Publications by authors named "Luigi Schips"

165 Publications

Association of statin use and oncological outcomes in patients with first diagnosis of T1 high grade non-muscle invasive urothelial bladder cancer: results from a multicentre study.

Minerva Urol Nefrol 2021 Jan 13. Epub 2021 Jan 13.

Department of Medical, Oral and Biotechnological Sciences, G. d'Annunzio University of Chieti, Urology Unit, SS. Annunziata Hospital, Chieti, Italy.

Introduction: We aimed to test the hypothesis that the immune-modulatory effect of statins may improve survival outcomes in patients with non-muscle invasive bladder cancer (NMIBC). We focused on a cohort of patients diagnosed with high risk NMIBC, that were treated with intravesical BCG immunotherapy.

Patients And Methods: We included patients at first diagnosis of T1 high grade NMIBC after transurethral resection of bladder (TURB). All procedures were performed at 18 different tertiary institutions between January 2002 and December 2012. Univariable and multivariable models were used to test differences in terms of residual tumour, disease recurrence, disease progression and overall mortality (OM) rates.

Results: Overall, 1510 patients with T1 high grade NMIBC at TURB were included in our analyses. Of these, 402 (26.6%) were statin users. At multivariable analysis, statin use was associated with a higher rates of high grade BC at re-TURB (OR: 1.37, 95%CI: 1.04-1.78; p=0.022), while at follow-up it was not independently associated with OM (HR: 0.71, 95%CI: 0.50-1.03; p=0.068) and disease progression rates (HR: 0.97, 95%CI: 0.79-1.19; p=0.753). Conversely, statin use has been shown to be independently associated with a lower risk of recurrence (HR:0.80, 95%CI: 0.67-0.95; p=0.009). The median recurrence-free survival was 47 (95%CI 40-49) months for those classified as non-statin users vs. 53 (95%CI 48-68) months in those classified as statin users.

Conclusions: Statin daily intake do not compromise oncological outcomes in high risk NMIBC patients treated with BCG. Moreover, statin may have a beneficial effect on recurrence rates in this cohort of patients.
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http://dx.doi.org/10.23736/S0393-2249.20.04076-XDOI Listing
January 2021

Initial Experience and Evaluation of a Nomogram for Outcome Prediction in Management of Medium-sized (1-2 cm) Kidney Stones.

Eur Urol Focus 2021 Jan 5. Epub 2021 Jan 5.

Department of Urology, Azienda Ospedaliero-Universitaria, Urological Residency School Network, University of Modena & Reggio Emilia, Modena, Italy.

Background: The gold standard treatment for solitary medium-sized (1-2 cm) renal stones is not defined by recent guidelines, since management modalities including shockwave lithotripsy (SWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PNL) are recommended. Improved ability to predict patient outcomes would aid in patients' counseling and decision-making.

Objective: To develop a nomogram predicting treatment failure, based on preoperative clinical variables, to be used in the preplanning setting.

Design, Setting, And Participants: We recruited 2605 patients from 14 centers and carried out a multicenter retrospective analysis of 699 SWL, 1290 RIRS, and 616 PN L procedures performed as first-line treatment for 1-2-cm kidney stones. The variables evaluated included age, gender, previous renal surgery, body mass index, stone size, location, stone density, skin-to-stone distance, presence of urinary tract infections (UTIs), and hydronephrosis.

Outcome Measurements And Statistical Analysis: Multivariate logistic regression was fitted to predict treatment failure, defined as the presence of residual fragments >4 mm. A nomogram was developed based on the coefficients of the logit function.

Results And Limitations: A total of 2431 (93.3%) patients were stone free; 174 (6.7%) treatment failures were recorded and considered the event to be predicted. On univariate analysis, type of procedure, preoperative hydronephrosis, stone density, stone location, and laterality turned out to be statistically significant. Skin-to-stone distance, UTIs, and previous renal surgery were predictors of failure on multivariate analysis. Each variable was given a score based on statistical relevance. The main limitation of the current study is its retrospective nature.

Conclusions: This nomogram provides a prediction of treatment failure and need of reintervention for medium-sized kidney stones. External validation is needed to determine its reproducibility and validity.

Patient Summary: We developed a preoperative model of treatment outcomes for 1-2-cm kidney stones. Its application may assist urologists to counsel patients with regard to stone management modality.
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http://dx.doi.org/10.1016/j.euf.2020.12.012DOI Listing
January 2021

The safety and feasibility of the simultaneous use of 180-W GreenLight laser for prostate vaporization during concomitant surgery.

Arch Ital Urol Androl 2020 Dec 17;92(4). Epub 2020 Dec 17.

Department of Urology, Private Hospital Villa Stuart, Rome.

Objectives: To explore the safety and feasibility of photo-selective vaporization of the prostate (PVP) with GreenLight XPS 180 Watt laser (GL-180- W XPS) combined with other surgical procedures.

Material And Methods: Data on patients in whom GL-180-W XPS was performed to relieve lower urinary tract symptoms/ benign prostatic hyperplasia (LUTS/BPH) symptoms were extracted from a multi-institutional database (2011-2016). Patients were stratified into two groups. In the first all patients who had GL-180-W XPS with a concomitant procedure during the same surgical session were included as cases while those who underwent GL-180-W XPS PVP only were included as control.

Results: A total of 487 patients were included. Fifty-eight (11.9%) patients underwent concomitant procedures. Multivariable linear regression models failed to find an association between concomitant procedures and longer laser time (p = 0.4). Similarly, multivariable linear regression models failed to find an association between concomitant procedures and laser time even when the analyses were repeated and stratified into endoscopic (p = 0.6) and open/laparoscopic (p = 0.4) procedures. Multivariable logistic regression models failed to demonstrate any association between concomitant procedures and early complications (OR:1.39, CI: 0.379-2.44, p = 0.2), late complications (OR:1.84, CI:0.78-3.98; p = 0.1) and acute urinary retention (OR:1.84, CI:0.78-3.98; p = 0.1). When the analyses were repeated and the concomitant procedures stratified into endoscopic and open/laparoscopic ones, they yielded virtually the same results.

Conclusions: GL-180-W XPS PVP could be safely performed in concomitant endoscopic or open/laparoscopic surgery. These results should be taken into consideration in the counseling of the patient who might choose to undergo simultaneous procedures.
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http://dx.doi.org/10.4081/aiua.2020.4.297DOI Listing
December 2020

How Can the COVID-19 Pandemic Lead to Positive Changes in Urology Residency?

Front Surg 2020 24;7:563006. Epub 2020 Nov 24.

Department of Urology, IEO European Institute of Oncology IRCCS, Milan, Italy.

The COVID-19 outbreak, in a few weeks, overloaded Italian hospitals, and the majority of medical procedures were postponed. During the pandemic, with hospital reorganization, clinical and learning activities performed by residents suffered a forced remodulation. The objective of this study is to investigate how urology training in Italy has been affected during the COVID-19 era. In this multi-academic study, we compared residents' training during the highest outbreak level with their previous activity. Overall 387 (67.1%) of the 577 Italian Urology residents participated in a 72-h anonymous online survey with 36 items sent via email. The main outcomes were clinical/surgical activities, social distancing, distance learning, and telemedicine. Clinical and learning activity was significantly reduced for the overall group, and after categorizing residents as those working only in COVID hospitals, both "junior" and "senior" residents, and those working in any of three geographical areas created (Italian regions were clustered in three major zones according to the prevalence of COVID-19). A significant decrease in outpatient activity, invasive diagnostic procedures, and endoscopic and major surgeries was reported. Through multivariate analysis, the specific year of residency has been found to be an independent predictor for all response modification. Being in zone 3 and zone 2 and having "senior" resident status were independent predictors associated with a lower reduction of the clinical and learning activity. Working in a COVID hospital and having "senior" resident status were independent predictors associated with higher reduction of the outpatient activity. Working in zone 3 and having "senior" resident status were independent predictors of lower and higher outpatient surgical activity, respectively. Working in a COVID hospital was an independent predictor associated with robotic surgical activity. The majority of residents reported that distance teaching and multidisciplinary virtual meetings are still not used, and 44.8% reported that their relationships with colleagues decreased. The COVID-19 pandemic presents an unprecedented challenge, including changes in the training and education of urology residents. The COVID era can offer an opportunity to balance and implement innovative solutions that can bridge the educational gap and can be part of future urology training.
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http://dx.doi.org/10.3389/fsurg.2020.563006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7732553PMC
November 2020

Editorial Comment.

