BTUEP are safe and effective in treating large-volume adenomas with durable results at three years when performed in experienced centers.

Item does not contain fulltext Background Lower urinary tract symptoms due to benign prostate enlargement (LUTS/BPE) can lead to significant disturbances to health-related quality of life (HRQoL) and psychological well-being. The aim of this study was to evaluate the effect of pharmacological treatment of LUTS/BPE on disease specific and generic QOL measures. Methods Evolution was a European prospective, multicenter multi-national, observational registry collecting real-life clinical data over 2 years on the management of LUTS/BPE in primary and secondary care. This study investigated disease-specific QOL using questionnaires such as IPSS Q8, BPH Impact Index (BII) and generic QOL using questionnaires like EuroQOL Five Dimension (EQ5D) which encompassed EQ5D VAS and EQ5D health index. Results The registry enrolled 1838 BPE patients and 1246 patients were evaluable at the end of 24 months. Nearly 70% of patients in the study were previously treated with medical therapy and 17% of these had already discontinued medical treatment previously for various reasons with lack of efficacy being the most common. The mean time since diagnosis of LUTS in the previously treated group was 4.7 years (0-26 years). Medical management produced statistically significant improvement in QOL (disease specific and generic) in previously untreated patients and an insignificant change in generic QOL in previously treated patients. Conclusions After 5-years from the onset of symptoms, LUTS/BPE patients previously treated with medication had significantly impaired QOL in patients in a manner comparable to other chronic diseases. Earlier intervention with minimally invasive surgical techniques (MIT) should be considered in LUTS/BPE patients that do not show a significant improvement in QOL with medical therapy.

Background: Urinary tract infections (UTI) are highly frequent in women, with a significant impact on healthcare resources. Although antibiotics still represent the standard treatment to manage recurrent UTI (rUTI), D-mannose, an inert monosaccharide that is metabolized and excreted in urine and acts by inhibiting bacterial adhesion to the urothelium, represents a promising nonantibiotic prevention strategy. The aim of this narrative review is to critically analyze clinical studies reporting data concerning the efficacy and safety of D-mannose in the management of rUTIs. Methods: A non-systematic literature search, using the Pubmed, EMBASE, Scopus, Web of science, Cochrane Central Register of Controlled Trials, and Cochrane Central Database of Systematic Reviews databases, was performed for relevant articles published between January 2010 and January 2021. The following Medical Subjects Heading were used: “female/woman”, “urinary tract infection”, and “D-mannose”. Only clinical studies, systematic reviews, and meta-analyses reporting efficacy or safety data on D-mannose versus placebo or other competitors were selected for the present review. Evidence was limited to human data. The selected studies were organized in two categories according to the presence or not of a competitor to D-mannose. Results: After exclusion of non-pertinent studies/articles, 13 studies were analyzed. In detail, six were randomized controlled trials (RCTs), one a randomized cross-over trial, five prospective cohort studies, and one a retrospective analysis. Seven studies compared D-mannose to placebo or others drugs/dietary supplements. Six studies evaluated the efficacy of D-mannose comparing follow-up data with the baseline. D-mannose is well tolerated, with few reported adverse events (diarrhea was reported in about 8% of patients receiving 2 g of D-mannose for at least 6 months). Most of the studies also showed D-mannose can play a role in the prevention or rUTI or urodynamics-associated UTI and can overlap antibiotic treatments in some cases. The possibility to combine D-mannose with polyphenols or Lactobacillus seems another important option for UTI prophylaxis. However, the quality of the collected studies was very low, generating, consequently, a weak grade of recommendations as suggested by international guidelines. Data on D-mannose dose, frequency, and duration of treatment are still lacking. Conclusion: D-mannose alone or in combination with several dietary supplements or Lactobacillus has a potential role in the non antimicrobial prophylaxis or recurrent UTI in women. Despite its frequent prescription in real-life practice, we believe that further well-designed studies are urgently needed to definitively support the role of D-mannose in the management of recurrent UTIs in women.

BACKGROUND Aim of our study was to assess the impact of vacation on urinary symptoms in health care workers. METHODS Between March 2018 to October 2019 a survey was carried out by enrolling health care system workers in three centers. Demographic and clinical characteristics of health care workers (i.e. age, smoking status, medical history) were collected. Lower Urinary tract symptoms (LUTS) and work related quality of life were assessed before and after vacation with validated questionnaires: Overactive Bladder Questionnaire Short Form (OABq-sf), International Prostate Symptom Score (IPSS), Work-related Quality of Life (WRQOL) and SF-36 questionnaires. As well, Night Shift Workers (NSWs), defined as working at least one time a week from 8 pm to 8 am, were compared to traditional workers (TWs). RESULTS A total of 236 participants (118 males and 118 females) with a median of 41 (32/49 IQR) years old were included in the survey. Healthcare workers presented after vacation an improvement in LUTS, in work related quality of life and overall health. Overall, 89 (37%) were NSWs and 147 (62%) subjects were TWs. NSWs reported a significant higher median OABq total score and IPSS than TWs: respectively, 27 (IQR 23-34) vs 20 (IQR 19-24) p 0,01, 2 (0/6) vs 0 (0/2) (p

