Publications by authors named "Giorgia Tema"

38 Publications

How many procedures are needed to achieve learning curve of Millin simple laparoscopic prostatectomy.

Minerva Urol Nephrol 2021 Mar 26. Epub 2021 Mar 26.

Complexo Hospitalario Universitario de Pontevedra, Galicia, Spain.

Background: Aim of our study was to evaluate learning curve of the Millin simple prostatectomy analysing three expert laparoscopic surgeons.

Methods: Learning curve of 3 expert laparoscopic surgeons with excellent radical prostatectomy training was evaluated. Surgeon 1 had more than 20 years of experience, while other surgeons had 10 years of experience. The first 45 procedures of the surgeons were considered for analysis. The cumulative sum (CUSUM) technique, one of the methods developed to monitor the performance and quality of the industrial sector, was adopted to analyse learning curves. The variables included to evaluate learning curve of the surgeons were: operative time (OT), hospitalisation (HO) and complication rate.

Results: Overall 135 patients were included in the analysis. Median age was 68 (64/74), median prostate volume was 83 (75/97), median Qmax 9 ml/s (6/11) and median IPSS 20 (18/22). Complications included: 9/135 (7%) transfusion, 4/135 (3%) Urinary retention, 3/135 (2%) fever, 1/35 (<1%) reintervention and 1/135 (<1%) conversion. Surgeon 1 presented a lower median operative time when compared to surgeon 2 and 3. No significant differences were recorded in terms of hospitalisation, blood loss and transfusion rate as well as postoperative outcomes. According to the CUSUM analysis the number of procedures needed to achieve a plateau in surgical time is 10/15 procedures (fig 1).

Conclusions: In conclusion, according to our results 15 procedures are needed to reach a plateau in surgical time for trained laparoscopic surgeons.
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http://dx.doi.org/10.23736/S2724-6051.21.04114-XDOI Listing
March 2021

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

Laparoscopic simple prostatectomy vs bipolar plasma enucleation of the prostate in large benign prostatic hyperplasia: a two-center 3-year comparison.

World J Urol 2020 Nov 11. Epub 2020 Nov 11.

Nuova Villa Claudia, Rome, Italy.

Purpose: To compare surgery outcomes and safety of button bipolar enucleation of the prostate vs laparoscopic simple prostatectomy in patients with large prostates (> 80 g) in a two-center cohort study.

Methods: All patients with lower urinary tract symptoms due to benign prostatic enlargement (Prostate volume > 80 cc) undergoing button bipolar enucleation of the prostate (BTUEP) or laparoscopic simple prostatectomy (LSP) in two centers were enrolled. Data on clinical history, physical examination, urinary symptoms, uroflowmetry and prostate volume were collected at 0, 1, 3 6, 12, 24 and 36 months. Early and long-term complications were recorded.

Results: Overall, 296 patients were enrolled. Out of them, 167/296 (56%) performed a LSP and 129/296 (44%) performed a BTUEP. In terms of efficacy both procedures showed durable results at three years with a reintervention rate of 8% in the LSP group and of 5% in the BTUEP group. In terms of safety, BTUEP and LSP presented similar safety profiles with a 9% of transfusion rate and no major complications.

Conclusion: LSP and BTUEP are safe and effective in treating large-volume adenomas with durable results at three years when performed in experienced centers.
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http://dx.doi.org/10.1007/s00345-020-03512-5DOI Listing
November 2020

The role of immune PSA complex (iXip) in the prediction of prostate cancer.

Biomarkers 2021 Feb 23;26(1):26-30. Epub 2020 Nov 23.

Department of Urology, Casa di Cura Nuova Villa Claudia, Rome, Italy.

Purpose: To analyse the performance of iXip in the prediction of prostate cancer (PCa) and high-grade PCa.

Methods: A consecutive series of men undergoing MRI/FUSION prostate biopsies were enrolled in one centre. Indications for prostate biopsy included abnormal prostate-specific antigen (PSA) levels (PSA>4 ng/ml) and/or abnormal digital rectal examination (DRE) and/or abnormal MRI. All patients underwent the evaluation of serum PSA-IgM concentration and the iXip ratio was calculated. Accuracy iXip for the prediction of PCa was evaluated using multivariable binary regression analysis and receiver operator characteristics (ROC) curves.

Results: Overall 160 patients with a median age of 65 (62/73) years were enrolled. Overall, 42% patients were diagnosed with PCa and 75% of them had high-grade cancer (Epstein ≥ 3). Patients with PCa were older and presented higher PSA levels, higher PIRADS scores and lower prostate volumes (PVs). On ROC analysis iXip presented an area under the curve (AUC) of 0.57 in the prediction of PCa and of 0.54 for the prediction of high-grade PCa.

Conclusions: In our experience, immune PSA complexes are not predictors of PCa. iXip analysis should not be included in the diagnostic pathway of patients at increased risk of PCa.
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http://dx.doi.org/10.1080/1354750X.2020.1841294DOI Listing
February 2021

Phosphodiesterases 5 Inhibitors and Erectile Dysfunction Recovery after Pelvic Surgery: Future Perspectives for New Drugs and New Formulations.

Curr Drug Targets 2021 ;22(1):31-37

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

Background: Phosphodiesterase 5 inhibitors (PDE5I) represent the first-line treatment in the management of post-operative erectile dysfunction (ED) after pelvic oncological surgery. The aim of our study is to evaluate the available evidence on the efficacy of PDE5Is, including new formulations and penile rehabilitation post-pelvic surgery.

Evidence Acquisition: A systematic review of the literature was performed until May 2020. The following databases were searched: Scopus, Medline and Web of Science. The MeSH search was conducted by combining the following terms: 'erectile dysfunction', 'radical prostatectomy' 'pelvic' 'bladder' 'phosphodiesterase' inhibitors' 'avanafil' 'sildenafil' 'tadalafil' 'lodenafil' 'mirodenafil' 'udenafil' 'vardenafil' 'sublingual' 'orodispersible' 'penile' 'rehabilitation'.

Evidence Synthesis: Sildenafil, Tadalafil, vardenafil and Avanafil improve EF compared with placebo in men with all levels of ED severity after radical prostatectomy with good tolerability. No specific recommendations can be suggested regarding the superiority of a drug over the other. The optimal dose, continuous vs. on-demand and duration of treatment, is still under investigation. In vitro and preclinical studies suggest the possible role for lodenafil, mirodenafil and oro-dispersible formulations in patients undergoing oncological pelvic surgery. Few studies demonstrated the efficacy of udenafil in improving ED after rectal surgery or radical prostatectomy. Complete recovery of EF after surgery is still an unmet need in the field of penile rehabilitation after pelvic surgery.

