Transurethral prostate surgery in prostate cancer patients: A population-based comparative analysis of complication and mortality rates.

Objective: Prostate cancer (PCa) patients might experience lower urinary tract symptoms as those diagnosed with benign prostatic hyperplasia (BPH). Some of them might be treated for their lower urinary tract symptoms instead of PCa. We aimed to test the effect of PCa versus BPH on surgical outcomes after transurethral prostate surgery, namely complication and mortality rates. Methods: Within the American College of Surgeons National Surgical Quality Improvement Program database (2011-2016), we identified patients who underwent transurethral resection of the prostate, photoselective vaporization, or laser enucleation. Patients were stratified according to postoperative diagnosis (PCa vs. BPH). Univariable and multivariable logistic regression models evaluated the predictors of perioperative morbidity and mortality. A formal test of interaction between diagnosis and surgical technique used was performed. Results: Overall, 34 542 patients were included. Of all, 2008 (5.8%) had a diagnosis of PCa. The multivariable logistic regression model failed to show statistically significant higher rates of postoperative complications in PCa patients (odds ratio: 0.9, 95% confidence interval: 0.7-1.1; p=0.252). Moreover, similar rates of perioperative mortality (p=0.255), major acute cardiovascular events (p=0.581), transfusions (p=0.933), and length of stay of more than or equal to 30 days (p=0.174) were found. Additionally, all tests failed to show an interaction between post-operative diagnosis and surgical technique used. Conclusion: Patients diagnosed with PCa do not experience higher perioperative morbidity or mortality after transurethral prostate surgery when compared to their BPH counterparts. Moreover, the diagnosis seems to not influence surgical technique outcomes.

The role of warm ischemia time on functional outcomes after robotic partial nephrectomy: a radionuclide renal scan study from the clock randomized trial.

PURPOSE: To evaluate the relationship between warm ischemia time (WIT) duration and renal function after robot-assisted partial nephrectomy (RAPN). METHODS: The CLOCK trial is a phase 3 randomized controlled trial comparing on- vs off-clamp RAPN. All patients underwent pre- and postoperative renal scintigraphy. Six-month absolute variation of eGFR (AV-GFR), rate of relative variation in eGFR over 25% (RV-GFR > 25), absolute variation of split renal function (SRF) at scintigraphy (AV-SRF). The relationships WIT/outcomes were assessed by correlation graphs and then modeled by uni- and multivariable regression. RESULTS: 324 patients were included (206 on-clamp, 118 off-clamp RAPN). Correlation graphs showed a threshold on WIT equal to 10 min. The differences in outcome measures between cases with WIT < vs ≥ 10 min were: AV-GFR - 3.7 vs - 7.5 ml/min (p < 0.001); AV-SRF - 1% vs - 3.6% (p < 0.001); RV-GFR > 25 9.3% vs 17.8% (p = 0.008). Multivariable models found that AV-GFR was related to WIT ≥ 10 min (regression coefficient [RC] - 0.52, p = 0.019), age (RC - 0.35, p = 0.001) and baseline eGFR (RC - 0.30, p < 0.001); RV-GFR > 25 to WIT ≥ 10 min (odds ratio [OR] 1.11, p = 0.007) and acute kidney injury defined as > 50% increase in serum creatinine (OR 19.7, p = 0.009); AV-SRF to WIT ≥ 10 min (RC - 0.30, p = 0.018), baseline SRF (RC - 0.76, p < 0.001) and RENAL score (RC - 0.60. p = 0.028). The main limitation was that the CLOCK trial was designed on a different endpoint and therefore the present analysis could be underpowered. CONCLUSIONS: Up to 10 min WIT had no consequences on functional outcomes. Above the 10-min threshold, a statistically significant, but clinically negligible impact was found.

Micro-RNAs Predict Response to Systemic Treatments in Metastatic Renal Cell Carcinoma Patients: Results from a Systematic Review of the Literature.

