Intravescical prostatic protrusion is a predictor of alpha blockers response: results from an observational study.

BACKGROUND: To investigate the efficacy of tamsulosin in patients with lower urinary tract symptoms (LUTS) and benign prostatic enlargement (BPE) with intravesical prostatic protrusion (IPP). Ultrasound measurement of the IPP has been previously described as an effective instrument for the evaluation of benign prostatic obstruction (BPO) and could help in clarifying the role of alpha-blockers in patients with (BPE). METHODS: Patients with BPE and LUTS were enrolled in this observational study. Intravesical prostatic protrusion was graded as grade 1 (< 5 ml), 2 (5 < IPP < 10 ml) and 3 (> 10 ml). Patients were treated with tamsulosin for twelve weeks. Evaluation was performed before and at the end of treatment by means of International Prostate Symptom Score (IPSS) and uroflowmetry. Patients were considered responders if a reduction of IPSS > 3 points was reported. RESULTS: One hundred forty-two patients were enrolled. Twelve patients were excluded because of incomplete data. Fifty patients showed an IPP grade 1 (group A), 52 a grade 2 (group B) and 28 a grade 3 (group C). Treatment success was obtained in 82%, 38,5% and 7,1% of patients respectively; these differences (group A vs B-C and group B vs C) were highly significant. The odd ratio to obtain a treatment success was of 59 and 8.1 in group A and group B respectively, in comparison to group C. After a multivariate regression, the relationship between IPP grade and treatment success remained significant. Improvement of uroflowmetry parameters has been reported in all the groups especially in patients with a low grade IPP (p value = 0,016 group A vs group B; p value = 0,005 group A vs group C). Prostate volume seems not to influence this relationship. CONCLUSIONS: Intravesical prostatic protrusion has found to be significantly and inversely correlated with treatment success in patients with LUTS and BPE under alpha-blockers therapy. Alpha blockers odd ratio of success is 59 times higher in patients with a low grade IPP in comparison to patients with a high grade.

Transperineal versus transrectal prostate biopsy for predicting the final laterality of prostate cancer: are they reliable enough to select patients for focal therapy? Results from a multicenter international study.

OBJECTIVES: To compare the concordance of prostate cancer (PCa) laterality between the extended transperineal (TP) or transrectal (TR) prostate biopsy (BP) and radical prostatectomy (RP) specimens. To identify predictors of laterality agreement between BP and RP. MATERIALS AND METHODS: Data from 533 consecutive patients with PCa (278 TP and 255 TR-diagnosed) treated with RP were analyzed. A 12-core technique was used for both TP and TR biopsies. Additional cores were obtained when necessary. RESULTS: Overall, the percentage of agreement of PCa laterality between BP and RP was 60% (K = 0.27, p < 0.001). However, the RP confirmation of unilaterality at BP was obtained in just 33% of the cases. Considering the concordance on bilaterality as the ″target″ of our analysis, the sensitivity and specificity were 54.3% and 98.2% , respectively, with TP and 47.5% and 92.5%, respectively with TR. Focusing on patients with unilaterality at biopsy, none of the evaluated preoperative variables (biopsy technique, age, total positive biopsy cores, PSA, prostate volume, Gleason score on biopsy) were able to predict RP bilaterality in the multivariate analyses. CONCLUSIONS: Most of the patients with unilateral involvement at BP harbored bilateral PCa after RP. TR and TP biopsy showed no difference in their capacity to predict the concordance of tumor laterality at RP. None of the preoperative evaluated variables can predict the tumor laterality at RP. Using BP unilaterality to include patients in focal therapy (FT) protocols may hinder the oncologic efficacy of FT.

The use of oxybutynin in patients treated by means of botulinum neurotoxin A for neurogenic detrusor overactivity: an observational study.

