Increased risk of cardiac failure with a-blockers in hypertension studies and 5-alpha reductase inhibitors in prostate studies have raised safety concerns for long term management of benign prostatic hyperplasia. The objective of this study was to determine if these medications are associated with an increased risk of cardiac failure in routine care. Materials and Methods: This population based study used administrative databases including all men over 66 with a diagnosis of benign prostatic hyperplasia between 2005 and 2015. Men were categorized based on 5-alpha reductase inhibitor exposure and/or a-blocker exposure with a primary outcome of new cardiac failure utilizing competing risk models. Explanatory variables examined included exposure thresholds, formulations, age, and comorbidities associated with cardiac disease. Results: The data set included 175,201 men with a benign prostatic hyperplasia diagnosis with 8,339, 55,383, and 41,491 exposed to 5-alpha reductase inhibitor, a-blocker and combination therapy, respectively. Men treated with 5-alpha reductase inhibitor and a-blocker, alone or in combination, had a statistically increased risk of being diagnosed with cardiac failure compared to no medication use. Cardiac failure risk was highest for a-blockers alone (HR 1.22; 95% CI 1.18e1.26), intermediate for combination a-blockers/5-alpha reductase inhibitors (HR 1.16; 95% CI 1.12e1.21) and lowest for 5-alpha reductase inhibitors alone (HR 1.09; 95% CI 1.02e1.17). Nonselective a-blocker had a higher risk of cardiac failure than selective a-blockers (HR 1.08; 95% CI 1.00e1.17). Conclusions: In routine care, men with a benign prostatic hyperplasia diagnosis and exposed to both 5-alpha reductase inhibitor and a-blocker therapy had an increased association with cardiac failure, with the highest risk for men exposed to nonselective a-blockers.

Introduction: We sought to determine if patients’ perceptions of success or failure of interstitial cystitis/bladder pain syndrome (IC/ BPS) therapies proposed in treatment guidelines align with the evidence from available clinical trial treatment data.Methods: A total of 1628 adult females with a self-reported diagnosis of IC completed a web-based survey in which patients described their perceived outcomes with the therapies they were exposed to. Previously published literature, used in part to develop IC/ BPS guidelines, provided the clinical trial data outcomes. Patientreported outcomes were compared to available clinical trial outcomes and published treatment guidelines.Results: Based on patient perceived outcomes (benefit:risk ratio), the most effective treatments were opioids, phenazopyridine, and alkalizing agents, with amitriptyline and antihistamines reported as moderately effective. The only surgical procedure with any effectiveness was electrocautery of Hunner’s lesions. In order of efficacy reported in the literature, the therapies for IC/BPS with predicted superior outcomes should be: cyclosporine A, amitriptyline, hyperbaric oxygen, pentosan polysulfate plus subcutaneous heparin, botulinum toxin A plus hydrodistension, and L-arginine. While some of the guideline recommendations aligned with patientreported effectiveness data, there was a general disconnect between guidelines and effectiveness reported in clinical practice.Conclusions: There is a disconnect between real-world patient perceived effectiveness of IC/BPS treatments compared to the efficacy reported from clinical trial data and subsequent guidelines developed from this efficacy data. Optimal therapy must include the best evidence from clinical research, but should also include real-life clinical practice implementation and effectiveness.

No abstract

CSS[cancer specific survival; OS[overall survival; cT stage[ stage from most proximal transurethral resection; pT stage[stage from cystectomy. * Reference[no chemotherapy in a Cox Proportional Hazards Model, reporting subhazard ratio. Adjusted for age and Charlson comorbidity.