Conclusion: PDE5Is have a crucial role in the management of post pelvic surgery of ED. New drugs and new formulations have shown excellent results in patients with ED; however, data in patients after surgery is still scarce. Further well designed RCT should clarify the role of these new compounds and oro-dispersible formulations in the management of ED in patients undergoing pelvic surgery.
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http://dx.doi.org/10.2174/1389450121666200925145347DOI Listing
January 2021

Comparative Effectiveness of Surveillance, Primary Chemotherapy, Radiotherapy and Retroperitoneal Lymph Node Dissection for the Management of Early Stage Testicular Germ Cell Tumors: A Systematic Review.

J Urol 2021 02 11;205(2):370-382. Epub 2020 Sep 11.

The Johns Hopkins Evidence-Based Practice Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

Purpose: Cancer specific survival for men with early stage (I to IIB) testicular germ cell tumors is greater than 90% with any management strategy. The data regarding the comparative effectiveness of surveillance, primary chemotherapy, radiotherapy and retroperitoneal lymph node dissection were synthesized with a focus on oncologic outcomes, patient reported outcomes, and short and long-term toxicities.

Materials And Methods: PubMed®, Embase® and the Cochrane Central Register of Controlled Trials were searched from 1980 to 2018 for studies addressing the effectiveness of surveillance, chemotherapy, radiotherapy and retroperitoneal lymph node dissection, according to pathology and clinical stage, for men with an early stage testicular germ cell tumor.

Results: Cancer specific survival ranged from 94% to 100% for patients with early stage testicular germ cell tumors regardless of tumor histology and initial management strategy. For men with seminoma the median cancer specific survival was 99.7% (range 97% to 100%), 99.5% (96.8% to 100%) and 100% (100% to 100%) among those managed by surveillance, radiotherapy and chemotherapy, respectively. Median cancer specific survival for men with nonseminomatous testicular germ cell tumors was 100% (range 98.6% to 100%), 100% (96.9% to 100%) and 100% (94% to 100%) when managed by surveillance, retroperitoneal lymph node dissection and chemotherapy, respectively. Recurrence rates and toxicities varied by management strategy. For men with seminoma surveillance, chemotherapy and radiotherapy were associated with median recurrence rates of 15%, 2% and 3.7%, respectively. For men with nonseminomatous testicular germ cell tumors the median recurrence rates were 20.5%, 3.3% and 11.1% for surveillance, chemotherapy and retroperitoneal lymph node dissection, respectively. Surveillance was associated with minimal toxicities compared to other approaches. Primary chemotherapy had the highest rate of short-term toxicities and was associated with long-term risks of metabolic syndrome, hypogonadism, renal impairment, neuropathy, infertility and secondary malignancies. Toxicities with radiotherapy included acute dermatitis and long-term gastrointestinal complications, infertility and high rates of secondary malignancies (2% to 3%). Patients undergoing retroperitoneal lymph node dissection had significant risk of toxicity perioperatively and long-term infertility in men with anejaculation. Transient detriments in patient reported outcomes and quality of life were noted with all management options.

Conclusions: Men with early stage testicular germ cell tumors experience excellent cancer specific survival regardless of management strategy. Management options, however, differ in terms of associated recurrence rates, short and long-term toxicities, and patient reported outcomes. The profile for each approach should be clearly communicated to patients and matched with patient preferences to offer the best individual outcome.
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http://dx.doi.org/10.1097/JU.0000000000001364DOI Listing
February 2021

Assessing the Impact of the Absence of Detrusor Muscle in Ta Low-grade Urothelial Carcinoma of the Bladder on Recurrence-free Survival.

Eur Urol Focus 2020 Sep 6. Epub 2020 Sep 6.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Background: Obtaining detrusor muscle (DM) in transurethral resection of bladder tumor (TURBt) specimen is considered a surrogate marker of resection quality. However, evidence was principally investigated in high-risk tumors. Therefore, DM sampling for low-grade (LG) urothelial carcinoma (UC) remains poorly investigated and certainly requires further investigation.

Objective: To assess whether the absence of DM in TURBt specimen has a negative impact on recurrence-free survival (RFS) in patients with a Ta LG UC.

Design, Setting, And Participants: A multicenter TURBt database was queried for "LG, Ta, UC of the bladder." All patients treated between 1996 and 2018 with tumor grade assessed according to both 1973 World Health Organization and 2004 WHO/International Society of Urological Pathology grading classifications and with a minimum follow-up of 1 yr were included. Patients with a previous history of high-grade UC, upper urinary tract UC, or bladder tumor differentiations other than UC were excluded.

Intervention: TURBt.

Outcome Measurements And Statistical Analysis: Baseline demographic, clinical, and pathologic data were analyzed. The European Organization for Research and Treatment of Cancer (EORTC) risk group was recorded. Kaplan-Meier analysis was performed to assess the predictive role of clinical and pathologic data for RFS. Univariable and multivariable Cox regression analyses were performed to identify the predictors of recurrence.

Results And Limitations: Overall, 521 patients were included. At Kaplan-Meier analysis, the low-risk cohort displayed significantly higher RFS than the intermediate-risk cohort (1-yr RFS 87% vs 79%; log-rank p = 0.007). At univariable Cox regression analysis, only gender, multiple tumors, tumor diameter ≥3 cm, and EORTC risk group were significant predictors of recurrence. Absence of DM had no impact on RFS. Multivariable Cox regression analysis confirmed gender and EORTC risk group as independent predictors of recurrence.

Conclusions: Absence of DM in TURBt specimen has negligible role in RFS of patients with Ta LG tumors of the bladder.

Patient Summary: In this study, we assessed the role that detrusor muscle (DM) in transurethral resection of bladder tumor specimen has in recurrence-free survival, in patients with a Ta low-grade urothelial carcinoma of the bladder. Absence of DM has no impact on tumor recurrence; therefore, it does not require additional attention.
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http://dx.doi.org/10.1016/j.euf.2020.08.007DOI Listing
September 2020

The role of metabolic syndrome in high grade prostate cancer: development of a clinical nomogram.

Minerva Urol Nefrol 2020 Dec 4;72(6):729-736. Epub 2020 Aug 4.

Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.

