A 10-year renaissance of en bloc resection of bladder tumors (ERBT): Are we approaching the peak or is it back to the trough?

BACKGROUND: The number of studies suggesting that en bloc resection of bladder tumor (ERBT) is superior to transurethral resection of bladder tumor (TURBT) for non-muscle-invasive bladder cancer (NMIBC) management is growing. The aim of this review is to discuss the features of these procedures and to determine the prospects of en bloc in NMIBC management. MATERIALS AND METHODS: We conducted a literature search using two databases (Medline and Scopus) and included any research which reported ERBT outcomes. RESULTS: The lasers with minimal tissue penetration depth are becoming the main tool for ERBT. Unfortunately, most of the systematic reviews continue to be characterized by high heterogeneity. However, recent studies indicate that ERBT may have the edge when it comes to the detrusor muscle rate and the quality of the histological specimen. ERBT may favor in terms of in-field relapse, but its rate in the studies varies greatly. As for out-field relapse-free survival, the data are still lacking. The strongest evidence supports that ERBT is superior to TURBT in complications rate (bladder perforation). ERBT is feasible irrespective to tumor size and location. CONCLUSIONS: ERBT has gained in momentum with the increasingly widespread use of this kind of laser surgery. The introduction of novel sources (TFL and Thulium:YAG pulsed laser) will definitely affect how the field develops and will result in further improvements in safety and precision. The latest trials make us more certain in our belief that ERBT will be beneficial in terms of histological specimen quality, relapse rate and complications rate.

Characterization of the histological response to the Butterfly Prostatic Retraction Device in patients with benign prostatic hyperplasia.

PURPOSE: The Butterfly Prostatic Retraction Device ("Butterfly") is a permanent nitinol implant for benign prostatic hyperplasia. This study examines the chronic response of prostate tissue to the Butterfly in histological specimens from patients in the Butterfly pilot clinical study. METHODS: Retrospective qualitative and semi-quantitative review of histological specimens of seven (7) patients who participated in the Butterfly pilot clinical study. Patients had at least 1-month implantation with the Butterfly prior to implant removal and TURP. Tissue samples were graded by two pathologists. RESULTS: Four out of six patients had IPSS decreased from baseline. All seven patients' samples had signs of chronic inflammation; one demonstrated acute inflammation and one demonstrated fibrosis. In three cases, intraglandular calcification was identified. There was no ischemic necrosis induced by the implant, and no encrustation, urethral edema, or cellular atypia was noted. CONCLUSION: The Butterfly demonstrated an overall favorable safety profile in terms of tissue response. This study demonstrates that there is no significant tissue reaction in the prostatic urethra due to presence of Butterfly device.

Comparison of EEP and TURP long-term outcomes: systematic review and meta-analysis.

OBJECTIVE: To compare long-term reoperation rate and functional outcomes between EEP (endoscopic enucleation of the prostate) and TURP (transurethral resection of the prostate). EVIDENCE ACQUISITION: A systematic literature review of Medline, Scopus, and Web of Science was conducted with primary outcome assessed being reoperation rate and secondary outcomes after a long term (> 3 years) being functional outcomes or related values (prostate volume, PSA level, etc.). EVIDENCE SYNTHESIS: Five studies were found with long-term follow-up 4-7 years. EEP reoperation rate ranged from 0 to 1.27%, while from 1.7 to 17.6% for TURP. Meta-analysis showed significantly lower OR for EEP, 0.27 (95% CI 0.24-0.31), with notable homogeneity of the results, I2 = 0%. Long-term Qmax and IPSS were significantly better for EEP. Qmax pooled mean difference was 1.79 (95% CI 1.72-1.86) ml/s with a high concordance among the studies, I2 = 0%. IPSS mean difference -1.24 (95% CI - 1.28 to - 1.2) points, I2 = 57% but QoL did not differ, with mean difference being 0.01 (95% CI - 0.02 to 0.04), I2 = 0%. IIEF-5 score was also significantly better for EEP, mean difference 1.08 (95% CI 1.03-1.13), but heterogeneity was high, I2 = 70%. PSA level and prostate volume were only reported in one study and favored EEP slightly yet statistically significant. CONCLUSION: EEP had a significantly lower reoperation rate and better functional outcomes (Qmax and IPSS) at long term compared with TURP. It may also be beneficial in terms of IIEF-5, PVR, and PSA level.