J Urol 2021 02 30;205(2):398-399. Epub 2020 Nov 30.

Department of Medical, Oral and Biotechnological Sciences, Università degli Studi "G.d'Annunzio",, Chieti, Italy.

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http://dx.doi.org/10.1097/JU.0000000000001370.01DOI Listing
February 2021

Outcomes of Robot-assisted Partial Nephrectomy for Clinical T3a Renal Masses: A Multicenter Analysis.

Eur Urol Focus 2020 Nov 25. Epub 2020 Nov 25.

Department of Urology, UC San Diego School of Medicine, La Jolla, CA, USA. Electronic address:

Background: Use of partial nephrectomy (PN) in T3 renal cell carcinoma (RCC) is controversial.

Objective: To evaluate quality outcomes of robot-assisted PN (RAPN) for clinical T3a renal masses (cT3aRM).

Design, Setting, And Participants: This was a retrospective multicenter analysis of patients with cT3aN0M0 RCC who underwent RAPN.

Intervention: RAPN.

Outcome Measurements And Statistical Analysis: The primary endpoint was a trifecta composite outcome of negative surgical margins, warm ischemia time (WIT) ≤25 min, and no perioperative complications. The optimal outcome was defined as achieving this trifecta and ≥90% preservation of the estimated glomerular filtration rate (eGFR) and no stage upgrading of chronic kidney disease. Multivariable analysis (MVA) identified risk factors associated with lack of the optimal outcome. Kaplan-Meier analysis was conducted for survival outcomes.

Results And Limitations: Analysis was conducted for 157 patients (median follow-up 26 mo). The median tumor size was 7.0 cm (interquartile range [IQR] 5.0-7.8) and the median RENAL score was 9 (IQR 8-10). Median estimated blood loss (EBL) was 242 ml (IQR 121-354) and the median WIT was 19 min (IQR 15-25). A total of 150 patients (95.5%) had negative margins. Complications were noted in 25 patients (15.9%), with 4.5% having Clavien grade 3-5 complications. The median change in eGFR was 7 ml/min/1.72 m, with ≥90% eGFR preservation in 55.4%. The trifecta outcome was achieved for 64.3% and the optimal outcome for 37.6% of the patients. MVA revealed that greater age (odds ratio [OR] 1.06; p = 0.002), increasing RENAL score (OR 1.30; p = 0.035), and EBL >300 ml (OR 5.96, p = 0.006) were predictive of failure to achieve optimal outcome. The 5-yr recurrence-free survival, cancer-specific survival, and overall survival, were 82.1%, 93.3%, and 91.3%, respectively. Limitations include the retrospective design.

Conclusions: RAPN for select cT3a renal masses is feasible and safe, with acceptable quality outcomes. Further investigation is requisite to delineate the role of RAPN in cT3a RCC.

Patient Summary: Robot-assisted partial nephrectomy in patients with stage 3a kidney cancer provided acceptable survival, functional, and morbidity outcomes in the hands of experienced surgeons, and may be considered as an option when clinically indicated.
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http://dx.doi.org/10.1016/j.euf.2020.10.011DOI Listing
November 2020

Bladder cancer: do we need contrast injection for MRI assessment of muscle invasion? A prospective multi-reader VI-RADS approach.

Eur Radiol 2020 Nov 19. Epub 2020 Nov 19.

Department of Neuroscience, Imaging and Clinical Sciences, "G. d'Annunzio" University, Via Luigi Polacchi 11, 66100, Chieti, Italy.

Objectives: (1) To investigate whether a contrast-free biparametric MRI (bp-MRI) including T2-weighted images (T2W) and diffusion-weighted images (DWI) can be considered an accurate alternative to the standard multiparametric MRI (mp-MRI), consisting of T2, DWI, and dynamic contrast-enhanced (DCE) imaging for the muscle-invasiveness assessment of bladder cancer (BC), and (2) to evaluate how the diagnostic performance of differently experienced readers is affected according to the type of MRI protocol.

Methods: Thirty-eight patients who underwent a clinically indicated bladder mp-MRI on a 3-T scanner were prospectively enrolled. Trans-urethral resection of bladder was the gold standard. Two sets of images, set 1 (bp-MRI) and set 2 (mp-MRI), were independently reviewed by four readers. Descriptive statistics, including sensitivity and specificity, were calculated for each reader. Receiver operating characteristic (ROC) analysis was performed, and the areas under the curve (AUCs) were calculated for the bp-MRI and the standard mp-MRI. Pairwise comparison of the ROC curves was performed.

Results: The AUCs for bp- and mp-MRI were respectively 0.91-0.92 (reader 1), 0.90 (reader 2), 0.95-0.90 (reader 3), and 0.90-0.87 (reader 4). Sensitivity was 100% for both protocols and specificity ranged between 79.31 and 89.66% and between 79.31 and 83.33% for bp-MRI and mp-MRI, respectively. No significant differences were shown between the two MRI protocols (p > 0.05). No significant differences were shown accordingly to the reader's experience (p > 0.05).

Conclusions: A bp-MRI protocol consisting of T2W and DWI has comparable diagnostic accuracy to the standard mp-MRI protocol for the detection of muscle-invasive bladder cancer. The experience of the reader does not significantly affect the diagnostic performance using VI-RADS.

Key Points: • The contrast-free MRI protocol shows a comparable accuracy to the standard multiparametric MRI protocol in the bladder cancer muscle-invasiveness assessment. • VI-RADS classification helps non-expert radiologists to assess the muscle-invasiveness of bladder cancer. • DCE should be carefully interpreted by less experienced readers due to inflammatory changes representing a potential pitfall.
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http://dx.doi.org/10.1007/s00330-020-07473-6DOI Listing
November 2020

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.

Minerva Urol Nefrol 2020 Nov 17. Epub 2020 Nov 17.

Department of Urology, Università La Sapienza, Ospedale Sant'Andrea, Rome, Italy.

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). 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.
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http://dx.doi.org/10.23736/S0393-2249.20.04088-6DOI Listing
November 2020

Effectiveness of abiraterone acetate plus prednisone in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer in a large prospective real-world cohort: the ABItude study.

Ther Adv Med Oncol 2020 29;12:1758835920968725. Epub 2020 Oct 29.

Department of Medical Oncology, University Campus Biomedico, Rome, Italy.

Background: Real-world data on chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone plus prednisone are limited, largely deriving from small retrospective studies.

Methods: ABitude is an Italian, observational, prospective, multicenter study of mCRPC patients receiving abiraterone plus prednisone in clinical practice. Chemotherapy-naïve mCRPC patients were consecutively enrolled at abiraterone start (February 2016 to June 2017) and are being followed for 3 years, with evaluation approximately every 6 months. Several clinical and patients reported outcomes were examined.