Background: The aim of our study is to develop a clinical nomogram including metabolic syndrome status for the prediction of high-grade prostate cancer (HG PCa).

Methods: A series of men at increased risk of PCa undergoing prostate biopsies were enrolled in a single center. Demographic and clinical characteristics of the patients were recorded. Metabolic syndrome was defined according to the adult treatment panel III. A nomogram was generated based on the logistic regression model and used to predict high grade prostate cancer defined as grade group ≥3 (ISUP 2014). ROC curves, calibration plots and decision curve analysis were used to evaluate the performance of the nomogram.

Results: Overall, 738 patients were enrolled. Greater than or equal to 294/738 (40%) of the patients presented PCa and of those patients, 84/294 (39%) presented high grade disease (Grade Group ≥3). On multivariate analysis, DRE (OR: 3.24, 95% CI: 1.80-5.84), PSA (OR: 1.10, 95% CI: 1.05-1.16), PV (OR: 0.98, 95% CI: 0.97-0.99) and MetS (OR: 2.02, 95% CI: 1.13-3.59) were predictors of HG PCa. The nomogram based on the model presented good discrimination (AUC: 0.76), good calibration (Hosmer-Lemeshow Test, P>0.05) and a net benefit in the range of probabilities between 10% and 70%.

Conclusions: Metabolic syndrome is highly prevalent in patients at risk of prostate cancer and is particularly associated with high-grade prostate cancer. Our nomogram offers the possibility to include metabolic status in the assessment of patients at risk of prostate cancer to identify men who may have a high-grade form of the disease. External validation is warranted before its clinical implementation.
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http://dx.doi.org/10.23736/S0393-2249.20.03797-2DOI Listing
December 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

The urothelium, the urinary microbioma and men LUTS: a systematic review.

Minerva Urol Nefrol 2020 Dec 16;72(6):712-722. Epub 2020 Jun 16.

Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.

Introduction: The pathophysiology and management of male patients with lower urinary tract symptoms (LUTS) is still a matter of debate. In the past few years, the urothelium and the urinary microbiota represented important areas of research to improve the understanding and management of these patients. Aim of the present review was to summarize the available data on the urothelium and the microbiota related to male LUTS.

Evidence Acquisition: A National Center for Biotechnology Information (NCBI) PubMed search for relevant articles published between January 2000 and December 2019 was performed using the medical subjects heading "urothelium," "microbioma," "microbiota," "urobioma," "urobiota," "benign prostatic hyperplasia," "benign prostatic enlargement," "lower urinary tract symptoms," "lower urinary tract dysfunction," "men," "male," "overactive bladder," "receptors." Exclusion criteria included: animal studies and studies on muscarinic and adrenergic pathways.

Evidence Synthesis: The urothelium has been recently evaluated in humans to evaluate new possible markers and pathways. New possible targets for the treatment of male LUTS include the neural growth factor, the cannabinoid, the vanilloid and the ATP pathways. However, studies in humans are still needed to elucidate the exact role of these pathways in the management of male patients with LUTS. The available evidence on the urinary microbioma in male is poor. Standing to the available, urinary microbioma is evident in healthy urine in males. Moreover, the urinary microbioma varies depending on the method of collection, sexually transmitted disease status, inflammation and urinary symptoms. A possible role of probiotics in the management of LUTS in women has been proposed and may have a role in male patients as well.

Conclusions: The urothelium and the urinary microbiota are still poorly studied in men with LUTS. Most of the evidence and the hypothesis on the relationship between urothelium/urinary microbiota and LUTS comes from animal/in-vitro evidence while clinical trials are lacking. These pathways seem interesting even in LUTS pathogenesis in men but their possible role as a new therapeutic target is still an open debate.
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http://dx.doi.org/10.23736/S0393-2249.20.03762-5DOI Listing
December 2020

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

Neurourol Urodyn 2020 04 28;39(4):1115-1123. Epub 2020 Feb 28.

Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.

Aims: The aim of our study was to investigate noninvasive predictors for detrusor underactivity (DUA) in male patients with lower urinary tract symptoms (LUTS) and benign prostatic enlargement (BPE).

Methods: A consecutive series of patients aged 45 years or older with non-neurogenic LUTS were prospectively enrolled. Patients underwent standard diagnostic assessment including International Prostatic Symptoms Score, uroflowmetry, urodynamic studies (cystometry and pressure-flow studies), transrectal ultrasound of the prostate, and ultrasound measurements of the bladder wall thickness (BWT). Logistic regression analysis was used to investigate predictors of DUA, defined as a bladder contractility index < 100 mm H O. A nomogram was developed based on the multivariable logistic regression model.

Results: Overall 448 patients with a mean age of 66 ± 11 years were enrolled. In a multivariable logistic age-adjusted regression model BWT (odds ratio [OR]: 0.50 per mm; 95% confidence interval [CI], 0.30-0-66; P = .001) and Qmax (OR: 0.75 per mL/s; 95% CI, 0.70-0.81; P = .001) were significant predictors for DUA. The nomogram based on the model presented good discrimination (area under the curve [AUC]: 0.82), good calibration (Hosmer-Lemeshow test, P > .05) and a net benefit in the range of probabilities between 10% and 80%.

Conclusions: According to our results, BWT and Qmax can noninvasively predict the presence of DUA in patients with LUTS and BPE. Although our study should be confirmed in a larger prospective cohort, we present the first available nomogram for the prediction of DUA in patients with LUTS.
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http://dx.doi.org/10.1002/nau.24327DOI Listing
April 2020

Adverse events related to Radium 223 treatment: "real life" data from Eudra-Vigilance database.

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

Department of Urology, Ospedale Sant'Andrea, Rome, Italy -

Background: Aim of our study was to analyze adverse events (AEs) associated with Radium 223 using real life data from Eudra-Vigilance (EV) database.

Methods: EV database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We recorded number of AEs for Radium 223 per category and severity from 2013 to May 2019. We recorded AEs per age group (<65 years old; between 65 and 85 years; >85 years old) Pooled Relative Risk (PRR) were used to compare groups. The number of individual cases identified in EV database was 4339.

Results: According to the registry study the most frequent AEs in patients treated with Radium 223 were hematological, general and gastrointestinal disorders and they were confirmed as the most frequent AEs in the EV database. In the EV database over 90% of the reported AEs were defined as serious and 8% were fatal. Older patients (>85 years) treated with Radium 223 were at increased risk of cardiac, infectious, and metabolism disorders when compared to younger patients (<65). However, we have no information on the number of patients under treatment in the EV database.