STUDY DESIGN: This is an observational prospective noncontrolled study. We enrolled 105 patients affected by neurogenic detrusor overactivity (NDO) who underwent botulinum neurotoxin A (BONT-A) intradetrusor injection and were followed-up for 270 days. OBJECTIVES: To investigate the use of oxybutynin after BONT-A administration in NDO patients. SETTING: Careggi University Hospital in Florence and Tor Vergata University Hospital in Rome. METHODS: Prospective data from two Italian centers were collected in 1 year. Patients showing limited efficacy but good tolerability and adherence to oxybutynin 5 mg three times a day (t.i.d.). were enrolled in the study. Patients received BONT-A intradetrusor injection (onabotulinumtoxinA, 300 U) with a trigone-sparing technique, and the use of oxybutynin was registered at every visit. RESULTS: 105 patients were included. At visit 1, only 30 patients (28.6%) used oxybutynin t.i.d., whereas 47 (45,2%) used a lower dosage and 28 (26.7%) stopped the therapy. At visit 2, 77.3% of patients who had reduced oxybutynin intake, maintained the dosage decided at visit 1. At visit 3, 51.9% returned to oxybutynin t.i.d.; 44.8% were on a reduced dosage and only 3 (2.9%) were not taking the drug. At visit 4, only 37.5% of patients were taking less than oxybutynin t.i.d. CONCLUSION: This study provides some important insights on the use of oral antimuscarinics in patients treated by means of BONT-A intradetrusor administration for NDO; in particular, it suggests that, after an initial reduction in the use of oxybutynin, patients tend to increase the dosage of this drug during the follow-up after the BONT-A treatment.

Allium stent for treatment of ureteral stenosis.

AIM: The aim of our study is to value the efficacy of self-expanding Allium ureteral stent in the treatment of ureteral stenosis. METHODS: From 2010 to 2013, we treated 12 patients, aged from 23 to 64 years. Six patients were affected by congenital UPJ obstruction, four patients by iatrogenic unilateral ureteral stenosis and two patients by bilateral ureteral stenosis. All the patients showed hydronephrosis before the stenotic lesion and pain. In all the patients, we use a 30 Fr, 10 cm length self-expanding Allium ureteral stent. The medium follow-up is 10 months after Allium stent removal. RESULTS: All the patients were immediately free of pain after the procedure. We didn't experience intra, peri and postoperative complications. In all the patients, a complete correction of the stenotic lesion was obtained. No recurrence of stenosis occurred during follow-up. CONCLUSION: Self-expanding allium ureteral stent represents an effective treatment of ureteral stenosis in patients not suitable for surgery.

The treatment of lower urinary tract symptoms in patients with multiple sclerosis: a systematic review.

This is a systematic review on the treatment of lower urinary tract symptoms (LUTS) in patients with multiple sclerosis (MS). The heterogeneity of the outcome criteria did not allow a meta-analysis of the published evidence. In the last few decades, the therapeutic options for neurogenic bladder dysfunction have broadened. Despite this, no consensus has been reached as to the management of LUTD and LUTS in patients with MS, and the subject remains controversial. Bladder dysfunction is common in MS, affecting 80 %-100 % of patients during the course of the disease. Several studies have shown that urinary incontinence has a severe effect on patients' quality of life, with 70 % of patients classifying the impact bladder symptoms had on their life as "high" or "moderate." Moreover, the progressive feature of MS makes its treatment complex, since any achieved therapeutic result may be short-lived, with the possibility that symptoms will recur or develop de novo.

Collecting system invasion and Fuhrman grade but not tumor size facilitate prognostic stratification of patients with pT2 renal cell carcinoma.

PURPOSE: The 7th edition of TNM for renal cell carcinoma introduced a subdivision of pT2 tumors at a 10 cm cutoff. In the present multicenter study the influence of tumor size as well as further clinical and histopathological parameters on cancer specific survival in patients with pT2 tumors was evaluated. MATERIALS AND METHODS: A total of 670 consecutive patients with pT2 tumors (10.4%) of 6,442 surgically treated patients with all tumor stages were pooled (mean followup 71.4 months). Tumors were reclassified according to the current TNM classification, and subdivided in stages pT2a and pT2b. Cancer specific survival was analyzed using the Kaplan-Meier method, and univariable and multivariable analyses were used to assess the influence of several parameters on survival. RESULTS: Tumor size continuously applied and subdivided at 10 cm or alternative cutoffs did not significantly influence cancer specific survival. In addition to N/M stage, Fuhrman grade and collecting system invasion also had an independent influence on survival. Integration of a dichotomous variable subsuming Fuhrman grade and collecting system invasion (grade 3/4 and/or collecting system invasion present vs grade 1/2 and collecting system invasion absent) into multivariate models including established prognostic parameters resulted in improvement of predictive abilities by 11% (HR 2.3, p <0.001) for all pT2 cases and 151% (HR 3.1, p <0.001) for stage pT2N0M0 cases. CONCLUSIONS: Tumor size did not have a significant influence on cancer specific survival in pT2 tumors, neither continuously applied nor based on various cutoff values. To enhance prognostic discrimination, multifactorial staging systems including pathological features should be implemented. The prognostic relevance of the variable subsuming Fuhrman grade and collecting system invasion should be considered for future evaluation.