Results: In this second interim analysis, among 481 enrolled patients, 453 were evaluable for analyses. At baseline, the median age was 77 years and ~69% of patients had comorbidities (mainly cardiovascular diseases). Metastases were located mainly at bones and lymph nodes; 8.4% of patients had visceral metastases. During a median follow-up of 18 months, 1- and 2-year probability of radiographic progression-free survival were 73.9% and 56.2%, respectively; the corresponding rates for overall survival were 87.3% and 70.4%. In multivariable analyses, the number of bone metastases significantly affected radiographic progression-free survival and overall survival. During abiraterone plus prednisone treatment, 65% of patients had a ⩾50% prostate-specific antigen decline, and quality of life remained appreciably high. Among symptomatic patients according to the Brief Pain Inventory) (32%), scores significantly declined after 6 months of treatment. Overall, eight patients (1.7%) had serious adverse reactions to abiraterone.

Conclusions: Abiraterone plus prednisone is effective and safe for chemotherapy-naïve mCRPC patients in clinical practice.
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http://dx.doi.org/10.1177/1758835920968725DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7604981PMC
October 2020

Outcomes of minimally invasive partial nephrectomy among very elderly patients: report from the RESURGE collaborative international database.

Cent European J Urol 2020 8;73(3):273-279. Epub 2020 Sep 8.

Unit of Urology, Division of Experimental Oncology, Urological Research Institute (URI), IRCCS Ospedale San Raffaele, Milan, Italy.

The aim of the study was to perform a comprehensive investigation of clinical outcomes of robot-assisted partial nephrectomy (RAPN) or laparoscopic partial nephrectomy (LPN) in elderly patients presenting with a renal mass. The REnal SURGery in Elderly (RESURGE) collaborative database was queried to identify patients aged 75 or older diagnosed with cT1-2 renal mass and treated with RAPN or LPN. Study outcomes were: overall complications (OC); warm ischemia time (WIT) and 6-month estimated glomerular filtration rate (eGFR); positive surgical margins (PSM), disease recurrence (REC), cancer-specific mortality (CSM) and other-cause mortality (OCM). Descriptive statistics, Kaplan-Meier, smoothed Poisson plots and logistic and linear regression models (MVA) were used. Overall, 216 patients were included in this analysis. OC rate was 34%, most of them being of low Clavien grade. Median WIT was 17 minutes and median 6-month eGFR was 54 ml/min/1.73 m. PSM rate was 5%. After a median follow-up of 20 months, the 5-year rates of REC, CSM and OCM were 4, 4 and 5%, respectively. At MVA predicting perioperative morbidity, RAPN relative to LPN (odds ratio [OR] 0.33; p <0.0001) was associated with lower OC rate. At MVA predicting functional outcomes, RAPN relative to LPN was associated with shorter WIT (estimate [EST] -4.09; p <0.0001), and with higher 6-month eGFR (EST 6.03; p = 0.01). In appropriately selected patients with small renal masses, minimally-invasive PN is associated with acceptable perioperative outcomes. The use of a robotic approach over a standard laparoscopic approach can be advantageous with respect to clinically relevant outcomes, and it should be preferred when available.
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http://dx.doi.org/10.5173/ceju.2020.0179DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7587491PMC
September 2020

Active surveillance for small renal masses in elderly patients does not increase overall mortality rates compared to primary intervention: a propensity score weighted analysis.

Minerva Urol Nefrol 2020 Sep 29. Epub 2020 Sep 29.

Department of Urology, Instituto Valenciano de Oncología (IVO), Valencia, Spain -

Background: To test the effect of active surveillance (AS) versus primary intervention (PI) on overall mortality (OM) in elderly patients diagnosed with SRM.

Methods: Elderly patients (75 years or older) diagnosed with SRMs (< 4cm) and treated with either PI [i.e. partial nephrectomy or kidney ablation] or AS between 2009 and 2018 were abstracted from the REnal SURGery in the Elderly (RESURGE) and Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) datasets, respectively. OM rates were estimated among groups with Kaplan Meier method and Cox proportional hazards regression models after applying inverse probability of treatment weighting (IPTW). Multivariable logistic regression model was used to estimate IPTW. Covariates of interest were those unbalanced and/or significantly correlated with the treatment choice or with OM.

Results: A total of 483 patients were included; 121 (25.1%) underwent AS. 60 patients (12.4%) died. Overall, 6.7% of all deaths were related to cancer. IPTW-Kaplan Meier curves showed a 5-year overall survival rates of 70.0 ± 3.5% and 73.2 ± 4.8% in AS and PI groups, respectively (IPTW-Log-rank p-value=0.308). IPTW-Cox regression model did not show meaningfully increased OM rates in AS group (HR=1.31, 95% CI: 0.69-2.49).

Conclusions: AS represents an appealing treatment option for very elderly patients presenting with SRM, as it avoids the risks of a PI while not compromising the survival outcomes of these patients.
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http://dx.doi.org/10.23736/S0393-2249.20.03785-6DOI Listing
September 2020

Management of erectile dysfunction following robot-assisted radical prostatectomy: a systematic review.

Minerva Urol Nefrol 2020 Oct 4;72(5):543-554. Epub 2020 Aug 4.

European Associations of Urology-European Society of Residents in Urology (EAU-ESRU).

Introduction: We aimed to summarize evidences about the efficacy of available treatments for erectile disfunction after robotic assisted radical prostatectomy (RARP).

Evidence Acquisition: A systematic literature review searching on PubMed (Medline), Scopus, and Web of Science databases was performed in December 2019. PRISMA guidelines were followed. Population consisted of patients with erectile disfunction after RARP (P), conservative and surgical intervention were considered of interest (I). No comparator was considered mandatory (C). Outcomes of interest were the recovery of erectile function after conservative treatments and sexual function after surgical treatments (O).

Evidence Synthesis: Eleven studies were included. Seven studies focused on the use of phosphodiesterase-5 inhibitors (PDE5i) alone (five studies) or associated with other treatments (two studies). All the studies confirmed the efficacy of PDE5i, while the most promising association is with vacuum pump erectile devices. Two studies investigated topical treatments, namely low intensity extracorporeal shock wave therapy and alprostadil. Low intensity extracorporeal shock wave therapy may be a promising option in patients in whom nerve-sparing surgery was performed. The use of alprostadil could be an effective alternative to intracorporeal injection in those who underwent non-nerve-sparing surgery. One study focused and confirmed the efficacy of penile implants. Furthermore, one study reported the efficacy of a multi-modal treatment with preoperative medication, showing the benefits of a multimodal approach.

Conclusions: Penile rehabilitation with PDE5i is effective after nerve sparing RARP. The association of PDE5i with vacuum devices could led to a faster recovery. A multimodal approach with preoperative specific care seems to be effective to fasten erectile function recovery.
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http://dx.doi.org/10.23736/S0393-2249.20.03780-7DOI Listing
October 2020

Enzalutamide in patients with castration-resistant prostate cancer: retrospective, multicenter, real life study.

Minerva Urol Nefrol 2020 Aug 4. Epub 2020 Aug 4.

Department of Urology, ASL Abruzzo2, Chieti, Italy -

Background: Metastatic castration-resistant prostate cancer (mCRPC) is the final stage of pCa history and represents a clinically relevant phenotype with an elevated burden of mortality. The aim of the present study is to evaluate the efficacy and safety of enzalutamide in a "real-life" setting in mCRPC patients.

Methods: Data about all mCRPC patients treated with enzalutamide from September 2017 to September 2018 were collected. Demographics, comorbidities, clinical parameters, outcomes, toxicity, overall survival and progression free survival were analyzed.

