Publications by authors named "Sergio Serni"

193 Publications

The feasibility of multimodal fiber optic spectroscopy analysis in bladder cancer detection, grading, and staging.

Urologia 2021 Mar 31:3915603211007018. Epub 2021 Mar 31.

Unit of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, Careggi University Hospital, Florence, Italy.

Objective: To prove the feasibility of Multimodal Fiber Optic Spectroscopy (MFOS) analysis in bladder cancer (BCa) detection, grading, and staging.

Materials And Methods: Bladder specimens from patients underwent TURBT or TURP were recorded and analyzed with MFOS within 30 min from excision. In detail, our MFOS combined fluorescence, Raman spectroscopy, and diffuse reflectance. We used these optical techniques to collect spectra from bladder biopsies, then we compared the obtained results to gold standard pathological analysis. Finally, we developed a classification algorithm based on principal component analysis-linear discriminant analysis.

Results: A total of 169 specimens were collected and analyzed from 114 patients, 40 (23.7%) healthy (from TURP), and 129 (76.3%) with BCa. BCa specimens were divided according to their grade-34 (26.4%) low grade (LG) and 95 (73.6%) high grade (HG) BCa-and stage-64 (49.6%) Ta, 45 (34.9%) T1, and 20 (15.5%) T2. MFOS-based classification algorithm correctly discriminated healthy versus BCa with 90% accuracy, HG versus LG with 83% accuracy. Furthermore, it assessed tumor stage with 75% accuracy for Ta versus T1, 85% for T1 versus T2, and 86% for Ta versus T2.

Conclusions: Our preliminary results suggest that MFOS could be a reliable, fast, and label-free tool for BCa assessment, providing also grading and staging information. This technique could be applied in future for in vivo inspection as well as of ex vivo tissue biopsies. Thus, MFOS might improve urothelial cancer management. Further studies are required.
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http://dx.doi.org/10.1177/03915603211007018DOI Listing
March 2021

L'Essentiel est Invisible pour les Yeux: The Art of Decision-making and The Mission of Patient-centred Care for Patients with Localised Renal Masses.

Eur Urol 2021 Mar 1. Epub 2021 Mar 1.

Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy; Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

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http://dx.doi.org/10.1016/j.eururo.2021.02.027DOI Listing
March 2021

Advance Xp® Male Sling can be an Effective and Safe Treatment for Post-Prostatectomy Stress Urinary Incontinence Also in Patients with Prior History of External Beam Radiation Therapy: A Multicentric Experience.

Surg Innov 2021 Feb 18:1553350621995042. Epub 2021 Feb 18.

Chirurgia Urologica Robotica Mininvasiva e dei Trapianti Renali, Azienda Ospedaliero-Universitaria Careggi, Università di Firenze, Italy.

Post-prostatectomy stress urinary incontinence (PPSUI) is one of the major complaints after radical prostatectomy. Transoburator male sling (TMS) placement is indicated in persistent mild to moderate PPSUI. External beam radiation therapy (EBRT) might be a negative prognostic factor for TMS outcomes. Study objective was to analyze EBRT impact on TMS outcome. We retrospectively investigated patients submitted to TMS for PPSUI, with or without previous EBRT, in two tertiary referral centers since 2010. Objective outcome was measured through ICIQ-SF, 1-hour pad test, and pad per die and subjective improvement through PGI-I. Patients were divided according to EBRT to make in-group and between-group comparisons. Patients were 56, 18 (32.1%) had previous EBRT. Median follow-up was 43.0 months (IQR: 22.3-64.0). TMS was placed at mean 18.8 months (SD 4.6) after EBRT. TMS determined a statistically significant reduction of pads, 1-hour pad test, and ICIQ-SF score (<.05). Improvement diminished during long-term follow-up. At last follow-up, 12 patients (21.4%) used 1 safety pad, while 15 (26.8%) used 0 pads. Median PGI-I was 2 (IQR 2-3). Recorded complications were 9 (16.1%) and none exceeded Clavien-Dindo grade 2. There were no differences in outcomes, failures, and complications between groups. TMS failures were 6 (10.7%), 2 of whom in the EBRT group. Four of them (7.1%) subsequently placed an artificial urinary sphincter (AUS). . Advance XP© placement seems effective and safe in well-selected patients complaining with PPSUI, even after EBRT. Surgical outcomes slightly deteriorate over time. Further studies are needed in these patients to assess TMS efficacy.
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http://dx.doi.org/10.1177/1553350621995042DOI Listing
February 2021

Robot-Assisted Laparoscopic Living Donor Nephrectomy: The University of Florence Technique.

Front Surg 2020 15;7:588215. Epub 2021 Jan 15.

Unit of Urological Robotic Surgery and Renal Transplantation, Careggi Hospital, University of Florence, Florence, Italy.