Efficacy and efficiency of Green-Light XPS 180-watt laser system for benign prostatic enlargement in patients treated with 5α-reductase inhibitors.

OBJECTIVE: Aim of the study was to evaluate efficacy and efficiency of 180-watt Green-Light XPS (GL-XPS) laser photoselective vaporization of the prostate (PVP) in patients under 5-Alpha-Reductase Inhibitors (5ARI) treatment. PATIENTS AND METHODS: A consecutive series of patients with lower urinary tract symptoms due to benign prostatic enlargement treated by PVP with the GL-XPS were enrolled. Patients were divided in two groups according to the chronic use (>6 months) of 5ARI. These two groups were compared on lasing density (kilojoules per prostate volume), vaporization efficiency (prostate volume per lasing time), vaporization power (kilojoules per lasing time), Prostate Specific Antigen (PSA) reduction from baseline, symptom score change from baseline and uroflowmetry parameters improvement. Follow-up was performed at 3, 6 and 12 months with International Prostate Symptom Score, Uroflowmetry parameters and PSA. RESULTS: Overall 193 patients were enrolled. Out of them 87/193 (45%) were on 5ARI treatment. No significant differences were recorded between the two groups at baseline. Median age was 68 years old and median prostate volume was 60 ml. In terms of laser efficiency, no statistically significant differences were recorded in terms of lasing time (25 min vs. 24.5 min; p>0.05); energy used (250 kJ vs. 221 kJ; p>0.05), lasing density (6.8 kJ/ml vs. 6.6 kJ/ml, p>0.05), vaporization efficiency (1.4 ml/min vs. 1.3 ml/min, p>0.05) and vaporization power (9.6 kJ/min vs. 9.4 kJ/min; p>0.05). Finally, no significant differences were also recorded postoperatively in the two groups in terms of PSA reduction, improvement in symptom score and uroflowmetry parameters (p>0.05). CONCLUSIONS: Thirty-seven efficacy and efficiency outcomes were not statistically different between the two groups. 5ARI does not reduce the performance and ability of the 180-watt Green-Light XPS laser system.

Cardiovascular toxicity following sunitinib therapy in metastatic renal cell carcinoma: a multicenter analysis.

BACKGROUND: Recent data have shown that cardiotoxicity represents a potentially important side-effect in patients treated with sunitinib. We reviewed cardiac adverse events in patients with metastatic renal cell carcinoma (RCC) who underwent treatment with this agent. PATIENTS AND METHODS: The medical records of 175 patients with metastatic RCC treated with sunitinib at eight Italian institutions were retrospectively reviewed. Alterations in left ventricular ejection fraction (LVEF) and blood pressure were evaluated. Patients with preexisting cardiac risk factors were specifically scrutinized for increased expression of cardiac changes. RESULTS: Grade 3 hypertension was seen in 17 patients (9.7%); in 12 of these 17, hypertension developed after receiving the third sunitinib cycle. Among these 17 patients, 12 (70.6%) also experienced left ventricular systolic (LVEF) dysfunction; in all, 33 of the 175 patients (18.9%) developed some degree of cardiac abnormality, of which 12 were classified as grade 3 LVEF dysfunction and/or congestive heart failure (CHF) (6.9%). Significant univariate associations for predictors of CHF were history of hypertension (P = 0.008), history of coronary heart disease (P = 0.0005) and prior treatment with an angiotensin-converting enzyme inhibitor (P = 0.04). Multivariate analysis suggested that a history of coronary artery disease [odds ratio (OR) 18, 95% confidence interval (CI) 4-160, P = 0.005] and hypertension (OR 3, 95% CI 1.5-80, P = 0.04) was the only significant independent predictors of CHF. CONCLUSIONS: Patients undergoing sunitinib, especially those with a previous history of hypertension and coronary heart disease, are at increased risk for cardiovascular events and should be monitored for exacerbations of their hypertension and for evidence of LVEF dysfunction during treatment.