Locally advanced or metastatic renal cell carcinomas (mRCCs) account for up to 15% of all kidney cancer diagnoses. Systemic therapies (with or without surgery) represent gold standard treatments, mostly based on tyrosine kinase inhibitors in association with immunotherapy. We provide an overview of the current knowledge of miRNAs as predictors of treatment resistance. A systematic review of the literature was carried out in January 2022 following the PICO methodology. Overall, we included seven studies-four testing plasmatic miRNAs, two exosomal miRNAs, and one urinary miRNA. A total of 789 patients were included (354 for plasmatic miRNAs, 366 for urinary miRNAs, and 69 for exosomal miRNAs). Several miRNAs were tested within the included studies, but six plasmatic (miR9-5-p¸ miR-192, miR193-3p, miR-501-3p¸ miR-221, miR-376b-3p) one urinary (miR-30a-5p), and three exosomal (miR-35-5p, miR-301a-3p, miR-1293) were associated with resistance to systemic treatments or treatment failure in mRCC patients. Results showed a fair accuracy of these biomarkers in predicting treatment resistance and overall survival. However, to date, the biomarkers tested have not been validated and their clinical uses are not recommended. Nevertheless, the literature results are encouraging; future large clinical trials are warranted to validate the effectiveness of these tools in clinical decision-making.

Patients' perceptions of quality of care delivery by urology residents: A nationwide study.

OBJECTIVE: To present the results of a nationwide survey among urological patients to evaluate their perception of the quality of care provided by residents. METHODS: An anonymous survey was distributed to patients who were referred to 22 Italian academic institutions. The survey aimed to investigate the professional figure of the urology resident as perceived by the patient. RESULTS: A total of 2587 patients were enrolled in this study. In all, 51.6% of patients were able to correctly identify a urology resident; however, almost 40% of respondents discriminated residents from fully trained urologists based exclusively on their young age. Overall, 98.2% patients rated the service provided by the resident as at least sufficient. Urology trainees were considered by more than 50% of the patients interviewed to have good communication skills, expertise and willingness. Overall, patients showed an excellent willingness to be managed by urology residents. The percentage of patients not available for this purpose showed an increasing trend that directly correlated with the difficulty of the procedure. Approximately 5-10% of patients were not willing to be managed by residents for simple procedures such as clinical visits, cystoscopy or sonography, and up to a third of patients were not prepared to undergo any surgical procedure performed by residents during steps in major surgery, even if the residents were adequately tutored. CONCLUSIONS: Our data showed that patients have a good willingness to be managed by residents during their training, especially for medium- to low-difficulty procedures. Furthermore, the majority of patients interviewed rated the residents' care delivery as sufficient. Urology trainees were considered to have good communication skills, expertise and willingness.

Conspicuity and muscle-invasiveness assessment for bladder cancer using VI-RADS: a multi-reader, contrast-free MRI study to determine optimal b-values for diffusion-weighted imaging.

OBJECTIVE: To (1) compare bladder cancer (BC) muscle invasiveness among three b-values using a contrast-free approach based on Vesical Imaging-Reporting and Data System (VI-RADS), to (2) determine if muscle-invasiveness assessment is affected by the reader experience, and to (3) compare BC conspicuity among three b-values, qualitatively and quantitatively. METHODS: Thirty-eight patients who underwent a bladder MRI on a 3.0-T scanner were enrolled. The gold standard was histopathology report following transurethral resection of BC. Three sets of images, including T2w and different b-values for DWI, set 1 (b = 1000 s/mm2), set 2 (b = 1500 s/mm2), and set 3 (b = 2000 s/mm2), were reviewed by three differently experienced readers. Descriptive statistics and Intraclass Correlation Coefficient (ICC) were calculated. Comparisons among readers and DWI sets were performed with the Wilcoxon test. Receiver operating characteristic (ROC) analysis was performed. Areas under the curves (AUCs) and pairwise comparison were calculated. RESULTS: AUCs of muscle-invasiveness assessment ranged from 0.896 to 0.984 (reader 1), 0.952-0.968 (reader 2), and 0.952-0.984 (reader 3) without significant differences among different sets and readers (p > 0.05). The mean conspicuity qualitative scores were higher in Set 1 (2.21-2.33), followed by Set 2 (2-2.16) and Set 3 (1.82-2.14). The quantitative conspicuity assessment showed that mean normalized intensity of tumor was significantly higher in Set 2 (4.217-4.737) than in Set 1 (3.923-4.492) and Set 3 (3.833-3.992) (p < 0.05). CONCLUSION: Muscle invasiveness can be assessed with high accuracy using a contrast-free protocol with T2W and DWI, regardless of reader's experience. b = 1500 s/mm2 showed the best tumor delineation, while b = 1000 s/mm2 allowed for better tumor-wall interface assessment.

