Purely Off-Clamp Sutureless Robotic Partial Nephrectomy for Novice Robotic Surgeons: A Multi-Institutional Propensity Score-Matched Analysis.

Objectives: To compare perioperative outcomes of patients treated with sutureless off-clamp robotic partial nephrectomy (sl-oc RAPN) by either a novice or an expert robotic surgeon at two different institutions. Methods: Data concerning two continuous series of patients with cT1-2N0M0 renal tumors treated with sl-oc RAPN either by a novice or an expert surgeon were extracted from prospectively populated institutional databases over the last 4 years. Perioperative outcomes as well as the baseline characteristics of patients and tumors were compared by using χ2 and Mann-Whitney tests for categorical and continuous variables, respectively. A 1:1 propensity match score analysis (PMSa) generated two homogeneous cohorts. Logistic regression analysis was performed to assess predictors of trifecta outcomes, defined as negative surgical margins, no Clavien-Dindo ≧ 3 grade complications, and no ≧ 30% postoperative eGFR reduction. Results: Overall, 328 patients were treated by an expert surgeon, while 40 were treated by a novice surgeon. After PMSa analysis, two cohorts of 23 patients each were generated, homogeneous for all baseline variables (p ≥ 0.07). Hospital stay was the only significantly different outcome observed between the two groups (5 days vs. 2 days; p < 0.001). No statistically significant differences were recorded when comparing trifecta outcomes (expert: 100% vs. novice: 87%; p = 0.07). In the logistic regression analysis, no statistically significant predictors of trifecta outcomes were recorded. Conclusions: sl-oc RAPN is a feasible and safe nephron sparing technique, even when performed by a novice robotic surgeon.

Is EMA warning on quinolones and fluoroquinolones really assessed? An EudraVigilance database analysis.

BACKGROUND: On March 11th 2019, European Medicines Agency (EMA) issues a warning after a review of serious, disabling and potentially permanent adverse events (AEs), particularly on musculoskeletal and nervous system, with quinolone (QN) and fluoroquinolone (FQ) antibiotics. Aim of this study was to evaluate the effect of the EMA warning on the rate of AEs after QN and FQ treatments, reported in the EudraVigilance (EV) database. METHODS: EV database is the system for managing and analyzing information on suspected AEs to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We retrospectively explored the effect of FQs and QNs on musculoskeletal and nervous system from the EMA warning up to now (21 months) and compared these results with the 21 months before the EMA warning. RESULTS: Main part of AEs in EV database were reported for ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin. Ciprofloxacin total AEs before 21 months till 12 months of EMA warning were 2763. 12 months before EMA Warning they were 2935. Twelve months after EMA Warning they were 3419. Between 12 months till 21 months they were 3174. Musculoskeletal disorders were respectively 574 (21% of the total) 21 months before, 558 (19%) 12 months before, 1048 (31%) after 12 months, 540 (17%) after 21 months of EMA Warning. Nervous system disorders were respectively 606 (22% of the total) 21 months before, 517 (18%) 12 months before, 680 (20%) after 12 months, 560 (18%) after 21 months of EMA Warning (respectively OR 1,16 95%CI 1,10 -1,22, P 0,12 ; OR 0,76 95%CI 0,69-0,83, P 0,27 ; OR 1,01 95%CI 0,96-1,06 P 0,05). CONCLUSIONS: Our analysis clearly showed no significant differences before and after EMA warning, opening new insights in the role of the EMA warning in clinical practice.

Adverse events related to antimuscarinics and beta-3-agonist: "real-life" data from the Eudra-Vigilance Database.

