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Purpose: Pathologic upstaging in renal cell carcinoma (RCC) is common and confers a significant risk of poor surgical and survival outcomes. Preoperative predictors of upstaging are of great clinical relevance but empirical evidence specific to racial minorities remains scarce. Methods: National Cancer Database (NCDB) analysis of T3a‐specific upstaging among White, African‐American, Hispanic and Asian Pacific Islander (API) patients with AJCC cT1N0M0 RCC who underwent partial or radical nephrectomy between 2010 and 2015. Independent preoperative predictors of tumour upstaging were identified using multivariate logistic regression analyses. Results: A total of 81 002 patients met the criteria for inclusion (5.6% T3a‐specific upstaging). Increased age, increased Charlson‐Deyo comorbidity index, clinical stages cT1b and unspecified cT1, and increased Fuhrman nuclear grade were identified as independent risk factors for upstaging. Independent protective factors for upstaging were younger age, female sex, African‐American race and papillary, chromophobe, and unspecified RCC histologic subtypes. Significant risk factors and protective factors within individual racial subgroups were highly consistent with those observed in the overall study sample. All independent factors identified on race‐specific subgroup analyses were significant in the same direction relative to the overall study sample. Variables found to be non‐significant in the overall study sample remained non‐significant across all racial subgroup analyses. Conclusion: The present study of nationally representative data found no clinically significant differences in upstaging risk across individual racial subgroups relative to the overall study sample. Preoperative factors that can be used to predict pT3a‐specific tumour upstaging in CT1N0M0 RCC likely persist across different racial groups. [ABSTRACT FROM AUTHOR]

Aims: Nocturia has been increasingly recognized as a potential manifestation of cardiovascular disease. However, the relationship between nocturia and electrocardiographic (ECG) abnormalities has not been studied. This study aims to characterize the diagnostic utility of nocturia in identifying left ventricular hypertrophy (LVH), left atrial enlargement (LAE), and prolonged QTc on ECG. Methods: Retrospective analysis of nocturnal voiding frequency and contemporaneous ECG data from consecutive patients evaluated at a university‐based outpatient cardiology clinic. Three sets of three incremental binary multiple logistic regression models controlling for (1) age, (2) sex and race, and (3) body mass index, hypertension, diabetes mellitus, and diuretic utilization were performed to determine whether nocturia was predictive of LVH, LAE, and prolonged QTc. Results: Included patients (n = 143, 77.6% nocturia) were predominantly African‐American (89.5%), female (74.1%), and obese (61.5%), of whom 44.1%, 41.3%, and 27.3% had LVH, LAE, and prolonged QTc, respectively. Older age, African‐American race, obesity, hypertension, diuretic use, LVH, and LAE were significantly associated with nocturia on univariate analysis. No significant differences were observed in the strength of associations between nocturia and LVH, LAE, or QTc prolongation based on age. Nocturia independently predicted LVH in Models I–III (odds ratios [ORs], 2.99–3.20; relative risks [RRs], 1.18 for all, p ≤.046) and LAE in Models I–III (ORs, 4.24–4.72; RRs, 1.21 for all, p ≤.015). No significant associations were observed between nocturia and prolonged QTc. Conclusions: Nocturia may be a risk marker for underlying structural cardiac abnormalities. [ABSTRACT FROM AUTHOR]