Is off-clamp robot-assisted partial nephrectomy beneficial for renal function? Data from the CLOCK trial.

OBJECTIVES: To compare the functional outcomes of on- vs off-clamp robot-assisted partial nephrectomy (RAPN) within a randomized controlled trial (RCT). MATERIALS AND METHODS: The CLOCK study (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy; NCT02287987) is a multicentre RCT including patients with normal baseline function, two kidneys and masses with RENAL scores ≤ 10. Pre- and postoperative renal scintigraphy was prescribed. Renal defatting and hilum isolation were required in both study arms; in the on-clamp arm, ischaemia was imposed until the completion of medullary renorraphy, while in the off-clamp condition it was not allowed throughout the procedure. The primary endpoint was 6-month absolute variation in estimated glomerular filtration rate (AV-GFR); secondary endpoints were: 12, 18 and 24-month AV-GFR; 6-month estimated glomerular filtration rate variation >25% rate (RV-GFR >25); and absolute variation in ipsilateral split renal function (AV-SRF). The planned sample size was 102 + 102 cases, after taking account crossover of cases to the alternate study arm; a 1:1 randomization was performed. AV-GFR and AV-SRF were compared using analysis of covariation, and RV-GFR >25 was assessed using multivariable logistic regression. Intention-to-treat (ITT) and per-protocol analyses (PP) were performed. RESULTS: A total of 160 and 164 patients were randomly assigned to on- and off-clamp RAPN, respectively; crossover was observed in 14% and 43% of the on- and off-clamp arms, respectively. We were unable to find any statistically significant difference between on- vs off-clamp with regard to the primary endpoint (ITT: 6-month AV-GFR -6.2 vs -5.1 mL/min, mean difference 0.2 mL/min, 95% confidence interval [CI] -3.1 to 3.4 [P = 0.8]; PP: 6-month AV-GFR -6.8 vs -4.2 mL/min, mean difference 1.6 mL/min, 95% CI -2.3 to 5.5 [P = 0.7]) or with regard to the secondary endpoints. The median warm ischaemia time was 14 vs 15 min in the ITT analysis and 14 vs 0 min in the PP analysis. CONCLUSION: In patients with regular baseline function and two kidneys, we found no evidence of differences in functional outcomes for on- vs off-clamp RAPN.

Efficacy and safety of intravesical fibrin glue instillation for management of patients with refractory hemorrhagic cystitis: 12-months results. A promising therapy for hemorrhagic cystitis.

OBJECTIVES: Fibrin glue (FG) endo-vesical application seems to be a promising therapy for hemorrhagic cystitis (HC). We aimed to evaluate efficacy and safety of FG instillation in patients with HC. METHODS: Patients with HC not responsive to conventional treatments (bladder irrigation, catheterization, blood transfusions, hyperhydration and endoscopic coagulation) were treated with FG endo-vesical instillation (April 2017- December 2018). FG was prepared from 120 mL of patient blood with the Vivostat® system. After standard cystoscopy, bladder was insufflated with carbon dioxide (CO2) according to bladder compliance and autologous FG was applied to bladder wall and bleeding sites. RESULTS: Ten patients included with grade 2 or higher HC secondary to bone marrow graft for hematological diseases (30%) or to actinic cystitis caused by prostate cancer radiotherapy (RT) (70%). The median HC onset time after RT was 4.8 (IQR 3.9- 6.3) years and 35 (IQR 27.5-62.5) days after hematopoietic stem cell transplantation (HSCT). Five patients had a complete response after one treatment, three patients had clinical response (grade < 2 hematuria, amelioration of symptoms), one of them required catheterization and bladder irrigation. One patient required a second instillation of FG achieving a clinical response. No adverse events related to the procedure were recorded, however one patient died for causes not related to the procedure. Median Interstitial Cystitis Symptoms Index was 13.0 (IQR 11.0-15.0) pre-operatively and 4.0 (IQR 2.0-5.0) post-operatively. CONCLUSIONS: Our study showed that, even in hematological patients, autologous FG instillation maybe a safe, repeatable and effective treatment modality in patients with refractory HC.