To provide a step-by-step overview of the University of Florence technique for robotic living donor nephrectomy (LDN), focusing on its technical nuances and perioperative outcomes. A dedicated robotic LDN program at our Institution was codified in 2012. Data from patients undergoing robotic LDN from 2012 to 2019 were prospectively collected. All robotic LDNs were performed by a highly experienced surgeon, using the da Vinci Si robotic platform in a three-arm configuration. In this report we provide a detailed overview of our surgical technique for robotic LDN. The main objective of the study was to evaluate the technical feasibility and safety of the technique, including perioperative surgical complications rate and mid-term functional outcomes. Overall, 36 patients undergoing robotic LDNs were included in the study. Of these, 28 (78%) were left LDNs. Median (IQR) donor pre-operative eGFR was 88 (75.6-90) ml/min/1.73 m. In all cases, robotic LDN was completed without need of conversion. The median (IQR) overall operative time was 230 (195-258) min, while the median console time was 133 (IQR 117-166) min. The median (IQR) warm ischemia time was 175 (140-255) s. No intraoperative adverse events or 90-d major surgical complications were recorded. At a median (IQR) follow-up of 24 months (IQR 11-46), median (IQR) eGFR patients undergoing in living donor nephrectomy was 57.4 (47.9; 63.9) ml/min/1.73 m. In our experience, robotic LDN is technically feasible and safe. The use of robotic surgery for LDN may provide distinct advantages for surgeons while ensuring optimal donors' perioperative and functional outcomes.
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http://dx.doi.org/10.3389/fsurg.2020.588215DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7844329PMC
January 2021

The Investigative Role of Statins in Ameliorating Lower Urinary Tract Symptoms (LUTS): A Systematic Review.

J Clin Med 2021 Jan 22;10(3). Epub 2021 Jan 22.

Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, 50100 Florence, Italy.

Previous data have shown that patients with metabolic syndrome (MetS) and lower urinary tract symptoms (LUTS) secondary to benign prostatic enlargement (BPE) could be refractory to the medical treatment. In this context, the evidence suggests a role for statin use in LUTS/BPE patients. The present systematic review aimed to evaluate the impact of statins on the treatment of men with LUTS/BPE. This review has been registered on PROSPERO (CRD42019120729). A systematic review of English-language literature was performed up to January 2020 in accordance with the preferred reporting items for systematic reviews and meta-analyses (PRISMA statement) criteria. Retrieved studies had to include adults with LUTS connected to BPE treated with statins drugs for metabolic syndrome. After removing duplicates, a total of 381 studies were identified by the literature search and independently screened. Of these articles, 10 fit the inclusion criteria and were further assessed for eligibility. Data from our systematic review suggest that a long-term therapy with statins, at least 6 months, is required to achieve significant impacts on prostate tissue and LUTS. Moreover, besides statins' direct activity, the risk reduction of LUTS might be connected to the improvement of hypercholesterolemia and MetS. The role of statins for the treatment of LUTS/BPE may be beneficial; however, evidence from robust studies is not enough, and more clinical trial are required.
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http://dx.doi.org/10.3390/jcm10030416DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7865704PMC
January 2021

Contrast-enhanced ultrasound (CEUS) imaging for active surveillance of small renal masses.

World J Urol 2021 Jan 22. Epub 2021 Jan 22.

Department of Urological Robotic Surgery and Renal Transplantation, Careggi Hospital, University of Florence, Florence, Italy.

Purpose: To assess the safety and efficacy of contrast-enhanced ultrasound (CEUS) imaging for monitoring small (< 4 cm) renal masses (SRM) in patients undergoing active surveillance (AS).

Methods: We retrospectively selected all consecutive patients with SRMs who underwent AS for at least 6 months at our Institution between January 2014 and December 2018. CEUS imaging was performed by two experienced genitourinary radiologists at established time points. The accuracy of CEUS for monitoring SRM size was compared with that of CT scan. For solid SRMs, four enhancement patterns (EP) were recorded. Radiological progression was defined as SRM growth rate ≥ 5 mm/year.

Results: Overall, 158/1049 (15.1%) patients with SRMs underwent AS. At a median follow-up of 25 months (IQR 13-39), no patient died due to renal cell carcinoma (RCC). No patients experienced CEUS-related adverse events. There was a large variability in the pattern of growth of SRMs (overall median growth rate: 0.40 mm/year), with 9.5% of SRMs showing radiological progression. The median SRM size was comparable between CEUS and CT scan examinations at all time points. The vast majority (92.7%) of SRMs did not show a change in their EP over time; and there was no association between the SRM's EP and radiological progression or SRM size. Overall, 43 (27.2%) patients underwent delayed intervention (DI); median SRM size, and median growth rate were significantly higher in these patients as compared to those continuing AS.

Conclusion: In experienced hands, CEUS is a safe and effective strategy for active monitoring of SRMs in well-selected patients undergoing AS.
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http://dx.doi.org/10.1007/s00345-021-03589-6DOI Listing
January 2021

Protocol of the Italian Radical Cystectomy Registry (RIC): a non-randomized, 24-month, multicenter study comparing robotic-assisted, laparoscopic, and open surgery for radical cystectomy in bladder cancer.

BMC Cancer 2021 Jan 11;21(1):51. Epub 2021 Jan 11.

Department of Urology, Policlinico Abano Terme, Abano Terme, PD, Italy.

Background: Bladder cancer is the ninth most common type of cancer worldwide. In the past, radical cystectomy via open surgery has been considered the gold-standard treatment for muscle invasive bladder cancer. However, in recent years there has been a progressive increase in the use of robot-assisted laparoscopic radical cystectomy. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence.

Methods: We describe a protocol for an observational, prospective, multicenter, cohort study to assess patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion. The Italian Radical Cystectomy Registry is an electronic registry to prospectively collect the data of patients undergoing radical cystectomy conducted with any technique (open, laparoscopic, robotic-assisted). Twenty-eight urology departments across Italy will provide data for the study, with the recruitment phase between 1st January 2017-31st October 2020. Information is collected from the patients at the moment of surgical intervention and during follow-up (3, 6, 12, and 24 months after radical cystectomy). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerve sparing and lymphadenectomy. Follow-up data collection includes histological information (e.g., post-op staging, grading, and tumor histology), short- and long-term outcomes (e.g., mortality, post-op complications, hospital readmission, sexual potency, continence etc).

