URINARY CONTINENCE RESTORATION THROUGH AN ENDOURETHRAL DEVICE: A 3-MONTH PILOT STUDY ON TEN PATIENTS.

BACKGROUNDː Stress urinary incontinence (SUI) is a widespread and frustrating condition that affects millions of people worldwide, with severe consequences on patients' quality of life and healthcare systems' costs. Currently, the most severe cases of SUI are treated using implanted (and rather invasive) extraurethral artificial sphincters. The authors propose an innovative, minimally invasive endourethral device for the treatment of SUI. METHODSː Ten patients with SUI were enrolled in three Italian centers and underwent device implantation. After 10, 30, 60 and 90 days, correct device position was confirmed by ultrasonography. Improvements in continence and quality of life were evaluated through a 24 h pad-test, an International Consultation on Incontinence Questionnarie- Short Form (ICI-Q) and a custom checklist. The device was explanted after 90 days. RESULTSː The proposed device was successfully implanted and explanted in 8 out of 10 patients. The results of the pad-test, ICI-Q and custom checklist demonstrated remarkable improvements in continence (median improvement: 82% with respect to the initial condition) and quality of life (mean reduction of the impact of urine losses on the quality of life: 61%). No major pain or discomfort was reported. CONCLUSIONSː The results demonstrate the efficacy of the proposed endourethral artificial sphincter in addressing SUI. The proposed device was successfully implanted and explanted in a short time (~ 10 min) without intrinsic side effects and without triggering pain or discomfort.

State of the Art in Robotic Surgery with Hugo RAS System: Feasibility, Safety and Clinical Applications.

Since its introduction in the early 2000s, robotic surgery has represented a significative innovation within a minimally invasive surgery approach. A variety of robotic platforms have been made available throughout the years, and the outcomes related to those platforms have been described in the literature for many types of surgeries. Medtronic's HugoTM RAS system is one of the newest robotic generations launched, but because of its recent placing on the field, comprehensive clinical data are still lacking. The aim of the present state of the art is to address the current literature concerning the use of the HugoTM RAS robot in order to report its feasibility, safety and clinical applications in different surgical branches. Two reviewers independently conducted a search on the "PubMed" electronic database, using the keywords "Hugo" and "Hugo RAS". After the initial screening of 35 results, a total of 15 articles concerning the Hugo RAS system were selected for the review, including both oncological and benign surgery. Patients' demographic and baseline data were compared including, when available, docking system times, complications and oncological outcomes in the fields of urologic, gynecologic and general surgery. With reference to urological procedures, a total of 156 robot-assisted radical prostatectomies, 10 robot-assisted partial nephrectomies, and 5 robot-assisted adrenalectomies were performed, involving a total of 171 patients. The surgical branch in which the Hugo system found its major application was urology, which was followed by gynecology and general surgery. The Hugo RAS system by Medtronic represents an innovative and safe surgical platform, with excellent perspective for the future and different clinical applications in many surgical branches. More studies are needed to validate the safety and results from this new robotic platform.

A magnetic endourethral sphincter against stress urinary incontinence: preliminary pilot study in humans.

BACKGROUND: Urinary incontinence (UI) is a common and frustrating condition that affects patients' quality of life as well as the Healthcare systems. Currently, the most severe cases of UI are treated using implanted, invasive artificial sphincters. We propose an innovative, minimally invasive magnetic endourethral sphincter for the treatment of stress UI (SUI) in patients for whom previous medical and surgical treatments have failed. METHODS: Six patients with severe SUI were enrolled at a single center and underwent cystoscopic sphincter implantation. After 10 days, correct device position was confirmed by ultrasonography. The sphincter was explanted after 28 days. RESULTS: In all patients, the sphincter was successfully implanted using an endoscopic approach. One patient reached the end of the pilot test (28 days) with the sphincter correctly placed. Patients' responses on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire improved from a score of 18 out of 21 at the screening visit (UI without reasons) to a score of 3 out of 21 (almost perfect continence). No major pain and discomfort were reported. CONCLUSIONS: This study showed the feasibility of sphincter implantation, explantation, and overall tolerability, although a redesign of the sphincter distal part is needed.