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

OBJECTIVES: (1) To investigate whether a contrast-free biparametric MRI (bp-MRI) including T2-weighted images (T2W) and diffusion-weighted images (DWI) can be considered an accurate alternative to the standard multiparametric MRI (mp-MRI), consisting of T2, DWI, and dynamic contrast-enhanced (DCE) imaging for the muscle-invasiveness assessment of bladder cancer (BC), and (2) to evaluate how the diagnostic performance of differently experienced readers is affected according to the type of MRI protocol. METHODS: Thirty-eight patients who underwent a clinically indicated bladder mp-MRI on a 3-T scanner were prospectively enrolled. Trans-urethral resection of bladder was the gold standard. Two sets of images, set 1 (bp-MRI) and set 2 (mp-MRI), were independently reviewed by four readers. Descriptive statistics, including sensitivity and specificity, were calculated for each reader. Receiver operating characteristic (ROC) analysis was performed, and the areas under the curve (AUCs) were calculated for the bp-MRI and the standard mp-MRI. Pairwise comparison of the ROC curves was performed. RESULTS: The AUCs for bp- and mp-MRI were respectively 0.91-0.92 (reader 1), 0.90 (reader 2), 0.95-0.90 (reader 3), and 0.90-0.87 (reader 4). Sensitivity was 100% for both protocols and specificity ranged between 79.31 and 89.66% and between 79.31 and 83.33% for bp-MRI and mp-MRI, respectively. No significant differences were shown between the two MRI protocols (p > 0.05). No significant differences were shown accordingly to the reader's experience (p > 0.05). CONCLUSIONS: A bp-MRI protocol consisting of T2W and DWI has comparable diagnostic accuracy to the standard mp-MRI protocol for the detection of muscle-invasive bladder cancer. The experience of the reader does not significantly affect the diagnostic performance using VI-RADS. KEY POINTS: • The contrast-free MRI protocol shows a comparable accuracy to the standard multiparametric MRI protocol in the bladder cancer muscle-invasiveness assessment. • VI-RADS classification helps non-expert radiologists to assess the muscle-invasiveness of bladder cancer. • DCE should be carefully interpreted by less experienced readers due to inflammatory changes representing a potential pitfall.

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

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 Sklodowska-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.

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

INTRODUCTION: Robotic assisted radical prostatectomy (RARP) is getting more and more popular becoming the most common radical prostatectomy technique. Unfortunately, a not negligible proportion of patients in whom RARP is performed experience urinary incontinence. We aimed to systematically review the current literature evidence on urinary incontinence conservative treatment after RARP. EDIDENCE AQUISITION: A systematic literature review search using PubMed (Medline), Scopus, and Web of Science databases was performed in December 2019. PRISMA guidelines have been adopted. Population consisted of patients with urinary incontinence after RARP (P), conservative intervention was considered of interest (I). No comparator was considered mandatory (C). Outcomes of interest were the recovery of continence and quality of life (O). EVIDEDENCE SYNTHESIS: Six studies were included. Four of them investigated the use of pelvic floor muscle training (PFMT). PFMT improved pelvic muscle strength. Continence recovery was faster when guided PFMT was adopted. Moreover, two studies tested the effect of solifenacin on urinary incontinence. One of them, a randomized clinical trial, failed to show shorter time to continence in solifenacin group compared to placebo. CONCLUSIONS: The use of pads is associated with a detrimental effect on quality of life thus active treatments for UI post-RARP are warranted. PFMT has the main advantage to shorten the time for recovery. The use of solifenacin seems to not offer striking advantages in UI following RARP. Future studies should focus on testing the efficacy of these treatments when used after robotic vs. open radical prostatectomy.