Results: Overall 158 patients were enrolled. Mean age was 75.8 (±8.7) years with a baseline median PSA of 16.5 (IQR 7.4-47.8) ng/mL. The median follow-up lasted 7.7 (IQR 4-14.1) months. Of all the 10.1% of patients reported grade 3-4 adverse events. 43.7% of patients experienced a progression. Overall the 6 and 12 months PFS rates were 69.5% (95% CI: 61.7-78.3%) and the 45.6% (95% CI: 36.5-57.1%); a median baseline PSA >16 ng/mL (HR:2.0, 95% CI: 1.2-3.3, p=0.005), the use of opioid (HR:3.1, 95% CI 1.9-5.0, p<0.001), a previous treatment (abiraterone, docetaxel or abiraterone + docetaxel) were significantly associated with higher rates of cancer progression. Conversely, a brief pain questionnaire of 0-1 (HR: 0.4, 95% CI: 0.2-0.7, p<0.001), a 12 weeks 50% PSA reduction (HR: 0.4, 95% CI: 0.2-0.8, p=0.006) and a longer time to mCRPC (HR: 0.4, 95% CI: 0.3-0.7, p=0.002) were related to lower cancer progression rates.

Conclusions: Our data shows an effective and safe profile of enzalutamide in a "realworld" perspective in patients with mcRPC.
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http://dx.doi.org/10.23736/S0393-2249.20.03723-6DOI Listing
August 2020

Radical penectomy, a compromise for life: results from the PECAD study.

Transl Androl Urol 2020 Jun;9(3):1306-1313

Department of Urology, ASL 2 Abruzzo, Hospital "S. Pio da Pietrelcina", Vasto, Italy.

Background: The use of organ sparing strategies to treat penile cancer (PC) is currently supported by evidence that has indicated the safety, efficacy and benefit of this surgery. However, radical penectomy still represents up to 15-20% of primary tumor treatments in PC patients. The aim of the study was to evaluate efficacy in terms of overall survival (OS) and disease-free survival (DFS) of radical penectomy in PC patients.

Methods: Data from a retrospective multicenter study (PEnile Cancer ADherence study, PECAD Study) on PC patients treated at 13 European and American urological centers (Hospital "Sant'Andrea", Sapienza University, Roma, Italy; "G.D'Annunzio" University, Chieti and ASL 2 Abruzzo, Hospital "S. Pio da Pietrelcina", Vasto, Italy; Department of Genitourinary Oncology, Moffitt Cancer Center, Tampa, FL, USA; Hospital of Budapest, Hungary; Department of Emergency and Organ Transplantation, Urology and Andrology Unit II, University of Bari, Italy; Hospital "Spedali Civili", Brescia, Italy; Istituto Europeo di Oncologia, University of Milan, Milan, Italy; University of Modena & Reggio Emilia, Modena, Italy; Hospital Universitario La Paz, Madrid, Spain; Ceara Cancer Institute, Fortaleza, Brazil; Virginia Commonwealth University, Richmond, VA, USA; Aristotle University of Thessaloniki, Thessaloniki, Greece; Maria Skłodowska-Curie Memorial Cancer Center, Warsaw, Poland) between 2010 and 2016 were used. Medical records of patients who specifically underwent radical penectomy were reviewed to identify main clinical and pathological variables. Kaplan-Meier method was used to estimate 1- and 5-year OS and DFS.

Results: Of the entire cohort of 425 patients, 72 patients (16.9%) treated with radical penectomy were extracted and were considered for the analysis. The median age was 64.5 (IQR, 57.5-73.2) years. Of all, 41 (56.9%) patients had pT3/pT4 and 31 (43.1%) pT1/pT2. Moreover, 36 (50.0%) were classified as pN1-3 and 5 (6.9%) M1. Furthermore, 61 (84.7%) had a high grade (G2-G3) with 6 (8.3%) positive surgical margins. The 1- and 5-year OS rates were respectively 73.3% and 59.9%, while the 1- and 5-year DFS rates were respectively 67.3% and 35.1%.

Conclusions: PC is an aggressive cancer particularly in more advanced stage. Overall, more than a third of patients do not survive at 5 years and more than 60% report a disease recurrence, despite the use of a radical treatment.
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http://dx.doi.org/10.21037/tau.2020.04.04DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7354339PMC
June 2020

Toward Individualized Approaches to Partial Nephrectomy: Assessing the Correlation Between Ischemia Time and Patient Health Status (RECORD2 Project).

Eur Urol Oncol 2020 Jul 6. Epub 2020 Jul 6.

Department of Urology, University of Florence, Unit of oncologic minimally-Invasive Urology and Andrology, Careggi Hospital, Florence, Italy. Electronic address:

Background: Ischemia time during partial nephrectomy (PN) is among the greatest determinants of acute kidney injury (AKI). Whether this association is affected by the preoperative risk of AKI has never been investigated.

Objective: To assess the effect of the interaction between the preoperative risk of AKI and ischemia time on the probability of AKI during PN.

Design, Setting, And Participants: Data of 944 patients treated with on-clamp PN for cT1 renal tumors were extracted from the Registry of Conservative and Radical Surgery for Cortical Renal Tumor Disease (RECORD2) database, a prospective multicenter project.

Outcome Measurements And Statistical Analysis: We estimated the preoperative risk of AKI (defined according to the risk/injury/failure/loss/end-stage [RIFLE] criteria) according to age, baseline renal function, clinical stage, preoperative aspects and dimensions used for an anatomical (PADUA) score, and surgical approach. Classification and regression tree (CART) analysis identified patients at "high" and "low" risk of AKI. Finally, we plotted the probability of AKI over ischemia time stratified by the preoperative risk of AKI.

Results And Limitations: Overall, 235 (25%) patients experienced AKI after surgery. At multivariable analysis, older patients, those with more complex tumors, those with higher baseline function, and those treated with open surgery had an increased risk of AKI (all p ≤ 0.011). According to the first split at CART analysis, patients were categorized as those with "high" and "low" risk of AKI having a probability of >40% or <40%. For low-risk patients, the probability of AKI in case of <10 versus >20 min of ischemia was 13% versus 28% (absolute risk increase 15%). The risk of AKI for high-risk patients who had <10 versus >20 min of ischemia was 31% versus 77%. This corresponds to an absolute risk increase of 45%. Limitations include retrospective data analyses and lack of surgeons' prior experience.

Conclusions: Ischemia time during PN has different implications for patients with different health status. Clamp time seems less clinically relevant for patients in good conditions who may endure prolonged ischemia with a mild increase in the risk of AKI, whereas frail patients seem to be more vulnerable to ischemic damage even for short clamp time. For individualized intra- and postoperative management, duration of ischemia needs to be questioned in the context of the individual health status.

Patient Summary: Functional sequelae related to ischemia time during partial nephrectomy depend on baseline health status. The correlation between the duration of ischemia and baseline health status should be taken into account toward individualized intra- and postoperative management.
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http://dx.doi.org/10.1016/j.euo.2020.05.009DOI Listing
July 2020

How Targeted Therapy Influence Renal Surgery for Renal Cell Carcinoma.

Curr Drug Targets 2020 ;21(15):1550-1557

Department of Urology, Campus Biomedico, University of Rome, Rome, Italy

Between the end of 2005 and the beginning of 2006, several new target therapies have been introduced for the treatment of renal cell carcinoma. In this review, we aimed to explore and summarize the main findings of the use of systemic treatment and its effect on surgery in patients with renal cell carcinoma. We identified three different settings: neoadjuvant and adjuvant settings as well as the association of systemic therapy with surgery in the metastatic renal cell carcinoma patients. Neoadjuvant target therapy with tyrosine kinase inhibitor may facilitate the tumor resection and reduce the overall tumor diameter and its complexity. However, most of the evidence is from small phase I or II clinical trials and results are often conflicting without determining a relevant change in the main parameters investigated, such as tumor complexity. In the adjuvant setting, results from pivotal trials investigating the use of tyrosine kinase inhibitors for patients with non-metastatic RCC treated with surgery discourage this practice. Indeed, most of the evidence from single clinical trials and pooled results from meta-analysis failed to find a survival advantage with the use of adjuvant systemic treatment. To date, an improvement of clinical outcomes after systemic targeted therapies could be only found in the setting of cytoreductive nephrectomy. However, the CARMENA and SURTIME trials recently confirmed the evidence against a surgical treatment in patients with mRCC and poor prognosis. In the near future, significant changes may be introduced by the use of immunotherapies.
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http://dx.doi.org/10.2174/1389450121666200704150933DOI Listing
January 2020

Conservative management of urinary incontinence following robot-assisted radical prostatectomy.