Association between Hidradenitis Suppurativa and Abnormalities in Semen Parameters and Sexual Function: A Pilot Study.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease affecting patients of reproductive age. Although HS shares risk factors with male infertility, only 1 epidemiological study has evaluated this association. To further evaluate this potential association, findings on semen and hormonal analysis, testicular ultrasound, and the International Index of Erectile Function (IIEF-15) were compared between 28 men attending a tertiary HS clinic during the period April 2019 to April 2021, and 44 healthy controls, spouses of infertile women undergoing semen evaluation before in vitro fertilization. Patients with HS were divided based on the absence or presence of gluteal and genital lesions. Patients with HS were younger than controls (median 27 vs 34 years, p < 0.0004) and had a higher proportion of smokers (86% vs 33%, p < 0.0001). Semen parameters in patients with gluteal-genital lesions, specifically those with severe scrotal involvement necessitating surgery, were lower than the WHO reference values and significantly lower than in patients without gluteal-genital lesions and controls. Erectile dysfunction was reported by 93% of patients with HS. These findings suggest that spermatogenesis and sexual function may be impaired in young men with HS. Therefore, multidisciplinary management of HS should include their evaluation to identify patients who might benefit from semen cryopreservation and sexual treatment.

The Butterfly: A Novel Minimally Invasive Transurethral Retraction Device for Benign Hypertrophy of the Prostate.

INTRODUCTION: The Butterfly Prostatic Retraction device is a novel transurethral implant designed to dilate the prostatic urethra and treat lower urinary tract symptoms. We assessed its safety, efficacy and impact on urinary flow, ejaculation, and quality of life. MATERIALS AND METHODS: We included 64 men, treated for benign prostate hyperplasia for at least 1 year. All patients had Qmax≤ 13 mL/s and IPSS >12. Insertion of the device was performed via cystoscopy. Follow-up visits were performed at 2 weeks, 1, 3, 6, and 12 months and included uroflowmetry, IPSS, QoL, and sexual function questionnaires. Cystoscopy was performed on 3 and 12 months. RESULTS: Patients age was 50-83 years. 28 patients completed a 1-year follow-up with an intact device. Mean Qmax improved by 2 mL/s (25%), IPSS median drop was 10 points (40%), and QoL score was 1.5 points (38%). Sexually active patients reported antegrade ejaculation. On cystoscopy, gradual coverage of the devices with urethral mucosa was observed. In 1 patient, the device was repositioned. In 19 patients, the device was removed. 12 patients returned to alpha-blocker therapy and 7 patients underwent TURP. One patient developed a bulbar urethral stricture. CONCLUSIONS: We demonstrated feasibility and good tolerability of the Butterfly device.

Association between early change in neutrophil-to-lymphocyte ratio after radical cystectomy and treatment outcomes.

OBJECTIVES: To evaluate the associations of peri-operative neutrophil-to-lymphocyte ratio (NLR) and change in NLR with survival after radical cystectomy. PATIENTS AND METHODS: We retrospectively reviewed a multicentre cohort of patients with bladder cancer who underwent radical cystectomy between 2010 and 2020. Preoperative NLR, postoperative NLR, delta-NLR (postoperative minus preoperative NLR) and NLR change (postoperative divided by preoperative NLR) were calculated. Patients were stratified based on elevation of preoperative and/ or postoperative NLR above the median values. Multivariable Cox regression models were used to evaluate the associations of peri-operative NLR and NLR change with survival. RESULTS: The study cohort included 346 patients with a median age of 69 years. The median (interquartile range) preoperative NLR, postoperative NLR, delta-NLR and NLR change were 2.55 (1.83, 3.90), 3.33 (2.21, 5.20), 0.43 (-0.50, 2.08) and 1.2 (0.82, 1.96), respectively. Both preoperative and postoperative NLR were elevated in 110 patients (32%), 126 patients (36%) had an elevated preoperative or postoperative NLR, and 110 patients (32%) did not have an elevated NLR. On multivariable analysis, increased preoperative and postoperative NLR were significantly associated with decreased survival. While delta-NLR and NLR change were not associated with outcome, patients with elevations in both preoperative and postoperative NLR had the worst overall (hazard ratio [HR] 2.97, 95% confidence interval [CI] 1.78, 4.95; P < 0.001) and cancer-specific survival rates (HR 2.41, 95% CI 1.3, 4.4; P = 0.004). CONCLUSIONS: Preoperative and postoperative NLR are significant predictors of survival after radical cystectomy; patients in whom both NLR measures were elevated had the worst outcomes. Future studies should evaluate whether an increase in NLR during long-term follow-up may precede disease recurrence.

