Introduction The ULTra study was designed to better understand the relationship of lifestyle factors with urinary urgency, specifically by assessing physical activity and sleep quality using a wearable tracker. Our objectives here are to describe study design and enrollment, adherence, and data evaluability results. Methods The Urinary Urgency and Lifestyle Wearable Tracker (ULTra) study of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) is a 3-month, prospective study performed within the larger 1-year Urinary Urgency Phenotyping (UUP) study. The UUP and ULTra studies enrolled adults with bothersome urinary urgency without (URG) or with urgency urinary incontinence (UUI) and a sex- and age-matched control group (no urinary symptoms). Data collection using the wearable tracker, including steps, heart rate, logged physical activities, and sleep episode information, occurred over two weeks at baseline and again 3-months after enrollment. Adherence and data validity criteria were developed for physical activity and sleep data obtained via the wearable tracker. Results We enrolled 270 participants (64 URG, 143 UUI, 63 controls), and 205 (76%) had evaluable data (at least 5 valid days) for either physical activity or sleep. In cases, data evaluability differed by sex, but not by age or case-control status. Female participants (versus male) and those with higher comorbidity and incontinence scores were less likely to contribute evaluable data. Conclusion This manuscript describes the design of the LURN ULTra study and discusses feasibility and challenges encountered in conducting a multicenter study employing wearable technology in an adult population seeking care for urinary symptoms.
Introduction:Automated peritoneal dialysis (APD) is the predominant peritoneal dialysis (PD) modality in many high-income countries and is increasingly adopted in low- and middle-income settings. Outcome differences between APD and continuous ambulatory PD (CAPD) remain unclear. A clearer understanding could inform clinical and policy decisions. Methods:Patients in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS; N = 9463 patients across 6 countries/regions) who were enrolled within 3 months of starting PD were analyzed in intent-to-treat Cox regression models examining associations between PD modality (CAPD vs. APD) and patient survival, permanent transfer to hemodialysis (HD, HDT), and time to first peritonitis, adjusting for patient and facility-level factors and stratified by country. Results:Of the patients, 87% were prescribed APD (range: 37% in South Korea to 91% in USA). APD patients were younger, had lower urine output, more often used hypertonic solutions, and less often used icodextrin. Overall, there was no evident difference between APD and CAPD in survival (adjusted hazard ratio [AHR]: 0.82, 95% confidence interval [CI]: 0.66-1.03) or HDT (AHR: 0.96, 95% CI: 0.83-1.11), though results varied by country and subgroups (APD had lower death risk in those having assisted PD). APD patients had a lower risk of peritonitis overall (AHR: 0.83, 95% CI: 0.72-0.97), and specifically of gram-positive (AHR: 0.67, 95% CI: 0.52-0.87) and culture-negative (AHR: 0.64, 95% CI: 0.44-0.95) peritonitis. Conclusion:APD and CAPD showed comparable patient and technique survival. APD's lower peritonitis rate highlights the importance of aseptic technique; its benefits in assisted PD patients suggest that it may be suited for those requiring support.
Background:Evidence linking chronic kidney disease-mineral and bone disorder (CKD-MBD) therapies to hard clinical outcomes in hemodialysis remains limited. Treatment with vitamin D receptor activators (VDRAs) and calcimimetics is often adjusted or discontinued in response to parathyroid hormone values, which complicates the evaluation of their associations with clinical outcomes in observational research. Methods:Because VDRA/calcimimetic prescriptions change over time in response to CKD-MBD markers that also predict outcomes, data from Phases IV-VII (2009-2022) of the Dialysis Outcomes and Practice Patterns Study were analyzed using marginal structural models with time-updated, four-category exposure status (neither use, VDRA only, calcimimetics only, or both) to investigate the hazard ratios (HRs) associated with all-cause mortality, cardiovascular disease (CVD) mortality, bone fractures, and hip fractures. Results:A total of 117 452 hemodialysis patients were included in the all-cause mortality analysis, 50 111 patients in the CVD mortality analysis, and 33 906 patients in the fracture analysis. Compared with neither use, VDRA-only use (HR 0.71, P < .001), calcimimetics-only use (HR 0.76, P < .001), and combination therapy (HR 0.58, P < .001) were significantly associated with a reduced risk of all-cause mortality. For CVD mortality, VDRA-only (HR 0.83, P < .001), calcimimetics-only (HR 0.71, P < .001), and combination therapy (HR 0.71, P < .001) were significantly associated with a lower risk of CVD mortality. For bone fractures, calcimimetics-only (HR 0.59, P < .001) and combination therapy (HR 0.74, P < .01) were associated with lower risk of fracture, whereas VDRA-only was not (HR 0.89, P = .102). For hip fractures, only combination therapy was associated with lower hip fracture risk (HR 0.56, P < .01), while VDRA-only (HR 0.93, P = .494) and calcimimetics-only (HR 0.67, P = .082) were not statistically significant. Exploratory subgroup analyses by baseline characteristics showed broadly similar directions of association, although several estimates were imprecise. Conclusions:Calcimimetics and combination therapy were associated with lower fracture risk in addition to lower mortality, but these findings should be interpreted cautiously and regarded as hypothesis-generating.