Minerva Urol Nefrol 2020 Oct 20;72(5):555-562. Epub 2020 May 20.

European Association of Urology - European Society of Residents in Urology (EAU-ESRU).

Introduction: Robotic assisted radical prostatectomy (RARP) is getting more and more popular becoming the most common radical prostatectomy technique. Unfortunately, a not negligible proportion of patients in whom RARP is performed experience urinary incontinence. We aimed to systematically review the current literature evidence on urinary incontinence conservative treatment after RARP.

Edidence Aquisition: A systematic literature review search using PubMed (Medline), Scopus, and Web of Science databases was performed in December 2019. PRISMA guidelines have been adopted. Population consisted of patients with urinary incontinence after RARP (P), conservative intervention was considered of interest (I). No comparator was considered mandatory (C). Outcomes of interest were the recovery of continence and quality of life (O).

Evidedence Synthesis: Six studies were included. Four of them investigated the use of pelvic floor muscle training (PFMT). PFMT improved pelvic muscle strength. Continence recovery was faster when guided PFMT was adopted. Moreover, two studies tested the effect of solifenacin on urinary incontinence. One of them, a randomized clinical trial, failed to show shorter time to continence in solifenacin group compared to placebo.

Conclusions: The use of pads is associated with a detrimental effect on quality of life thus active treatments for UI post-RARP are warranted. PFMT has the main advantage to shorten the time for recovery. The use of solifenacin seems to not offer striking advantages in UI following RARP. Future studies should focus on testing the efficacy of these treatments when used after robotic vs. open radical prostatectomy.
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http://dx.doi.org/10.23736/S0393-2249.20.03782-0DOI Listing
October 2020

Operative profile, safety and functional outcomes after GreenLight laser prostate surgery: results from a 12 months follow-up multicenter Italian cohort analyses.

Minerva Urol Nefrol 2020 Oct 10;72(5):622-628. Epub 2020 Apr 10.

Department of Urology, Villa Stuart Private Hospital, Rome, Italy.

Background: Over the two past decades, GreenLight laser therapy has been considered a valid alternative for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia/benign prostatic obstruction (BPH/BPO). However, the debate on the effectiveness of laser therapy compared to conventional techniques is still open. The aim of our study is to analyze and describe the use of GreenLight laser prostate surgery in Italy, with regard to the surgical techniques performed and the surgical and functional outcomes at mid-term follow-up.

Methods: From March 2012 to July 2018, patients who underwent GreenLight laser prostate surgery for LUTS due to BPH/BPO from 19 Italian centers were included. The following parameters were evaluated in the population: age, prostate volume, prostate adenoma volume, PSA tot, Qmax at uroflowmetry (UFM), International Prostatic Symptoms Score (IPSS), previous therapy for LUTS, use of anticoagulants and antiplatelet drugs. We recorded also the kind of anesthesia, mean laser time (min), mean irradiation time (min), TURP conversion/completion rate, postoperative day of catheter removal, postoperative acute urinary retention (AUR), hospital stay, variation of hematocrit (Ht) and hemoglobin levels (Hb). Early complications were classified according to the Clavien-Dindo classification, the re-operation rate within 30 days and after 30 days, the late complications and the Patient Global Impression of Improvement were also collected. Changes over time in terms of blood loss and functional outcomes (IPSS and Qmax at the UFM at 6 and 12 months) were tested with Student's test for paired samples. We assumed P≤0.05 as level of statistical significance.

Results: Overall, 1077 were enrolled in the study, 554 (56.4%) were treated with standard vaporization and 523 (48.6%) with anatomical vaporization. Student's t-test for paired samples showed no statistically significant differences in terms of reduction of Ht preoperative vs. Ht postoperative (42.80±3.91 vs. 39.93±5.35 95% CI P=0.3) and preintervention and postintervention Hb levels (14.28±1.46 vs. 13.72 P=0.35). Compared with the preoperative Qmax (8.60±2.64), the 6- and 12-month UFM showed a significant improvement [19.56±6.29, P<0.01 and 19.99±5.92 P<0.01]. In terms of IPSS variation, compared to the baseline level (22±5.51) the 6- and 12-month follow-up confirmed a significant reduction (8.01±4.41 P<0.01 and 5.81±4.12 P<0.01 respectively). Postoperative complications were CD0, CD1, CD2, CD3, CD4 in 33.0%,35.3%, 2.9%, 0.3%, and 0.6%.

Conclusions: To the best of our knowledge, this is one of the most numerous surgical series of GreenLight laser vaporization and with the longest follow-up. This technique should be considered as a safe and effective alternative in the treatment of secondary LUTS to BPH.
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http://dx.doi.org/10.23736/S0393-2249.20.03597-3DOI Listing
October 2020

Could Bladder Multiparametric MRI Be Introduced in Routine Clinical Practice? Role of the New VI-RADS Score: Results From a Prospective Study.

Clin Genitourin Cancer 2020 10 13;18(5):409-415.e1. Epub 2020 Mar 13.

Department of Medical, Oral and Biotechnological Sciences, G. d'Annunzio University of Chieti, Urology Unit, SS Annunziata Hospital, Chieti, Italy.

Background: The Vesical Imaging Reporting and Data System (VI-RADS) was recently introduced as a standardized approach to reporting multiparametric magnetic resonance imaging (mpMRI) for bladder cancer. We aimed to prospectively analyze its routine use and its diagnostic performance in discriminating non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC).

Patients And Methods: A total of 38 patients with diagnosis of suspect bladder cancer at cystoscopy underwent bladder mpMRI before transurethral resection of the bladder (TURB). Bladder tumors were categorized according to the VI-RADS. After TURB, the VI-RADS score was compared with histological report for each lesion separately. Receiving operating characteristic and decision curve analyses were used to assess its accuracy and clinical utility.

Results: A total of 68 lesions were included, of which 7 (10.3%) were MIBC. The pooled accuracy was 90.0% (95% confidence interval [CI], 75.4%-98.7%). The best threshold was estimated as VI-RADS 4, showing a sensitivity of 85.7% (95% CI, 57.1%-100%) and a specificity of 86.9% (95% CI, 78.7%-95.1%). Decision curve analyses showed that using VI-RADS ≥4 improved the net benefit compared with any default strategy for threshold probabilities of MIBC up to ∼40%, which is a reasonable clinical threshold for planning further treatments.

Conclusions: Our prospective study shows that the use of VI-RADS as a standardized reporting method is appealing and could be considered in clinical practice owing to its high accuracy.
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http://dx.doi.org/10.1016/j.clgc.2020.03.002DOI Listing
October 2020

Effectiveness of a novel oral combination of D-Mannose, pomegranate extract, prebiotics and probiotics in the treatment of acute cystitis in women.

Arch Ital Urol Androl 2020 Apr 6;92(1):34-38. Epub 2020 Apr 6.

Department of Urology "Villa Stuart" Private Hospital, Rome.