Background A prostate cancer diagnosis is based on biopsy sampling that is an invasive, expensive procedure, and doesn’t accurately represent multifocal disease. Methods To establish a model using plasma miRs to distinguish Prostate cancer patients from non-cancer controls, we enrolled 600 patients histologically diagnosed as having or not prostate cancer at biopsy. Two hundred ninety patients were eligible for the analysis. Samples were randomly divided into discovery and validation cohorts. Results NGS-miR-expression profiling revealed a miRs signature able to distinguish prostate cancer from non-cancer plasma samples. Of 51 miRs selected in the discovery cohort, we successfully validated 5 miRs (4732-3p, 98-5p, let-7a-5p, 26b-5p, and 21-5p) deregulated in prostate cancer samples compared to controls (p ≤ 0.05). Multivariate and ROC analyses show miR-26b-5p as a strong predictor of PCa, with an AUC of 0.89 (CI = 0.83–0.95;p To distinguish between low and high-grade prostate cancer, we found that miR-4732-3p levels were significantly higher; instead, miR-26b-5p and miR-98-5p levels were lower in low-grade compared to the high-grade group (p ≤ 0.05). Combining miR-26b-5p and miR-4732-3p we have the highest diagnostic accuracy for high-grade prostate cancer patients, (AUC = 0.80; CI 0,69-0,873). Conclusions Noninvasive diagnostic tests may reduce the number of unnecessary prostate biopsies. The 2-miRs-diagnostic model (miR-26b-5p and miR-98-5p) and the 2-miRs-grade model (miR-26b-5p and miR-4732-3p) are promising minimally invasive tools in prostate cancer clinical management.

Purpose Few tools are available to predict uretero-lithotripsy outcomes in patients with ureteral stones. Aim of our study was to develop a nomogram predicting the probability of stone free rate in patients undergoing semi-rigid uretero-lithotripsy (ULT) for ureteral stones. Methods From January 2014 onwards, patients undergoing semi-rigid Ho: YAG laser uretero-lithotripsy for ureteral stones were prospectively enrolled in two centers. Patients were preoperatively evaluated with accurate clinical history, urinalysis and renal function. Non-contrast CT was used to define number, location and length of the stones and eventually the presence of hydronephrosis. A nomogram was generated based on the logistic regression model used to predict ULT success. Results Overall, 356 patients with mean age of 54 years (IQR 44/65) were enrolled. 285/356 (80%) patients were stone free at 1 month. On multivariate analysis single stone (OR 1.93, 95% CI 1.05–3.53, p = 0.034), stone size (OR 0.92, 95% CI 0.87–0.97, p = 0.005), distal position (OR 2.12, 95% CI 1.29–3.48, p = 0.003) and the absence of hydronephrosis (OR 2.02, 95% CI 1.08–3.78, p = 0.029) were predictors of success and these were used to develop a nomogram. The nomogram based on the model presented good discrimination (area under the curve [AUC]: 0.75), good calibration (Hosmer–Lemeshow test, p > 0.5) and a net benefit in the range of probabilities between 15 and 65%. Internal validation resulted in an AUC of 0.74. Conclusions The implementation of our nomogram could better council patients before treatment and could be used to identify patients at risk of failure. External validation is warranted before its clinical implementation.

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), radiotherapy 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, 1 537 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

Contains fulltext : 233937.pdf (Publisher’s version ) (Closed access) BACKGROUND: Owing to the large variation in treatment response among patients with high-risk prostate cancer, it would be of value to use objective tools to monitor the status of bone metastases during clinical trials. Automated Bone Scan Index (aBSI) based on artificial intelligence has been proposed as an imaging biomarker for the quantification of skeletal metastases from bone scintigraphy. OBJECTIVE: To investigate how an increase in aBSI during treatment may predict clinical outcome in a randomised controlled clinical trial including patients with high-risk prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively selected all patients from the Zometa European Study (ZEUS)/SPCG11 study with image data of sufficient quality to allow for aBSI assessment at baseline and at 48-mo follow-up. Data on aBSI were obtained using EXINIbone(BSI) software, blinded for clinical data and randomisation of zoledronic acid treatment. Data on age, overall survival (OS), and prostate-specific antigen (PSA) at baseline and upon follow-up were available from the study database. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Association between clinical parameters and aBSI increase during treatment was evaluated using Cox proportional-hazards regression models, Kaplan-Meier estimates, and log-rank test. Discrimination between prognostic variables was assessed using the concordance index (C-index). RESULTS AND LIMITATIONS: In this cohort, 176 patients with bone metastases and a change in aBSI from baseline to follow-up of ≤0.3 had a significantly longer median survival time than patients with an aBSI change of >0.3 (p