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

BACKGROUND: The Vesical Imaging Reporting and Data System (VI-RADS) was recently introduced as a standardized approach to reporting multiparametric magnetic resonance imaging (mpMRI) for bladder cancer. We aimed to prospectively analyze its routine use and its diagnostic performance in discriminating non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). PATIENTS AND METHODS: A total of 38 patients with diagnosis of suspect bladder cancer at cystoscopy underwent bladder mpMRI before transurethral resection of the bladder (TURB). Bladder tumors were categorized according to the VI-RADS. After TURB, the VI-RADS score was compared with histological report for each lesion separately. Receiving operating characteristic and decision curve analyses were used to assess its accuracy and clinical utility. RESULTS: A total of 68 lesions were included, of which 7 (10.3%) were MIBC. The pooled accuracy was 90.0% (95% confidence interval [CI], 75.4%-98.7%). The best threshold was estimated as VI-RADS 4, showing a sensitivity of 85.7% (95% CI, 57.1%-100%) and a specificity of 86.9% (95% CI, 78.7%-95.1%). Decision curve analyses showed that using VI-RADS ≥4 improved the net benefit compared with any default strategy for threshold probabilities of MIBC up to ∼40%, which is a reasonable clinical threshold for planning further treatments. CONCLUSIONS: Our prospective study shows that the use of VI-RADS as a standardized reporting method is appealing and could be considered in clinical practice owing to its high accuracy.

Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial.

PURPOSE: To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN). METHODS: 302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial-ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared. RESULTS: Due to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09-0.52, p = 0.008). CONCLUSIONS: The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.

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

PURPOSE: Docetaxel represent the standard of care in patients with metastatic, hormone sensitive prostate cancer. However, androgen receptor axis targeted therapies have also been shown to be effective. We aimed to analyze findings in randomized controlled trials investigating first-line treatment for hormone sensitive prostate cancer. MATERIALS AND METHODS: We systematically reviewed the literature according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria and the PICO (Population, Intervention, Comparator, Outcomes) methodology. Outcomes of interest were overall and progression-free survival, and the rate of high grade adverse events. RESULTS: No treatment was superior to docetaxel in terms of overall survival. However, abiraterone (HR 0.89, 95% CI 0.76-1.05), enzalutamide (HR 0.90, 95% CI 0.69-1.19) and apalutamide (HR 0.90, 95% CI 0.67-1.22) showed nonstatistically significant lower overall mortality rates than docetaxel. Abiraterone (HR 0.71, 95% CI 0.59-0.86), enzalutamide (HR 0.61, 95% CI 0.49-0.75) and apalutamide (HR 0.74, 95% CI 0.57-0.95) also showed statistically significant lower disease progression rates than docetaxel. Furthermore, abiraterone (OR 0.83, 95% CI 0.56-1.21) showed no statistically significant lower rate of high grade adverse events compared to docetaxel. Finally, enzalutamide (OR 0.56, 95% CI 0.35-0.92) and apalutamide (OR 0.44, 95% CI 0.24-0.79) showed statistically significant lower rates of high grade adverse events compared to docetaxel. CONCLUSIONS: Treatment with androgen receptor axis targeted therapies combined with androgen deprivation therapy in patients with hormone sensitive prostate cancer did not offer a statistically significant advantage in overall survival compared to the standard, docetaxel. However, it was associated with a lower disease progression rate. Moreover, apalutamide and enzalutamide offer a better safety profile.

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

Introduction: To evaluate the safety profile characteristics of abiraterone acetate (AA) in the treatment of metastatic prostate cancer (mPCa). Areas covered: 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). Expert opinion: 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.

Predictors of the Transition from Off to On Clamp Approach during Ongoing Robotic Partial Nephrectomy: Data from the CLOCK Randomized Clinical Trial.