BACKGROUND: Antimuscarinic (AM) and beta-3-agonist (B3A) treatment are the standard first-line pharmacological treatment used to manage overactive bladder (OAB) patients. Aim of our study was to analyze real-life data of adverse events related to AMs and B3A reported on Eudra-Vigilance (EV) Database. METHODS: EV database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We recorded the number of AEs for antimuscarinic and beta-3-agonist per category and severity until January 2021. RESULTS: Overall, 2313 AEs were reported for oxybutinin, 5129 for solifenacin, 2483 for tolterodine, 3523 for fesoterodine, 787 for trospium, 621 for propiverine and 7213 for mirabegron. Urinary retention was higher for fesoterodine (43%) and tolterodine (23%) when compared to solifenacin (10%), mirabegron (11%) and oxybutinin (4%). Cognitive disorder was uncommon for all the analyzed drugs analyzed. Regarding anticolinergic AEs: vision blurred, dry mouth and constipation were higher for AMs when compared to mirabegron. Their prevalence was higher in female patients. Mirabegron presented a higher risk of hypertension (7%) when compared to oxybutinin (2%, P<0.01), solifenacin (2%, P<0.01), tolterodine (2%, P<0.01) and fesoterodine (1%, P<0.01); the rate of hypertension was higher in females (63%) than males (29%) (P<0.01). The risk of acute urinary retention was also significantly higher (15% vs. 10%, P<0.01) in older patients (>85 years). CONCLUSIONS: Real life data is consistent with registry studies regarding the rate of AEs related to antimuscarinic and beta-3-agonist. However some differences were observed. Female patients present higher rates of AEs when compared to male patients. The risk of acute urinary retention was particularly evident in the octogenarians.

MRI and MR voiding cystourethrography in the evaluation of male primary bladder neck obstruction: preliminary experience.

PURPOSE: Evaluation of male with primary bladder neck obstruction (PBNO) using MRI and MR voiding cystourethrography (MR-VCU) to study both anatomical aspects of bladder neck and urethral lumen. METHODS: In this retrospective study 21 male patients (mean age 33 ± 14) with urodynamic diagnosis of PBNO and 5 healthy volunteers ((mean age 28 ± 2) as control group were enrolled. Both patients and control group underwent 1.5 T MRI. Sagittal and oblique coronal Turbo-Spin-Echo T2-weighted scans were performed. Only patients underwent MR voiding cystourethrography (MR-VCU) performed with T1-weighted spoiled 3D gradient-echo sagittal acquisitions. Bladder lumen was filled with contrast-material-enhanced urine. Blinded test by two radiologists was performed to evaluate causes of bladder outlet obstruction evaluating MR-VCU. Anatomical MRI features of both control group and patients were compared in consensus by senior radiologist and urologist using the analysis of variance (ANOVA) test. RESULTS: MRI allowed evaluation of the bladder neck muscular structures. We found 4 groups of PBNO patients: 52% hypertrophy of posterior lip of bladder sphincter; 20% asymmetry of lateral portion of bladder sphincter; 14% bladder neck cyst; 14% showed normal aspect of bladder neck. Comparison between the control group and first and second PBNO groups was considered statistically significant (p < 0.05) with diagnostic accuracy of 87%. Only 13 patients (61%) were able to perform MR-VCU and radiologists always made the diagnosis of PBNO. CONCLUSION: MRI together with MR-VCU provides useful anatomical and functional information in the study of bladder neck and urethral lumen. These preliminary results suggest that MRI could substitute for standard cystourethrogram in patients with PBNO.

Phamacological treatment of persistant lower urinary tract symptoms after a transurethral resection of the prostate is predictive of a new surgical treatment: 10 years follow-up study.