Discussion: The current protocol aims to contribute additional data to the field concerning the short- and long-term outcomes of three different radical cystectomy surgical techniques for patients with bladder cancer, including open, laparoscopic, and robot-assisted. This is a comparative-effectiveness trial that takes into account a complex range of factors and decision making by both physicians and patients that affect their choice of surgical technique.

Trial Registration: ClinicalTrials.gov , NCT04228198 . Registered 14th January 2020- Retrospectively registered.
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http://dx.doi.org/10.1186/s12885-020-07748-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802145PMC
January 2021

SECRET - SExual Chronicle REcording Table: Validation and reliability.

Andrology 2020 Dec 4. Epub 2020 Dec 4.

Department of Experimental and Clinical Medicine, University of Florence - Unit of Urological Minimally Invasive Robotic Surgery and Renal Transplantation, Careggi Hospital, Florence, Italy.

Background: Recording the entire sexual history of a patient from the very first sexual experiences to the current sexual habits is a challenging issue that physicians usually address with partial and non-standardized interviews.

Objectives: To validate the SExual Chronicle REcording Table (SECRET ), a structured written interview, developed and copyrighted both in English and Italian languages.

Materials And Methods: A multicenter national validation study was performed asking 300 male patients affected by uro-andrological diseases to complete SECRET . The structured interview is based on four sexual dimensions (masturbation, oral, vaginal and anal sex), declined in seven items (1.Have you ever performed/Do you perform; 2.At what age did you first experience; 3.How many times a month; 4.With how many partners; 5.How much did/do you enjoy; 6.How many times did/do you use a condom; 7.How many times did/do you use the pull-out method). Data were stratified according to four stages of life (<30; 30-45; 45-60; >60 years old). Validity and reliability were assessed by using standard statistical methods for SECRET validation.

Results: Overall, 295 patients (98.4%) filled all the questions. SECRET showed a high level of internal coherence (Cronbach's alpha coefficient ranged from 0.85 to 0.97) and reproducibility (paired sample t-test at Test-Retest: p > .10).

Conclusions: SECRET represents a novel, simple instrument to record a patient's sexual history in daily clinical practice and clinical research. SECRET has shown a good validity, internal consistence and reliability in different clusters of patients with uro-andrological diseases.
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http://dx.doi.org/10.1111/andr.12955DOI Listing
December 2020

The University of Florence Technique for Robot-Assisted Kidney Transplantation: 3-Year Experience.

Front Surg 2020 11;7:583798. Epub 2020 Nov 11.

Unit of Urological Robotic Surgery and Renal Transplantation, Careggi Hospital, University of Florence, Florence, Italy.

To report the University of Florence technique for robot-assisted kidney transplantation (RAKT) from living donor (LD) and deceased donor (DD), highlighting the evolution of surgical indications and technical nuances in light of a single surgeon's learning curve. A dedicated program for RAKT from LDs was developed at our Institution in 2017 and implemented later with a specific framework for DDs. All RAKTs were performed by a single highly experienced surgeon. Data from patients undergoing RAKT between January 2017 and December 2019 were prospectively collected in a dedicated web-based data platform. In this report we provide a comprehensive step-by-step overview of our technique for RAKT, focusing on the potential differences in peri-operative and mid-term functional outcomes between LDs vs. DDs. Overall, 160 KTs were performed in our center during the study period. Of these, 39 (24%) were performed with a robot-assisted laparoscopic technique, both from LDs ( = 18/39 [46%]) and from DDs ( = 21/39 [54%]). Eleven (11/39 [18%]), 13(13/39 [26%]), and 15 (15/39 [30%]) RAKTs were performed in 2017, 2018, and 2019, respectively, highlighting an increasing adoption of robotics for KT over time at our Institution. Median time for arterial (19 min for LD and 18 min for DD groups), venous (21 min for LD, 20 min for DD) and uretero-vesical (18 min for LD and 15 for DD) anastomosis were comparable between the two groups (all > 0.05), as the median rewarming time (59 min vs. 56 min, = 0.4). The rate of postoperative surgical complications according to Clavien-Dindo classification did not differ between the two study groups, except for Clavien-Dindo grade II complications (higher among patients undergoing RAKT from DDs, 76 vs. 44%, = 0.042). Overall, 7/39 (18%) patients (all recipients from DDs) experienced DGF; two of them were on dialysis at last FU. Our experience confirms the feasibility, safety, and favorable mid-term outcomes of RAKT from both LDs and DDs in appropriately selected recipients, highlighting the opportunity to tailor the technique to specific recipient- and/or graft-characteristics. Further research is needed to refine the technique for RAKT and to evaluate the benefits and harms of robotics for kidney transplantation from DDs.
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http://dx.doi.org/10.3389/fsurg.2020.583798DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7686135PMC
November 2020

"Letter to the Editor" with regard to the manuscript: A comparison of two intravesical bladder instillations for interstitial cystitis/Bladder Pain Syndrome (doi.org/10.1016/j.ejogrb.2020.10.060).

Eur J Obstet Gynecol Reprod Biol 2021 01 17;256:510-511. Epub 2020 Nov 17.

Department of Urological Robotic Surgery and Renal Transplantation, Careggi University Hospital, University of Florence, Florence, Italy.