The Discipline of Pediatric Urology: Prerogatives and Necessities.

To the Editor, The aim of this "position paper" is to describe the discipline of Pediatric Urology with its clinical and cultural competencies, represent the reasons for legitimizing its existence, and reinforce its importance in the "scenario" of the National Italian Healthcare System. The requisites and the educational requirements were defined by both the Italian Ministry of Health with the State-Regions Conference, and the European Union [...].

Are Urologists Ready for Interpretation of Multiparametric MRI Findings? A Prospective Multicentric Evaluation.

Aim: To assess urologists' proficiency in the interpretation of multiparametric magnetic resonance imaging (mpMRI). Materials and Methods: Twelve mpMRIs were shown to 73 urologists from seven Italian institutions. Responders were asked to identify the site of the suspicious nodule (SN) but not to assign a PIRADS score. We set an a priori cut-off of 75% correct identification of SN as a threshold for proficiency in mpMRI reading. Data were analyzed according to urologists' hierarchy (UH; resident vs. consultant) and previous experience in fusion prostate biopsies (E-fPB, defined as <125 vs. ≥125). Additionally, we tested for differences between non-proficient vs. proficient mpMRI readers. Multivariable logistic regression analyses (MVLRA) tested potential predictors of proficiency in mpMRI reading. Results: The median (IQR) number of correct identifications was 8 (6−8). Anterior nodules (number 3, 4 and 6) represented the most likely prone to misinterpretation. Overall, 34 (47%) participants achieved the 75% cut-off. When comparing consultants vs. residents, we found no differences in terms of E-fPB (p = 0.9) or in correct identification rates (p = 0.6). We recorded higher identification rates in urologists with E-fBP vs. their no E-fBP counterparts (75% vs. 67%, p = 0.004). At MVLRA, only E- fPB reached the status of independent predictor of proficiency in mpMRI reading (OR: 3.4, 95% CI 1.2−9.9, p = 0.02) after adjusting for UH and type of institution. Conclusions: Despite urologists becoming more familiar with interpretation of mpMRI, their results are still far from proficient. E-fPB enhances the proficiency in mpMRI interpretation.

The fight between PCNL, laparoscopic and robotic pyelolithotomy: do we have a winner? A systematic review and meta-analysis.

INTRODUCTION: The aim of this systematic review and meta-analysis was to provide an updated comparison between the currently available minimally invasive approaches (PCNL, laparoscopic [LP] and robotic pyelolithotomy [RP]) for the management of large renal stones. EVIDENCE ACQUISITION: An electronic search of the current literature was conducted through the Medline and NCBI PubMed, Embase, Scopus and Cochrane Collaboration Central Register of Controlled Clinical Trials databases in March 2021. Studies about minimally-invasive treatment for kidney stones were considered. Inclusion criteria were: studies evaluating patients with large renal calculi (≥2 cm); the comparison of at least two of the three approaches (PCNL, LP, RP), and reporting data suitable for meta-analysis evaluation. Patients with concomitant management for ureteropelvic junction obstruction (UPJ-O) were excluded. EVIDENCE SYNTHESIS: Overall, 17 reports were considered for qualitative and quantitative synthesis, for a total cohort of 1079 patients, of which 534 with PCNL, 525 treated with LP, and 20 with RP. Of those, 16 compared PCNL with LP, while only 1 study compared LP with RP. PCNL mean operative time was statistically significantly shorter than LP and RP while mean estimated blood loss was statistically significantly higher for PNCL. No statistically significant differences were recorded among the three surgical approaches. Finally, PCNL demonstrated slightly, albeit statistically significant lower stone free rate when compared with LP. CONCLUSIONS: PCNL, LP and RP may be safely and efficiently used to manage large renal stones. All three procedures showed reasonably low rate of complications with a satisfactory stone clearance rate.

Current management of radiation cystitis after pelvic radiotherapy: a systematic review.