PURPOSE: We sought to identify predictive factors of the transition from off clamp to on clamp robotic partial nephrectomy following an intraoperative decision. MATERIALS AND METHODS: In the multicenter, randomized, prospective CLOCK (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy) trial 152 and 149 of the 301 patients with a localized renal mass were assigned to undergo off clamp and on clamp robotic partial nephrectomy, respectively. Surgery was done at a total of 7 referral institutions by 1 surgeon per institution. A localized renal mass was defined as having a R.E.N.A.L. (radius, exophytic/endophytic, nearness to collecting system or sinus, anterior/posterior, location relative to polar lines, hilar) score less than 10. Surgeons had similar experience with at least 100 previous robotic partial nephrectomies. All patients underwent a preoperative and a 6-month renal scan. The current study deals with one of the secondary end points of the trial, comparing cases finalized as clampless (off robotic partial nephrectomy group) with those which were converted (shift robotic partial nephrectomy group). RESULTS: Of the 152 patients randomized to off clamp 61 (40%) were shifted to clamp with a median ischemia time of 15 minutes. In the shift robotic partial nephrectomy group the masses were larger (3.5 vs 2.2 cm) and more complex (R.E.N.A.L. score 7 vs 6). A significant association with transition was found for tumor diameter (OR 1.4) and the R.E.N.A.L. score continuously (OR 1.4) and when recoded in groups, including 4-no risk (referent OR 1), 5-6-low risk (OR 1.8), 7-8-intermediate risk (OR 3.6) and 9 or greater-high risk (OR 6.6). The shift robotic partial nephrectomy group had longer operative time, higher blood loss and increased performance of 2-layer renorrhaphy. No significant differences were noted in postoperative complications or renal function after 6 months. CONCLUSIONS: The transition from off to on clamp robotic partial nephrectomy is associated with renal mass diameter and complexity. Under the specific conditions of the current trial no harm was related to this decision.

Survival after Cytoreductive Nephrectomy in Metastatic Non-clear Cell Renal Cell Carcinoma Patients: A Population-based Study.

BACKGROUND: The benefit of cytoreductive nephrectomy (CNT) for cancer-specific mortality (CSM)-free survival is unclear in contemporary metastatic non-clear cell renal cell carcinoma (non-ccmRCC) patients. OBJECTIVE: To assess the role of CNT in non-ccmRCC patients. DESIGN, SETTING, AND PARTICIPANTS: Within Surveillance, Epidemiology, and End Results registry (2001-2014), we identified patients with non-ccmRCC. INTERVENTION: CNT versus no CNT in non-ccmRCC patients. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariable logistic regression, cumulative incidence, competing-risks regression models, incremental survival benefit (ISB), conditional survival, and landmark analyses were performed. Sensitivity analyses focused on histological subtypes and most contemporary patients (2010-2014). RESULTS AND LIMITATIONS: Of 851 patients with non-ccmRCC, 67.6% underwent CNT. In multivariable logistic regression, year of diagnosis in contemporary (p<0.001) and intermediate (p=0.008) tertiles, as well as age ≥75 yr (p<0.001) yielded lower CNT rates. Cumulative incidence showed 2-yr CSM of 52.6% versus 77.7%, respectively, after CNT versus no CNT. CSM after CNT versus no CNT was invariably lower in all histologic subtypes and in contemporary patients. Multivariable competing-risks regression models predicting CSM favored CNT (hazard ratio [HR]: 0.38, confidence interval: 0.30-0.47, p<0.001) in all patients and in all subgroups defined by histologic subtypes (HR: 0.14-0.43, all p≤0.02), as well as in contemporary patients (HR: 0.32, p<0.001). The ISB analyses yielded statistically significant and clinically meaningful CSM-free survival benefit of +3 mo after CNT versus no CNT in individuals with observed CSM-free survival ≤24 mo. The 2-yr CSM-free survival increased from baseline of 46.1% versus 19.4% (Δ=26.7%, p<0.001) to 70.3% versus 54.4% (Δ=15.9%, p=0.005) after CNT versus no CNT, in patients that survived 12 mo, respectively. Landmark analyses rejected bias favoring CNT. Data were retrospective. CONCLUSIONS: CSM is lower after CNT for non-ccmRCC in all histologic subtypes and in contemporary patients except for unproven ISB in collecting duct patients. This observation should encourage greater CNT consideration in non-ccmRCC. PATIENT SUMMARY: Cytoreductive nephrectomy appears to improve survival in metastatic non-clear cell renal cell carcinoma, but it is used infrequently.

The Effect of Institution Teaching Status on Perioperative Outcomes After Robotic Partial or Radical Nephrectomy.