Objectives To examine the relationships between erectile dysfunction (ED) and diabetes and related complications, metabolic syndrome (MetS) components and lower urinary tract symptoms (LUTSs) in a cohort of men seeking care for urinary urgency and other LUTSs.Design Cross-sectional analysis of baseline data from the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN II) Urinary Urgency Phenotyping study, which aimed to characterise subgroups of persons with urinary urgency.Setting Six clinical sites of the NIH/NIDDK-sponsored Symptoms of LURN, US.Participants 305 men enrolled in the LURN II Urinary Urgency Phenotyping study who provided complete baseline erectile function data.Primary and secondary outcome measures Erectile function was assessed using the erectile function domain of the International Index of Erectile Function (IIEF). MetS components, diabetes-related complications and LUTS severity were compared between men with and without ED.Results Among 305 men with urinary urgency, 181 (59%) had ED. Men with ED were significantly older and more likely to have type 2 diabetes (25% vs 12%, p<0.01). Peripheral neuropathy (38% vs 25%, p=0.02) and autonomic neuropathy (57% vs 43%, p=0.02) were more common in men with ED. The majority of men without ED correspondingly did not report MetS components. Finally, men with ED reported more severe LUTS, including higher total LUTS scores and a greater burden of storage symptoms.Conclusions These data suggest that diabetes as well as markers of metabolic dysfunction are important factors in ED in treatment-seeking men with urinary urgency and other LUTS. Studies evaluating the mechanisms contributing to these interactions are warranted for targeting effective prevention or treatment.
BACKGROUND:Patients receiving dialysis, particularly those on hemodialysis with central venous catheters (CVC), are at higher risk of bloodstream infections, often caused by Staphylococcus aureus. After years of declining CVC prevalence, pandemic-related shifts in dialysis practices led to higher CVC use and increased concern regarding contemporary infection risk. This study used national data spanning pre-, intra-, and post-pandemic periods to determine current rates and risk factors for S. aureus-related sepsis in the US dialysis population. METHODS:A retrospective cohort study was conducted using Centers for Medicare & Medicaid Services claims and United States Renal Data System data from 2016 through 2023 for adults >18 years of age receiving maintenance dialysis. S. aureus-related sepsis was identified using ICD-10 codes A41.01 and A41.02. Event rates per 100 patient-years (PY) were calculated for first and multiple events, stratified by demographic and clinical characteristics. Cox regression was used to identify risk factors. RESULTS:CVC use rose from 16% in 2016 to 24% in 2023. S. aureus-related sepsis incidence was 3.3 per 100 PY for first events and 4.1 per 100 PY for multiple events. First-event rates were higher among HD recipients using CVCs (8.4) versus those with arteriovenous fistulas (2.0) or peritoneal dialysis recipients (1.0). Rates were elevated in younger patients, males, and those with diabetes, heart failure, or immunosuppressive conditions. In adjusted models, catheter use (vs. fistulas) was strongly associated with S. aureus-related sepsis (hazard ratio: 4.24, 95% confidence interval: 4.15 to 4.33). CONCLUSIONS:S. aureus-related sepsis remains a substantial burden among US dialysis patients, especially among CVC users, presenting a persistent challenge for the nephrology community in the context of rising CVC prevalence post-pandemic. Despite modest overall declines since 2016, persistent high rates underscore the need for targeted prevention, particularly optimizing vascular access and managing high-risk subgroups.
Rationale & Objective: Gabapentinoids, including gabapentin and pregabalin, are indicated for patients with neuropathic pain and are also prescribed off-label to treat chronic kidney disease-associated pruritus in hemodialysis (HD) patients. With limited data on effectiveness in pruritus and concerns about adverse effects, the risk-benefit profile is controversial. Study Design: A retrospective analysis of registry data. Setting & Participants: A total of 533,232 HD patients from the United States Renal Data System from 2016-2020 Exposures: Gabapentinoid use/dose, updated over time based on prescription changes. Outcomes: Five adverse effects based on ICD-10 codes: altered mental state, dizziness, fracture, falls, somnolence. Analytical Approach: We investigated gabapentinoid utilization patterns and associations between dose and adverse effects using Cox-based recurrent event Anderson-Gill models. Analyses were adjusted for potential confounders and stratified by time-updated diagnosis groups (NP vs pruritus). Results: Among patients with neuropathic pain, 19% used gabapentin with a mean dose 503 mg/ day. Among patients with pruritus, 11% used gabapentin with mean dose 433 mg/day. Event rates (per 100 patient-years) for adverse effects were 37.8 for altered mental state, 20.4 for falls, 19.3 for dizziness, 15.2 for somnolence, and 9.3 for fracture. Adjusted models showed a clear dose-response association (P < 0.001) between gabapentin dose and all adverse effects-especially among patients with pruritus-with elevated risk observed at doses as low as 100 mg/day. Pregabalin use was only 2%, with a dose-response adverse effect profile similar to gabapentin. Limitations: Under-ascertainment of pruritus via diagnosis codes; residual confounding. Conclusions: Gabapentinoid utilization patterns differed by diagnosis, with use and doses higher among those with neuropathic pain versus pruritus. Adverse effects-even at low doses-were common, particularly when used off-label in patients with pruritus and no neuropathic pain. With new alternatives available, prescribers should weigh the clinically relevant adverse effects of gabapentinoids when providing treatment options to patients with pruritus.