AIM: To evaluate possible risk factors of re intervention in patients with benign prostatic enlargement (BPE) undergoing transurethral resection of the prostate (TURP). MATERIALS AND METHODS: A consecutive series of patients with LUTS and BPE underwent TURP in our center in 2004 and 2005 and they were then followed up to September 2016. Patients were assessed at baseline, 3-, 6-month postoperatively and yearly thereafter with medical history, international prostate symptom score, prostate specific antigen, maximal urinary flow rate, post void residual urine. Reoperation was defined as the requirement of a new TURP to relieve bothersome LUTS. Cox regression was used to determine covariates associated with reoperation rate and the Kaplan-Meier curve assessed the time to reoperation. RESULTS: Overall, 92 patients were enrolled. Median follow up was 142 months. 13 patients underwent a second TURP during the follow-up period (reoperation rate was 14%); out of them 9/13 (69%) received medical treatment for persistent LUTS (p = .001). The need of LUTS/BPE pharmacological treatment after TURP is an independent risk factor for a second surgical procedure (odds ratio 9,3; p = .001). Out of the 13 patients treated with a re-TURP, 12 (92%) underwent surgery within 5 years of follow-up. CONCLUSION: In our single center study, the need of LUTS/BPE pharmacological treatment was a predictive factor of a re-TURP. Considering that more than 90% of re-TURP were performed during the first 5 years of follow-up, it is assumable that a follow-up longer than 5 years is not needed in these patients.

Night shift workers refer higher urinary symptoms with an impairment quality of life: a single cohort study.

BACKGROUND: The aim of the present study is to assess the impact of night shift work (NSW) on urinary symptoms. METHODS: 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-sf>30, OABq-SB≥12, OABq HRQL≥18). RESULTS: 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 (P<0.05) 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-sf>30 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). CONCLUSIONS: 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.

Ultrasound prostate parameters as predictors of successful trial without catheter after acute urinary retention in patients ongoing medical treatment for benign prostatic hyperplasia: a prospective multicenter study.

BACKGROUND: Alpha-blockers (ABs) are considered the standard treatment after initial management of acute urinary retention (AUR). However, no data are available on the predictors of a successful trial without catheter (TWOC) in patients previously on treatment with ABs and 5alpha reductase inhibitors (5ARI). The aim of our study was to investigate prostate ultrasound parameters as predictors of TWOC outcome. METHODS: A consecutive series of patients, on treatment with ABs alone or in combination with 5ARI, experiencing AUR were prospectively enrolled. Clinical data (i.e., age, body mass index (BMI) and IPSS), urinary ultrasound features including hydronephrosis, prostate volume-TRUS, bladder wall thickness (BWT), intravesical prostatic protrusion more than 10mm (IPP≥10) were related to TWOC outcome performed seven days after AUR. A binary logistic regression analysis was computed to detect predictors of successful TWOC. RESULTS: Overall,143 patients with a median age of 72 years (IQR 64-77) were enrolled. Seventy-mine patients (54%) with smaller prostate volume (59 [IQR 52-74] vs. 99 [IQR 74-125] mL, P=0.008) and a thinner BWT (5[IQR 4.8-5.2] vs. 5.2 [4.7-5.5] mm P=0.001) recovered voiding at TWOC. IPP≥10 was less common in patients with successful TWOC 11 (14%) vs. 33 (52%), P=0.001. On multivariate analysis, IPP<10mm (OR 6.10 [95%CI 2.61-14.20], P=0.001), lower IPSS (OR 0.95 [95% CI 0.89-0.99], P=0.045), smaller TRUS (OR 0.96 [95% CI 0.95-0.97], P=0.001), thinner BWT OR 1.23 (95%CI 0.73-0,92) P=0.001were the independent predictors of voiding recovery. CONCLUSIONS: Patients receiving medical treatment for BPH and experiencing AUR still present a 54% probability of a successful TWOC. Ultrasound may help to identify patients with successful TWOC.

Complications and quality of life of ileal conduit, orthotopic neobladder and ureterocutaneostomy: systematic review of reports using the Clavien-Dindo Classification.