OBJECTIVES: To test rates over time of robotic partial and radical nephrectomy (RPN and RRN) at teaching vs nonteaching institutions and to examine associated complication rates and length of stay. MATERIALS AND METHODS: Within the National Inpatient Sample (2008-2013), after stratification according to institutional teaching status, we examined the rates of robotic, open, and laparoscopic PN and RN. Subsequently, we tested complication rates and length of stay associated with RPN or RRN according to institutional teaching status. We relied on estimated annual percentage change (EAPC) with the least squares linear regression to test temporal trends and on multivariable logistic regression (MLR) and Poisson regression models to test complication rates and length of stay. RESULTS: Overall, 4070 and 1683 RPN and RRN were identified. In MLR, RPN rates were lower at teaching vs nonteaching institutions (odds ratio [OR]: 0.79, p < 0.001). RPN increased at similar rates over time at teaching and nonteaching institutions (EAPC: +32.1% and +30.1%, all p < 0.05). In MLR, RRN rates were similar at teaching and nonteaching institutions (p: 0.4). RRN rate increase over time was of similar magnitude at teaching vs nonteaching institutions (EAPC: +35.5% and +43.0%, all p < 0.05). RPN at teaching institutions yielded higher genitourinary complication rates (OR: 1.46, p: 0.01). RRN at teaching institutions resulted in lower respiratory complications (OR: 0.66, p: 0.04) and shorter length of stay (rate ratio [RR]: 0.93, p: 0.01), but higher intraoperative complication rates (OR: 3.39, p: 0.04). CONCLUSION: Despite statistically significant differences in rates of RPN use, according to the institutional teaching status and despite statistically significant difference in selected complications, no meaningful differences distinguish teaching vs nonteaching institution when RPN and RRN are considered.

Trifecta and Pentafecta Rates After Robotic Assisted Partial Nephrectomy: Comparative Study of Patients with Renal Masses <4 and ≥4 cm.

OBJECTIVES: Robotic-assisted partial nephrectomy (RAPN) is preferred to radical nephrectomy because it guarantees superior functional outcomes in patients with small renal masses (RMs). Only a few studies so far have evaluated the feasibility of RAPN for the treatment of RM ≥4 cm. The aim of this study is to evaluate the safety and feasibility of RAPN based on a comparison of trifecta and pentafecta rates for RMs ≥4 cm. MATERIAL AND METHODS: We retrospectively analyzed prospectively collected data from an institutional database of patients undergoing RAPN from September 2013 to November 2016. Demographic and perioperative data were collected and statistically analyzed. Pentafecta is defined as achievement of trifecta (negative surgical margins, no postoperative complications, and warm ischemia time ≤25 minutes) with the addition of two other variables, namely, over 90% estimated glomerular filtration rate preservation and no chronic kidney disease stage progression 1 year after surgery. RESULTS: Overall, 123 patients underwent RAPN. Of those, 38 (30.9%) had RMs ≥4 cm. Trifecta was achieved in 72.9% of patients with RMs <4 cm and in 44.7% of those with ≥4 cm, whereas pentafecta was achieved by 23.5% of patients with RMs <4 cm and by 10.5% of those with RMs ≥4 cm. No significant predictive factors were found in connection with trifecta, whereas only one was found in connection with pentafecta, namely, age (odds ratio: 0.91; 95% confidence interval 0.85-0.98; P = .01). CONCLUSIONS: RAPN may be considered a feasible and safe surgical approach ensuring good functional outcome even for patients with RMs ≥4 cm. Pentafecta rates after RAPN were comparable between RMs <4 and ≥4 cm in diameter.

Bladder Neck Contracture After Endoscopic Surgery for Benign Prostatic Obstruction: Incidence, Treatment, and Outcomes.

PURPOSE OF REVIEW: In recent years, new endoscopic techniques have been developed to reduce the morbidity of transurethral resection of the prostate. Nonetheless, complications are still frequently encountered and bladder neck contracture (BNC) is a well-described complication after endoscopic surgery for benign prostatic obstruction (BPO). Our aim is to review and discuss the contemporary incidence, the relevant treatment strategies, and their outcomes. RECENT FINDINGS: Findings suggest that BNC is a common complication with an acceptably low incidence but can range in complexity. Most contractures were usually managed successfully with conservative measures; nevertheless, in patients with refractory BNC, various valuable management strategies were employed with different kinds of success and re-treatment rates. In consideration of these challenging possibilities, the treatment of BNC requires a tailored approach with patient-specific management that can range from simple procedures to complex surgical reconstruction.