Resumo Introdução: A gota comumente coexiste com a doença renal crônica (DRC), com aumento da prevalência à medida que a função renal declina. Apesar de seu ônus, há poucos dados sobre as práticas de monitoramento e tratamento na DRC. Este estudo descreve a prevalência, as características e o manejo da gota em pacientes com DRC não dialíticos. Métodos: Foram analisados dados transversais de 3.524 pacientes com DRC estágios 3a–5 no Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps), no Brasil (n = 942) e nos Estados Unidos (n = 2.582), no momento da inclusão (2013–2022). O histórico de gota foi extraído dos prontuários médicos. Resultados: A prevalência de gota foi de 18,7% no total — 20,5% nos EUA e 13,9% no Brasil — sendo maior nos estágios 4–5 quando comparada aos estágios 3a–3b da DRC. O alopurinol foi o medicamento mais utilizado (Brasil 75%; EUA 62%). Colchicina (13%) e febuxostato (8%) foram relatados nos EUA, mas raramente no Brasil. O ácido úrico foi dosado em 70% dos pacientes com gota no Brasil versus 33% nos EUA. Conclusões: A gota é comum na DRC, com diferenças marcantes entre os países quanto ao monitoramento e ao tratamento.
Background:Multidrug-resistant organisms (MDROs) present significant challenges in the treatment of peritoneal dialysis (PD)-related peritonitis. This study aimed to describe the incidence, risk factors, and outcomes of MDRO-peritonitis in a national cohort from the PDOPPS (Peritoneal Dialysis Outcomes and Practice Patterns Study)-Korea. Methods:Between July 2019 and December 2021, 147 of 292 peritonitis episodes had available data on organism sensitivity and resistance. Episodes were categorized as MDRO-defined as resistance to three or more classes of antibiotics-or non-MDRO. Multivariate logistic regression analysis identified factors associated with MDRO versus non-MDRO peritonitis and predictors of peritonitis cure. Results:Forty-one of the total 292 peritonitis episodes (14.0%) were identified as MDRO. Prior hospitalization (odds ratio [OR], 32.9; 95% confidence interval [CI], 3.5-313.1), diabetes mellitus (OR, 4.1; 95% CI, 1.2-14.2), and recurrent peritonitis (OR, 48.3; 95% CI, 3.2-735.8) were independent risk factors for MDRO-peritonitis. In the analysis of factors associated with peritonitis cure, longer PD vintage (OR, 0.8; 95% CI, 0.7-1.0) and Gram-negative organisms (OR, 0.1; 95% CI, 0.0-0.4) were associated with lower cure rates, while higher serum albumin level (OR, 1.2; 95% CI, 1.1-1.4) and management at a tertiary referral hospital (OR, 8.8; 95% CI, 1.6-48.0) were associated with higher cure rates. MDRO status itself was not significantly associated with peritonitis cure. Conclusion:Nearly one in seven peritonitis episodes (14.0%) was caused by MDROs. Prior hospitalization, diabetes mellitus, and recurrent peritonitis were independent risk factors for MDRO-peritonitis. Regarding peritonitis cure, characteristics of causative organisms tended to have a greater impact than did MDRO status itself.
INTRODUCTION:Gout commonly coexists with chronic kidney disease (CKD), with prevalence increasing as kidney function declines. Despite its burden, data on monitoring and treatment practices in CKD are limited. This study describes the prevalence, characteristics, and management of gout in non-dialysis CKD patients. METHODS:Cross-sectional data were analyzed from 3,524 stages 3a-5 CKD patients in the Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps) in Brazil (n = 942) and the United States (n = 2,582) at enrollment (2013-2022). History of gout was extracted from medical records. RESULTS:Gout prevalence was 18.7% overall-20.5% in the US and 13.9% in Brazil-higher in stages 4-5 vs. 3a-3b CKD. Allopurinol was most used (Brazil 75%; US 62%). Colchicine (13%) and febuxostat (8%) were reported in the US but rarely in Brazil. Uric acid was measured in 70% of Brazilian vs. 33% of US gout patients. CONCLUSIONS:Gout is common in CKD, with notable cross-country differences in monitoring and treatment.