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http://dx.doi.org/10.1016/j.ejogrb.2020.11.029DOI Listing
January 2021

Outcomes of combination therapy with daily Tadalafil 5mg plus Tamsulosin 0.4mg to treat lower urinary tract symptoms and erectile dysfunction in men with or without metabolic syndrome.

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

Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Careggi Hospital, Florence, Italy.

Background: To assess the impact of Tadalafil 5mg/die plus Tamsulosin 0.4mg/die combination therapy on LUTS and ED, according to presence vs. absence of Mets.

Methods: 75 consecutive men presenting with ED and LUTS were enrolled. Patients were divided into two groups according to MetS presence. All subjects were treated with combination therapy for 12 weeks. Patients were re-evaluated after treatment with Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5.

Results: After enrollment, 50 patients were included: 31(62.0%) with MetS and 19(38.0%) without MetS. At baseline, patients without MetS showed a significantly better IPSS, IIEF and OAB-q, as compared to those with MetS. After 12 weeks of combination therapy LUTS, ED and flowmetry significantly improved in both groups(p<0.001). The improvement after 12 weeks was similar between groups in all parameters(p>0.05), except for ΔOAB-q that was significantly better for patients with MetS(p=0.028). Nevertheless, total IPSS, all IPSS subscores and OAB-q were significantly better at 12 weeks in men without MetS(p<0.05). Despite IIEF-5 was significantly different at baseline, after 12 weeks of combination therapy, erectile function was similar in men with or without METS:16.3±3.8 vs 7.7±4.7(p=0.238). No serious AE was reported and complications were comparable between groups(p>0.05).

Conclusions: Patients with MetS have worse LUTS and ED profiles. However, tadalafil plus tamsulosin combination treatment provided them a similar ED profile and a greater relief of OAB symptoms at the end of the trial. Combination therapy had the same safety profile in men besides MetS. Further randomized controlled trials are needed.
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http://dx.doi.org/10.23736/S0393-2249.20.04099-0DOI 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

The waiting time for prostate cancer treatment in Italy: analysis from the Pros-IT CNR study.

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

National Research Council (CNR), Neuroscience Institute, Aging Branch, Padua, Italy.

Background: Prostate cancer (PCa) is the second most common neoplasm in male patients. To date, there's no certain indication about the maximum waiting time (WT) acceptable for treatment beginning and the impact on oncological and functional outcomes has not been well established.

Methods: Data from the National Research Council PCa monitoring multicenter project in Italy (Pros-IT CNR) were prospectively collected and analyzed. WT was defined as the time from the bioptical diagnosis of PCa to the first treatment received. Patients were divided in two groups, using a time frame of 90 days. Quality of life was measured through the Italian version of the University of California Los Angeles-Prostate Cancer Index (UCLA-PCI) and of the Short-Form Health Survey (SF-12). The occurrence of upgrading, upstaging, presence of lymph node metastasis and positive surgical margins at the final histopathological diagnosis, and PSA at 12 months follow-up were evaluated.

Results: The overall median WT was 93 days. The logistic multivariable model confirmed that age, being resident in Southern regions of Italy and T staging at diagnosis were significantly associated with a WT >90 days. At 6 months from diagnosis the mean SF-12 score for the emotionalpsychological component was significantly lower in WT ≥ 90 days group (p=0.0428). Among patients treated with surgical approach, no significant differences in oncological outcomes were found in the two groups.

Conclusions: In our study age, clinical T stage and provenance from Southern regions of Italy are associated with a WT > 90 days. WT might have no impact on functional and oncological outcome.
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http://dx.doi.org/10.23736/S0393-2249.20.03925-9DOI Listing
November 2020

Intra-peritoneal versus retropubic implantation of three-piece inflatable penile prosthesis: Patient-reported outcomes and complications.

Urologia 2020 Oct 23:391560320967876. Epub 2020 Oct 23.

Department of Urology, Careggi Hospital, University of Florence, Florence, Italy.

Introduction: The role of reservoir position was investigated in this series of patients treated with three-pieces penile prosthesis implantation (PPI). The outcomes and the patients' reported quality of life after insertion of the balloon in the retropubic space, or the Retzius's space (SOR), were compared with the outcomes of patients who received an intraperitoneal implantation (IP). The study aimed to analyze how the anatomy of the SOR influenced the long-term results of PPI, especially in patients who have been previously exposed to pelvic surgery or radiotherapy. The SOR has usually been identified as ideal for concealing and protecting the reservoir; nevertheless, an increasing rate of patients that ask for a PPI do not conserve the typical favorable characteristic of the SOR. In these cases, the tissue alteration can cause a higher rate of undesired events and can impair the satisfaction from device use. In the recent literature, few articles focus on the topic of reservoir position and very poor information is available about the results of the IP insertion.

Materials: Our cohort of patients was retrospectively inspected; the two different subgroups, according to the reservoir position (SOR or IP) were evaluated considering the pre-operative condition, the post-operative complication, the development of undesired events or uncomfortable sensations during the follow-up. The quality of life after PPI was observed as well, with a questionnaire specifically developed for patients treated with PPI. The surgical technique adopted for the intraperitoneal implantation was described.

Results: The results of penile prosthesis functionality and patients' and partners' reported quality of life (QoL) showed similar results between the two groups but greater satisfaction in the relational domain of the questionnaires adopted was described in the IP subgroup.

Conclusion: According to our observations, the IP reservoir insertion guarantees good functionality and lower rates of undesired events after PPI.
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http://dx.doi.org/10.1177/0391560320967876DOI Listing
October 2020

Deferring Elective Urologic Surgery During the COVID-19 Pandemic: The Patients' Perspective.