Item does not contain fulltext Background To use the European Association of Urology Research Foundation (EAURF) registry data to determine the proportion of contemporary Lower Urinary Tract Symptoms associated with Benign Prostatic Enlargement (LUTS/BPE) patients prescribed phytotherapy, and to determine their subjective quality of life and clinical progression responses. Methods This was a prospective multicenter multinational observational registry study, conducted over 2 years. Men >= 50 years seeking LUTS/BPE were divided at baseline into two cohorts, presently/recently untreated patients (PUP) commencing pharmacotherapy at baseline and presently/recently treated patients (c-PTP) continuing previously received pharmacotherapy, with 24-month follow-up (FU). Results Overall, 2175 patients were enrolled with 1838 analyzed. Of the PUP cohort (n = 575), 92 (16%) received phytotherapy and 65 (71%,n = 65/92) completed 24-month FU, with France prescribing 34% (n = 30/89) the highest proportion of phytotherapy among all LUTS/BPE medications. In the c-PTP group (n = 1263), only 69 (5%) patients were using phytotherapy, falling ton = 35/69 (51%) at 24-month FU (highest in France 20% (n = 43/210)). Though defined disease progression occurred in

Item does not contain fulltext Purpose: We evaluated unmet needs of lower urinary tract symptoms-benign prostatic enlargement pharmacological treatment by measuring symptom improvement, persistence and deterioration in real life. A prospective registry was conducted for 24 months in 5 European countries and analyzed by the European Association of Urology Research Foundation. Materials and Methods: Previously untreated and treated patients were enrolled to the registry in both primary care and urology referral centers in France, Germany, Italy, Spain and the UK. Results: Overall, 2,175 patients were enrolled with 1,838 analyzed, consisting of 575 previously untreated lower urinary tract symptoms-benign prostatic enlargement patients (no alpha blockers for at least 1 month or no 5-alpha reductase inhibitors for at least 6 months) and 1,263 previously treated patients. During the registry 90% of patients adhered to the prescribed regimen. After 24 months, 70% of previously untreated and 42% of previously treated patients experienced symptom improvement (International Prostate Symptom Score [IPSS] reduction of >= 3 points). Symptomatic patients (IPSS >= 8) remained in both groups (59% in previously untreated and 61% in previously treated), with greater symptom deterioration (IPSS increase >= 3 points) in 18.9% in previously treated vs 7.8% in previously untreated patients. Both clinical lower urinary tract symptoms-benign prostatic enlargement progression and surgery rates were similar in untreated vs treated groups at 16% vs 17% and 5% vs 7%, respectively, at 24 months. Conclusions: This prospective registry confirmed lower urinary tract symptoms-benign prostatic enlargement pharmacological treatment effectiveness in a realworld setting, with low clinical progression observed in about 1 in 6 patients and lower surgery rates below 1 in 20, by 24 months.

Background Benign prostatic hyperplasia (BPH), a progressive condition and common cause of lower urinary tract symptoms (LUTS), is underdiagnosed in primary care, impacting patient outcomes. Here, we evaluate the utility of a BPH screening tool in general practice, to identify men confirmed to have BPH after urologist assessment of diagnostic test results. Methods A 3-item questionnaire was developed to discriminate between LUTS due to BPH versus other conditions, and was translated and validated cross-culturally. Its utility was assessed in a cohort study (FDC116114/NCT02757963) conducted in 47 centers across France, Germany, Italy, Russia, and Spain. The study enrolled men ≥50 years of age presenting to general practice clinics with a score of ≥3 on the BPH screening tool or ≥8 on the International Prostate Symptom Score (IPSS). In total, 561 men completed the study. The primary endpoint was the proportion of patients with a urologist-confirmed BPH diagnosis among those with a positive result on the BPH screening tool (score ≥3) and serum prostate specific antigen (PSA) ≥2ng/mL. Results The primary endpoint was fulfilled; 88.3% (95% CI: 84.9, 91.2) of patients had urologistconfirmed BPH diagnoses among those with positive results on the BPH screening tool and serum PSA ≥2ng/mL, similar to the proportion seen with IPSS ≥8 and serum PSA ≥2ng/mL (87.7%; 95% CI 84.6, 90.4). Conclusions The BPH screening tool, in conjunction with serum PSA, demonstrated adequate predictive value by allowing general practitioners to quickly screen men presenting with different medical conditions but identified as having urological symptoms.