Objective: Urinary tract infections (UTIs) are defined as the symptomatic presence of pathogens in the urinary tract that are typically diagnosed by microscopy and culture of urine samples. Over the long-term antibiotic courses, alternative prophylactic methods as probiotics, cranberry juices and D-mannose have been introduced for recurrence prevention. The present study aimed to determine whether a new combination of D-Mannose, Pomegranate extract, Prebiotics and Probiotics is effective in modifying symptoms reported by women with acute uncomplicated acute cystitis.

Material And Methods: This is a pilot study, performed between September 2018 and November 2018 at the Department of Urology of Villa Stuart Private Hospital. A dose of a new combination of agents was administered twice daily for 5 days and then once a day for 10 days. Together with the compound, forced hydration (> 2 liters/day) has been strongly suggested. Antibiotics were permitted only in case of clinical worsening. Changes in patients' symptoms, the therapeutic effects and changes in quality of life (QoL) were evaluated clinically and through a validated questionnaire, the Acute Cystitis Symptom Score (ACSS) at the first visit (T0), 15 (T1) and 30 (T2) days later.

Results: Thirty-three patients were enrolled in the study (mean age 38,1 ± 11.2 years) and all completed the treatment protocol. At T1 visit, all symptoms or the majority of symptoms went off in 10 women (30.3%) and at T2 in 30 women (90.9%); some symptoms still remained in 16 women (48.5%) at T1 and in 3 women (9.1%) at T2; the persistence of all symptoms or the worsening of the condition was observed in 7 patients (21.2%) at T1 and in none at T2. The mean score reported at all the ACSS sub-scales significantly decreased between baseline and T1 and T2. Typical symptoms decreased from 11.5 (10.5-12.6) to 4.9 (4.0-5.9) and to 2.7 (2.1-3.3) (p-values < 0.0001); differential symptoms decreased from 3.1 (2.6-3.6) to 0.6 (0.3-0.9) and to 0.3 (0.1-0.5) (p-values 0.009 to < 0.0001); QoL mean score also decrease from 7.2 (6.7- 7.7) to 4.0 (3.3-4.6) and to 1.7 (1.2-2.1) (p-values < 0.0001). Six patients required antibiotics and no adverse events were recorded.

Conclusions: Our study suggests that the action of the compounds, administered in this new combination, could help in an effective management of symptoms of acute cystitis in women, without antibiotics, in a wide majority of the cases. Lack of microbiological assessment is a clear limitation of the study. Moreover, lack of a control group is another important limitation. Finally, hyperhydration could have been a confounding factor in interpretation of results.
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http://dx.doi.org/10.4081/aiua.2020.1.34DOI Listing
April 2020

Robotic partial nephrectomy vs minimally invasive radical nephrectomy for clinical T2a renal mass: a propensity score-matched comparison from the ROSULA (Robotic Surgery for Large Renal Mass) Collaborative Group.

BJU Int 2020 07 15;126(1):114-123. Epub 2020 Jun 15.

Department of Urology, UC San Diego School of Medicine, La Jolla, CA, USA.

Objective: To compare outcomes of minimally invasive radical nephrectomy (MIS-RN) and robot-assisted partial nephrectomy (RAPN) in clinical T2a renal mass (cT2aRM).

Patients And Methods: Retrospective, multicentre, propensity score-matched (PSM) comparison of RAPN and MIS-RN for cT2aRM (T2aN0M0). Cohorts were PSM for age, sex, body mass index, American Society of Anesthesiologists (ASA) class, clinical tumour size, and R.E.N.A.L. score using a 2:1 ratio for RN:PN. The primary outcome was disease-free survival (DFS). Secondary outcomes included overall survival (OS), complication rates, and de novo estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m . Multivariable (MVA) and Kaplan-Meier survival analyses (KMSA) were conducted.

Results: In all, 648 patients (216 RAPN/432 MIS-RN) were matched. There were no significant differences in intraoperative complications (P = 0.478), Clavien-Dindo Grade ≥III complications (P = 0.063), and re-admissions (P = 0.238). The MVA revealed high ASA class (hazard ratio [HR] 2.7, P = 0.044) and sarcomatoid (HR 5.3, P = 0.001), but not surgery type (P = 0.601) to be associated with all-cause mortality. Increasing R.E.N.A.L. score (HR 1.31, P = 0.037), high tumour grade (HR 2.5, P = 0.043), and sarcomatoid (HR 2.8, P = 0.02) were associated with recurrence, but not surgery (P = 0.555). Increasing age (HR 1.1, P < 0.001) and RN (HR 3.9, P < 0.001) were predictors of de novo eGFR of <45 mL/min/1.73 m . Comparing RAPN and MIS-RN, KMSA revealed no significant differences for 5-year OS (76.3% vs 88.0%, P = 0.221) and 5-year DFS (78.6% vs 85.3%, P = 0.630) for pT2 RCC, and no differences for 3-year OS (P = 0.351) and 3-year DFS (P = 0.117) for pT3a upstaged RCC. The 5-year freedom from de novo eGFR of <45 mL/min/1.73 m was 91.6% for RAPN vs 68.9% for MIS-RN (P < 0.001).

Conclusions: RAPN had similar oncological outcomes and morbidity profile as MIS-RN, while conferring functional benefit. RAPN may be considered as a first-line option for cT2aRM.
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http://dx.doi.org/10.1111/bju.15064DOI Listing
July 2020

Conservative treatment of upper urinary tract carcinoma in patients with imperative indications.

Minerva Urol Nefrol 2020 Feb 19. Epub 2020 Feb 19.

Department of Urology, IRCCS San Raffaele Hospital, Ville Turro, Milan, Italy.

Background: To report our experience for endoscopic treatment of upper urinary tract carcinoma (UTUC) in patients with imperative indications for management.

Methods: Retrospective data were collected for all patients who underwent endoscopic management of UTUC for imperative situations, from September 2013 to January 2019. Comorbidity was determined by using the age-adjusted Charlson comorbidity index (CCI). The primary endpoint of the study was overall survival (OS). Secondary outcomes were recurrence- free survival (RFS) rates, complication rates and global renal function.

Results: A total of 29 patients were enrolled in the study. The median age was 69.0 (IQR 63.0- 79.0) years and the median CCI was 6 (IQR 4-8). Overall, 137 endoscopic procedures were performed; 117 (85.4%) had no complication. Clavien-Dindo grade III and IV complications were 3 (2.2%) and 1 (0.7%) respectively. The median follow-up of 23 months (IQR 14-35). During the follow-up, 2 (6.9%) patients died for cause not related to cancer. Recurrence of UTUC occurred in 18 patients (61.1%). The 24-month OS was 96.4 ± 3.5% and the 24-month RFS was 31.7 ± 9.4%. Lower RFS rates were found in high grade tumor patients (22.2 ± 13.9%) compared to low grade tumor patients (35.6 ± 12.3%) (p=0.237). There was statistical difference in creatinine and eGFR values when comparing baseline to last follow-up (p=0.018 and p=0.005, respectively).

Conclusions: Endoscopic management of UTUC in patients with imperative indications appears to be a reasonable alternative to nephroureterectomy. However, stringent endoscopic follow- up is necessary due to the high risk of disease recurrence.
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http://dx.doi.org/10.23736/S0393-2249.20.03710-8DOI Listing
February 2020

Effect of Obesity and Overweight Status on Complications and Survival After Minimally Invasive Kidney Surgery in Patients with Clinical T Renal Masses.

J Endourol 2020 03;34(3):289-297

Department of Medical, Oral and Biotechnological Sciences, Urology Unit, SS Annunziata Hospital, "G.D'Annunzio" University of Chieti, Chieti, Italy.