INTRODUCTION: Radical cystectomy (RC) and urinary diversion (UD) are two steps of the same surgical procedure involving likely complications and important impact on quality of life (QoL). The literature was reviewed to identify recent studies reporting UDs complications occurred 90 days after surgery and graded by Clavien-Dindo Classification System (CCS). EVIDENCE ACQUISITION: A comprehensive systematic Medline search was performed in PubMed/Medline, Embase and Scopus databases to identify reports published in English starting from 2013 using key words related to review outcome (i.e. neobladder, ileal conduct, ureterocutaneostomy, cystectomy, QoL). Complications were defined as minor or major whether the CCS grade was ≤2 or ≥3, respectively. Then, manuscripts references were screened to identify unfounded studies. Only studies using CCS to report surgical complications were considered. EVIDENCE SYNTHESIS: Retrieved studies were reported according to two main items of complications and QoL. About UDs complications, fourteen studies were identified incorporating overall 4436 patients. Up to 50% of patients experienced at least one low-grade complications (CCS≤2) requiring pharmacological treatment to be healed. On the other hand, high-grade complications (CCS≥3) occurred in 0.7-42% of cases and required surgical interventions (CCS 3a and 3b) or life support (CCS=4). Finally, mortality (CCS=5) rated between 0.4-7%. Regarding QoL, six studies were analyzed with overall 445 patients. Most of them were retrospective and showed conflicting results whether the external UDs were better than neobladder in term of impact on QoL. CONCLUSIONS: The use of a standardized system such as CCS improves analyses of literature. However, rigorous patient selection for UD type makes unable a randomized comparison between UDs in terms of complications and QoL impact.

The role of bladder wall thickness in the evaluation of detrusor underactivity: Development of a clinical nomogram.

AIMS: The aim of our study was to investigate noninvasive predictors for detrusor underactivity (DUA) in male patients with lower urinary tract symptoms (LUTS) and benign prostatic enlargement (BPE). METHODS: A consecutive series of patients aged 45 years or older with non-neurogenic LUTS were prospectively enrolled. Patients underwent standard diagnostic assessment including International Prostatic Symptoms Score, uroflowmetry, urodynamic studies (cystometry and pressure-flow studies), transrectal ultrasound of the prostate, and ultrasound measurements of the bladder wall thickness (BWT). Logistic regression analysis was used to investigate predictors of DUA, defined as a bladder contractility index < 100 mm H2 O. A nomogram was developed based on the multivariable logistic regression model. RESULTS: Overall 448 patients with a mean age of 66 ± 11 years were enrolled. In a multivariable logistic age-adjusted regression model BWT (odds ratio [OR]: 0.50 per mm; 95% confidence interval [CI], 0.30-0-66; P = .001) and Qmax (OR: 0.75 per mL/s; 95% CI, 0.70-0.81; P = .001) were significant predictors for DUA. The nomogram based on the model presented good discrimination (area under the curve [AUC]: 0.82), good calibration (Hosmer-Lemeshow test, P > .05) and a net benefit in the range of probabilities between 10% and 80%. CONCLUSIONS: According to our results, BWT and Qmax can noninvasively predict the presence of DUA in patients with LUTS and BPE. Although our study should be confirmed in a larger prospective cohort, we present the first available nomogram for the prediction of DUA in patients with LUTS.

Smoking reduces PSA accuracy for detection of prostate cancer: results from an Italian cross-sectional study.

BACKGROUND: The aim of our study is to evaluate the diagnostic accuracy of prostate-specific antigen (PSA) according to the smoking status in a cohort of European men undergoing prostate biopsy. METHODS: From 2008 onwards, we consecutively enrolled, at a single institution in Italy, men undergoing 12 core transrectal ultrasound-guided prostate needle biopsy. Demographic, clinical and histopathological data were collected. We excluded men who had PSA >30 ng/mL. Patients were classified in three groups: non-smokers, smokers and former smokers. Receiver-operator characteristics (ROC) curve analysis were used to compare predictive properties of PSA across smoking categories for the final histopathological diagnosis of prostate cancer. RESULTS: 872 patients were enrolled. with a median age and PSA of 67 years (IQR: 61/74) and 6.2 ng/mL (IQR: 4.4/9.7) respectively.402/872 patients (46%) were non-smokers; 151 of 872 were smokers (17%) and 319 of 872 were former smokers (36%); 374 of 872 (43%) had cancer on biopsy. PSA accuracy for smokers (AUC= 0.47, P=0.490) was lower when compared to non-smokers (AUC=0.59, P=0.003) and former smokers (AUC=0.59, P=0.005). CONCLUSIONS: In a cohort of Italian men undergoing prostate biopsy, the performance accuracy of PSA, as a predictor of prostate cancer, is lower in smokers. Although the molecular link behind our findings is still unknown, our study firstly showed that the PSA accuracy for PCa diagnosis is significantly influential by smoking.