Purpose: Low nocturnal urine production (NUP) may be sufficient to rule out global polyuria (GP) in men. This study determines the sensitivity of indices for nocturnal polyuria (NP), defined as nocturnal polyuria index (NPi; nocturnal urine volume/24-hour urine volume) ≥0.33 or NUP ≥90 mL/hr, for detecting GP in women. Methods: Data were analyzed from 2 prospective protocols involving subjects recruited from a urology ambulatory care unit and a continence clinic. Women ≥18 years with nocturia were included if they met either of 2 common criteria for GP: (1) ≥40 mL/kg/24 hr or (2) ≥3,000 mL/24 hr. Results: Thirty-one women were included (NPi, 28.6 [21.3-40.7]; NUP, 100.8 [68.3-135.8] mL/hr). At the ≥40 mL/kg/24-hr cutoff, 40% and 63% of women reporting ≥1 nocturnal void(s) (n=30) had NPi ≥0.33 and NUP ≥90 mL/hr, respectively. Additionally, 53% and 71% of subjects reporting ≥2 nocturnal voids (n=17) had NPi ≥0.33 and NUP ≥90 mL/hr, respectively. At the ≥3,000 mL/24-hr cutoff, 38% and 69% of women reporting ≥1 nocturnal void(s) (n=13) had NPi ≥0.33 and NUP ≥90 mL/hr, respectively, and 63% and 88% of subjects reporting ≥2 nocturnal voids (n=8) had NPi ≥0.33 and NUP ≥90 mL/hr, respectively. By extension, 37%-62% of women with nocturia and GP did not have NP by NPi ≥0.33 criteria, and 12%-37% did not have NP by NUP ≥90 mL/hr criteria. Conclusions: Indices of excess nighttime urination do not reliably predict GP in women. A full-length voiding diary may be particularly important in the evaluation of women with nocturia. Nocturia in women merits further consideration as a distinct entity. [ABSTRACT FROM AUTHOR]

Introduction: The following is a report on the proceedings of the 2019 International Consultation on Incontinence‐Research Society nocturia think tank (NTT). Objectives: The objectives of the 2019 NTT were as follows: (a) to evaluate the role of urothelium in the pathophysiology of nocturia; (b) to determine whether nocturia is a circadian disorder; (c) to discuss the role of melatonin in nocturia; (d) to consider ambulatory urodynamic monitoring in evaluating patients with nocturia; (e) to explore studies of water handling in human compartments utilizing heavy water; and (f) to explore whether basic science is the key to understanding the treatment options for diminished bladder capacity in patients with nocturia. Methods: A compendium of discussions of the role of experimental science in understanding the pathophysiology of nocturia is described herein. Results and Conclusions: Translational science will play an increasing role in understanding the pathophysiology of nocturia, which may result in improved treatment strategies. [ABSTRACT FROM AUTHOR]

This study aims to determine whether dietary sodium restriction counseling decreases nocturnal voiding frequency in cardiology patients with concomitant nocturia. Patients who had established care at a cardiology clinic from 2015 to 2018 reporting ≥1 average nocturnal void(s) underwent a comprehensive sodium intake interview by their cardiologist, who provided them with individualized strategies for dietary sodium reduction and assessed adherence at follow-up. Average nocturnal voiding frequency and dietary adherence were documented in the medical record. A nocturia database was compiled for retrospective analysis. A total of 74 patients were included. Patients considered to be adherent with dietary sodium restriction at follow-up (n = 56) demonstrated a decrease in median nocturia frequency (2.5 [2.3-3.0] vs 1.0 [1.0-2.0] voids, P < .001). Among nonadherent patients (n = 18), median nocturia frequency did not significantly change from baseline to follow-up (2.0 [1.5-3.8] vs 2.0 [1.5-4.8] voids, P = .423). Median changes were significantly different between the adherent and nonadherent groups (P < .001). Examination of second follow-up available from 37 patients showed a continued effect. In conclusion, adherence with dietary sodium counseling appears to improve nocturia. Accordingly, dietary modification may represent an important adjunct therapy to lifestyle and pharmacologic interventions for decreasing nocturia frequency. Reduction in nocturnal voiding frequency may also reflect an additional benefit of dietary sodium restriction in accordance with best practice standards for cardiovascular disease. [ABSTRACT FROM AUTHOR]