Urology 2021 01 24;147:21-26. Epub 2020 Sep 24.

Department of Urology, Careggi Hospital, University of Florence, Florence, Italy; Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

Objectives: To explore the perspective of urological patients on the possibility to defer elective surgery due to the fear of contracting COVID-19.

Methods: All patients scheduled for elective urological procedures for malignant or benign diseases at 2 high-volume centers were administered a questionnaire, through structured telephone interviews, between April 24 and 27, 2020. The questionnaire included 3 questions: (1) In light of the COVID-19 pandemic, would you defer the planned surgical intervention? (2) If yes, when would you be willing to undergo surgery? (3) What do you consider potentially more harmful for your health: the risk of contracting COVID-19 during hospitalization or the potential consequences of delaying surgical treatment?

Results: Overall, 332 patients were included (51.5% and 48.5% in the oncology and benign groups, respectively). Of these, 47.9% patients would have deferred the planned intervention (33.3% vs 63.4%; P < .001), while the proportion of patients who would have preferred to delay surgery for more than 6 months was comparable between the groups (87% vs 80%). These answers were influenced by patient age and American Society of Anesthesiologists score (in the Oncology group) and by the underlying urological condition (in the benign group). Finally, 182 (54.8%) patients considered the risk of COVID-19 potentially more harmful than the risk of delaying surgery (37% vs 73%; P < .001). This answer was driven by patient age and the underlying disease in both groups.

Conclusions: Our findings reinforce the importance of shared decision-making before urological surgery, leveraging patients' values and expectations to refine the paradigm of evidence-based medicine during the COVID-19 pandemic and beyond.
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http://dx.doi.org/10.1016/j.urology.2020.09.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7513799PMC
January 2021

Quantitative Polymerase Chain Reaction Detection of Microchimerism in Female Transplant Renal Recipients.

Urol Int 2020 21;104(11-12):865-870. Epub 2020 Sep 21.

Molecular and Clinical Biochemistry Unit, Department of Experimental and Clinical Biomedical Sciences "Mario Serio," Careggi Hospital, University of Florence, Florence, Italy.

Introduction: Microchimerism (MC) is the presence of a small amount of foreign cells or DNA within a person's circulation or tissues. It has been identified also in recipients of solid organ transplants where it seems to be critical for the development and maintenance of immunological tolerance. Nevertheless, natural and/or iatrogenic MC can be acquired prior to transplantation, through pregnancy and/or blood transfusion.

Objective: The aim of this study was to detect the presence of MC in women after renal transplantation from male cadaveric donors and its relationship with graft outcomes.

Methods: We studied by qPCR the presence of the DYS14 gene sequence of the Y chromosome in 12 females who received a kidney graft from a male donor before transplantation (T0), after 15 days (T1) and 1 year of transplantation (T2). We found the sequence in all recipients after renal transplantation.

Results: All the women were negative for this sequence prior to transplantation (T0). Mean (SD) Y-related DNA quantity was 0.80 (0.69) ng/mL plasma and 0.15 (0.26) ng/mL plasma at T1 and T2, respectively. No acute rejection was observed, and mean (SD) estimated Cr clearance was 68.8 (16.9) mL/min within 1 year from transplantation.

Conclusions: Presence of MC was associated with good kidney graft outcomes after 1 year of transplantation, but further studies will be needed to investigate the relationship between clinical outcomes and the development of MC in renal transplant recipient.
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http://dx.doi.org/10.1159/000508796DOI Listing
September 2020

Robot-assisted kidney transplantation: update from the European Robotic Urology Section (ERUS) series.

BJU Int 2021 02 29;127(2):222-228. Epub 2020 Sep 29.

Department of Urology, Hospital Clinic de Barcelona Instituto Clínic de Nefrología y Urología, Barcelona, Spain.

Objective: To report the results of the robot-assisted kidney transplantation (RAKT) experience performed in 10 European centres by members of the European Robotic Urology Section (ERUS)-RAKT group.

Patients And Methods: This is a multicentre prospective observational study of RAKT. Descriptive analysis of recipients and donor characteristics, surgical data, intraoperative outcomes, complications rate and functional results were collected and analysed.

Results: Between July 2015 and September 2019, 291 living-donor RAKTs were performed. Recipients were mostly male (189 [65%]), the mean Standard deviation (sd) age was 45.2 (13.35) years, the mean (sd) body mass index was 27.13 (19.28) kg/m , and RAKT was pre-emptive in 155 (53.8%) cases. Right and multiple arteries kidneys were used in 15.4%. The mean (sd) total surgical and re-warming time was 244 (70.5) min and 53.16 (15.27) min, respectively. In all, 17 patients presented with postoperative bleeding (5.7%). Five kidneys had delayed graft function; five (2%) were lost due to thrombosis and one due to acute rejection. Two patients had arterial stenosis, three had incisional hernias, six had ureteric stenosis, and nine had lymphoceles. Neither surgical nor re-warming times were correlated with postoperative serum creatinine levels (P > 0.05). Comparison of surgical data between the first 120 cases and the following 171 cases showed a significantly shorter total surgical time in the second group (265 vs 230 min, P = 0.005).

Conclusions: This is the largest European multicentre study of RAKT with good surgical and functional results competitive with open kidney transplant series, with a relatively short learning curve when performed in centres with a wide experience in open kidney transplantation and robotic surgery.
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http://dx.doi.org/10.1111/bju.15199DOI Listing
February 2021

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

How radical prostatectomy procedures have changed over the last 10 years in Italy: a comparative analysis based on more than 1500 patients participating in the MIRROR-SIU/LUNA and the Pros-IT CNR study.