INTRODUCTION: We aimed to summarize current literature about radiation cystitis treatments, providing physician of a summary of current management options. EVIDENCE ACQUISITION: A systematic literature review searching on PubMed (Medline), Scopus, and Web of Science databases was performed in March 2021. PRISMA guidelines were followed. Population consisted of patients with a diagnosis of radiation cystitis after pelvic radiotherapy (P). We focused our attention on different treatments, such as conservative or surgical one (I). Single or multiple arms studies were deemed eligible with no mandatory comparison (C). Main outcomes of interest were symptoms control and adverse events rates (O). EVIDENCE SYNTHESIS: The search identified 1194 records. Of all, four studies focused on the use of hyperbaric oxygen therapy showing complete response rates ranging from 52% to 87% approximately. Oral administration of cranberry compounds was investigated in one study showing no superiority to placebo. Intravesical instillation of different compounds were investigated in five studies showing the highest complete response rates after alum (60%) and formalin administration (75%). Endoscopic conservative surgical treatments (fibrin glue or vaporization) also showed 75% complete response rates. In patients who did not respond to conservative treatments robotic cystectomy is feasible with overall complication rates of about 59.3% at 90 days. CONCLUSIONS: Radiotherapy induced cystitis is an under-reported condition after pelvic radiotherapy. Several treatments have been proposed, but in up to 10% of cases salvage cystectomy is necessary. A stepwise approach, with progressive treatment aggressiveness is recommended.

Bladder perforation during transurethral resection of the bladder: a comprehensive algorithm for diagnosis, management and follow-up.

INTRODUCTION: Despite bladder perforation (BP) is a frequent complication during transurethral resection of bladder (TURB) for bladder cancer (BCa), literature lacks systematic reviews focusing on this issue. We aimed to investigate incidence, diagnosis, therapy, and prognosis after BP during TURB for BCa; therapy was distinguished between conservative (without the need for bladder repair) and surgical management (requiring bladder wall closure). EVIDENCE ACQUISITION: A systematic search was conducted up to April 2021 using PubMed, Scopus, Cochrane Database of Systematic Reviews, and Web of Science to identify articles focusing on incidence, detection, management, or survival outcomes after iatrogenic BP. The selection of articles followed the preferred reporting items for systematic review and meta-analyses process. EVIDENCE SYNTHESIS: We included 41 studies, involving 21,174 patients. Overall, 521 patients experienced BP during TURB for BCa, with a mean incidence of 2.4%, up to 58.3% when postoperative cystography is routinely performed after all TURB procedures. Risk factors were low body mass index (BMI) (P=0.01), resection depth (P=0.006 and P=0.03), and low surgical experience (P=0.006). Extraperitoneal BP (68.5%) were treated conservatively in 97.5% of patients; intraperitoneal BP were managed with surgical bladder closure in 56% of cases. Overall, three immediate BP-related deaths were recorded due to septic complications. Extravesical tumor seeding was observed after 6 intraperitoneal and 1 extraperitoneal BP (median time: 6.2 months). Intraperitoneal BP (P=0.0003) and bladder closure (P<0.001) were found as independent predictors of extravesical tumor recurrence. CONCLUSIONS: BP is more frequent than expected when proper diagnosis is routinely performed after all TURB procedures. Risk factors include low BMI, resection depth, and unexperienced surgeon. The risk of sepsis after BP suggests empirical antibiotic prophylaxis after BP.

Potential prognostic value of miRNAs as biomarker for progression and recurrence after nephrectomy in renal cell carcinoma: a literature review.