Conclusions: EV database highlights several AEs which are not reported in registry studies as well as different AEs profiles according to age. Clinicians should consider these data when treating patients with Radium 223.
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http://dx.doi.org/10.23736/S0393-2249.20.03690-5DOI Listing
February 2020

Laparoscopic simple prostatectomy: a large single-center prospective cohort study.

Minerva Urol Nephrol 2021 Feb 12;73(1):107-113. Epub 2019 Dec 12.

Pontevedra University Hospital, Pontevedra, Spain.

Backround: The aim of our study was to analyze outcomes and safety of laparoscopic simple prostatectomy (LSP) in a high-volume center.

Methods: A consecutive series of men with lower urinary tract symptoms and large prostates (>80 cc) prospectively enrolled between November 2015 and December 2017 in one center. All patients underwent laparoscopic simple prostatectomy. Outcomes were evaluated considering the trifecta favorable outcome which was defined as a combination of the following items: 1) no perioperative complications; 2) postoperative IPSS <8; 3) postoperative Qmax >15 mL/s. Complications were evaluated according to the modified Clavien classification system. Univariate and multivariate binary logistic regression was performed to identify predictors of a positive trifecta outcome.

Results: Overall 272 patients were enrolled. At three months after surgery median IPSS total score was 4 (IQR: 3-7), median IPSS QoL was 1 (IQR:1-2), median prostate-specific antigen was 0.53 (IQR: 0.33-1.00) ng/ml and median Qmax was 23 (IQR: 17-30) mL/s. All these parameters improved statistically when compared to baseline (P<0.001). The overall complication rate was 21% however most of the complications were low grade complications according to modified Clavien-Dindo classification (grade ≤2). Overall, 68% of the patients presented a positive trifecta outcome. On multivariate analysis only preoperative hemoglobin and hospital stay were confirmed predictors of positive trifecta outcome.

Conclusions: LSP represents a safe and effective procedure in the treatment of large adenomas. Although RCTs are needed before reaching definitive conclusions, LSP is a promising technique for patients with LUTS and large prostates.
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http://dx.doi.org/10.23736/S0393-2249.19.03567-7DOI Listing
February 2021

Evaluation of Incisional Negative Pressure Wound Therapy in the Prevention of Surgical Site Occurrences After Radical Cystectomy: A New Addition to Enhanced Recovery After Surgery Protocol.

Eur Urol Focus 2020 07 6;6(4):698-703. Epub 2019 Nov 6.

The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, USA; Department of Urology, Johns Hopkins University School of Medicine, Baltimore, USA.

Background: Surgical site infection (SSI) remains a significant complication after radical cystectomy (RC). Enhanced recovery after surgery (ERAS) focuses on interventions to decrease length of stay, but few address wound-related complications directly.

Objective: To determine the impact that prophylactic incisional negative pressure wound therapy (iNPWT) will have to reduce the rate of surgical site occurrences (SSOs = SSI + seroma + superficial dehiscence) after RC.

Design, Settings, And Participants: We retrospectively reviewed patients undergoing RC by a single surgeon from 2012 to 2017. As part of our ERAS pathway, we employed prophylactic iNPWT during abdominal closure and compared it with a contemporary cohort of standard wound closure.

Outcome Measurements And Statistical Analysis: We compared 90-d SSIs, SSOs, and readmissions between iNPWT and standard skin staple closure. Univariate and multivariate regressions were used to compare the two groups.

Results And Limitations: We identified 158 (104 iNPWT, 54 standard) patients from 2012 to 2017. The rates of SSIs and SSOs were 9.7% and 19.0%, respectively. The overall readmission rate for the cohort was 21.5%, with 4.4% of patients requiring readmission for SSI. The iNPWT group had lower rates of SSIs (5.8% vs 16.7%, p = 0.03) and SSOs (11.5% vs 33.3%, p < 0.01). There was no difference between the groups for readmission (21.1% vs 22.2%, p = 0.5). The iNPWT protected against both SSI (odds ratio [OR] 0.89, 95% confidence interval [CI]: 0.81-0.98) and 90-d SSO (OR 0.77, 95% CI: 0.68-0.87).

Conclusions: Prophylactic iNPWT is feasible after RC with a modest decrease in both 90-d SSIs and 90-d SSOs, but not readmissions. Wound closure assisted by iNPWT should be considered in RC ERAS pathways.

Patient Summary: In this report, we looked at the impact of new vacuum suction dressing on the prevention of surgical infections after radical cystectomy (RC). We found that this wound dressing can decrease the impact of surgical infections and aid in recovery after RC.
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http://dx.doi.org/10.1016/j.euf.2019.09.016DOI Listing
July 2020

Adverse events related to abiraterone and enzalutamide treatment: analysis of the EudraVigilance database and meta-analysis of registrational phase III studies.

Prostate Cancer Prostatic Dis 2020 06 4;23(2):199-206. Epub 2019 Nov 4.

Department of Urology, Ospedale Sant'Andrea, Rome, Italy.

Background: Data from clinical trials do not always provide adequate information to judge the impact of new treatments when used in a real-world setting. The aim of our study was to analyze adverse events (AEs) associated with enzalutamide (ENZ) and abiraterone (ABI) using real-life data from the EudraVigilance (EV) database.

Methods: The EV database is the system for managing and analyzing information on suspected adverse reactions to medicines, which have been authorized or are being studied in clinical trials in the European Economic Area. We recorded the number of AEs for ABI and ENZ per category and severity from January 2013 to January 2019. In addition, we recorded AEs per age group. A meta-analysis of AEs reported in registrational phase III studies (AFFIRM, PREVAIL, COU-AA) was performed.

Results: The number of individual cases identified in EV database was 13,562 for ABI and 40,599 for ENZ. Over 90% of the reported AEs were defined as serious for both drugs. Older patients (>85 years and 65-85 years) treated with ABI or ENZ are at increased risk of cardiac, infectious, metabolic, and respiratory disorders when compared with younger patients (<65). According to registrational phase III studies, the most frequent AEs in patients treated with ABI are hepatobiliary disorders, while the most frequent AEs in patients treated with ENZ are psychiatric and vascular disorders. Several AEs present in the EV database are not reported in the registrational phase III studies. It is important to note that we have no information on the number of patients under treatment in the EV database.