Physical Activity as a Protective Factor for Lower Urinary Tract Symptoms in Male Patients: A Prospective Cohort Analysis.

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.

Cigarette smoking is not associated with prostate cancer diagnosis and aggressiveness: a cross sectional Italian study.

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.

Patient centred care for the medical treatment of lower urinary tract symptoms in patients with benign prostatic obstruction: a key point to improve patients' care - a systematic review.

BACKGROUND: Even though evidence based medicine, guidelines and algorithms still represent the pillars of the management of chronic diseases (i.e: hypertension, diabetes mellitus), a patient centred approach has been recently proposed as a successful strategy, in particular to improve drug adherence. Aim of the present review is to evaluate the unmet needs in LUTS/BPH management and the possible impact of a patient centered approach in this setting. METHODS: A National Center for Biotechnology Information (NCBI) PubMed search for relevant articles published from January 2000 until December 2016 was performed by combining the following MESH terms: patients centred medicine, patient centered care, person centered care, patient centered outcomes, value based care, shared decision making, male, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, treatment. We followed the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA). All studies reporting on patient centred approach, shared decision making and evidence-based medicine were included in the review. All original article, reviews, letters, congress abstracts, and editorials comments were included in the review. Studies reporting single case reports, experimental studies on animal models and studies not in English were not included in the review. RESULTS: Overall 751 abstracts were reviewed, out of them 87 full texts were analysed resulting in 36 papers included. The evidence summarised in this systematic review confirmed how a patient centred visit may improve patient's adherence to medication. Although a patient centred model has been rarely used in urology, management of Low Urinary Tract Symptoms (LUTS) and Benign Prostatic Obstruction (BPO) may represent the perfect ground to experiment and improve this approach. Notwithstanding all the innovations in LUTS/BPO medical treatment, the real life picture is far from ideal. CONCLUSIONS: Recent evidence shows a dramatical low drug adherence and satisfaction to medical treatment in LUTS/BPH patients. A patient centred approach may improve drug adherence and some unmet needs in this area, potentially reducing complications and costs. However further well designed studies are needed to confirm this data.

Tamsulosin or Silodosin Adjuvant Treatment Is Ineffective in Improving Shockwave Lithotripsy Outcome: A Short-Term Follow-Up Randomized, Placebo-Controlled Study.

INTRODUCTION: The role of α-blockers after shockwave lithotripsy (SWL) is controversial. The aim of our study was to evaluate the effect of tamsulosin and silodosin after SWL for kidney stones. METHODS: From 2012 onward, a consecutive series of patients undergoing SWL were prospectively enrolled and randomized by closed envelopes in three groups receiving tamsulosin 0.4 mg (A), silodosin 8 mg (B), and placebo (C) daily for 21 days after SWL. Anthropometrics, stone size, and location were recorded before SWL. Visual analogue scale (VAS) score was collected at 6, 12, and 24 hours after treatment to evaluate patients' discomfort. Stone-free rate was assessed 1 and 3 weeks postoperatively. Complications and medical treatment-related adverse events (AEs) were recorded. Differences in VAS score, stone-free rate, and complications were compared among the groups. RESULTS: Overall, 60 patients were enrolled. Mean stone sizes were 10.28 ± 2.46 mm, 10.45 ± 1.73 mm, and 9.23 ± 2.04 mm in groups A, B, and C, respectively (p = 0.474). There was no significant difference between the three groups with regard to stone location. Comparable energy was used to treat patients from the three groups. The overall 3-week stone-free rate was 53%: 58% in the tamsulosin group, 47% in the silodosin group, and 55% in the placebo group (p = 0.399). No significant differences were observed in the VAS scores reported by the groups at 6 hours (p = 1.254), 12 hours (p = 0.075), and 24 hours (p = 0.490). Overall, 12 complications were reported: 11 patients (7 in group C and 4 in group B) needed analgesics for colic, and 1 patient (group B) was surgically treated for Steinstrasse. Tamsulosin was superior to placebo (p = 0.008) and silodosin (p = 0.021) in preventing complications; no difference between silodosin and placebo (p = 0.629) was noted. CONCLUSIONS: Tamsulosin and silodosin are ineffective in increasing stone-free rate as well as early patients' discomfort after extracorporeal lithotripsy.