Fascial dehiscence after radical cystectomy: Is abdominal exploration mandatory?

BACKGROUND: Fascial dehiscence after radical cystectomy may have serious clinical implications. To optimize its management, we sought to describe accompanying intraabdominal findings of post-cystectomy dehiscence repair and determine whether a thorough intraabdominal exploration during its operation is mandatory. METHODS: We retrospectively reviewed a multi-institutional cohort of patients who underwent open radical cystectomy between 2005 and 2020. Patients who underwent exploratory surgery due to fascial dehiscence within 30 days post-cystectomy were included in the analysis. Data collected included demographic characteristics, the clinical presentation of dehiscence, associated laboratory findings, imaging results, surgical parameters, operative findings, and clinical implications. Potential predictors of accompanying intraabdominal complications were investigated. RESULTS: Of 1301 consecutive patients that underwent cystectomy, 27 (2%) had dehiscence repair during a median of 7 days post-surgery. Seven patients (26%) had accompanying intraabdominal pathologies, including urine leaks, a fecal leak, and an internal hernia in 5 (19%), 1 (4%), and 1 (4%) patients, respectively. Accompanying intraabdominal findings were associated with longer hospital stay [20 (IQR 17, 23) vs. 41 (IQR 29, 47) days, P = 0.03] and later dehiscence identification (postoperative day 7 [IQR 5, 9] vs. 10 [IQR 6, 15], P = 0.03). However, the rate of post-exploration complications was similar in both groups. A history of ischemic heart disease was the only predictor for accompanying intraabdominal pathologies (67% vs. 24%; P = 0.02). CONCLUSIONS: A substantial proportion of patients undergoing post-cystectomy fascial dehiscence repair may have unrecognized accompanying surgical complications without prior clinical suspicion. While cardiovascular disease is a risk factor for accompanying findings, meticulous abdominal inspection is imperative in all patients during dehiscence repair. Identification and repair during the surgical intervention may prevent further adverse, possibly life-threatening consequences with minimal risk for iatrogenic injury.

Diagnostic Performance of 68Ga Prostate-specific Membrane Antigen PET/MRI Compared with Multiparametric MRI for Detecting Clinically Significant Prostate Cancer.

Background Gallium 68 (68Ga) prostate-specific membrane antigen (PSMA) PET/MRI may improve detection of clinically significant prostate cancer (CSPC). Purpose To compare the sensitivity and specificity of 68Ga-PSMA PET/MRI with multiparametric MRI for detecting CSPC. Materials and Methods Men with prostate specific antigen levels of 2.5-20 ng/mL prospectively underwent 68Ga-PSMA PET/MRI, including multiparametric MRI sequences, between June 2019 and March 2020. Imaging was evaluated independently by two radiologists by using the Prostate Imaging Reporting and Data System (PI-RADS) version 2.1. Sensitivity and specificity for CSPC (International Society of Urological Pathology grade group ≥ 2) were compared for 68Ga-PSMA PET/MRI and multiparametric MRI by using the McNemar test. Decision curve analysis compared the net benefit of each imaging strategy. Results Ninety-nine men (median age, 67 years; interquartile range, 62-71 years) were included; 79% (78 of 99) underwent biopsy. CSPC was detected in 32% (25 of 78). For CSPC, specificity was higher for 68Ga-PSMA PET/MRI than multiparametric MRI (76% [95% CI: 62, 86] vs 49% [95% CI: 35, 63], respectively; P < .001). Sensitivity was similar (88% [95% CI: 69, 98] vs 92% [95% CI: 74, 99], respectively; P > .99). For PI-RADS 3 lesions, specificity was also higher for 68Ga-PSMA PET/MRI than for multiparametric MRI: 86% (95% CI: 73, 95) versus 59% (95% CI: 43, 74), respectively (P = .002). Decision curve analysis showed that biopsies targeted to PSMA uptake increased the net benefit of multiparametric MRI only among PI-RADS 3 lesions. The net benefit of targeted biopsy for a PI-RADS 3 lesion with PSMA uptake was higher across all threshold probabilities over 8%. The net benefit of targeted biopsy was similar for PI-RADS 4 and 5 lesions, regardless of PSMA uptake. Conclusions Gallium 68 prostate-specific membrane antigen PET/MRI improved specificity for clinically significant prostate cancer compared with multiparametric MRI, particularly in Prostate Imaging Reporting and Data System grade 3 lesions. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Williams and Estes in this issue.