Conclusions: The EV database highlights several AEs that are not reported in registrational phase III studies as well as different AEs profiles according to age. Clinicians should consider these data when treating patients with castration-resistant prostate cancer with ABI or ENZ.
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http://dx.doi.org/10.1038/s41391-019-0182-xDOI Listing
June 2020

Performance Characteristics of Clinical Staging Modalities for Early Stage Testicular Germ Cell Tumors: A Systematic Review.

J Urol 2020 05 14;203(5):894-901. Epub 2020 Oct 14.

The Johns Hopkins Evidence-Based Practice Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

Purpose: We synthesized evidence on the comparative performance characteristics, benefits and harms of diagnostic imaging modalities used in combination with serum tumor markers for clinical staging of testicular germ cell tumors. The diagnostic imaging modalities included computerized tomography, magnetic resonance imaging, positron emission tomography and chest radiographs.

Materials And Methods: Paired reviewers independently searched PubMed, Embase® and the Cochrane Central Register of Controlled Trials from 1980 to 2018 using title-abstract and full-text screening to identify original studies of the use of computerized tomography, magnetic resonance imaging, positron emission tomography, chest radiographs and serum tumor markers for the clinical staging of early stage testicular germ cell tumors.

Results: We found 21 studies of a total of 1,702 patients. With significant bias and limitations to the data, the performance characteristics of computerized tomography, magnetic resonance imaging and positron emission tomography for staging of the retroperitoneum were similar, with median sensitivity ranging from 67% to 80% and median specificity ranging from 95% to 100%. Computerized tomography of the chest (median sensitivity 100%) was more sensitive than a chest radiograph (median sensitivity 76%), especially in men with nonseminomatous germ cell tumors. The addition of serum tumor markers to diagnostic imaging improved staging sensitivity from 38% to 41% to 59% to 60%. No study specifically reported on harms of the imaging modalities.

Conclusions: The combination of axial imaging with computerized tomography or magnetic resonance imaging and serum tumor markers demonstrates optimal performance characteristics for staging early stage testicular germ cell tumors. There is little use for chest computerized tomography in men with seminoma, negative abdominal imaging and negative serum tumor markers.
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http://dx.doi.org/10.1097/JU.0000000000000594DOI Listing
May 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

Multicenter Analysis of Postoperative Complications in Octogenarians After Radical Cystectomy and Ureterocutaneostomy: The Role of the Frailty Index.

Clin Genitourin Cancer 2019 10 19;17(5):402-407. Epub 2019 Jul 19.

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

Background: The purpose of this study was to assess patient frailty as a risk factor for radical cystectomy (RC) complications.

Materials And Methods: We performed an analysis of prospectively collected data of consecutive patients 80 years of age or older who underwent RC and ureterocutaneostomy in 6 primary care European urology centers. Frailty was measured using a simplified frailty index (sFI) with a 5-item score including: (1) diabetes mellitus; (2) functional status; (3) chronic obstructive pulmonary disease; (4) congestive cardiac failure; and (5) hypertension, with a maximum 5-item score meaning high level of frailty. Within 90 days surgical complications were scored according to the Clavien Classification System (CCS). sFI ≥3 was considered as poor frailty status. Clinical and pathological variables were analyzed as predictors of severe complications (CCS ≥3).

Results: One hundred seventeen patients were enrolled. Most patients reported an sFI score of 2 and 3, respectively, 31/117 (26.5%) and 45/117 patients (38.5%). CCS ≥3 occurred in 17/117 patients (14.5%). Patients with sFI ≥3 were significantly older than patients with sFI <3 (median age, 85 years [interquartile range (IQR), 82-86] versus 82 years [IQR, 80-84]; P = .001). Most CCS ≥3 scores occurred in patients with sFI ≥3: 13 (11.1%) versus 4 (3.4%; P = .02). No significative differences were detected in terms of length of hospital stay, pathological stage, and postoperative bowel canalization when related to sFI. sFI ≥3 was an independent risk factor of CCS ≥3 in univariate and multivariate analysis (respectively, odds ratio [OR], 3.81 [95% confidence interval (CI), 1.16-12.5; P = .02] and OR, 3.1 [95% CI, 0.7-13.7; P = .01]). Body mass index, age, American Society of Anesthesiologists score ≥3, and pathological stage were not related to CCS ≥3.

Conclusion: RC appears feasible in elderly patients with an sFI <3. In cases of sFI ≥3, this choice should be carefully valued, discussed, and possibly avoided because of a higher risk of complications.
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http://dx.doi.org/10.1016/j.clgc.2019.07.002DOI Listing
October 2019

A drug safety evaluation of abiraterone acetate in the treatment of prostate cancer.

Expert Opin Drug Saf 2019 Sep;18(9):759-767

a Department of Urology, SS. Annunziata Hospital , Chieti , Italy.

: To evaluate the safety profile characteristics of abiraterone acetate (AA) in the treatment of metastatic prostate cancer (mPCa). : In this literature review the authors evaluate safety data from phase III trials investigating the combination of abiraterone acetate plus prednisone (AAP) in patients with metastatic prostate cancer. In particular, the aim was to clarify its toxicity profile, long-term exposure impact, and the correlation with general health-related quality of life (HRQoL). : Based on the studies reviewed, it appears that abiraterone acetate has favourable outcomes, is effective and well tolerated, mostly in asymptomatic or slightly symptomatic patients, and has recognised toxicity profile characteristics. Incidence of adverse events (AEs), such as mineralocorticoid- and corticosteroid-releated AEs, and hepatotoxicity is well known and widely described. Understanding the toxicity profile of AA could assist decision-making in clinical practice.
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http://dx.doi.org/10.1080/14740338.2019.1648428DOI Listing
September 2019

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

Minerva Urol Nefrol 2019 Dec 28;71(6):583-589. Epub 2019 May 28.

Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.

Background: The aim of our study is to evaluate the diagnostic accuracy of prostate-specific antigen (PSA) according to the smoking status in a cohort of European men undergoing prostate biopsy.

Methods: From 2008 onwards, we consecutively enrolled, at a single institution in Italy, men undergoing 12 core transrectal ultrasound-guided prostate needle biopsy. Demographic, clinical and histopathological data were collected. We excluded men who had PSA >30 ng/mL. Patients were classified in three groups: non-smokers, smokers and former smokers. Receiver-operator characteristics (ROC) curve analysis were used to compare predictive properties of PSA across smoking categories for the final histopathological diagnosis of prostate cancer.