To evaluate the effect of obesity and overweight on surgical, functional, and survival outcomes in patients with large kidney masses after minimally invasive surgery. Within a multicenter multinational dataset, patients found to have ≥cT renal mass and treated with minimally invasive (laparoscopic or robotic) kidney surgery (radical or partial nephrectomy) during the period 2003 to 2017 were abstracted. They were stratified according to the body mass index classes as normal weight (18.5-24.9 kg/m), overweight (25.0-29.9 kg/m), and obese (≥30.0 kg/m). Mixed models and Cox proportional hazard regression tested differences in complication rates, estimated glomerular filtration rate (eGFR) change over time, overall mortality (OM), and disease recurrence (DR) rates. Of 812 patients, 30.6% were normal weight, 42.7% were overweight, and 26.7% obese. Overweight (odds ratio 0.82, 95% confidence interval [CI]: 0.51-1.31,  = 0.406) and obese patients (OR: 0.81, 95% CI: 0.44-1.47,  = 0.490) experienced similar complication rates than normal weight. Moreover, no statistically significant differences in eGFR were found for overweight ( = 0.129) or obese ( = 0.166) patients compared to normal weight. However, higher OM rates were recorded in overweight (hazard ratio [HR] 3.59, 95% CI: 1.03-12.51,  = 0.044), as well as in obese, patients (HR 7.83, 95% CI: 2.20-27.83,  = 0.002). Similarly, higher DR rates were recorded in obese (HR 2.76, 95% CI: 1.40-5.44,  = 0.003) patients. Obese and overweight patients do not experience higher complication rates or worse eGFR after minimally invasive kidney surgery, which therefore can be deemed feasible and safe also in this subset of patients. Nevertheless, obese and overweight patients seem to carry a higher risk of OM, and therefore, they should undergo a strict follow-up after surgery.
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http://dx.doi.org/10.1089/end.2019.0604DOI Listing
March 2020

External validation of Cormio nomogram for predicting all prostate cancers and clinically significant prostate cancers.

World J Urol 2020 Oct 6;38(10):2555-2561. Epub 2020 Jan 6.

Department of Urology, Ospedale Sant'Andrea-Universitá di Roma "Sapienza", Rome, Italy.

Purpose: 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.

Methods: 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.

Results: 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.

Conclusion: 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.
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http://dx.doi.org/10.1007/s00345-019-03058-1DOI Listing
October 2020

Persistence and adherence to androgen deprivation therapy in men with prostate cancer: an administrative database study.

Minerva Urol Nefrol 2020 Oct 12;72(5):615-621. Epub 2019 Dec 12.

Department of Urology, ASL Abruzzo 02, Chieti, Italy.

Background: The aim of this study was to assess adherence to and persistence with androgen deprivation therapy (ADT) in a large cohort of prostate cancer (PCa) patients selected from an administrative database, with special attention to elderly patients.

Methods: Patients treated with LHRH analogues, LHRH antagonists, the novel androgen antagonist enzalutamide, and the CYP17 inhibitor abiraterone were included spanning the years 2011-2017. Descriptive statistics were used to analyze persistence and adherence in older patients stratified by age (46-55, 56-65, 66-75, 76-85, and >85 years). The effect of persistence duration on overall survival in super-elderly patients was analyzed by the Kaplan-Meier method, together with the influence of multiple prescriptions on overall survival.

Results: A total of 1160 male patients were treated with ADT. Of these, 1075 were given LHRH analogues, 80 LHRH antagonists, 14 novel androgen antagonists, and 109 the CYP17 inhibitor. Median adherence values were 0.93, 0.97, 0.95, and 0.99 respectively. The highest persistence was recorded for LHRH analogues/antagonists (24 months), followed enzalutamide and abiraterone (8 months). A total of 107 patients (9.2%) were classified as super-elderly (age range 85-97 years). Median persistence and OS in this group were 13 months and 29 months, respectively. The adherence was 0.92. Overall survival was significantly associated with additional prescriptions for other conditions-indications (P=0.0047) but not with differences in adherence rates (P=0.98).

Conclusions: Our data showed high adherence and persistence rates in men on ADT. The overall survival in the super-elderly is not influenced by persistence and/or adherence but rather by coprescriptions.
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http://dx.doi.org/10.23736/S0393-2249.19.03595-1DOI Listing
October 2020

Perioperative Outcomes of Open, Laparoscopic, and Robotic Partial Nephrectomy: A Prospective Multicenter Observational Study (The RECORd 2 Project).

Eur Urol Focus 2019 Nov 11. Epub 2019 Nov 11.

Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital, Florence, Italy. Electronic address:

Background: Partial nephrectomy (PN) has a non-negligible perioperative morbidity. Comparative evidence of the available surgical techniques is limited.

Objective: To compare the perioperative outcomes of open, laparoscopic, and robotic PN.

Methods: Data of 2331 patients treated with PN for cT1 renal tumors were extracted from the RECORd2 database, a prospective multicenter project. Multivariable regression models assessed the relationship between surgical technique and surgical margins, warm ischemia time, postoperative complications, and acute kidney injury (AKI). The probability of achieving a modified trifecta (negative margins, warm ischemia time <25min, and no Clavien-Dindo ≥2 complications) was examined for each surgical approach.

Results: Minimally invasive techniques had lower rate of Clavien-Dindo ≥2 complications than that of open surgery (odds ratio [OR] for robotic surgery: 0.27; 95% confidence interval [95% CI]: 0.15-0.47, p< 0.0001; OR for laparoscopy: 0.52; 95% CI: 0.34-0.78; p= 0.002). The probability of receiving ischemia was highest for robotic PN (p< 0.001). Among on-clamp PN, laparoscopy had longer ischemia than open (estimate: 1.09; 95% CI: -0.00 to 2.18; p= 0.050) and robotic (estimate: 1.36; 95% CI: 0.31-2.40; p= 0.011) surgery. When compared with open PN, the risk of AKI was roughly halved for patients treated by robotic and laparoscopic surgery (both p< 0.0001). Positive margins rate did not differ between the groups (all p≥ 0.1). The likelihood to achieve a modified trifecta was not affected by surgical technique in the overall population (all p≥ 0.075). In Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) score < 10 lesions, robotic surgery had higher probability of achieving a modified trifecta than open PN (OR: 1.66; 95% CI: 1.09-2.53; p= 0.018) and laparoscopy (OR: 1.34; 95% CI: 0.94-1.90; p= 0.11).

Conclusions: In PADUA<10 renal tumors, robotic PN allows for higher rates of trifecta than open and laparoscopic surgeries. The impact of surgical technique on perioperative outcomes of PN might be limited in more complex lesions.

Patient Summary: We evaluated the association between surgical technique and perioperative outcomes of partial nephrectomy. In less complex (Preoperative Aspects and Dimensions Used for an Anatomical [PADUA] score < 10) lesions, robotic PN allows for higher rates of trifecta when compared with other surgical techniques.
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http://dx.doi.org/10.1016/j.euf.2019.10.013DOI Listing
November 2019

New Antiandrogen Compounds Compared to Docetaxel for Metastatic Hormone Sensitive Prostate Cancer: Results from a Network Meta-Analysis.

J Urol 2020 04 5;203(4):751-759. Epub 2019 Nov 5.

Department of Medical, Oral and Biotechnological Sciences, G. d'Annunzio University of Chieti, Chieti, Italy.

Purpose: Docetaxel represent the standard of care in patients with metastatic, hormone sensitive prostate cancer. However, androgen receptor axis targeted therapies have also been shown to be effective. We aimed to analyze findings in randomized controlled trials investigating first-line treatment for hormone sensitive prostate cancer.

Materials And Methods: We systematically reviewed the literature according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria and the PICO (Population, Intervention, Comparator, Outcomes) methodology. Outcomes of interest were overall and progression-free survival, and the rate of high grade adverse events.