Physical activity as a risk factor for prostate cancer diagnosis: a prospective biopsy cohort analysis.

OBJECTIVES: To assess the association between physical activity, evaluated by the Physical Activity Scale for the Elderly (PASE) questionnaire, and prostate cancer risk in a consecutive series of men undergoing prostate biopsy. PATIENTS AND METHOD: From 2011 onwards, consecutive men undergoing 12-core prostate biopsy were enrolled into a prospective database. Indications for a prostatic biopsy were a prostate-specific antigen (PSA) value of ≥4 ng/mL and/or a positive digital rectal examination. Body mass index (BMI) and waist circumferences were measured before the biopsy. Fasting blood samples were collected before biopsy and tested for: total PSA, glucose, high-density lipoprotein cholesterol, and trygliceride levels. Blood pressure was recorded. Metabolic syndrome (MetS) was defined according to the Adult Treatment panel III. The PASE questionnaire was completed before the biopsy. RESULTS: In all, 286 patients were enrolled with a median (interquartile range, IQR) age and PSA level of 68 (62-74) years and 6.1 (5-8.8) ng/mL, respectively. The median (IQR) BMI was 26.4 (24.6-29) kg/m(2) and waist circumference was 102 (97-108) cm, with 75 patients (26%) presenting with MetS. In all, 106 patients (37%) had prostate cancer at biopsy. Patients with prostate cancer had higher PSA levels (median [IQR] 6.7 [5-10] vs 5.6 [4.8-8] ng/mL; P = 0.007) and lower LogPASE scores (median [IQR] 2.03 [1.82-2.18] vs 2.10 [1.92-2.29]; P = 0.005). On multivariate analysis, in addition to well-recognised risk factors such as age, PSA level and prostate volume, LogPASE score was an independent risk factor for prostate cancer diagnosis (odds ratio [OR] 0.146, 95% confidence interval [CI] 0.037-0.577; P = 0.006]. LogPASE score was also an independent predictor of high-grade cancer (OR 0.07, 95% CI 0.006-0.764; P = 0.029). CONCLUSION: In our single-centre study, increased physical activity, evaluated by the PASE questionnaire, is associated with a reduced risk of prostate cancer and of high-grade prostate cancer at biopsy. Further studies should clarify the molecular pathways behind this association.

Transrectal-ultrasound prostatic biopsy preparation: rectal enema vs. mechanical bowel preparation.

INTRODUCTION: Transrectal prostate biopsy (TRUSbx) is the standard for the diagnosis of prostate cancer. Different bowel preparations are used for patients undergoing TRUSbx. The aim of our study was to compare two different bowel preparations for TRUSbx. MATERIAL AND METHODS: From May 2012 and onwards, a selected group of men undergoing TRUS 12-core prostate biopsy were enrolled into a prospective database. Patients were randomized 1:1 to receive a rectal enema (Group A) the night before the procedure or polyethylene glycol 34.8 grams/4 liters of water the day before the procedure (Group B). A VAS scale to evaluate the patients' discomfort according to the two preparations was collected. The same antibiotic prophylaxis was performed in both groups. All complications were prospectively recorded and graded according to the Clavien Classification System (CCS). RESULTS: A total of 198 patients were consecutively enrolled. Mean age was 67.5 ±7.9 years, mean body mass index (BMI) was 27.1 ±4.2 Kg/m(2), mean PSA value was 9.3 ±12.6 ng/ml and the mean prostatic volume was 60.6 ±29 ml. 97 patients were enrolled in Group A and 101 in Group B. Overall post-biopsy morbidity rate was 60%. No significant differences for low-grade and high-grade complications was observed between the two groups. Patients receiving the rectal enema presented with a significantly lower VAS score (3.1 ±1.1 vs. 5.9 ±1.7; p = 0.02). CONCLUSIONS: Our study confirmed that a rectal enema should be considered as the standard bowel preparation in patients undergoing a TRUS biopsy; it is as effective as PEG and associated with less discomfort.