World J Urol 2020 Aug 1. Epub 2020 Aug 1.

Aging Branch, National Research Council (CNR), Neuroscience Institute, Padua, Italy.

Purpose: Therapeutic strategies for prostate cancer (PCa) have been evolving dramatically worldwide. The current article reports on the evolution of surgical management strategies for PCa in Italy.

Methods: The data from two independent Italian multicenter projects, the MIRROR-SIU/LUNA (started in 2007, holding data of 890 patients) and the Pros-IT-CNR project (started in 2014, with data of 692 patients), were compared. Differences in patients' characteristics were evaluated. Multivariable logistic regression models were used to identify characteristics associated with robot-assisted (RA) procedure, nerve sparing (NS) approach, and lymph node dissection (LND).

Results: The two cohorts did not differ in terms of age and prostate-specific antigen (PSA) levels at biopsy. Patients enrolled in the Pros-IT-CNR project more frequently were submitted to RA (58.8% vs 27.6%, p < 0.001) and NS prostatectomy (58.4% vs. 52.9%, p = 0.04), but received LND less frequently (47.7% vs. 76.7%, p < 0.001), as compared to the MIRROR-SIU/LUNA patients. At multivariate logistic models, Lower Gleason Scores (GS) and PSA levels were significantly associated with RA prostatectomy in both cohorts. As for the MIRROR-SIU/LUNA data, clinical T-stage was a predictor for NS (OR = 0.07 for T3, T4) and LND (OR = 2.41 for T2) procedures. As for Pros-IT CNR data, GS ≥ (4 + 3) and positive cancer cores ≥ 50% were decisive factors both for NS (OR 0.29 and 0.30) and LND (OR 7.53 and 2.31) strategies.

Conclusions: PCa management has changed over the last decade in Italian centers: RA and NS procedures without LND have become the methods of choice to treat newly medium-high risk diagnosed PCa.
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http://dx.doi.org/10.1007/s00345-020-03350-5DOI Listing
August 2020

Triggers for delayed intervention in patients with small renal masses undergoing active surveillance: a systematic review.

Minerva Urol Nefrol 2020 Aug;72(4):389-407

European Society of Residents in Urology (ESRU), Arnhem, the Netherlands.

Introduction: Patients with small renal masses (SRM) can be exposed to overdiagnosis and overtreatment. As such, active surveillance (AS) is recommended by all Guidelines for selected patients. However, it remains underutilized. One key reason is the lack of consensus on the factors prompting delayed intervention (DI). Herein we provide an updated overview of the triggers for DI in patients with SRMs initially undergoing AS.

Evidence Acquisition: A systematic review of the English-language literature was performed according to the PRISMA statement recommendations using the MEDLINE, Cochrane Central Register of Controlled Trials and Web of Science databases.

Evidence Synthesis: Overall, 10 prospective studies including 1870 patients were included. Median patient age ranged between 64 and 75 years, while median tumor size between 1.7 cm to 2.3 cm. The proportion of cystic SRMs ranged from 0% to 30%. Baseline renal tumor biopsy was performed in 7-45.2% of patients. Among these, malignant histology was found in 28.5%-83.3% of cases. Overall, the median growth rate of SRMs ranged between 0.10 and 0.27 cm/year. The proportion of patients undergoing DI ranged between 7% and 44%, after a median AS period of 12-27 months. The most commonly performed type of DI was surgery. Of resected SRMs, 0% to 30% were benign. The actual triggers for DI were either tumor-related (renal mass growth, stage progression, development of local complications/symptoms) or patient-related (patient preference, improved medical conditions, or qualification for other surgical procedures). At a median follow-up of 21.7 - 57-6 months, the proportion of patients experiencing metastatic disease, cancer-specific and other-cause mortality was 0-3.1%, 0-4% and 0-45.6%, respectively.

Conclusions: The available evidence shows that both tumor-related and patient-related factors are ultimate triggers for DI in patients with SRMs undergoing AS. However, the level of evidence is still low and further research is needed to individualize AS strategies according to both tumor biology and patient-related characteristics and values.
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http://dx.doi.org/10.23736/S0393-2249.20.03870-9DOI Listing
August 2020

The use of a novel smartphone app for monitoring male luts treatment during the COVID-19 outbreak.

Prostate Cancer Prostatic Dis 2020 12 14;23(4):724-726. Epub 2020 Jul 14.

Department of Urological minimally invasive and Robotic Surgery and kidney Transplantation, Careggi Hospital, University of Florence, Florence, Italy.

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http://dx.doi.org/10.1038/s41391-020-0253-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7359441PMC
December 2020

Delayed graft function and perfusion parameters of kidneys from uncontrolled donors after circulatory death.

Perfusion 2021 Apr 10;36(3):299-304. Epub 2020 Jul 10.

Tuscany Authority for Transplantation (Centro Regionale Allocazione Organi e Tessuti CRAOT), Florence, Italy.