BACKGROUND The aim of our study is to develop a clinical nomogram including metabolic syndrome status for the prediction of high-grade prostate cancer (HG PCa). METHODS A series of men at increased risk of PCa undergoing prostate biopsies were enrolled in a single center. Demographic and clinical characteristics of the patients were recorded. Metabolic syndrome was defined according to the adult treatment panel III. A nomogram was generated based on the logistic regression model and used to predict high grade prostate cancer defined as grade group ≥3 (ISUP 2014). ROC curves, calibration plots and decision curve analysis were used to evaluate the performance of the nomogram. RESULTS Overall, 738 patients were enrolled. Greater than or equal to 294/738 (40%) of the patients presented PCa and of those patients, 84/294 (39%) presented high grade disease (Grade Group ≥3). On multivariate analysis, DRE (OR: 3.24, 95% CI: 1.80-5.84), PSA (OR: 1.10, 95% CI: 1.05-1.16), PV (OR: 0.98, 95% CI: 0.97-0.99) and MetS (OR: 2.02, 95% CI: 1.13-3.59) were predictors of HG PCa. The nomogram based on the model presented good discrimination (AUC: 0.76), good calibration (Hosmer-Lemeshow Test, P>0.05) and a net benefit in the range of probabilities between 10% and 70%. CONCLUSIONS Metabolic syndrome is highly prevalent in patients at risk of prostate cancer and is particularly associated with high-grade prostate cancer. Our nomogram offers the possibility to include metabolic status in the assessment of patients at risk of prostate cancer to identify men who may have a high-grade form of the disease. External validation is warranted before its clinical implementation.

The narrative review of Fujita K et al [...]

The aim of the present study is to assess the impact of night shift work (NSW) on urinary symptoms.Between March 2018 to October 2018, we evaluated a group of National Health care system workers. Urinary symptoms and quality of life were measured by Overactive Bladder Questionnaire Short Form (OABq-sf). Clinical variables (i.e. age, smoking status, medical history) were collected and analyzed according to be NS workers (NSWs) from subjects working at least one time from 8 pm to 8 am or from traditional workers (TWs). Univariate and multivariate analysis was performed to identify predictive variables of worse OAB outcomes (OABq-sf30, OABq-SB≥12, OABq HRQL≥18).A total of 136 participants (68 males and 68 females) were included in the study. On OABq-sf, total score, symptoms bother (OABq-SB) and health related quality of life (OABq-HRQL) domains were significantly (P0.05) higher in NSWs group, respectively: 31 (IQR 26-35) vs. 19 (IQR 19-20); 11 (IQR 10-13) vs. 6 (IQR 6-7); 19 (IQR 16-22) vs. 13 (13-14). Finally, seven NSWs (10.6%) referred nocturia respect to only one (1%) TWs, (P=0.02). On multivariate analysis NSW was an independent predictor of OABq-sf30 units (OR:30; CI: 9-111, P=0.001), OABq-SB ≥12 units (OR:16, CI: 6-43, P=0.001) and OABq HRQL≥18 units (OR:20, CI: 6-70, P=0.001).Night shift workers presented worst OAB Score and poor QL when compared to similar traditional workers. Long-term data on NSWs patients are also needed to further clarify this relationship.

INTRODUCTION AND OBJECTIVE:To provide a snapshot of toxicities and oncologic outcomes of Abiraterone (AA) and Enzalutamide (EZ) in a chemo-naive metastatic Castration Resistant Prostate Cancer (mCP...

INTRODUCTION AND OBJECTIVE:Aim of our study was to analyze adverse events (AEs) associated with drugs approved for the treatment of metastatic renal cell carcinoma reported in the eudra-vigilance d...

Recently, the Cormio et al. nomogram has been developed to predict prostate cancer (PCa) and clinically significant PCa using benign prostatic obstruction parameters. The aim of the present study was to externally validate the nomogram in a multicentric cohort. Between 2013 and 2019, patients scheduled for ultrasound-guided prostate biopsy were prospectively enrolled at 11 Italian institutions. Demographic, clinical and histological data were collected and analysed. Discrimination and calibration of Cormio nomogram were assessed with the receiver operator characteristics (ROC) curve and calibration plots. The clinical net benefit of the nomogram was assessed with decision curve analysis. Clinically significant PCa was defined as ISUP grade group > 1. After accounting for inclusion criteria, 1377 patients were analysed. 816/1377 (59%) had cancer at final pathology (574/816, 70%, clinically significant PCa). Multivariable analysis showed age, prostate volume, DRE and post-voided residual volume as independent predictors of any PCa. Discrimination of the nomogram for cancer was 0.70 on ROC analysis. Calibration of the nomogram was excellent (p = 0.94) and the nomogram presented a net benefit in the 40–80% range of probabilities. Multivariable analysis for predictors of clinically significant PCa found age, PSA, prostate volume and DRE as independent variables. Discrimination of the nomogram was 0.73. Calibration was poor (p = 0.001) and the nomogram presented a net benefit in the 25–75% range of probabilities. We confirmed that the Cormio nomogram can be used to predict the risk of PCa in patients at increased risk. Implementation of the nomogram in clinical practice will better define its role in the patient’s counselling before prostate biopsy.