Results: 872 patients were enrolled. with a median age and PSA of 67 years (IQR: 61/74) and 6.2 ng/mL (IQR: 4.4/9.7) respectively.402/872 patients (46%) were non-smokers; 151 of 872 were smokers (17%) and 319 of 872 were former smokers (36%); 374 of 872 (43%) had cancer on biopsy. PSA accuracy for smokers (AUC= 0.47, P=0.490) was lower when compared to non-smokers (AUC=0.59, P=0.003) and former smokers (AUC=0.59, P=0.005).

Conclusions: In a cohort of Italian men undergoing prostate biopsy, the performance accuracy of PSA, as a predictor of prostate cancer, is lower in smokers. Although the molecular link behind our findings is still unknown, our study firstly showed that the PSA accuracy for PCa diagnosis is significantly influential by smoking.
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http://dx.doi.org/10.23736/S0393-2249.19.03360-5DOI Listing
December 2019

Metabolic syndrome and smoking are associated with persistence of nocturia after transurethral resection of the prostate.

Neurourol Urodyn 2019 08 20;38(6):1692-1699. Epub 2019 May 20.

Department of Urology, Ospedale Sant'Andrea, Rome, Italy.

Aims: The aim of our study was to evaluate the relationship between smoking, metabolic syndrome (MetS) and persistence of nocturia in patients with moderate/severe nocturia (nocturia episodes ≥2), lower urinary tract symptoms (LUTSs), and benign prostatic enlargement (BPE) undergoing transurethral resection of the prostate (TURP).

Methods: From 2015 onward, a consecutive series of patients with moderate/severe nocturia (nocturia episodes ≥2), LUTS, and BPE undergoing TURP were prospectively enrolled. Medical history, physical examination, and smoking status were recorded. MetS was defined according to Adult Treatment Panel III. Moderate/severe persistent nocturia after TURP was defined as nocturia episodes ≥2. Binary logistic regression analysis was used to evaluate the risk of persisting nocturia.

Results: One hundred two patients were enrolled with a median age of 70 years (interquartile range: 65/73). After TURP, moderate/severe nocturia was reported in 43 of 102 (42%) of the patients. Overall 40 of 102 (39%) patients presented a MetS, and out of them, 23 of 40 (58%) presented a moderate/severe persistent nocturia after TURP ( P = .001). Overall 62 of 102 (61%) patients were smokers, and out of them, 32 of 62 (52%) presented moderate/severe persistent nocturia after TURP ( P = .034). On multivariate analysis, prostate volume, MetS, and smoking were independent risk factors for moderate/severe persistent nocturia after TURP.

Conclusion: In our single-center study, MetS and smoking increased the risk of moderate/severe persistent nocturia after TURP in patients with LUTS-BPE. Although these results should be confirmed, and the pathophysiology is yet to be completely understood, counseling smokers and MetS patients about the risk of postoperative persistent nocturia is warranted.
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http://dx.doi.org/10.1002/nau.24041DOI Listing
August 2019

Adherence to the EAU guidelines on Penile Cancer Treatment: European, multicentre, retrospective study.

J Cancer Res Clin Oncol 2019 Apr 1;145(4):921-926. Epub 2019 Mar 1.

Department of Urology, G. D'Annunzio University, Chieti, Italy.

Purpose: The European Association of Urology (EAU) guidelines for penile cancer (PC) are exclusively based on retrospective studies and have low grades of recommendation. The aim of this study was to assess the adherence to guidelines by investigating the management strategies for primary tumours and inguinal lymph nodes.

Methods: We retrospectively reviewed the clinical charts of 176 PC patients who underwent surgery in eight European centres from 2010 to 2016. The stage and grade were assessed according to the 2009 AJCC-UICC TNM classification system. To assess adherence rates, we compared theoretical and practical adherence to the EAU guidelines.

Results: Overall, 176 patients were enrolled. Partial amputation was the most frequent surgical approach (39%). 53.7% of tumours were stage Tis-T1b and the remaining 46.3% were stage T2-T4. Palpable lymph nodes were detected in 30.1% of patients and 45.1% underwent lymphadenectomy (LY). A sizeable group of tumours (43.2%) were N0. For primary treatment, adherence to the EAU guidelines was good (66%). In non-adherent cases, reasons for discrepancy were patient's choice (17%), surgeon's preference (36%), and other causes (47%). For LY, the guideline adherence was 70%, with either patient's or surgeon's choice or other causes accounting for discrepancy in 28, 20, and 52% of non-adherent cases, respectively.

Conclusion: Adherence to the EAU guidelines for PC was quite high across the eight European centres involved in the study. This notwithstanding, strategies for further improvement should be developed and evenly adopted.
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http://dx.doi.org/10.1007/s00432-019-02864-9DOI Listing
April 2019

Bipolar Plasma Enucleation of the Prostate: 5 Years Outcomes.

J Endourol 2019 05;33(5):396-399

2 Department of Urology, University "La Sapienza," Rome, Italy.

Aim of our study is to assess outcomes and safety of button bipola transurethral enucleation of the prostate (B-TUEP) in patients with lower urinary tract symptoms (LUTS) caused by benign prostatic enlargement (BPE) in a single-center cohort study. All patients with LUTS caused by BPE undergoing button B-TUEP between May 2012 and December 2013 were prospectively enrolled in our study. Data on clinical history, physical examination, urinary symptoms, erectile function, uroflowmetry, and prostate volume were collected at 0, 1, 3, 6, 12, 24, 36, 48, and 60 months. Early and long-term complications were recorded. Overall 50 patients were enrolled at baseline. Nine patients were excluded during the 5 years. All patients completed the procedure without severe complications. In terms of outcomes, improvement in International Prostate Symptom Score (IPSS) were sustained for all 5 years and mean difference from baseline at 5 years was 17 points. As well, improvements in Q (maximum urinary flow rate) were sustained for all 5 years and mean improvement at 5 years was 16 mL/second. Erectile function was slightly improved after surgery and maintained for the following 5 years. Our single-center study suggests that B-TUEP may have excellent outcomes at 5 years with no recurrence. Further multicentre studies should confirm our results.
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http://dx.doi.org/10.1089/end.2019.0050DOI Listing
May 2019

Impact of intravesical therapy for non-muscle invasive bladder cancer on the accuracy of urine cytology.

World J Urol 2019 Oct 23;37(10):2051-2058. Epub 2019 Jan 23.

Department of Urology, James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, The Johns Hopkins University School of Medicine, 600 North Wolfe Street, Park 224, Baltimore, MD, 21287, USA.