Better preservation and evaluation of kidneys from donors after circulatory death serve to increase the number of kidneys available for transplantation and hypothermic machine perfusion has been shown to decrease ischemia reperfusion injury and delayed graft function. Data on relation between hemodynamic parameters during hypothermic machine perfusion and delayed graft function in kidneys from donors after circulatory death are so far scarce and not univocal. We aimed at assessing whether hemodynamic parameters measured during hypothermic machine perfusion (flow, mean perfusion pressure, and renal resistance) are associated with delayed graft function in 26 kidneys retrieved from uncontrolled donors after circulatory death. In our series, the incidence of delayed graft function was 57.7% (15/26). Recipients who developed delayed graft function had a longer warm ischemic time (p = 0.04). All hemodynamic parameters measured during hypothermic machine perfusion were comparable between recipients with delayed graft function and those without. According to our data, in kidneys from uncontrolled donors after circulatory death, a longer warm ischemic time (that is the overall time of no flow, as the sum of the no-flow and the no-touch period) is associated with delayed graft function. This finding underscores the pivotal role of ischemic injury in terms of absence of flow in affecting graft function. No association was detectable between hemodynamic parameters during hypothermic machine perfusion and the development of delayed graft function in our series.
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http://dx.doi.org/10.1177/0267659120938928DOI Listing
April 2021

Out-of-hospital cardiac arrest and donation after circulatory death during the COVID-19 pandemia.

Resuscitation 2020 09 6;154:10-11. Epub 2020 Jul 6.

Intensive Care Unit and Regional ECMO Referral Centre, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy; Tuscany Authority for Transplantation.

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http://dx.doi.org/10.1016/j.resuscitation.2020.06.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336904PMC
September 2020

Robotic-assisted kidney transplantation in obese recipients compared to non-obese recipients: the European experience.

World J Urol 2020 Jun 19. Epub 2020 Jun 19.

Department of Urology and Kidney Transplantation, University Hospital of Rangueil, Toulouse, France.

Purpose: The main objective was to compare minor (Clavien I-II) and major (Clavien ≥ III) intra- and postoperative complications of living donor robotic assisted kidney transplantation (RAKT) in obese (≥ 30 kg/m BMI), overweight (< 30/ ≥ 25 kg/m BMI) and non-overweight recipients (< 25 kg/m BMI).

Methods: For the present retrospective study, we reviewed the multi-institutional ERUS-RAKT database to select consecutive living donor RAKT recipients. Functional outcomes, intra- and postoperative complications were compared between obese, overweight and non-overweight recipients.

Results: 169 living donor RAKTs were performed, by 10 surgeons, from July 2015 to September 2018 in the 8 European centers. 32 (18.9%) recipients were obese, 66 (39.1%) were overweight and 71 (42.0%) were non-overweight. Mean follow-up was 1.2 years. There were no major intra-operative complications in either study group. Conversion to open surgery occurred in 1 obese recipient, in 2 overweight recipients and no conversion occurred in non-overweight recipients (p = 0.3). Minor and major postoperative complications rates were similar in the 3 groups. At one-year of follow-up, median eGFR was similar in all groups [54 (45-60) versus 57 (46-70) versus 63 (49-78) ml/min/1.73 m in obese, overweight and non-overweight recipient groups, respectively, p = 0.5]. Delayed graft function rate was similar in the 3 groups. Only the number of arteries was an independent predictive factor of suboptimal renal function at post-operative day 30 in the multivariate analysis.

Conclusion: RAKT in obese recipients is safe, compared to non-overweight recipients and yields very good function, when it performed at high-volume referral centers by highly trained transplant teams.
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http://dx.doi.org/10.1007/s00345-020-03309-6DOI Listing
June 2020

Forecasting the Future of Urology Practice: A Comprehensive Review of the Recommendations by International and European Associations on Priority Procedures During the COVID-19 Pandemic.

Eur Urol Focus 2020 Sep 31;6(5):1032-1048. Epub 2020 May 31.

Division of Urology, Department of Oncology, School of Medicine, San Luigi Hospital, University of Turin, Orbassano, Turin, Italy. Electronic address:

Context: The unprecedented health care scenario caused by the coronavirus disease 2019 (COVID-19) pandemic has revolutionized urology practice worldwide.

Objective: To review the recommendations by the international and European national urological associations/societies (UASs) on prioritization strategies for both oncological and nononcological procedures released during the current emergency scenario.

Evidence Acquisition: Each UAS official website was searched between April 8 and 18, 2020, to retrieve any document, publication, or position paper on prioritization strategies regarding both diagnostic and therapeutic urological procedures, and any recommendations on the use of telemedicine and minimally invasive surgery. We collected detailed information on all urological procedures, stratified by disease, priority (higher vs lower), and patient setting (outpatient vs inpatient). Then, we critically discussed the implications of such recommendations for urology practice in both the forthcoming "adaptive" and the future "chronic" phase of the COVID-19 pandemic.

Evidence Synthesis: Overall, we analyzed the recommendations from 13 UASs, of which four were international (American Urological Association, Confederation Americana de Urologia, European Association of Urology, and Urological Society of Australia and New Zealand) and nine national (from Belgium, France, Germany, Italy, Poland, Portugal, The Netherlands, and the UK). In the outpatient setting, the procedures that are likely to impact the future burden of urologists' workload most are prostate biopsies and elective procedures for benign conditions. In the inpatient setting, the most relevant contributors to this burden are represented by elective surgeries for lower-risk prostate and renal cancers, nonobstructing stone disease, and benign prostatic hyperplasia. Finally, some UASs recommended special precautions to perform minimally invasive surgery, while others outlined the potential role of telemedicine to optimize resources in the current and future scenarios.

Conclusions: The expected changes will put significant strain on urological units worldwide regarding the overall workload of urologists, internal logistics, inflow of surgical patients, and waiting lists. In light of these predictions, urologists should strive to leverage this emergency period to reshape their role in the future.