The purpose of this study was to assess patient frailty as a risk factor for radical cystectomy (RC) complications.We performed an analysis of prospectively collected data of consecutive patients 80 years of age or older who underwent RC and ureterocutaneostomy in 6 primary care European urology centers. Frailty was measured using a simplified frailty index (sFI) with a 5-item score including: (1) diabetes mellitus; (2) functional status; (3) chronic obstructive pulmonary disease; (4) congestive cardiac failure; and (5) hypertension, with a maximum 5-item score meaning high level of frailty. Within 90 days surgical complications were scored according to the Clavien Classification System (CCS). sFI ≥3 was considered as poor frailty status. Clinical and pathological variables were analyzed as predictors of severe complications (CCS ≥3).One hundred seventeen patients were enrolled. Most patients reported an sFI score of 2 and 3, respectively, 31/117 (26.5%) and 45/117 patients (38.5%). CCS ≥3 occurred in 17/117 patients (14.5%). Patients with sFI ≥3 were significantly older than patients with sFI 3 (median age, 85 years [interquartile range (IQR), 82-86] versus 82 years [IQR, 80-84]; P = .001). Most CCS ≥3 scores occurred in patients with sFI ≥3: 13 (11.1%) versus 4 (3.4%; P = .02). No significative differences were detected in terms of length of hospital stay, pathological stage, and postoperative bowel canalization when related to sFI. sFI ≥3 was an independent risk factor of CCS ≥3 in univariate and multivariate analysis (respectively, odds ratio [OR], 3.81 [95% confidence interval (CI), 1.16-12.5; P = .02] and OR, 3.1 [95% CI, 0.7-13.7; P = .01]). Body mass index, age, American Society of Anesthesiologists score ≥3, and pathological stage were not related to CCS ≥3.RC appears feasible in elderly patients with an sFI 3. In cases of sFI ≥3, this choice should be carefully valued, discussed, and possibly avoided because of a higher risk of complications.

INTRODUCTION AND OBJECTIVES:Metabolic syndrome (MetS) is associated with an increased risk of aggressive prostate cancer (PCa). However, MetS has not yet been included in the available nomograms us...

INTRODUCTION AND OBJECTIVES:Detrusor underactivity (DU) is a common clinical problem in patient being referred with lower urinary tract symptoms (LUTS). DU is defined as a contraction of reduced st...

INTRODUCTION AND OBJECTIVES:Aim of our study was to analyze adverse events (AEs) associated with ENZ and ABI over time and to compare real life data from Eudra-Vigilance to registry studies.METHODS...

INTRODUCTION AND OBJECTIVES:To evaluate Metabolic syndrome (MetS) as a risk factor of Prostate cancer (PC) in patient undergone to repeat trans-rectal prostate biopsy (PB).METHODS:Between May 2010 ...

INTRODUCTION AND OBJECTIVES:To analyze age influence on adverse events (AEs) associated with Enzaliutamide (ENZ), Abiraterone (AAP) and Radium223, analyzing real life data from Eudra-Vigilance.METH...

Male lower urinary tract symptoms are frequently due to benign prostatic enlargement. Medical therapy is strongly recommended in patients with moderate to severe symptoms. Lower urinary tract symptoms may require a different medical approach using drugs with different mechanisms of action. Alpha-1 blockers, muscarinic receptor antagonists and phosphodiesterase type 5 inhibitors are the most frequently used drugs. 5-Alpha reductase inhibitors are commonly prescribed to reduce prostate volume and to prevent benign prostatic hyperplasia progression. Currently, medical treatment of lower urinary tract symptoms suggestive of benign prostatic enlargement can be tailored according to different symptom characteristics and severity, and to different patient comorbidities and preferences. For this reason, the decision-making process should be based on an accurate patient counselling with detailed clarification of potential benefits and, above all, potential side effects of different drugs. This non-systematic review of the literature presents an update of the current options for medical treatment of lower urinary tract symptoms suggestive of benign prostatic enlargement, helping urologists in the decision-making and counselling process.

Objective To analyze the performance of two mobile phone apps—the Rotterdam prostate cancer risk app and the Coral app—in a cohort of patients undergoing prostate biopsies. Methods A consecutive series of men undergoing prostate biopsies were enrolled in two centers. Indications for prostate biopsy included abnormal prostate-specific antigen levels (PSA >4 ng/mL) and/or an abnormal digital rectal examination (DRE). Prostate cancer risk and high-grade prostate cancer risk were assessed using the Rotterdam prostate cancer risk app (iOS) and the Coral app (iOS). The usability of the apps was also assessed and compared using the Post-Study System Usability Questionnaire (PSSUQ) developed by IBM. Results Overall, 1682 patients with a median age of 68 (62–73) years were enrolled. The Rotterdam app outperformed the Coral app in the prediction of prostate cancer (AUC: 0.70 versus 0.631, p = 0.001) and of high-grade prostate cancer (0.75 versus 0.69, p = 0.001) (Fig. 1). PSSUQ data revealed that both Rotterdam and Coral applications were comparable in terms of usefulness (87% versus 83%, p = 0.708), information quality (74% versus 72%, p = 0.349), interface quality (79% versus 74%, p = 0.216) and satisfaction (76% versus 76%, p = 0.935), respectively. In terms of preferences, 26/50 (54%) preferred the Rotterdam app, while 24/50 (46%) preferred the Coral app. Conclusion In our experience the Rotterdam App outperformed the Coral App for the prediction of prostate cancer or high-grade cancer diagnosis. In particular we confirmed, using the Rotterdam app, that only one out of ten patients with a low Rotterdam score will harbor high-grade prostate cancer on biopsy.