Cardiovascular Proteomics: A Post Hoc Analysis from a Phase II Randomized Clinical Trial Comparing GnRH Antagonist vs GnRH Agonist among Men with Advanced Prostate Cancer.

PURPOSE: Recent studies demonstrated reduced cardiovascular (CV) risk with gonadotropin-releasing hormone (GnRH) antagonist, yet the underlying mechanism remains undetermined. The objective of this study was to examine longitudinal changes over time in established CV related proteins among men treated with GnRH agonists vs GnRH antagonist. MATERIALS AND METHODS: We performed a proteomics analysis of serum samples collected during a phase II randomized study among 80 men with advanced prostate cancer and preexisting CV disease who were randomized to receive a GnRH agonist (39) or GnRH antagonist (41) for 1 year. Serum samples were collected at baseline and at 3, 6 and 12 months following treatment, and analyzed levels of 188 proteins using the CV panel II and III of the Olink Multiplex platform (Olink Proteomics AB, Uppsala, Sweden). We fitted a linear mixed effects model to assess evidence of a treatment effect across CV related protein values. This included terms for treatment arm, protein levels and time-by-treatment interaction. Results were corrected for multiple testing using the Benjamini-Hochberg method. RESULTS: The CV proteomics analysis included 283 samples from 78 subjects. We identified 5 proteins with distinct patterns over time depending on study arm: human chitotriosidase, macrophage receptor with collagenous structure, cathepsin D, superoxide dismutase 2 and hydroxyacid oxidase 1. All 5 are associated with plaque stability and demonstrated an increased level among subjects in the GnRH antagonist arm compared to agonist. CONCLUSIONS: We compared longitudinal changes in CV proteins among men using androgen deprivation therapy. Our results support a direct protective effect of GnRH antagonist on plaque stability rather than a hazardous consequence of GnRH agonists on plaque rupture. This is a hypothesis generating study, and requires further confirmation.

Association of patients' sex with treatment outcomes after intravesical bacillus Calmette-Guérin immunotherapy for T1G3/HG bladder cancer.

PURPOSE: To investigate the association of patients' sex with recurrence and disease progression in patients treated with intravesical bacillus Calmette-Guérin (BCG) for T1G3/HG urinary bladder cancer (UBC). MATERIALS AND METHODS: We analyzed the data of 2635 patients treated with adjuvant intravesical BCG for T1 UBC between 1984 and 2019. We accounted for missing data using multiple imputations and adjusted for covariate imbalance between males and females using inverse probability weighting (IPW). Crude and IPW-adjusted Cox regression analyses were used to estimate the hazard ratios (HR) with their 95% confidence intervals (CI) for the association of patients' sex with HG-recurrence and disease progression. RESULTS: A total of 2170 (82%) males and 465 (18%) females were available for analysis. Overall, 1090 (50%) males and 244 (52%) females experienced recurrence, and 391 (18%) males and 104 (22%) females experienced disease progression. On IPW-adjusted Cox regression analyses, female sex was associated with disease progression (HR 1.25, 95%CI 1.01-1.56, p = 0.04) but not with recurrence (HR 1.06, 95%CI 0.92-1.22, p = 0.41). A total of 1056 patients were treated with adequate BCG. In these patients, on IPW-adjusted Cox regression analyses, patients' sex was not associated with recurrence (HR 0.99, 95%CI 0.80-1.24, p = 0.96), HG-recurrence (HR 1.00, 95%CI 0.78-1.29, p = 0.99) or disease progression (HR 1.12, 95%CI 0.78-1.60, p = 0.55). CONCLUSION: Our analysis generates the hypothesis of a differential response to BCG between males and females if not adequately treated. Further studies should focus on sex-based differences in innate and adaptive immune system and their association with BCG response.

Trends in urological emergencies in the Era of COVID-19.