OBJECTIVES: We provide a systematic literature review on tissue miRNAs in patients with RCC to evaluate and summarize their usefulness as prognostic markers. We undertook a systematic search for articles in English using the PubMed-Medline database from January 2010 to December 2020. Studies were identified and selected according to the PRISMA criteria and the PICO methodology. The population consisted of RCC patients undergoing nephrectomy and the main outcome of interest was recurrence-free survival (RFS). Only studies providing hazard ratios (HRs) from multivariate or univariate analyzes with corresponding 95% confidence intervals (CI) and/or area under the curve (AUC) were considered. CONTENT: All nine included studies (1,541 patients) analyzed the relationship between tissue miRNA expression levels (up or downregulated) and RFS. Some of these found that the methylation status of miR-9-1, miR-9-3 and miR-124 was associated with a high risk of relapse. Moreover, miR-200b overexpression was associated with OS. MiR-210 overexpression indicated a shorter OS than those who were miR-210 negative. Finally, patients with high miR-125b expression had shorter cancer-specific survival (CSS) than those with low expression; similarly, patients with low miR-126 expression also had shorter CSS time. SUMMARY AND OUTLOOK: Several studies tested the usefulness of specific miRNAs to predict RCC recurrence. Some of them showed a fair accuracy and strong relationship between specific miRNA over or under-expression and survival outcomes. However, results from these studies are preliminary and miRNAs use in routine clinical practice is still far to come.

Bioethical implications of robotic surgery in urology: a systematic review.

INTRODUCTION: Robotic technologies are being increasingly implemented in healthcare, including urology, and holding promises for improving medicine worldwide. However, these new approaches raise ethical concerns for professionals, patients, researchers and institutions that need to be addressed. The aim of this review was to investigate the existing literature related to bioethical issues associated with robotic surgery in urology, in order to identify current challenges and make preliminary suggestions to ensure an ethical implementation of these technologies. EVIDENCE ACQUISITION: We performed a review of the pertaining literature through a systematic search of two databases (PubMed and Web of Science) in August 2020. EVIDENCE SYNTHESIS: Our search yielded 76 articles for full-text evaluation and 48 articles were included in the narrative review. Several bioethical issues were identified and can be categorized into five main subjects: 1) robotic surgery accessibility (robotic surgery is expensive, and in some health systems may lead to inequality in healthcare access. In more affluent countries the national distribution of several robotic platforms may influence the centralization of robotic surgery, therefore potentially affecting oncological and functional outcomes in low-volume centers); 2) safety (there is a considerable gap between surgical skills and patients' perception of competence, leading to ethical consequences on modern healthcare. Published incidence of adverse events during robotic surgery in large series is between 2% and 15%, which does not significantly differ amongst open or laparoscopic approaches); 3) gender gap (no data about gap differences in accessibility to robotic platforms were retrieved from our search); 4) costs (robotic platforms are expensive but a key reason why hospitals are willing to absorb the high upfront costs is patient demand. It is possible to achieve cost-equivalence between open and robotic prostatectomy if the volume of centers is higher than 10 cases per week); and 5) learning curve (a validated, structured curriculum and accreditation has been created for robotic surgery. This allows acquisition and development of basic and complex robotic skills focusing on patient safety and short learning curve). CONCLUSIONS: Tech-medicine is rapidly moving forward. Robotic approach to urology seems to be accessible in more affluent countries, safe, economically sustainable, and easy to learn with an appropriate learning curve for both sexes. It is mandatory to keep maintaining a critical rational approach with constant control of the available evidence regarding efficacy, efficiency and safety.

Prospective evaluation of urinary steroids and prostate carcinoma-induced deviation: preliminary results.

BACKGROUND: The serum prostate-specific antigen is the most widespread biomarker for prostate disease. Its low specificity for prostatic malignancies is a matter of concern and the reason why new biomarkers for screening purposes are needed. The correlation between altered production of the main steroids and prostate carcinoma (PCa) occurrence is historically known. The purpose of this study is to evaluate the modifications of a comprehensive urinary endogenous steroidal profile (USP) induced by PCa, by multivariate statistical methods. METHODS: A total of 283 Italian subjects were included in the study, 139 controls and 144 PCa-affected patients. The USP, including 17 steroids and five urinary steroidal ratios, was quantitatively evaluated using gas chromatography coupled with single quadrupole mass spectrometry (GC-MS). The data were interpreted using a chemometric, multivariate approach (intrinsically more sensible to alterations with respect to traditional statistics) and a model for the discrimination of cancer-affected profiles was built. RESULTS: Two multivariate classification models were calculated, the former including three steroids with the highest statistical significance (e.g. testosterone, etiocholanolone and 7ß-OH-DHEA) and PSA values, the latter considering the three steroids' levels only. Both models yielded high sensitivity and specificity scores near to 70%, resulting significantly higher than PSA alone. CONCLUSIONS: Three USP steroids resulted significantly altered in our PCa population. These preliminary results, combined with the simplicity and low-cost of the analysis, open to further investigation of the potential role of this restricted USP in PCa diagnosis.