Purpose: Urine cytology remains an essential diagnostic tool in the surveillance of patients with non-muscle invasive bladder cancer (NMIBC). The correlation of urine cytology with biopsy specimens to determine its accuracy following induction intravesical therapy has not been investigated.

Methods: A retrospective review was performed of patients who underwent intravesical therapy for biopsy-proven non-muscle invasive disease between 2013 and 2016 at our institution. All patients uniformly underwent cytology and systematic bladder biopsies in the operating room within 12 weeks following intravesical therapy. The accuracy of urinary cytology in predicting high-grade disease recurrence following intravesical therapy was confirmed by correlating cytology results to post-treatment systematic biopsies, regardless of endoscopic findings. Only patients with complete information regarding urine cytology and pathologic biopsy results, both pre- and post-intravesical therapy, were included.

Results: 90 cytology samples following intravesical therapy were analyzed from 76 patients who met inclusion criteria. 72 (80.0%) and 18 (20.0%) of the samples were collected from patients initially treated for high- and low-grade disease, respectively. Fifty-six (62.2%) specimens were obtained from patients following induction of bacillus Calmette-Guerin (BCG) therapy; the remainder were from patients treated with intravesical gemcitabine/docetaxel, mitomycin, or BCG/interferon. For patients treated with BCG, cytology was positive for high-grade disease in 8/15 patients with high-grade pathology on follow-up biopsy, thus demonstrating a sensitivity of 53% (95% CI 27-79%), specificity of 95% (95% CI 84-99%), positive predictive value of 80% (95% CI 44-98%), and negative predictive value of 85% (95% CI 71-94%). If cytologic interpretation was broadened to include high-grade and "suspicious for high-grade" findings, sensitivity increased to 67% (95% CI 38-88%) and specificity decreased to 88% (95% CI 74-96%).

Conclusions: While urinary cytology maintains a high specificity following intravesical therapy, it demonstrates a low sensitivity for potentially aggressive high-grade urothelial carcinoma. Further evaluation of more effective, clinic-based enhanced cystoscopy techniques and biomarkers is warranted to better identify patients at risk for disease recurrence following BCG therapy.
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http://dx.doi.org/10.1007/s00345-018-02624-3DOI Listing
October 2019

External validation of Imamura nomogram as a tool to predict preoperatively laser semi-rigid ureterolithotripsy outcomes.

Minerva Urol Nefrol 2019 Oct 14;71(5):531-536. Epub 2018 Dec 14.

Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.

Background: We aimed to validate Imamura nomogram for prediction of stone free rate in patients undergoing ureterolithotripsy (ULT).

Methods: From January 2013 to June 2016, patients undergoing laser semi-rigid ULT were prospectively enrolled at our center. All patients were preoperatively assessed with clinical history, blood samples, uranalysis and non-contrast enhanced computed tomography (CT). Treatment efficacy was assessed 1 month later by non-contrast enhanced CT. ROC curve was used to evaluate the performance characteristics of Imamura nomogram.

Results: Overall, we enrolled 275 patients. Median age was 55 years (IQR: 46/64), median length of stone was 9.8 mm (IQR: 7.5/12). Pyuria was detected in 6/275 (2.1%) patients. Stones were located at ureteropelvic junction in 55/275 (19%) patients, proximal ureter in 74/275 (26%) patients, middle and distal ureter in 66/275 (24%) patients and 82/275 (30%) patients, respectively. At 1-month follow-up, 209/275 (76%) patients were stone free. Imamura nomogram presented an AUC of 0.67 (95% CI: 0.580-0.761) for the prediction of stone free rate. At the best cut-off value of 75%, sensitivity was 76%, specificity was 55%, positive predictive value (PPV) was 83% and negative predictive value was 45%.

Conclusions: We firstly validated Imamura nomogram in a European cohort study. It proved a reasonable accuracy (area under curve: 0.67) and a good PPV (83%). Further studies should confirm our results to support the routine clinical use of Imamura nomogram as a tool to predict ULT outcomes.
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http://dx.doi.org/10.23736/S0393-2249.18.03243-5DOI Listing
October 2019

Urotensin II receptor expression in prostate cancer patients: A new possible marker.

Prostate 2019 02 8;79(3):288-294. Epub 2018 Nov 8.

Nuova Villa Claudia, Rome, Italy.

Background: Urotensin II receptor has been poorly studied in prostate cancer. To evaluate the expression of urotensin II receptor (UII-R) in patients undergoing radical prostatectomy.

Methods: Overall, we identified 140 patients treated with retropubic radical prostatectomy (RP) in one center. UII-R was evaluated in prostate biopsies with immunohistochemical staining, resulting in a granular cytoplasmic positivity, through automated system using the kit Urotensin II Receptor Detection System provided by Pharmabullet srl. Immunostained slides were independently and blindly evaluated by ten uro-pathologists. To evaluate UTII-R expression three different parameters were considered: localization, granules dimensions and intensity of expression. A score from 0 to 3 was applied to each parameter to obtain a score from 0 to 9. Each parameter and the total score were evaluated as predictors of high grade disease on surgical pathology and of advanced stage disease. Accuracy of total score for the prediction of upgrading and upstaging was analyzed using receiver operator characteristics curve and decision curve analysis (DCA).

Results: On radical prostatectomy 92/140 (66%) presented high grade disease on surgical pathology. Patients with high grade disease presented an apical distribution of the receptor, larger granules and a more intense expression when compared to patients with low grade disease. A well they presented a higher total score. Subscores and total scores were found to be predictors of upgrading and upstaging. On ROC analysis total score presented an AUC of 0.72 and 0.70, respectively, for the prediction of upgrading and upstaging. On DCA total score showed a clinical benefit in the prediction of adverse pathological outcomes.

Conclusion: Urotensin II receptor is a potential marker of adverse pathological outcomes. Further studies should confirm our data and evaluate its role as a prognostic marker.
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http://dx.doi.org/10.1002/pros.23734DOI Listing
February 2019

Adherence to EAU guidelines on penile cancer translates into better outcomes: a multicenter international study.

World J Urol 2019 Aug 30;37(8):1649-1657. Epub 2018 Oct 30.

Department of Urology, "G.D'Annunzio" University, Chieti, Italy.

Introduction: We aimed to evaluate adherence to the EAU guidelines (GL) on penile cancer (PC) with regard to primary surgical treatment and management of lymph nodes and to estimate the influence of adherence to GL on clinical outcome.