Objective To assess the association between physical activity, evaluated by the Physical Activity Scale for Elderly (PASE) questionnaire and lower urinary tract symptoms (LUTS) in male patients. Methods From 2009 onward, a consecutive series of patients with LUTS-benign prostatic enlargement were enrolled. Symptoms were evaluated using the International Prostate Symptom Score (IPSS) with its subscores and prostate volume using transrectal ultrasound. Physical activity was evaluated with the PASE questionnaire, consisting of 12 questions regarding frequency and duration of leisure activity and recently used to evaluate physical activity in patients with prostatic disorders. The risk of detecting LUTS (IPSS ≥8), voiding LUTS (vIPSS≥5), and storage LUTS (sLUTS) (sIPSS ≥4) was evaluated using binary logistic regression analysis. Results Six hundred and seventeen patients were enrolled in 2 centers (Rome, Vasto, Italy). Median PASE score was 118 (IQR 73/169), and median IPSS was 9 (IQR 5/15). Overall 189 of 617 (30%) patients presented moderate/severe LUTS. These patients presented a lower PASE score (111 IQR 69/160 vs 125 IQR 83/180; P = .016) when compared to patients with total IPSS ≤7. On multivariate analysis, PASE score (OR = 0.997 per unit, 95%CI: 0.994-1.000; P = .023), and prostate volume (OR = 1.008 per mL, 1.000-1.016; P = .045) were independent predictors of LUTS severity. As well PASE score was an independent predictor of moderate/severe sLUTS (OR = 0.996, 95%CI:0.993-0.999; P = .015). Conclusion In our study a reduced physical activity, assessed using the PASE questionnaire, is associated with an increased risk of moderate severe LUTS, more specifically of moderate/severe sLUTS.

Objectives The aim of our study is to evaluate the role of preoperative quality of life (QL) as a possible risk factor for post robotic assisted radical prostatectomy (RARP) urinary incontinence. The secondary aim is to evaluate the possible effect of preoperative QL on post RARP lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Methods and materials Between 2012 and 2017, all patients undergoing RARP for prostate cancer were enrolled. Patient's demographic, clinical, and histological characteristics were recorded. ED, LUTS, urinary incontinence, and QL were evaluated at baseline and postoperatively at 3, 6, and 12 months. Incontinence was evaluated with the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form questionnaire and QL with the EORTC QLQ-C30 global health score (QLQ-GHS). Multivariate logistic regression analysis was used to evaluate the risk of postoperative incontinence, moderate/severe incontinence, LUTS, and moderate/severe ED. Results Overall 4,603 patients were enrolled. Incontinence rates at 3, 6, and 12 months were respectively 17%, 10%, and 8%. On multivariate analysis, QL was an independent predictor of early incontinence (QLQ-GHS:0.71, CI:0.59–0.86; P= 0.001), severe incontinence (QLQ-GHS:0.65, CI:0.49–0.97; P= 0.006), and LUTS (QLQ-GHS:0.48, CI:0.41–0.57; P= 0.001). Single center design may be considered a limitation. Conclusions In our study a comprehensive evaluation of preoperative patient's QL, assessed by the EORTC QLQ-C30 questionnaire, can predict the early and long-term moderate/severe incontinence risk in RARP treated patients. Further studies should confirm our results.

International audience; PURPOSE:To compare the outcomes of PN to those of RN in very elderly patients treated for clinically localized renal tumor.PATIENTS AND METHODS:A purpose-built multi-institutional international database (RESURGE project) was used for this retrospective analysis. Patients over 75 years old and surgically treated for a suspicious of localized renal with either PN or RN were included in this database. Surgical, renal function and oncological outcomes were analyzed. Propensity scores for the predicted probability to receive PN in each patient were estimated by logistic regression models. Cox proportional hazard models were estimated to determine the relative change in hazard associated with PN vs RN on overall mortality (OM), cancer-specific mortality (CSM) and other-cause mortality (OCM).RESULTS:A total of 613 patients who underwent RN were successfully matched with 613 controls who underwent PN. Higher overall complication rate was recorded in the PN group (33% vs 25%; p = 0.01). Median follow-up for the entire cohort was 35 months (interquartile range [IQR] 13-63 months). There was a significant difference between RN and PN in median decline of eGFR (39% vs 17%; p