Metabolic syndrome is associated with high grade Gleason score when prostate cancer is diagnosed on biopsy.

BACKGROUND: To evaluate the association between metabolic syndrome (MS) and prostate cancer diagnosis and grade in patients undergoing prostate biopsy. METHODS: From 2009 onwards, a consecutive series of patients undergoing 12-core prostate biopsy for PSA value ≥4 ng/ml and/or positive digital rectal examination (DRE) were prospectively enrolled. Body mass index (BMI), waist circumferences, and blood pressure were measured before the biopsy. Blood samples were tested for: PSA, fasting glucose, triglycerides, and cholesterol HDL. MS presence was defined according to Adult Treatment Panel III criteria. RESULTS: One hundred ninety five patients were enrolled with a median age and PSA of 69 years and 5.6 ng/ml respectively. Median BMI was 27.6 kg/m(2) with 64 patients (33%) being classified as obese (BMI ≥ 30 kg/m(2) ). Eighty-six patients (44%) had MS. Eighty-three patients (43%) had cancer on biopsy; 37 (45%) with MS and 46 (55%) without (P = 0.48). PSA was independently associated with higher risk of cancer (OR 1.12/1 U PSA, P = 0.01). Out of 83 patients with prostate cancer, 42 (51%) had Gleason score 6 (12 (28.5%) presented a MS) and 41 (49%) a Gleason score ≥7 (25 (61%) presented a MS). The presence of MS was not associated with an increased risk prostate cancer (OR: 0.97, P = 0.94) but with an increased risk of Gleason ≥7 (OR: 3.82; P = 0.013). CONCLUSIONS: In our single center study, MS is associated with an increased risk of high grade Gleason score when prostate cancer is diagnosed on biopsy. However, these results should be confirmed in a larger multicenter study. .

Prostate cancer does not influence androgen levels: a radical prostatectomy cohort study.

AIM: To investigate the relationship between androgens and prostate cancer in patients scheduled for radical prostatectomy. SUBJECTS AND METHODS: Patients scheduled for open radical prostatectomy were enrolled. Blood samples were collected before prostate biopsy and 12 months later to evaluate testosterone, free testosterone, sex hormone-binding globulin (SHBG), PSA, calculated free and bioavailable testosterone. RESULTS: 44 patients were consecutively enrolled. 15 patients (34%) presented a Gleason score (GS) of 6, 24 patients GS 7 (54%), 1 patient (2%) GS 8, and 4 patients GS 9 (9%). Mean prostate cancer volume was 4.3 ± 5.7 cm(3). 24 patients presented a pT2 stage, 16 a pT3a stage, and 4 a pT3b stage. Positive surgical margins were detected in 12 patients (27.3%). No significant change of testosterone (4.21 ± 1.49 vs. 4.00 ± 1.48 ng/ml, p = 0.46), free testosterone (9.01 ± 3.64 vs. 8.85 ± 3.04 pg/ml, p = 0.83), SHBG (38 ± 14.39 vs. 38.5 ± 17.23 nmol/l, p = 0.71), calculated free testosterone (0.091 ± 0.13 vs. 0.067 ± 0.026, p = 0.563), and bioavailable testosterone (1.89 ± 0.722 vs. 1.88 ± 0.53, p = 0.912) was observed. CONCLUSIONS: In our single-center study, prostate cancer does not impact on serum androgen levels, however our results should be confirmed in a larger study.