Results: No treatment was superior to docetaxel in terms of overall survival. However, abiraterone (HR 0.89, 95% CI 0.76-1.05), enzalutamide (HR 0.90, 95% CI 0.69-1.19) and apalutamide (HR 0.90, 95% CI 0.67-1.22) showed nonstatistically significant lower overall mortality rates than docetaxel. Abiraterone (HR 0.71, 95% CI 0.59-0.86), enzalutamide (HR 0.61, 95% CI 0.49-0.75) and apalutamide (HR 0.74, 95% CI 0.57-0.95) also showed statistically significant lower disease progression rates than docetaxel. Furthermore, abiraterone (OR 0.83, 95% CI 0.56-1.21) showed no statistically significant lower rate of high grade adverse events compared to docetaxel. Finally, enzalutamide (OR 0.56, 95% CI 0.35-0.92) and apalutamide (OR 0.44, 95% CI 0.24-0.79) showed statistically significant lower rates of high grade adverse events compared to docetaxel.

Conclusions: Treatment with androgen receptor axis targeted therapies combined with androgen deprivation therapy in patients with hormone sensitive prostate cancer did not offer a statistically significant advantage in overall survival compared to the standard, docetaxel. However, it was associated with a lower disease progression rate. Moreover, apalutamide and enzalutamide offer a better safety profile.
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http://dx.doi.org/10.1097/JU.0000000000000636DOI Listing
April 2020

GreenLight Photoselective Vaporization of the Prostate: One Laser for Different Prostate Sizes.

J Endourol 2020 01 20;34(1):54-62. Epub 2019 Nov 20.

Department of Urology, "Villa Stuart" Private Hospital, Rome, Italy.

GreenLight laser vaporization of the prostate (photoselective vaporization of the prostate [PVP]) is a safe and effective procedure for Benign Prostatic Hyperplasia. Long-term results and advantages of PVP in patients with large and symptomatic prostate are still under evaluation. In a multicenter experience, patients who underwent standard or anatomical PVP were retrospectively reviewed. Patients with follow-up >12 months were divided into two groups based on prostate volume (<100 cc ≥100 cc). Pre- and perioperative data, as well as postoperative results and complications, were recorded after 3, 6, and 12 months and then annually. One thousand and thirty-one patients were eligible, 916 of these had a prostate volume of <100 cc and 115 ≥ 100 cc. Median follow-up period was 25.0 months (interquartile range [IQR] 16.5-35.0) and 16.0 months (IQR 12.0-24.0) in ≥100 and <100 groups, respectively. No difference was found in terms of catheterization time, postoperative stay, and postoperative acute urine retention. Patients with prostate ≥100 required longer operative time (75 55 minutes), lasing time (41.7 24.9 minutes), and higher energy used but lower energy density. Patients with prostate ≥100 had a higher incidence of early (50.4% 35.7%) and late complications (21.7% 12.8%) and early urge/incontinence symptoms (40.9% 29.3%). No statistically significant differences were found for the maximum urinary flow (Qmax) and International Prostate Symptom Score (IPSS) results between the two groups. The reintervention rate in ≥100 group was 3.5% 2.3% in <100. In the midterm follow-up, GreenLight PVP guarantees the same results in different prostate volume groups. Early and late complications are more frequent in large prostates.
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http://dx.doi.org/10.1089/end.2019.0478DOI Listing
January 2020

Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort.

World J Urol 2020 Jul 12;38(7):1757-1764. Epub 2019 Oct 12.

Department of Urology, "Regina Elena" National Cancer Institute of Rome, Via Elio Chianesi 53, 00154, Rome, Italy.

Purpose: To provide a snapshot of toxicities and oncologic outcomes of Abiraterone (AA) and Enzalutamide (EZ) in a chemo-naïve metastatic castration-resistant prostate cancer (mCPRC) population from a longitudinal real-life multicenter cohort.

Methods: We prospectively collected data on chemo-naïve mCRPC patients treated with AA or EZ. Primary outcomes were PSA response, oncologic outcomes and toxicity profile. The Kaplan-Meier method was used to compare differences in terms of progression-free survival (PFS) between AA vs EZ and high- vs low-volume disease cohorts. Univariable and multivariable Cox regression analyses were performed to identify predictors of PFS. Toxicity, PSA response rates and oncologic outcomes on second line were compared with those observed on first line.

Results: Out of 137 patients, 88 received AA, and 49 EZ. On first line, patients receiving EZ had significantly higher PSA response compared with AA (95.9% vs 67%, p < 0.001), comparable toxicity rate (10.2% vs 16.3%, p = 0.437) and PFS probabilities (p = 0.145). Baseline PSA and high-volume disease were predictors of lower PFS probabilities at univariable analysis (p = 0.027 and p = 0.007, respectively). Overall, 28 patients shifted to a second-line therapy (EZ or radiometabolic therapy). Toxicity and PSA response rates on second line were comparable to those observed on first line (11.1% vs 12.4%, p = 0.77; 73.1% vs 77.4%, p = 0.62, respectively); 2-year PFS, cancer-specific and overall survival probabilities were comparable to those displayed in first-line cohort (12.1% vs 16.2%, p = 0.07; 85.7% vs 86.4%, p = 0.98; 71% vs 80.3%, p = 0.66, respectively).

Conclusions: Toxicity profile, PSA response rate and oncological outcomes were comparable between first-line and second-line courses in patients treated with either AA or EZ for mCRPC. Our findings showed the tolerability and oncological effectiveness, when feasible, of two lines of therapy other than chemotherapy.
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http://dx.doi.org/10.1007/s00345-019-02974-6DOI Listing
July 2020

Comprehensive analysis of in-hospital delirium after major surgical oncology procedures: A population-based study.

Can Urol Assoc J 2020 Mar 27;14(3):E84-E93. Epub 2019 Sep 27.

Cancer Prognostics and Health Outcomes Unit, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada.

Introduction: Very few population-based assessments of delirium have been performed to date. These have not assessed the implications of delirium after major surgical oncology procedures (MSOPs). We examined the temporal trends of delirium following 10 MSOPs, as well as patient and hospital delirium risk factors. Finally, we examined the effect of delirium on length of stay, inhospital mortality, and hospital charges.

Methods: We retrospectively identified patients who underwent prostatectomy, colectomy, cystectomy, mastectomy, gastrectomy, hysterectomy, nephrectomy, oophorectomy, lung resection, or pancreatectomy within the Nationwide Inpatient Sample (2003-2013). We yielded a weighted estimate of 3 431 632 patients. Multivariable logistic regression (MLR) analyses identified the determinants of postoperative delirium, as well as the effect of delirium on length of stay, in-hospital mortality, and hospital charges.

Results: Between 2003 and 2013, annual delirium rate increased from 0.7 to 1.2% (+6.0%; p<0.001). Delirium rates were highest after cystectomy (predicted probability [PP] 3.1%) and pancreatectomy (PP 2.6%), and lowest after prostatectomy (PP 0.15%) and mastectomy (PP 0.13%). Advanced age (odds ratio [OR] 3.80), maleness (OR 1.38), and higher Charlson comorbidity index (OR 1.20), as well as postoperative complications represent risk factors for delirium after MSOPs. Delirium after MSOP was associated with prolonged length of stay (OR 3.00), higher mortality (OR 1.15), and increased in-hospital charges (OR 1.13).

Conclusions: No contemporary population-based assessments of delirium after MSOP have been reported. According to our findings, delirium after MSOP has a profound impact on patient outcomes that ranges from prolonged length of stay to higher mortality and increased in-hospital charges.
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http://dx.doi.org/10.5489/cuaj.6030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7053373PMC
March 2020