BACKGROUND The aim of our study is to explore the association between cigarette smoking and the risk of prostate cancer (PCa) diagnosis as well as high grade disease in men undergoing prostate biopsies. METHODS From 2008 to 2016, we prospectively enrolled a consecutive series of men with no history of PCa undergoing prostate biopsies. Variables assessed the day of the biopsy included: Family history of PCa, age, body mass index (BMI), comorbidities, digital rectal examination (DRE), prostate volume, PSA, free PSA, smoking status, number of cigarette/day, smoking time, smoking starting age and smoking cessation. Smoking variables were evaluated as predictors of PCa and high grade PCa (Prognostic Grade Group ≥3) using adjusted logistic regression analyses. RESULTS Overall 1080 patients were enrolled, out of them 499/1080/753 (46%) had never smoked; 168/1080/753 (16%) were smokers and 413/1080 (38%) were former smokers. Out of the 451/1080 (41%) patients with PCa 175/451 (39%) presented high grade disease. As expected family history, age, dyslipidemia, PSA, digital rectal examination and prostate volume were independent predictors of PCa. As well age, DRE, and PSA were independent predictors of high-grade disease. Smoking status (OR=0.983; CI: 0.689-1.402) and the associated variables were not independent predictors of PCa or high grade PCa (OR: 1.250; CI: 0.593-1.327). CONCLUSIONS In our cross-sectional study, smoking is not predictive of PCa or high-grade disease. Further studies should evaluate if smoking could influence PCa diagnosis and aggressiveness.

Therapeutic options for the management of lower urinary tract symptoms (LUTS) secondary to benign prostatic enlargement (BPE) have considerably increased in recent years. However, the ideal timing to initiate medical treatment of LUTS/BPE has not been fully established. The aim of this review was to systematically collect available evidence on the influence of early treatment on the natural history of LUTS/BPE patients. A systematic literature search from January 1996 until April 2018 was performed by combining the following MESH terms: Lower Urinary Tract Symptoms, Benign Prostatic Enlargement, male, medical treatment, surgical treatment, early treatment/intervention, and early intervention/treatment. The Medline, PubMed, and Scopus databases were searched. Each article title and abstract was reviewed for relevance and appropriateness with regard to the topic of this review. In recent years, the medical armamentarium for the management of LUTS secondary to BPE has been extensively implemented, significantly improving treatment outcomes and markedly reducing the need for BPE surgery. Early intervention in patients at risk for disease progression may offer better clinical outcomes compared to a deferred approach. However, evidences supporting early treatment are scarce, and criteria to discriminate patients that could mostly benefit from immediate treatment remain poorly defined. Moreover, as a result of delayed surgery after prolonged medical treatment, patients undergoing surgical relief show larger prostates, older age, and comorbidities. Nevertheless, technological advancements in surgical techniques have largely counterweighed this critical scenario, and commonly, a non-pejorative trend has been reported in perioperative complications. The timeliest moment to start a medical treatment in LUTS/BPE patients is still undefined, and unexpectedly, peer-reviewed evidence remains scarce. Further studies are awaited to better discriminate patients who mostly benefit from early treatment of LUTS/BPE.

In the past years, the relationship between lower urinary tract symptoms and erectile dysfunction has been widely explored. The aim of our systematic review is to summarize the published evidence over the past year on lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Recent data support the relationship between LUTS and ED in Eastern Europe and in Asia. The role of phosphodiesterase inhibitors alone or in combination with alpha blockers to treat LUTS and ED, especially in younger patients, is strongly supported by high level of evidence. LUTS and ED are prevalent conditions in men over 50; epidemiologically, the relationship between both conditions has been confirmed all over the world. PDE5i alone or in combination with alpha blockers can be considered the gold standard for the treatment of young patients with storage symptoms and concomitant ED. In clinical research, a better understanding of the molecular pathways behind this association may also help to identify new possible targets and develop novel therapeutic approaches to manage both disorders; the identification of new biomarkers of both disorders is also compulsory in this area.

Aims To investigate the link between lower urinary tract symptoms (LUTS) and metabolic disorders. Materials and Methods This report results from presentations and subsequent discussions about LUTS and metabolic disorders at the International Consultation on Incontinence Research Society (ICI-RS) in Bristol, 2014. Results There are common pathophysiological determinants for the onset of LUTS and the metabolic syndrome (MetS). Both conditions are multifactorial, related to disorders in circadian rhythms and share common risk factors. As in men with erectile dysfunction, these potentially modifiable lifestyle factors may be novel targets to prevent and treat LUTS. The link between LUTS and metabolic disorders is discussed by using sleep, urine production and bladder function as underlying mechanisms that need to be further explored during future research. Conclusion Recent findings indicate a bidirectional relationship between LUTS and the MetS. Future research has to explore underlying mechanisms to explain this relationship, in order to develop new preventive and therapeutic recommendations, such as weight loss and increasing physical activity. The second stage is to determine the effect of these new treatment approaches on the severity of LUTS and each of the components of the MetS. Neurourol. Urodynam. 35:278–282, 2016. © 2016 Wiley Periodicals, Inc.