Meta-analysis of metabolic syndrome and prostate cancer.

BACKGROUND: Metabolic syndrome (MetS) and prostate cancer (PCa) are highly prevalent conditions worldwide. Current evidence suggests the emerging hypothesis that MetS could play a role in the development and progression of several neoplasms. The aims of this study are to evaluate the impact of MetS and MetS factors on PCa incidence, on the risk of high-grade PCa and to analyze the role of MetS and single MetS components on the development of aggressive PCa features. METHODS: A systematic literature search and analysis on PubMed, EMBASE, Cochrane and Academic One File databases until September 2015 was performed by 2 independent reviewers to evaluate the associations between MetS and PCa incidence, and between MetS and high-grade PCa incidence (bioptical Gleason Score⩾8, Prognostic Group 4-5 according to the novel prostate cancer grading system). Also the association between MetS and individual MetS components with pathological Gleason Score⩾8, extra-capsular extension, seminal vesicle invasion, positive surgical margins and biochemical recurrence (defined as two consecutive PSA values ⩾0.2 ng ml-1 after radical prostatectomy) was evaluated. RESULTS: 24 studies were selected including a total of 132 589 participants of whom 17.35% had MetS. There was a slight association between MetS and PCa incidence (odds ratio (OR)=1.17 (1.00-1.36), P=0.04) and between high-grade PCa and MetS (OR= 1.89 (1.50-2.38), P<0.0001) but the studies were statistically heterogeneous. No association was found between MetS components and PCa risk except for hypertension. MetS was significantly associated with pathologic Gleason Score⩾8 (OR= 1.77 (1.34-2.34); P<0.01), extra-capsular extension (OR=1.13 (1.09-1.18); P<0.01), seminal vesicle invasion (OR=1.09 (1.07-1.12); P<0.01), positive surgical margins (OR=1.67 (1.47-1.91); P<0.01) and biochemical recurrence (OR=1.67 (1.04-2.69); P<0.01). CONCLUSIONS: The presence of MetS is associated with worse oncologic outcomes in men with PCa, in particular with more aggressive tumor features, and biochemical recurrence.

Nephro-ileal conduit subcutaneous stent: an alternative to percutaneous nephrostomy.

Nephrostomy has been the standard method of urinary diversion for chronic ureteral obstruction or when placement of ureteral stents has failed. We describe the first case of left kidney ileal conduit (Briker's urinary diversion) subcutaneous urinary by-pass. This method made the patient free from a second collecting bag without any significant complications. This method may improve the quality of life of patients with severe ureteral obstruction and ileal conduit.

Combination therapies for improved management of lower urinary tract symptoms/benign prostatic hyperplasia.

Several urological and non-urological conditions can contribute to the onset of lower urinary tract symptoms (LUTS), including benign prostatic hyperplasia (BPH), which is one of the main underlying causes in male patients. Six pharmacological classes (alpha-adrenoceptor blockers [ABs], 5alpha-reductase inhibitors [5ARIs], phytotherapeutics, antimuscarinics [AMs], beta3-adrenoceptor agonists and phosphodiesterase type 5 inhibitors [PDE5Is]) are available, alone or in combination, for the treatment of male LUTS. The aim of this review is to summarize the latest evidence on combination medical treatments for male patients with LUTS/BPH. Standard combinations include AB + 5ARI (for patients with increased prostate volume who are at risk for BPH progression); AB + PDE5I (for patients with concomitant erectile dysfunction); and AB + AM or beta3 agonist (for patients with persistent storage symptoms and not at risk for acute urinary retention). Other possible multidrug treatments have been proposed in preliminary studies, but further randomized controlled trials are needed to determine whether these putative strategies will eventually be considered a new standard for patients with LUTS/BPH. The possibility of tailoring BPH treatment according to different patient characteristics and expectations, using two or more drugs, seems a promising path in the field of LUTS/BPH management; however, physicians should consider the risk of increasing costs without proven long-term efficacy with most of these combination treatments.