Materials And Methods: This is a retrospective multicenter study (PEnile Cancer ADherence study, PECAD Study) on PC patients treated at 12 European and American centers between 2010 and 2016. Adherence to the EAU GL on the surgical management of the primary penile tumor and lymphadenectomy was evaluated. Descriptive analyses were performed, and survival curves were estimated.

Results: Data on 425 patients were considered for the analysis. The EAU GL on surgical treatment of the primary tumor and lymphadenectomy were respected in 74.8% and 73.7% of cases, respectively. Survival analysis showed that adherence to the GL on primary penile surgery was significantly associated with a good overall survival [adjusted HR 0.40 (95% CI 0.20-0.83, p value = 0.014)]. Also, the adherence to the GL on lymphadenectomy was statistically significantly associated with overall survival [adjusted HR 0.48 (95% CI 0.24-0.96, p value = 0.038)]. Limited follow-up and retrospective design represent limitations of this study.

Conclusions: Our findings suggest that there is a good adherence to the EAU GL on PC. However, this should be further reinforced, endorsed and encouraged as it might translate into better clinical outcomes for PC patients.
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http://dx.doi.org/10.1007/s00345-018-2549-3DOI Listing
August 2019

Mobile phone apps for the prediction of prostate cancer: External validation of the Coral and Rotterdam apps.

Eur J Surg Oncol 2019 03 16;45(3):471-476. Epub 2018 Oct 16.

Department of Urology, Ospedale Sant' Andrea, Rome, Italy. Electronic address:

Objective: To analyze the performance of two mobile phone apps-the Rotterdam prostate cancer risk app and the Coral app-in a cohort of patients undergoing prostate biopsies.

Methods: A consecutive series of men undergoing prostate biopsies were enrolled in two centers. Indications for prostate biopsy included abnormal prostate-specific antigen levels (PSA >4 ng/mL) and/or an abnormal digital rectal examination (DRE). Prostate cancer risk and high-grade prostate cancer risk were assessed using the Rotterdam prostate cancer risk app (iOS) and the Coral app (iOS). The usability of the apps was also assessed and compared using the Post-Study System Usability Questionnaire (PSSUQ) developed by IBM.

Results: Overall, 1682 patients with a median age of 68 (62-73) years were enrolled. The Rotterdam app outperformed the Coral app in the prediction of prostate cancer (AUC: 0.70 versus 0.631, p = 0.001) and of high-grade prostate cancer (0.75 versus 0.69, p = 0.001) (Fig. 1). PSSUQ data revealed that both Rotterdam and Coral applications were comparable in terms of usefulness (87% versus 83%, p = 0.708), information quality (74% versus 72%, p = 0.349), interface quality (79% versus 74%, p = 0.216) and satisfaction (76% versus 76%, p = 0.935), respectively. In terms of preferences, 26/50 (54%) preferred the Rotterdam app, while 24/50 (46%) preferred the Coral app.

Conclusion: In our experience the Rotterdam App outperformed the Coral App for the prediction of prostate cancer or high-grade cancer diagnosis. In particular we confirmed, using the Rotterdam app, that only one out of ten patients with a low Rotterdam score will harbor high-grade prostate cancer on biopsy.
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http://dx.doi.org/10.1016/j.ejso.2018.09.018DOI Listing
March 2019

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

Minerva Urol Nefrol 2018 Dec 19;70(6):598-605. Epub 2018 Sep 19.

Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.

Background: The aim of our study is to explore the association between cigarette smoking and the risk of prostate cancer (PCa) diagnosis as well as high grade disease in men undergoing prostate biopsies.

Methods: From 2008 to 2016, we prospectively enrolled a consecutive series of men with no history of PCa undergoing prostate biopsies. Variables assessed the day of the biopsy included: Family history of PCa, age, body mass index (BMI), comorbidities, digital rectal examination (DRE), prostate volume, PSA, free PSA, smoking status, number of cigarette/day, smoking time, smoking starting age and smoking cessation. Smoking variables were evaluated as predictors of PCa and high grade PCa (Prognostic Grade Group ≥3) using adjusted logistic regression analyses.

Results: Overall 1080 patients were enrolled, out of them 499/1080/753 (46%) had never smoked; 168/1080/753 (16%) were smokers and 413/1080 (38%) were former smokers. Out of the 451/1080 (41%) patients with PCa 175/451 (39%) presented high grade disease. As expected family history, age, dyslipidemia, PSA, digital rectal examination and prostate volume were independent predictors of PCa. As well age, DRE, and PSA were independent predictors of high-grade disease. Smoking status (OR=0.983; CI: 0.689-1.402) and the associated variables were not independent predictors of PCa or high grade PCa (OR: 1.250; CI: 0.593-1.327).

Conclusions: In our cross-sectional study, smoking is not predictive of PCa or high-grade disease. Further studies should evaluate if smoking could influence PCa diagnosis and aggressiveness.
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http://dx.doi.org/10.23736/S0393-2249.18.03182-XDOI Listing
December 2018

Bipolar plasma enucleation of the prostate vs. open prostatectomy in large benign prostatic hyperplasia: a single centre 3-year comparison.

Prostate Cancer Prostatic Dis 2019 03 21;22(1):110-116. Epub 2018 Aug 21.

Nuova Villa Claudia, Rome, Italy.

Backround: Aim of our study is to compare the surgery outcomes and safety of button bipolar enucleation of the prostate vs. open prostatectomy in patients with large prostates (> 80 g) in a single-centre cohort study.

Materials And Methods: All patients with lower urinary tract symptoms due to benign prostatic enlargement undergoing button bipolar enucleation of the prostate (B-TUEP) or open prostatectomy (OP) between May 2012 and December 2013 were enroled in our study. Data on clinical history, physical examination, urinary symptoms, erectile function, uroflowmetry and prostate volume were collected at 0, 1, 3, 6, 12, 24 and 36 months. Early and long-term complications were recorded.

Results: Overall, 240 patients were enroled. Out of them 111 patients (46%) performed an OP and 129 patients (54%) performed a B-TUEP. In terms of efficacy, both procedures showed durable results at three years with a reintervention rate of 7.5% in the OP group and 5% in the B-TUEP group. In terms of safety, B-TUEP presented less high-grade complications when compared with OP.

Conclusions: In our single-centre study, B-TUEP represents a valid alternative to OP with excellent outcomes at three years. Further multicentre studies should confirm our results.
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http://dx.doi.org/10.1038/s41391-018-0080-7DOI Listing
March 2019