PURPOSE: To evaluate trends in emergency room (ER) urological conditions during COVID-19 pandemic lockdown. MATERIALS AND METHODS: Retrospective analyses of renal colic, hematuria, and urinary retention in ER's admissions of a tertiary hospital during the lockdown period (March 19 to May 4, 2020) in Israel. Patient's demographics and clinical characteristics were compared to those in corresponding periods during 2017-2019, with estimated changes in ER arrival and waiting times, utilization of imaging tests, numbers of hospitalizations, and urgent procedure rates. RESULTS: The number of ER visits for renal colic, hematuria, and urinary retention decreased by 37%, from an average of 451 (2017-2019) to 261 patients (2020). Clinical severity was similar between groups, with no major differences in patient's age, vital signs, or laboratory results. The proportion of ER visits during night hours increased significantly during lockdown (44.8% vs. 34.2%, p=0.002). There was a decrease in renal colic admission rate from 19.8% to 8.4% (p=0.001) without differences in urgent procedures rates, while the 30-day revisit rate decreased from 15.8% to 10.3% during lockdown (p=0.02). CONCLUSIONS: General lockdown was accompanied by a significant decrease in common urological presentations to the ER. This change occurred across the clinical severity spectrum of renal colic, hematuria, and urinary retention. In the short term, it appears that patients who sought treatment did not suffer from complications that could be attributed to late arrival or delay in treatment. The long-term implications of abstinence from seeking emergent care are not known and require further investigation.

[BLADDER PAIN SYNDROME - DOES DETRUSOR MASTOCYTOSIS PREDICT SYMPTOMATIC IMPROVEMENT FOLLOWING BLADDER HYDRODISTENTION UNDER ANESTHESIA?]

INTRODUCTION: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic, debilitating syndrome involving bladder pain and lower urinary tract symptoms (LUTS), with a substantial effect on patients' quality of life. IC/BPS poses a diagnostic challenge, and its available treatment options remain only moderately effective. Bladder-wall biopsies from IC/BPS patients commonly uncover mastocytosis. While mast-cells are suspected as pivotal in disease pathogenesis, the clinical significance of their presence remains unclear. Clinical guidelines differ on whether or not bladder biopsies should be a part of routine IC/BPS workup. AIMS: To determine whether detrusor mastocytosis can serve as a prognostic marker for treatment response and improvement duration. METHODS: We retrospectively collected patient data for IC/BPS patients who underwent bladder hydrodistension under anesthesia. We used statistical modelling to determine the effect of mastocystosis and other possible predictive factors - age, comorbidity, Hunner lesions - on the presence and duration of symptom improvement. RESULTS: A total of 35 patients (89% female, median age 63.5 [IQR 48.8-73.6] years) underwent hydrodistension, of whom 28 (89% female, median age 63.0 [44.8-73.1] years) had bladder biopsies; 11 (39%) of them had mastocystosis. Within a median follow-up of 8.8 [1.7-24.2] months, 11 (100%) of the patients with mastocytosis and 9 (53%) of the patients without it, experienced symptomatic improvement (p=0.007). Improvement duration was 8 months longer (p=0.006) in those with mastocystosis. Univariate logistic regression models were used to estimate odds ratios (OR). Mastocytosis (p=0.004) and Charlson Comorbidity score were the only variables with a statistically significant OR. Univariate survival models were fitted, and improvement duration was estimated to be longer in patients with mastocystosis (p=0.01). A multivariate Cox regression model found no variable to be statistically significant, though mastocystosis was borderline significant (p=0.055). CONCLUSIONS: Mastocystosis defines a discernible phenotype of IC/BPS, which exhibits higher rates and longer duration of hydrodistention treatment response. DISCUSSION: Notwithstanding limitations of sample size and retrospective study design, we were able to demonstrate that mastocystosis can serve as a prognostic factor for symptom improvement after hydrodistension in IC/BPS patients. Prospective studies are required to validate this finding and to investigate the mechanisms involved.

Short-Term Outcomes of Active Surveillance for Low Risk Prostate Cancer among Men with Germline DNA Repair Gene Mutations.

PURPOSE: Men with germline mutations in DNA repair genes have a higher risk of prostate cancer. Active surveillance is the preferred treatment modality for low risk prostate cancer. However, many fear offering this alternative to men with germline mutations. We describe the short-term oncologic outcomes of active surveillance in a population of men with a high genetic predisposition for prostate cancer. MATERIALS AND METHODS: A prospective cohort of men with germline DNA repair gene mutations were diagnosed with Grade Group 1 prostate cancer. All men were offered active surveillance. Followup consisted of prostate specific antigen every 3 months, multiparametric magnetic resonance imaging and a magnetic resonance imaging-ultrasound fusion confirmatory biopsy within 1 year of diagnosis. The primary end points included treatment and progression-free survival. RESULTS: Eighteen carriers of DNA repair gene mutations were diagnosed with low risk prostate cancer (BRCA1 [8], BRCA2 [6], CHEK2 [2], Lynch syndrome [2]). Of these patients 15 (83%) initiated active surveillance and 3 (17%) declined. All but 1 were fully compliant with the active surveillance protocol (93%). Overall 20% (3) had upgrading at confirmatory biopsy and were treated. At a median followup of 28 months (IQR 8.5-42) 80% of patients (12) on active surveillance are free from upgrading or radical treatment. CONCLUSIONS: Active surveillance may be feasible among carriers diagnosed with low risk prostate cancer. If embarking on active surveillance, carriers should be very carefully monitored at a specialized clinic, optimizing patient compliance and minimizing risk. Until larger scale studies with long-term followup become available, this option should be cautiously discussed with the patient.