Metabolic abnormalities linked to an increased cardiovascular risk are associated with high-grade prostate cancer: a single biopsy cohort analysis.

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.

Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database.

BACKGROUND: Since there is still an unmet need for potent adjuvant strategies for renal cancer patients with high progression risk after surgery, several targeted therapies are currently evaluated in this setting. We analyzed whether inclusion criteria of contemporary trials (ARISER, ASSURE, SORCE, EVEREST, PROTECT, S-TRAC, ATLAS) correctly identify high-risk patients. METHODS: The study group comprised 8873 patients of the international CORONA-database after surgery for non-metastatic renal cancer without any adjuvant treatment. Patients were divided into potentially eligible high-risk and assumable low-risk patients who didn't meet inclusion criteria of contemporary adjuvant clinical trials. The ability of various inclusion criteria for disease-free survival (DFS) prediction was evaluated by Harrell's c-index. RESULTS: During a median follow-up of 53 months 15.2% of patients experienced recurrence (5-year-DFS 84%). By application of trial inclusion criteria, 24% (S-TRAC) to 47% (SORCE) of patients would have been eligible for enrollment. Actual recurrence rates of eligible patients ranged between 29% (SORCE) and 37% (S-TRAC) opposed to <10% in excluded patients. Highest Hazard Ratio for selection criteria was proven for the SORCE-trial (HR 6.42; p < 0.001), while ASSURE and EVEREST reached the highest c-index for DFS prediction (both 0.73). In a separate multivariate Cox-model, two risk-groups were identified with a maximum difference in 5-year-DFS (94% vs. 61%). CONCLUSION: Results of contemporary adjuvant clinical trials will not be comparable as inclusion criteria differ significantly. Risk assessment according to our model might improve patient selection in clinical trials by defining a high-risk group (28% of all patients) with a 5-year-recurrence rate of almost 40%.

Trends in the use of partial nephrectomy for cT1 renal tumors: Analysis of a 10-yr European multicenter dataset.

AIM: Although extensively addressed in US registries, the utilization rate of Partial Nephrectomy has been poorly addressed in European settings. Our aim is to evaluate the impact of hospital volume on the use of PN for cT1 renal tumors. METHODS: 2526 patients with cT1N0M0 renal tumors treated with either PN or radical nephrectomy at 10 European centres in the last decade were included in the analysis. Joinpoint regression analysis was used to identify significant changes over time in linear slope of the trend for each center. The correlation between yearly caseload and the slopes was assessed with the non-parametric Spearman test. Coincident pairwise tests and regression analyses were used to generate and compare the trends of high-volume (HV), mid-volume (MV) and low-volume (LV) groups. RESULTS: Yearly caseload was significantly associated with increased use of PN (R = 0.69, p = 0.028). The utilization rate of PN was stable at LV centres (p = 0.67, p = 0.7, p = 0.76, for cT1, cT1a, and cT1b tumors, respectively), while increased significantly at MV (p = 0.002, 0.0005 and 0.007, respectively) and HV centers (all p < 0.0001). Regression analysis confirmed the trends for HV and MV as significantly different from those observed in LV centres (all p ≤ 0.002) and highlighted significant differences also between MV and HV centres (all p ≤ 0.03). CONCLUSIONS: We confirmed the association between caseload and the use of PN for cT1 tumors. Our findings suggest that a minimum caseload might turn the tide also in LV centres while a selective referral to HV centers for cT1b tumors should be considered.

C-erb-2 gene amplification and chromosomal anomalies in bladder cancer: preliminary results.