Smoke exposure is known to decrease total pulmonary surfactant and alter its composition, but the role of surfactant in chronic obstructive pulmonary disease (COPD) remains unknown. We aimed to analyze the compositional changes in the surfactant lipidome in COPD and identify specific lipids associated with pulmonary function decline. Bronchoalveolar lavage (BAL) fluid was obtained from 12 former smokers with COPD and 5 non-smoking, non-asthmatic healthy control volunteers. Lipids were extracted and analyzed by liquid chromatography and mass spectrometry. Pulmonary function data were obtained by spirometry, and correlations of lung function with lipid species were determined. Wild-type C57BL/6 mice were exposed to 6 months of second-hand smoke in a full-body chamber. Surfactant lipids were decreased by 60% in subjects with COPD. All phospholipid classes were dramatically decreased, including ether phospholipids, which have not been studied in pulmonary surfactant. Availability of phospholipid, cholesterol, and sphingomyelin in BAL strongly correlated with pulmonary function and this was attributable to specific lipid species of phosphatidylcholine with surface tension reducing properties, and of phosphatidylglycerol with antimicrobial roles, as well as to other less studied lipid species. Mice exposed to smoke for six months recapitulated surfactant lipidomic changes observed in human subjects with COPD. In summary, we show that the surfactant lipidome is substantially altered in subjects with COPD, and decreased availability of phospholipids correlated with decreased pulmonary function. Further investigation of surfactant alterations in COPD would improve our understanding of its physiopathology and reveal new potential therapeutic targets. [ABSTRACT FROM AUTHOR]

Aims: Nocturnal polyuria (NP) and global polyuria (GP) are not mutually exclusive. However, by rate, the common criteria for GP (40 mL/kg/24 hours [117 mL/kg/hour in a 70‐kg individual] or 3000 mL/24 hours [125 mL/h]) are more stringent than those for NP (90 mL/hour during the sleep period or NP index [NPi; nocturnal volume/24‐hour volume] > 0.33 [no minimum rate]). It remains unclear whether total nocturnal urine volume (NUV) may reliably delineate between NP patients with and without comorbid GP. Methods: A clinical database of men with lower urinary tract symptoms was searched for voiding diaries completed by patients reporting greater than or equal to 1 nocturnal void(s). Four separate analyses were performed using all combinations of the two NP and two GP criteria listed above. For each analysis, patients were included if they met the criteria for NP, and then stratified by presence or absence of GP (ie, NP + GP vs isolated NP). Results: Median NUV was greater among patients with NP + GP for all criteria combinations. Sensitivities greater than or equal to 80%/90%/100% for NP + GP were observed at 1275/1230/1085 mL for {NPi > 0.33 + 24‐hour volume > 3000 mL}; 1075/1035/1035 mL for {NPi > 0.33 + 24‐hour volume > 40 mL/kg}; 900/745/630 mL for {NUP > 90 mL/hour + 24‐hour volume > 3000 mL}; and 1074/1035/990 mL for {NUP > 90 mL/hour + 24‐hour volume > 40 mL/kg}. Conclusions: An inordinate NUV among men with NP is fairly sensitive for comorbid GP. In the appropriate clinical setting, nocturnal‐only diaries may suffice in the evaluation and follow‐up of patients with NP, so long as outlying nocturnal volumes prompt a 24‐hour diary/urine collection. [ABSTRACT FROM AUTHOR]