Tubeless supra-costal percutaneous nephrolithotomy is associated with significantly less hydrothorax: a prospective randomized clinical study.

OBJECTIVES: To evaluate prospectively whether a tubeless (JJ stent-only) percutaneous nephrolithotomy (PCNL) might reduce the risk of hydrothorax, compared to an approach where a nephrostomy tube is left. MATERIALS AND METHODS: We conducted a two-arm open-label prospective randomized study (NCT02036398) comparing tubeless supra-costal PCNL (with a JJ stent only) to standard PCNL (with nephrostomy tube and JJ stent) using intention-to-treat (ITT) and per-protocol (PP) analyses. All patients underwent a standard single-stage prone supra-costal procedure with single-tract access. Complication data were collected according to the Clavien-Dindo grading system. The primary endpoint was the rate of hydrothorax, and secondary endpoints included stone-free rate (SFR) and complication rate. Multivariable logistic regression analysis identified factors associated with hydrothorax formation. RESULTS: Out of 101 patients approached, 75 were finally analysed. No differences were observed between the two arms with regard to baseline demographic and stone characteristics. The mean largest stone size ranged between 23 and 24.2 mm. No significant difference was seen in the mean operating time and length of hospital stay. The incidence of hydrothorax was significantly higher in the nephrostomy group in comparison to the tubeless group (37.8% vs 15.8%, P = 0.031, and 38.4% vs 13.8%, P = 0.016, in the ITT and PP analyses, respectively). The SFR and complication rate were similar in both groups using the ITT and PP analyses. Multivariable logistic regression analysis showed that nephrostomy tube placement was the only covariate associated in a statistically significant manner to hydrothorax (odds ratio 3.628, 95% confidence interval 1.073-12.265; P = 0.038). CONCLUSION: The rate of hydrothorax in supra-costal PCNL is associated with the type of postoperative drainage left. When possible, a tubeless approach should be applied as it may confer a lower risk of hydrothorax.

Complication rate after cystectomy following pelvic radiotherapy: an international, multicenter, retrospective series of 682 cases.

PURPOSE: Conflicting evidence exists on the complication rates after cystectomy following previous radiation (pRTC) with only a few available series. We aim to assess the complication rate of pRTC for abdominal-pelvic malignancies. METHODS: Patients treated with radical cystectomy following any previous history of RT and with available information on complications for a minimum of 1 year were included. Univariable and multivariable logistic regression models were used to assess the relationship between the variable parameters and the risk of any complication. RESULTS: 682 patients underwent pRTC after a previous RT (80.5% EBRT) for prostate, bladder (BC), gynecological or other cancers in 49.1%, 27.4%, 9.8% and 12.9%, respectively. Overall, 512 (75.1%) had at least one post-surgical complication, classified as Clavien ≥ 3 in 29.6% and Clavien V in 2.9%. At least one surgical complication occurred in 350 (51.3%), including bowel leakage in 6.2% and ureteric stricture in 9.4%. A medical complication was observed in 359 (52.6%) patients, with UTI/pyelonephritis being the most common (19%), followed by renal failure (12%). The majority of patients (86%) received an incontinent urinary diversion. In multivariable analysis adjusted for age, gender and type of RT, patients treated with RT for bladder cancer had a 1.7 times increased relative risk of experiencing any complication after RC compared to those with RT for prostate cancer (p = 0.023). The type of diversion (continent vs non-continent) did not influence the risk of complications. CONCLUSION: pRTC carries a high rate of major complications that dramatically exceeds the rates reported in RT-naïve RCs.

Catheter-associated meatal pressure injury in hospitalized males.