Patient Summary: Overall, there was a large consensus among different urological associations/societies regarding the prioritization of most urological procedures, including those in the outpatient setting, urological emergencies, and many inpatient surgeries for both oncological and nononcological conditions. On the contrary, some differences were found regarding specific cancer surgeries (ie, radical cystectomy for higher-risk bladder cancer and nephrectomy for larger organ-confined renal masses), potentially due to different prioritization criteria and/or health care contexts. In the future, the outpatient procedures that are likely to impact the burden of urologists' workload most are prostate biopsies and elective procedures for benign conditions. In the inpatient setting, the most relevant contributors to this burden are represented by elective surgeries for lower-risk prostate and renal cancers, nonobstructing stone disease, and benign prostatic hyperplasia.
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http://dx.doi.org/10.1016/j.euf.2020.05.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7261455PMC
September 2020

The vaccine journey for COVID-19: a comprehensive systematic review of current clinical trials in humans.

Panminerva Med 2020 May 26. Epub 2020 May 26.

Department of Oncology, School of Medicine, San Luigi Hospital, University of Turin, Orbassano, Turin, Italy.

Introduction: Since December 2019, there has been an outbreak of a novel beta-coronavirus (SARS-CoV-2) in Wuhan, China. On March the 11th the World Health Organization (WHO) declared COVID-19 as a pandemic, with over 118,000 cases in more than 110 countries around the world. In response to the global coronavirus disease 2019 (COVID-19) emergency, clinical trial research assessing the efficacy and safety of experimental vaccines to prevent COVID-19 are emerging at an unprecedented rate. The aim of this systematic review is to summarize the preliminary experiences and ongoing clinical trials of the major candidates and challenges of the vaccine strategies in humans.

Evidence Acquisition: After a priori protocol registration with PROSPERO (181483), a systematic research of the published literature was conducted on 24 April 2020 using Medline (via PubMed), Embase (via Ovid), and WHO databases. Moreover, to explore the more recent literature we also searched the preprint server medRxiv. Finally, we scrutinized the Cochrane COVID-19 study register and the COVID-19 section of ClinicalTrials.gov database for identifying relevant ongoing clinical trials. Thereafter we selected the articles according to the PRISMA guidelines. Animal or in-vitro experimental studies were excluded. Moreover editorials, commentaries, abstracts, reviews, book chapters, and articles not in English were not included.

Evidence Synthesis: Our search identified 1359 published papers, 478 pre-print articles and 367 ongoing clinical trials. Finally, only ten ongoing clinical trials met the inclusion criteria. Specifically, seven developed vaccines for the S protein of SARS-CoV-2 and three clinical trials assessed the protective role of BCG vaccine against COVID-19. The first group included phase I/II trials with different types of molecules (DNA or mRNA vaccine, bacterial plasmid or viral vectors), the latter were phase III/IV trials designed on the basis of a heterologous lymphocyte activation by the BCG vaccine.

Conclusions: This new disease is pushing the scientific community to develop swiftly a safe and effective vaccine. Notwithstanding the limitations of our analysis, given by the absence of available results, we try to provide a comprehensive view of the ongoing clinical trials in humans. Our analysis reveals a worldwide effort of both scientists and enterprises to achieve one of the most challenging goals of our century.
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http://dx.doi.org/10.23736/S0031-0808.20.03958-0DOI Listing
May 2020

Assessing the Burden of Nondeferrable Major Uro-oncologic Surgery to Guide Prioritisation Strategies During the COVID-19 Pandemic: Insights from Three Italian High-volume Referral Centres.

Eur Urol 2020 Jul 11;78(1):11-15. Epub 2020 Apr 11.

Division of Urology, Department of Oncology, School of Medicine, San Luigi Hospital, University of Turin, Orbassano, Turin, Italy.

The coronavirus 2019 (COVID-19) pandemic has led to an unprecedented emergency scenario for all aspects of health care, including urology. At the time of writing, Italy was the country with the highest rates of both infection and mortality. A panel of experts recently released recommendations for prioritising urologic surgeries in a low-resource setting. Of note, major cancer surgery represents a compelling challenge. However, the burden of these procedures and the impact of such recommendations on urologic practice are currently unknown. To fill this gap, we assessed the yearly proportion of high-priority major uro-oncologic surgeries at three Italian high-volume academic centres. Of 2387 major cancer surgeries, 32.3% were classified as high priority (12.6% of radical nephroureterectomy, 17.3% of nephrectomy, 33.9% of radical prostatectomy, and 36.2% of radical cystectomy cases). Moreover, 26.4% of high-priority major cancer surgeries were performed in patients at higher perioperative risk (American Society of Anesthesiologists score ≥3), with radical cystectomy contributing the most to this cohort (50%). Our real-life data contextualise ongoing recommendations on prioritisation strategies during the current COVID-19 pandemic, highlighting the need for better patient selection for surgery. We found that approximately two-thirds of elective major uro-oncologic surgeries can be safely postponed or changed to another treatment modality when the availability of health care resources is reduced. PATIENT SUMMARY: We used data from three high-volume Italian academic urology centres to evaluate how many surgeries performed for prostate, bladder, kidney, and upper tract urothelial cancer can be postponed in times of emergency. We found that approximately two-thirds of patients with these cancers do not require high-priority surgery. Conversely, of patients requiring high-priority surgery, approximately one in four is considered at high perioperative risk. These patients may pose challenges in allocation of resources in critical scenarios such as the current COVID-19 pandemic.
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http://dx.doi.org/10.1016/j.eururo.2020.03.054DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151319PMC
July 2020