Studies recently suggested that different genetic factors are involved in the development and progression of bladder cancer. In this study, 30 consecutive patients affected by bladder neoplasm were evaluated in order to analyze the frequency of c-erb-2 gene amplification and chromosome 7, 9, 17 aneusomy using fluorescence in situ hybridization (FISH) technique. C-erb-2 gene amplification, chromosome 17 gain and aneusomy were respectively observed in 3.7% (1/27), in 47% (12/27) and in 74% (20/27) of examined tumors. Moreover, chromosome 7 and 9 aneusomy were detected in 74% (20/27) and in 72% (16/27) of specimens. A statistically significant correlation was observed between chromosome 17 aneusomy and tumor stage and grade (r: 0.642, p = 0.0001; r: 0.385, p = 0.04, respectively). In conclusion, we observed a low incidence of C-erb-2 gene amplification, while chromosome 17 aneusomy was confirmed as a marker of advanced and aggressive bladder cancer.

[Evaluation of sexual activity after prostatic surgery for benign prostatic hyperplasia assessed by pre-operative and post-operative questionnaire]. / Valutazione dell'attività sessuale dopo chirurgia prostatica per ipertrofia prostatica benigna mediante questionario pre e postoperatorio.

AIM: Different authors showed a 5-40% incidence of erectile dysfunction after prostatic surgery for benign prostatic hyperplasia. The aim of our study was to evaluate the effect of prostatic surgery due to benign prostatic hyperplasia on sexual activity. METHODS: We evaluated 56 patients (mean age 63 years, range 49-70) who underwent transurethral resection of the prostate (30 patients, mean age 64 years, range 56-70) and open prostatectomy (26 patients, mean age 59 years, range 49-70) with a questionnaire regarding the presence of sexual dysfunction before and 3, 6, 12 months after surgery. All patients were not affected by previous or present metabolic, neurological, cardiovascular diseases. RESULTS: Twenty percent of the patients with a normal sexual activity before treatment presented erectile dysfunction after surgery. However, 35% of patients with erectile dysfunction before treatment presented an improvement of their erectile function after surgery. CONCLUSIONS: A high incidence of erectile dysfunction was observed in patients undergoing prostatic surgery. Patients with erectile dysfunction should also recover a normal behaviour after prostatic surgery as well as an improvement of the erectile dysfunction.

Gross hematuria 10 years after radical cystectomy: adenomatous polyp.

Patients undergoing radical cystectomy with an ileal neobladder need intensive follow-up due to the recent studies concerning the potential neoplastic transformation of the intestinal mucosa. We report a case of a gross hematuria due to a lesion that developed in an ileal orthotopic bladder 10 years after a nerve and seminal sparing radical cystectomy for transitional bladder cancer. We performed a transurethral resection of the lesion and histopathological evaluation revealed an adenomatous polyp. In our case transurethral resection of the adenoma seems to be a safe and conservative approach in the management of these lesions, however further follow-up is requested.

Transuretral resection of the bladder (TURB): analysis of complications using a modified Clavien system in an Italian real life cohort.

INTRODUCTION: To evaluate the applicability of a modified Clavien classification system (CCS) in grading postoperative complications of transurethral resection of bladder tumours (TURB). MATERIALS AND METHODS: A series of patients undergoing monopolar TURB from April 2011 to March 2012 at five Italian centers were enrolled. All complications occurring within the first 30-day postoperative period were prospectively recorded and graded according to the CCS. RESULTS: Overall, 275 patients were included. Median age was 71 (63/78) years; median BMI was 28 (25.4/30.8) Kg/m(2), median tumour size was 2 (1-3) cm; median number of tumour lesions was 1 (1-3). Median operative time was 30 (20/45) min. Fifty-seven complications were recorded in 43 patients. Overall postoperative morbidity rate was 16%. Most of the complications were not serious and classified as Clavien type I (42 cases; 74%) or II (8 cases, 14%). Higher grade complications were scarce: CCS IIIa in 1 case (2%) and CCS IIIb in six cases (10%). No TURB related death was reported. Six patients were re-operated due to significant bleeding or clot retention on postoperative days 2-7. On univariate (73.5 ± 38 versus 36.7 ± 21.6 min) and multivariate analysis longer operative time was an independent predictor of complications (OR: 1.06 per min, 95%CI 1.04-1.08, p = 0.001). CONCLUSIONS: A modified CCS can be used as a standardized tool to objectively define the complications of TURB which confirms to be a safe procedure with a low surgical morbidity. This tool can be used to aid in patient counselling and to facilitate scientific assessment.