AIMS: To assess the prevalence of catheter-associated meatal pressure injury in acute hospitalized males, to determine risk factors for its formation and to propose a grading system for meatal pressure injury severity. METHODS: In this cross-sectional study, we screened all adult males concurrently hospitalized at a tertiary medical center for indwelling urethral catheters and for meatal pressure injury. We proposed a system to grade meatal pressure injury severity and used logistic-regression modeling to calculate odds ratios (ORs) of possible risk factors. RESULTS: A number of 168/751 (22.4%) hospitalized males with indwelling urethral catheters were included. Median age was 70.5 (inter-quartile range [IQR]: 57.0-80.3) years, median time from catheterization 5.5 (IQR: 2-11) days. A total of 61 (36%) had meatal pressure injury, as early as the first day after catheterization. Grade III injuries (<2 cm ulcer) developed in 22 (13%) patients, earliest noted on the second catheter day, and grade IV injuries (≥2 cm) in 7 (4%) patients, as early as 5 days post catheterization. In a multivariable analysis, catheter fixation (OR: 0.26 [95% CI: 0.10-0.70]; P = .008) was associated with reduced risk of meatal pressure injury, while catheter presence over 14 days (OR: 1.46 [95% CI: 1.01-1.08]; P = .005) and other skin ulcers (OR: 2.45 [95% CI: 1.05-5.71]; P = .038) were associated with a higher risk of meatal pressure injury. CONCLUSIONS: Meatal pressure injury is a common complication of indwelling catheters in hospitalized males, beginning days after catheterization. Meatal pressure injury was associated with prolonged catheter presence, other pressure injuries, and lack of catheter fixation. Prospective studies are needed to establish evidence-based guidelines.

Clinical Validation of IsoPSA™, a Single Parameter, Structure Based Assay for Improved Detection of High Grade Prostate Cancer.

PURPOSE: Current prostate specific antigen markers to detect prostate cancer are limited by low specificity for high grade disease. IsoPSA™ is a blood based, structure focused assay which predicts risk by partitioning the isoforms of prostate specific antigen that are linked to cancer in an aqueous 2-phase reagent system. We validated the clinical performance of this assay for identifying high grade disease in a new contemporary biopsy cohort. MATERIALS AND METHODS: We performed a multicenter prospective validation in 271 men scheduled for prostate biopsy at a total of 7 academic and community centers who were enrolled between May 2017 and March 2018. Blood samples were obtained for assay prior to biopsy. The discrimination power of the assay to detect high grade prostate cancer (Gleason 7 or greater) was evaluated by ROC analysis and compared to prior results. Clinical performance was further improved by comparison with multiparametric magnetic resonance imaging-ultrasound vs transrectal ultrasound guided biopsies. RESULTS: The assay AUC was 0.784 for high grade vs low grade cancer/benign histology, which was superior to the AUCs of total prostate specific antigen and percent free prostate specific antigen. If 1,000 patients were biopsied, the assay would have reduced the number of unnecessary biopsies from 705 to 402 (43%) with only 22 missed high grade cancers, of which 7 would have been Gleason sum 4 + 3 or higher. Subset analysis of multiparametric magnetic resonance imaging guided biopsy produced a substantial improvement of the AUC to 0.831. CONCLUSIONS: Validation of the structure based IsoPSA assay demonstrated statistical concordance with previously reported results and verified its superior performance vs concentration based prostate specific antigen and the free-to-total prostate specific antigen ratio. The assay improvement in detecting high grade prostate cancer using multiparametric magnetic resonance imaging-ultrasound guided biopsy may help define a new diagnostic paradigm.

Cardiovascular Morbidity in a Randomized Trial Comparing GnRH Agonist and GnRH Antagonist among Patients with Advanced Prostate Cancer and Preexisting Cardiovascular Disease.