Combination therapy with anti-muscarinics (AMs) and β3 agonists (β3As) has recently been proposed as a possible treatment for the management of patients with Overactive Bladder (OAB). Evidence acquisition: A National Center for Biotechnology Information PubMed search for relevant articles published between 2007 and 2014 was performed by combining the following Patient population, Intervention, Comparison, Outcome (PICO) terms: overactive bladder, antimuscarinics, β3 agonists, combination therapy, efficacy, tolerability and outcomes. Additional references were obtained from the reference list of full-text manuscripts. Abstracts presented at the annual congresses of the European Association of Urology, American Urology Association and the International Continence Society were included. Evidence Synthesis: The combination therapy, in the management of OAB symptoms, has recently been investigated in animal models and in a phase II randomized clinical trial. Compared with AMs monotherapy, combination treatment improved mean voided volume per micturition, micturition frequency and reduced urgency episodes. No dose related trends in adverse events (AEs) were observed between combination group and monotherapy group. Incidence of constipation was slightly increased in combination therapy group. Conclusions: Combination therapy seems to be an effective and safe treatment in the management of OAB. However, further cost-effectiveness studies are needed to evaluate the definitive role of this approach for the management of patients with OAB.

BACKGROUND Smoking, hypertension, abdominal obesity and metabolic abnormalities have been considered individual factors involved in prostate cancer (PCa) pathogenesis. All of these factors are used to define the individual cardiovascular risk (CVR). The aim of our study was to evaluate the association between CVR and PCa diagnosis and grade among a consecutive series of men undergoing prostate biopsy. METHODS From 2010 onwards, consecutive patients undergoing 12-core prostate biopsy were enrolled. Body mass index was measured before the biopsy. Blood samples were collected and tested for: PSA, fasting glucose, triglycerides and high-density lipoproteins. Blood pressure was also recorded. Metabolic syndrome was defined according to the Adult Treatment Panel III and CVR according to the European Association of Cardiologist Guidelines. We evaluated the association between CVR and PCa biopsy Gleason score using logistic regression analyses. RESULTS Five hundred and eighty-four patients were enrolled. Four hundred and six patients (70%) presented a moderate/high CVR. Two hundred and thirty-seven (40.6%) patients had cancer on biopsy; 157 with moderate/high CVR and 80 with low/no CVR (P=0.11). Out of the 237 patients with PCa, 113 had a Gleason score 6 and 124 a Gleason score ⩾7. Out of them, 92/124 (75%) presented a moderate/high CVR (P=0.004). Moderate/high CVR was not associated with an increased risk of PCa (odds ratio (OR): 0.741, confidence interval (CI): 0.474-1.156; P=0.186) but with an increased risk of Gleason score ⩾7 (OR: 2.154, CI: 1.076-4.314; P=0.030). CONCLUSIONS In our study, a moderate/high CVR is associated with an increased risk of a high-grade Gleason score when PCa is diagnosed on biopsy. Although these results should be confirmed in multicentre studies, patients with moderate/high CVR should be carefully evaluated for PCa diagnosis.

Background The National Research Council (CNR) prostate cancer monitoring project in Italy (Pros-IT CNR) is an observational, prospective, ongoing, multicentre study aiming to monitor a sample of Italian males diagnosed as new cases of prostate cancer. The present study aims to present data on the quality of life at time prostate cancer is diagnosed. Methods One thousand seven hundred five patients were enrolled. Quality of life is evaluated at the time cancer was diagnosed and at subsequent assessments via the Italian version of the University of California Los Angeles-Prostate Cancer Index (UCLA-PCI) and the Short Form Health Survey (SF-12). Results At diagnosis, lower scores on the physical component of the SF-12 were associated to older ages, obesity and the presence of 3+ moderate/severe comorbidities. Lower scores on the mental component were associated to younger ages, the presence of 3+ moderate/severe comorbidities and a T-score higher than one. Urinary and bowel functions according to UCLA-PCI were generally good. Almost 5% of the sample reported using at least one safety pad daily to control urinary loss; less than 3% reported moderate/severe problems attributable to bowel functions, and sexual function was a moderate/severe problem for 26.7%. Diabetes, 3+ moderate/severe comorbidities, T2 or T3-T4 categories and a Gleason score of eight or more were significantly associated with lower sexual function scores at diagnosis. Conclusions Data collected by the Pros-IT CNR study have clarified the baseline status of newly diagnosed prostate cancer patients. A comprehensive assessment of quality of life will allow to objectively evaluate outcomes of different profile of care.