Keywords: nocturnal-only; NOVD; voiding diary EN nocturnal-only NOVD voiding diary 555 557 3 01/15/21 20210101 NES 210101 Voiding diaries are a standard of care in the evaluation of nocturia.1-4 One parameter routinely derived from voiding diary analysis is the nocturia index (Ni), defined as nocturnal urine volume (NUV) divided by 24-h maximum voided volume (MVV; with the latter being a proxy for functional bladder capacity),5 such that Ni quantifies the degree of mismatch between nocturnal urine production and bladder storage capacity.6 The Ni is of central importance to the management of nocturia because it is the voiding diary parameter which most strongly correlates with nocturia severity (i.e., the actual number of nocturnal voids [ANV]), and improvement in this measure is characteristic of improvement in ANV, such that the Ni reflects an important target for nocturia treatment.7,8 However, in view of continued suboptimal utilization of voiding diaries in clinical practice,9,10 increasing investigative attention has been afforded to data which may be directly gleaned from nocturnal voiding diary data and a nocturnal-only workup for nocturia.11 Namely, restricting the voiding diary to only the hours of intended sleep stands to mitigate the potentially restrictive time commitment of the assessment period, as well as professional, familial, and social barriers that have been implicated as significant determinants of voiding diary nonadherence.12-15 Accordingly, we propose a modified Ni (mNi), analogous to the original Ni, but incorporating only values directly attainable from nocturnal urinary data: NUV divided by nocturnal maximum voided volume (NMVV). Fifth, the correlation between changes in mNi and ANV is significantly stronger than the correlation between changes in Ni and ANV, such that the mNi may thus be relatively favorable for monitoring treatment response. [Extracted from the article]

We aimed to describe changes in nocturnal voiding frequency, as well as changes in oedema, weight and blood pressure, in cardiovascular patients with overt volume overload following treatment with furosemide. All patients experienced a diuretic effect, as evidenced by self-reported greater urine output within the first few hours after diuretic administration. Taken together, our exploratory results suggest that nocturia may represent an early marker of response to diuretic therapy in the treatment of heart failure. [Extracted from the article]

Blinding mitigates several sources of bias which, if left unchecked, can quantitively affect study outcomes. Blinding remains under-utilized, particularly in non-pharmaceutical clinical trials, but is often highly feasible through simple measures. Although blinding is generally viewed as an effective method by which to eliminate bias, blinding does also pose some inherent limitations, and it behooves clinicians and researchers to be aware of such caveats. This article will review general principles for blinding in clinical trials, including examples of useful blinding techniques for both pharmaceutical and non-pharmaceutical trials, while also highlighting the limitations and potential consequences of blinding. Appropriate reporting on blinding in trial protocols and manuscripts, as well as future directions for blinding research, will also be discussed.

Purpose: The association between nocturia and hypertension has been widely reported yet remains poorly characterized, precluding a more refined understanding of blood pressure as it relates to the clinical urology setting. We synthesized current evidence on the relationship between nocturia and hypertension as a function of nocturia severity, age, gender, race, body mass index and diuretic use., Materials and Methods: We searched PubMed®, EMBASE® and Cochrane databases for studies published up to May 2020. Random effects meta-analyses were performed to identify pooled odds ratios for nocturia given the presence of hypertension. Meta-regression and subgroup analyses were performed to identify differences across study samples., Results: Of 1,193 identified studies, 25 met the criteria for inclusion. The overall pooled OR for the association of nocturia with hypertension was 1.25 (95% CI 1.21-1.28, p <0.001). Pooled estimates were 1.20 (1.16-1.25, p <0.001) and 1.30 (1.25-1.36, p <0.001) using a 1-void and 2-void cutoff for nocturia, respectively (p <0.001 between cutoffs). The association was more robust in patient-based (1.74 [1.54-1.98], p <0.001) vs community-based (1.24 [1.24-1.29], p <0.001) study samples (p <0.001). The association was stronger in females compared to males (1.45 [1.32-1.58] vs 1.28 [1.22-1.35], p <0.001), and Black (1.56 [1.25-1.94]) and Asian (1.28 [1.23-1.33]) vs White subgroups (1.16 [1.08-1.24]; p <0.05 for both). No effect was observed for age or body mass index. Evidence on diuretics was limited., Conclusions: Hypertension is associated with a 1.2-fold to 1.3-fold higher risk of nocturia. This association is more robust at a higher nocturia cutoff, in patient-based study samples, among females and in Black and Asian patients, but unrelated to age or body mass index.