PURPOSE: Androgen deprivation therapy may increase the risk of cardiovascular disease. Limited data suggest that GnRH (gonadotropin-releasing hormone) antagonist may be associated with a lower risk of cardiovascular disease than GnRH agonist. MATERIALS AND METHODS: We performed a phase II, randomized, open label study in men with prostate cancer and preexisting cardiovascular disease who were randomized to receive GnRH agonists or antagonists for 1 year. The primary outcome was endothelial function measured by the EndoPAT 2000 device (Itamar Medical, Caesarea, Israel). The predefined secondary outcome was a new cardiovascular event. Patients were followed for the development of cardiovascular disease, defined as death, myocardial infarction, a cerebrovascular event, percutaneous angioplasty with coronary stent insertion or hospitalizations due to cardiac events. RESULTS: A total of 80 patients were enrolled in study, including 41 and 39 who received GnRH antagonist and agonist, respectively. Patients in each arm had similar baseline characteristics. We did not detect a difference in the primary end point (endothelial function) between the groups (mean ± SD reactive hyperemia index 2.07 ± 0.15 vs 1.92 ± 0.11, p=0.42). However, during the trial period a new cardiovascular event (the secondary end point) developed in 15 patients. Of cases new major cardiovascular and cerebrovascular events developed in 9, including death in 2, myocardial infarction in 1, a cerebrovascular event in 2 and percutaneous angioplasty with coronary stent insertion in 4. Of the patients 20% randomized to GnRH agonist experienced a major cardiovascular and cerebrovascular event compared to 3% of those on GnRH antagonist (p=0.013). The absolute risk reduction in major cardiovascular and cerebrovascular events at 12 months using GnRH antagonist was 18.1% (95% CI 4.6-31.2, p=0.032). CONCLUSIONS: To our knowledge this is the first prospective study to test cardiovascular outcomes among patients with prostate cancer who received androgen deprivation therapy. No differences in the primary end point were noted between the study arms. However, the secondary end point revealed that patients treated with GnRH agonist experienced significantly more major cardiovascular and cerebrovascular events than those treated with GnRH antagonist. These phase II results suggest that in patients with prostate cancer who have preexisting cardiovascular disease selecting the androgen deprivation therapy modality may differentially affect cardiac outcomes.

Predictors of surgical site infection after radical cystectomy: should we enhance surgical antibiotic prophylaxis?

PURPOSE: To compare surgical site infections (SSI) rate after radical cystectomy (RC) over time and ascertain whether antibiotic prophylaxis should be enhanced. METHODS: All medical records of RC patients in a single tertiary uro-oncology center between 2007 and 2017 were analyzed. SSI was defined using the criteria of the US Centers for Disease Control and Prevention. All bacterial culture results and antimicrobial resistance rates were recorded. Lastly, multivariable logistic regression analysis was performed to ascertain SSI predictors. RESULTS: RC was performed in 405 patients, of which 96 (23.7%) developed SSI. No differences were demonstrated in the mean age, gender, NIDDM prevalence, neoadjuvant chemotherapy, positive preoperative urine culture, bowel preparation, and surgery time between both groups. However, statistically significant higher median BMI, age-adjusted Charlson Comorbidity score, usage of ceftriaxone preoperatively, and intensive care unit (ICU) hospitalization were noted in SSI patients. Overall, 62/96 (63.5%) SSI patients had a positive wound culture, with only 16.7% of the pathogens being sensitive to their perioperative antibiotics. Lastly, on multivariable analysis rising BMI, preoperative ceftriaxone and ICU hospitalization were associated with a higher SSI rate. CONCLUSIONS: Preoperative BMI reduction, and maximal preoperative medical optimization in an attempt to lower ICU admittance rates, should be part of the ideal strategy for lowering SSI rates. Additionally, preoperative antibiotics should be enhanced to harbor-wide spectrum coverage, based on local resistance rates.

How Prevalent is Hydronephrosis Secondary to Acute Appendicitis: A Cross-Sectional Study.

BACKGROUND: Right hydronephrosis secondary to acute appendicitis is an under-reported phenomenon with only several case reports published. OBJECTIVES: To assess the incidence of this phenomenon in our database of patients diagnosed with acute appendicitis. METHODS: Data were collected on 1092 patients who underwent surgery due to acute appendicitis between 2003 and 2007 in our tertiary medical center. The data entailed demographic, surgical, and hospitalization parameters including ultrasound or computed tomography examinations and presence of right hydronephrosis prior to surgery. RESULTS: Out of 1092 patients, appendicitis was eventually diagnosed in 87.4% of the patients. Only 594 (54%) had preoperative imaging performed prior to surgery (ultrasound or computed tomography). Out of these 594 patients, 21 (3.5%) had a new right hydronephrosis diagnosed and all had appendicitis with 15/21 (71%) having a retrocecal appendix. Of those with retrocecal appendix, 10 were pregnant women (48%). Erythrocyturia was present in 15/21 patients (71%) and in 10/11 of patients (91%) after excluding those who were pregnant. No significant differences were seen in patients with hydronephrosis regarding age, hospitalization, and surgery time. In all patients, an ultrasound was performed 2 weeks after surgery demonstrating the disappearance of hydronephrosis. Median follow-up time was 41.7 months (range 14.8-118.4 months). CONCLUSIONS: Our study shows that 3.5% of our cohort had right hydronephrosis secondary to acute appendicitis. Although this presentation is very rare, physicians should be aware of this phenomenon and the risk for delayed diagnosis and treatment of acute appendicitis.