Reduction of prostate-specific antigen after tamsulosin treatment in patients with elevated prostate-specific antigen and lower urinary tract symptoms associated with low incidence of prostate cancer at biopsy.

OBJECTIVES: To evaluate the effect of tamsulosin on reducing the serum levels of prostate-specific antigen (PSA) in patients with lower urinary tract symptoms and an elevated PSA level. METHODS: From June 2004 to July 2006, patients with lower urinary tract symptoms, a PSA level of >or=4 ng/mL, and a maximal flow rate of <15 mL/s received tamsulosin 0.4 mg daily for 2 months. They were then scheduled for 12-core prostate biopsy. PSA determination and a uroflow study were performed before biopsy. RESULTS: A total of 80 patients completed the present study. The mean patient age was 66.3 years, and the mean PSA level was 7.8 +/- 8.4 ng/mL at baseline and 7.1 +/- 9.1 ng/mL after treatment (P < .001). A total of 29 patients (36.25%) were diagnosed with prostate cancer from the biopsy findings. A significant increment in the PSA level was observed in patients with prostate cancer (6.7 versus 7.9 ng/mL; P = .002). A significant decrease in the PSA level was observed in patients with negative biopsy findings (6.9 versus 5.1 ng/mL, P = .000). Of the 38 patients with a decrease in the PSA level, 1 (2.6%) was diagnosed with prostate cancer and 37 (97.4%) with an benign prostatic hyperplasia/prostatitis. Of the 42 patients with no change in the PSA level, 28 (66.7%) had prostate cancer and 14 (33.3%) had negative findings. A change in PSA level after treatment gave a sensitivity of 96.6%, specificity of 72.5%, and diagnostic accuracy of 81% for prostate cancer. CONCLUSIONS: Treatment with tamsulosin seemed to reduce the PSA levels and identified patients at high risk of prostate cancer.

Photoselective prostatic vaporization for bladder outlet obstruction: 12-month evaluation of storage and voiding symptoms.

PURPOSE: We evaluated voiding and storage symptom evolution in patients treated with prostate photoselective vaporization by a KTP laser. MATERIALS AND METHODS: Enrolled in the study were 150 consecutive patients with lower urinary tract symptoms due to benign prostatic hyperplasia and a diagnosis of bladder outlet obstruction. Patients underwent prostate photoselective vaporization with the 80 W KTP laser. Baseline parameters included prostate volume, International Prostate Symptom Score with voiding and storage symptom subscores, uroflowmetry, pressure flow study and serum prostate specific antigen. Patients were followed 1, 3, 6 and 12 months after surgery. RESULTS: Mean +/- SD patient age was 69.6 +/- 10 years. Mean prostate volume was 52 +/- 18 ml. Mean International Prostate Symptom Score was 22.3 +/- 4, mean maximum urine flow was 9 +/- 2.9 ml per second and mean Schäfer obstruction class was 3.6 +/- 1. An average of 190 +/- 44 kJ were delivered in a mean of 68 +/- 24 minutes with an average of 3.6 kJ/ml prostate. The mean number of fibers was 1.2 +/- 0.4. Mean catheterization time was 20 +/- 8 hours. Retrograde ejaculation was reported in 67% of patients. Prostate specific antigen was significantly decreased at 12 months (2.6 +/- 2.3 vs 0.9 +/- 0.7 ng/ml, p = 0.001). Storage symptoms decreased by 54.5%, 63.6%, 72.7% and 81.8% at 1, 3, 6 and 12 months, respectively (p <0.001). Voiding symptoms decreased 63.6%, 72.7%, 81.8% and 90.9% at 1, 3, 6 and 12 months, respectively (p <0.001). CONCLUSIONS: As shown by a prostate specific antigen significant decrease, proper prostate debulking may be achieved by prostate photoselective vaporization. Significant continuous improvement in storage and voiding symptoms was observed at up to 12-month followup.