Introduction: Intraoperative surgical complications pose significant potential risks to patients. Uncontrolled bleeding during laparoscopic partial nephrectomy is one such event that requires collaboration and communication between surgical team members. We developed and evaluated a multidisciplinary surgical simulation scenario and model of intraoperative hemorrhage during a laparoscopic partial nephrectomy to facilitate the practice of these crucial non-technical skills. Methods: A simulation scenario using a novel, titratable bleeding partial nephrectomy model was developed. The operating room simulation consisted of an intubated mannequin placed in the lateral decubitus position and laparoscopic renal model. The multidisciplinary simulation scenario included anesthesia and urology residents and progressed from bleeding to a pulseless electrical activity arrest. The degree of renal model bleeding was modified based on the progression of the urology resident. After the scenario participants were debriefed and completed a post-simulation survey assessing: 1) their perception of the simulated scenario; and 2) their teaching of non-technical skills in their residency training. Results: The porcine model was successfully reproduced for nine consecutive weeks and functioned well to simulate bleeding from a laparoscopic partial nephrectomy site; the bleeding was able to be titrated based on resident progression and excision of the simulated tumor. All residents stated the scenario was valuable to assess and improve non-technical surgical skills and that their exposure to practice non-technical skills in their existing curriculum could be improved. Conclusions: Simulating an intraoperative bleeding partial nephrectomy, combined with an intraoperative crisis scenario, is a feasible, immersive, and reproducible model and can challenge residents’ non-technical skills.

Introduction: Benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms are highly prevalent in the aging male. Similarly, the prevalence of metabolic syndrome is increasing worldwide, with mounting evidence that these two common conditions share more than age as a predisposing factor. The objective of this study was to determine if medical management of BPH is associated with an increased risk of new-onset diabetes mellitus (DM) in routine care. Methods: This population-based, retrospective cohort study expands on a parent study of linked administrative databases identifying patients diagnosed and treated for BPH between 2005 and 2015. The primary outcome of this secondary analysis was a new diagnosis of DM after the index date of BPH diagnosis. Covariates included age, dyslipidemia, hypertension, and vascular diseases. A Cox proportional hazards regression model was used for inferential statistical analysis. Results: A total 129 223 men were identified with a BPH diagnosis and no prior history of DM. Of those men, 6390 (5%) were exposed to 5-alpha-reductase inhibitor (5-ARI), 39 592 (31%) exposed to alpha-blocker (AB), and 30 545 (24%) exposed to combination therapy. Compared to those men with no BPH medication use, those exposed to drugs had an increased risk of new DM. Men treated with combination therapy of 5-ARI and AB (hazard ratio [HR] 1.30, 95% confidence interval [CI] 1.25–1.35), 5-ARI monotherapy (HR 1.25, 95% CI 1.17–1.34), or AB monotherapy (HR 1.17, 95% CI 1.13–1.22) all were at higher risk of new DM diagnosis after adjusting for important covariates. When calculating the risk of a new diabetes diagnosis measured from the start of drug exposure, men treated with 5-ARIs had an increased risk of DM compared to AB monotherapy as the reference, with HR 1.12 (95% CI 1.03–1.21) for 5-ARI monotherapy and HR 1.20 (95% CI 1.14–1.25) for combination therapy. Conclusions: In this large, long-term, retrospective study of men with a BPH diagnosis in routine practice, the risk of a new diagnosis of DM was greater in patients receiving medical management compared to controls. This modest but significant increased risk was highest in men treated with any 5-ARIs, in combination as well as monotherapy, compared to the ABs.

INTRODUCTION AND OBJECTIVE: Worrisome reports of increased risk of cardiac failure with alpha blockers (ABs) in hypertension studies (alfuzosin in ALLHAT) and 5-alpha reductase inhibitors (5ARIs) in prostate studies (dutasteride in REDUCE) have raised safety concerns with these medications for long term management of Benign Prostatic Hyperplasia (BPH). The objective of this study was to determine if 5ARIs and/or ABs were associated with an increased risk of cardiac failure in males with BPH.METHODS: A retrospective cohort was created using the province of Ontario's health administrative databased at the Institute for Clinical Evaluative Sciences (ICES). Males aged 66 and over with a standardized diagnosis of BPH were included. Subjects were categorized based on exposure to 5ARI and/or AB exposure. Further information collected included: standardized diagnosis of "new" cardiac failure, exposure time to 5ARIs and/or ABs, dosage, formulations, age, socioeconomic status and comorbidities associated with cardiac disease. Subjects with a history of cardiac failure or prostate cancer were excluded. A competing risk model was used to determine if 5ARI and/or AB use was associated with an increased risk of cardiac failure.

No abstract