Sensitivity, which denotes the proportion of subjects correctly given a positive assignment out of all subjects who are actually positive for the outcome, indicates how well a test can classify subjects who truly have the outcome of interest. Specificity, which denotes the proportion of subjects correctly given a negative assignment out of all subjects who are actually negative for the outcome, indicates how well a test can classify subjects who truly do not have the outcome of interest. Positive predictive value reflects the proportion of subjects with a positive test result who truly have the outcome of interest. Negative predictive value reflects the proportion of subjects with a negative test result who truly do not have the outcome of interest. Sensitivity and specificity are inversely related, wherein one increases as the other decreases, but are generally considered stable for a given test, whereas positive and negative predictive values do inherently vary with pre-test probability (e.g., changes in population disease prevalence). This article will further detail the concepts of sensitivity, specificity, and predictive values using a recent real-world example from the medical literature.

Alpha-1 antitrypsin (AAT) has established anti-inflammatory and immunomodulatory effects in chronic obstructive pulmonary disease but there is increasing evidence of its role in other inflammatory and immune-mediated conditions, like diabetes mellitus (DM). AAT activity is altered in both developing and established type 1 diabetes mellitus (T1DM) as well in established type 2 DM (T2DM). Augmentation therapy with AAT appears to favorably impact T1DM development in mice models and to affect β-cell function and inflammation in humans with T1DM. The role of AAT in T2DM is less clear, but AAT activity appears to be reduced in T2DM. This article reviews these associations and emerging therapeutic strategies using AAT to treat DM.

Background: Primary small cell carcinoma of the kidney (PSCCK) is exceedingly rare and data on disease characteristics and outcomes are sparse. This study examines a nationally-representative cancer registry to better characterize PSCCK. Methods: We queried the National Cancer Database to identify patients with histology-confirmed PSCCK from 2004 to 2015. Adjusted Cox proportional hazards regression and Kaplan-Meier analyses were employed to assess predictors of mortality and estimate median survival time, respectively. Results: A total of 110 patients were included (47:53% female:male, 77% ≥60 years of age, 86% Caucasian). Significant predictors of mortality included female sex, age 60-69 years, treatment at an Integrated Network Cancer Program, stage cM1, and lack of surgical and chemoradiotherapy treatment. Independent protective factors were high socioeconomic status and treatment at an Academic Research Program. The estimated median overall survival time was 9.31 (95% CI 7.28-10.98) months for all patients. No differences in estimated survival time were observed across individual treatment modalities among those patients who underwent treatment ( p = 0.214). Conclusions: PSCCK is an aggressive malignancy with a median survival time of less than one year. Future studies that correlate clinical tumor staging with specific treatment modalities are needed to optimize and individualize management.