Impact of COVID-19 Pandemic on Health-Related Quality of Life in Uro-oncologic Patients: What Should We Wait For?

PURPOSE: To investigate the health-related quality of life of uro-oncologic patients whose surgery was postponed without being rescheduled during the coronavirus disease 2019 (COVID-19) pandemic. PATIENTS AND METHODS: From the March 1 to April 26, 2020, major urologic surgeries were drastically reduced at our tertiary-care referral hospital. In order to evaluate health-related quality-of-life outcomes, the SF-36 questionnaire was sent to all patients scheduled for major surgery at our department 3 weeks after the cancellation of the planned surgical procedures because of the COVID-19 emergency. RESULTS: All patients included in the analysis had been awaiting surgery for a median (interquartile range) time of 52.85 (35-72) days. The SF-36 questionnaire measured 8 domains: physical functioning (PF), role limitations due to physical health (PH), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EWB), social functioning (SF), bodily pain (BP), general health perceptions (GHP). When considering physical characteristics as measured by the SF-36 questionnaire, PF was 91.5 (50-100) and PH was 82.75 (50-100) with a BP of 79.56 (45-90). For emotional and social aspects, RE was 36.83 (0-100) with a SF of 37.98 (12.5-90). Most patients reported loss of energy (EF 35.28 [15-55]) and increased anxiety (EWB 47.18 [interquartile range, 20-75]). All patients perceived a reduction of their health conditions, with GHP of 49.47 (15-85). Generally, 86% of patients (n = 43) noted an almost intact physical function but a significant emotional alteration characterized by a prevalence of anxiety and loss of energy. CONCLUSION: The lockdown due to the novel coronavirus that has affected most operating rooms in Italy could be responsible for the increased anxiety and decrement in health status of oncologic patients. Without any effective solution, we should expect a new medical catastrophe-one caused by the increased risk of tumor progression and mortality in uro-oncologic patients.

Prone versus supine percutaneous nephrolithotomy: a systematic review and meta-analysis of current literature.

INTRODUCTION: Percutaneous nephrolithotomy (PNL) can be performed either in prone or supine position. This study aimed at gathering together randomized controlled trials (RCTs) comparing efficacy and safety between prone and supine PNL. EVIDENCE ACQUISITION: Systematic review of literature was conducted using the Scopus, Medline and Web of Science databases. Study selection, data extraction and quality assessment were independently assessed by two authors. Meta-analysis was performed with Review Manager 5.3. Sensitivity analyses were performed to exclude studies with high risk of bias. EVIDENCE SYNTHESIS: Pooled data from 12 studies including 1290 patients were available for analysis. Only one study was found to have overall low risk of bias. Significantly shorter operative time was found in favor of supine PNL (mean difference 13 minutes, 95% confidence interval [CI]: 3.4-22.7; P<0.01). Stone-free rate (SFR)≥14 days after surgery was significantly higher in prone PNL (odds ratio [OR]=2.15, 95% CI: 1.07-4.34; P=0.03). Significantly higher fever rate was found in prone PNL (OR=1.60, 95% CI: 1.03-2.47; P=0.04). Overall SFR, hospital stay length, complications rate, transfusions rate and blood loss, as well as non-lower calyx puncture rate, puncture attempts and tubeless intervention rate did not differ between prone and supine PNL (P>0.05). CONCLUSIONS: Efficacy of PNL seems balanced between prone and supine position, with comparable overall SFR and shorter operative time in favor of supine PNL. Safety of PNL appears in favor of supine PNL, with lower fever rate. Because of study heterogeneity and possible risks of outcome bias, results from this study should be interpreted with caution. Altogether, both prone and supine PNL account for appropriate therapy options.