Background: Patients with nocturnal polyuria (NP) experience a unique surge in nocturnal diuresis rate during the early hours of sleep., Objective: To determine the diagnostic utility of the volume and osmolality of a single early nocturnal urine sample in detecting NP., Design, Setting, and Participants: Analysis of 1 am urine samples obtained from two prospective observational studies at Ghent University Hospital involving participants recruited from a urology ambulatory care unit and those who consulted a continence clinic. Nocturic participants (one or more nocturnal void[s]; n=176) were stratified based on the presence (n=87) or absence (n=89) of NP (>90ml/h)., Outcome Measurements and Statistical Analysis: Receiver operating characteristic curves with Youden's Index were used to determine cutoff values for urine volume and urine osmolality (Uosm)., Results and Limitations: Individuals with NP demonstrated higher 1 am volume (400 [interquartile range 300-515] vs 210 [160-300] ml, area under the curve [AUC]=0.843, p< 0.001, cutoff = 350 ml) and lower Uosm (274 [201-348] vs 430 [320-664] mOsm/kg H 2 O, AUC=0.774, p<0.001, cutoff=314 mOsm/kg H 2 O) than those without NP. In combining cutoffs, the criteria of either 1 am volume ≥350ml or Uosm ≤314 mOsm/kg H 2 O were 85% sensitive and 75% specific for NP, while criteria of both 1 am volume ≥350ml and Uosm ≤314 mOsm/kg H 2 O were 60% sensitive and 92% specific for NP. Comparable AUC values, sensitivities, and specificities were observed in both men and women. Limitations include post hoc design and a relatively small study sample., Conclusions: Individuals with NP are more likely than those without NP to produce a higher volume of more dilute urine (ie, "aquaresis") in the early hours of sleep. Analysis of easily measurable parameters of the first nocturnal void (for which 1 am values serve as a surrogate) in men and women with nocturia can predict a diagnosis of NP with a reasonably high degree of sensitivity and specificity., Patient Summary: Urologists often try to understand the specific reason why people wake up to urinate at night by asking them to record the amount of urine they make every time they go to the bathroom (also known as a "voiding diary") during the nighttime as well as the daytime-typically for a total of 1-3 days. In this study, we showed that an analysis of the composition of the urine that people produce when they first wake up to urinate at night might be sufficient to determine whether their symptoms are caused by excessive urine production or something else, and some people might find this urine study easier than keeping a voiding diary., (Copyright © 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Introduction: Much of what is known about the etiology of nocturia (i.e., nocturnal polyuria [NP], small bladder capacity [SBC], etc.) at the population level stems from the Krimpen study, which enrolled aging males from a homogenous municipality in the Netherlands. Given the higher prevalence of benign prostatic hyperplasia and overactive bladder in black versus white males in population research, we aim to test the hypothesis that black males seeking treatment for lower urinary tract symptoms (LUTS) are more likely to have nocturia owing to SBC., Materials and Methods: We retrospectively analyzed 24 hour frequency-volume charts (FVCs) completed by males seeking treatment for LUTS at a Veterans Affairs urology clinic from 2008-2016. Patients were included if they were ≥ 18 years, identified as either Caucasian or African American, and had a complete baseline FVC showing ≥ 1 nocturnal void. Patients were stratified by race and classified as having nocturia owing to SBC (defined by a maximum voided volume < 200 mL or a nocturnal bladder capacity index > 1.3); NP (defined by a nocturnal polyuria index > 0.33); 'mixed' (SBC + NP); or 'other' (neither SBC nor NP)., Results: Between white and black patients, 28 (24%) versus 28 (26%) had NP, 32 (27%) versus 33 (30%) had SBC, and 35 (30%) versus 30 (28%) had mixed nocturia. Overall, there was no difference in distribution of underlying etiology by race (p = 0.51)., Conclusions: Our results demonstrate no difference in the etiology of nocturia between black and white males. Accordingly, race should not play a role in the evaluation of patients seeking treatment for nocturia.

Study Objectives: The goal of this study was to compare the urge perception associated with nocturnal voiding at the time of voiding in individuals with and without depression, posttraumatic stress disorder (PTSD), or anxiety diagnoses to test the hypothesis that patients with such diagnoses are more likely to experience insomnia-driven convenience voiding during the sleep period., Methods: A database of voiding diaries with urge perception grades (UPGs) from 429 adult males seeking treatment for nocturia at a Veterans Affairs-based urology clinic was analyzed. The UPG categorizes perception for urinating from 0 (out of convenience) to 4 (desperate urge). Diaries completed by males age 18 years and older showing ≥ 2 nocturnal voids were included. Those included (n = 178) were divided into two cohorts based on the presence (n = 62) or absence (n = 116) of one or more previously established mental health diagnoses (depression, PTSD, or anxiety). The chi-square test was used to determine significance between groups., Results: Patients with a mental health diagnosis were more likely to report convenience voiding compared to those without depression, PTSD, or anxiety (14.5% versus 0.8%, P < .01). However, most voids in both groups were associated with the perception of urinary urgency. There were no differences in urinary volumes or hourly rates of urine production between the groups., Conclusions: A relatively small subset of urology patients experience nocturnal voiding because they are awake for reasons other than the urge to void. Mental health factors had a substantial, albeit minimal, effect. Most nocturia reflects urgency to urinate rather than voiding by convenience., (© 2019 American Academy of Sleep Medicine.)