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Neurourology and Urodynamics Feb 2024To confirm the improved performance of the micro-hole zone catheter (MHZC) compared to a conventional eyelet catheter (CEC) in male users of clean intermittent... (Randomized Controlled Trial)
Randomized Controlled Trial
Improved emptying performance with a new micro-hole zone catheter in adult male intermittent catheter users: A comparative multi-center randomized controlled cross-over study.
AIMS
To confirm the improved performance of the micro-hole zone catheter (MHZC) compared to a conventional eyelet catheter (CEC) in male users of clean intermittent catheterizations (CICs).
METHODS
Male self-catheterizing subjects, who used hydrophilic sleeved soft/flexible CIC as the only bladder emptying method, were enrolled into a multi-center, randomized, cross-over study performed across six European sites. Subjects tested the MHZC, featuring a drainage zone with 120 micro-holes and a CEC with two eyelets. The study consisted of four study visits (V0-V3), during which endpoints related to catheter performance (urinary flow-stops, bladder emptying, and intra-catheter pressure) were measured and two 4-week test periods at home (T1 and T2) where dipstick hematuria and user perception between catheters were evaluated.
RESULTS
Seventy-three male subjects with non-neurogenic and neurogenic bladder dysfunction (3:2) were enrolled. On average, catheterizations with the MHZC led to close to mean zero flow-stops compared to ≥1 flow-stops with the CEC, during both HCP- and self-led catheterizations (both p < 0.001). Residual urine at first flow-stop was significantly reduced for the MHZC compared to CEC (p = 0.001 and p = 0.004, for HCP- and self-led catheterizations, respectively). This was substantiated by a significantly smaller pressure peak at first flow-stop, a proxy for minimized mucosal suction (both HCP- and self-led catheterizations, p < 0.001). After home-use catheterizations, dipstick hematuria was comparable between catheters, whereas catheterizations were associated with significantly improved perception in favor of MHZC regarding bladder emptying, less blocking sensation, and improved hygienic catheterization compared to the CEC.
CONCLUSION
This study confirmed the evidence of improved bladder emptying with the MHZC compared to a CEC without the need to reposition the catheter. The MHZC therefore offers an enhanced benefit for the dependent CIC user securing complete bladder emptying in an uninterrupted free flow and reducing the need to reposition the catheter during emptying.
Topics: Adult; Humans; Male; Cross-Over Studies; Hematuria; Urinary Tract Infections; Intermittent Urethral Catheterization; Urinary Catheters; Urinary Catheterization; Urinary Bladder, Neurogenic
PubMed: 38196237
DOI: 10.1002/nau.25383 -
Clinical Nephrology Feb 2024
Topics: Female; Humans; Urinalysis; Proteinuria; Reagent Strips; Sensitivity and Specificity
PubMed: 37997943
DOI: 10.5414/CN111086 -
Journal of Wound, Ostomy, and...To assess the performance of a new urinary intermittent catheter (IC) prototype designed with a micro-hole drainage zone compared to a conventional eyelet catheter (CEC)... (Randomized Controlled Trial)
Randomized Controlled Trial
Improved Performance With the Micro-Hole Zone Intermittent Catheter: A Combined Analysis of 3 Randomized Controlled Studies Comparing the New Catheter Technology With a Conventional Eyelet Catheter.
PURPOSE
To assess the performance of a new urinary intermittent catheter (IC) prototype designed with a micro-hole drainage zone compared to a conventional eyelet catheter (CEC) in terms of flow-stop, bladder emptying, and hematuria.
DESIGN
Randomized controlled crossover studies.
SUBJECT AND SETTING
The sample comprised 15 male healthy volunteers (HV) and 15 IC users, along with 15 female HV and 15 IC users. The age range was lower for HV participants than for IC users (range: 20-57 years for HV vs 21-82 years for IC users). The study setting was the Department of Urology, located in Rigshospitalet, Copenhagen.
METHODS
Number of flow-stop incidents, residual urine volume at first flow-stop (RV1), and dipstick hematuria were measured during and after catheterization by a health care professional (HV) and by self-catheterisation (IC-users). Results from the 3 studies were combined for HV and IC users on RV1 and number of flow-stop incidents but separated on sex. For incidents of hematuria, an effect of underlying condition was assumed, and a combined analysis on sex was performed, separating HV and IC users.
RESULTS
When compared to the micro-hole drainage zone design, catheterizations with CEC resulted in a significantly higher mean RV1 (mean difference: 49 mL in males and 32 mL in females, both P < .001) and average number of flow-stop incidents (8 and 21 times more frequent for males and females, respectively, both P < .001). The likelihood for hematuria was 5.84 higher with CEC than with micro-hole drainage hole design, P = .053, during normal micturition in HV postcatheterization. No serious adverse events were reported.
CONCLUSION
The micro-hole drainage zone catheter provides IC users fewer premature flow-stops. This design feature reduces modifiable urinary tract infection risk factors, such as residual urine and micro-trauma; additional research is needed to determine its effects on bladder health.
Topics: Adult; Female; Humans; Male; Middle Aged; Young Adult; Hematuria; Technology; Urinary Bladder; Urinary Catheterization; Urinary Catheters; Urinary Tract Infections; Cross-Over Studies
PubMed: 37966080
DOI: 10.1097/WON.0000000000001029 -
Langmuir : the ACS Journal of Surfaces... Oct 2023Water and food contamination has become the major contributor to infections and deaths. However, rapid and sensitive bacterial detection still remains an unmet demand...
Water and food contamination has become the major contributor to infections and deaths. However, rapid and sensitive bacterial detection still remains an unmet demand that has attracted widespread attention. Often water and food samples are sent out for laboratory testing to detect the presence of contamination, which is time-consuming and laborious. Herein, we have developed a highly ensitive, enable, ffordable, and obust (STAR) paper-based colorimetric dipstick sensor based on the principle of Prussian blue (PB) synthesis as an indicator of bacterial contamination. In the presence of bacteria, it leads to the formation of PB, a dye that acts as a colorimetric indicator. The intensity of the PB is the direct measure of the degree of contamination. The fabrication of the STAR dipstick sensor involves a simple and cost-effective process. The STAR dipstick sensor is ultrasensitive and can detect up to 10 CFU/mL of bacteria within minutes of contact with the test sample. The STAR dipstick sensor is fabricated using biodegradable components, which is speculated to facilitate quick and environmentally friendly degradation after each use. The sensor has been validated for its properties and capabilities at different pH to detect both Gram-positive and Gram-negative bacterial strains in real-time samples. The stability and degradation were also monitored. Comprehensively, the proposed STAR dipstick sensor can serve as a point-of-care device to detect bacterial contamination in a swift and sensitive manner.
PubMed: 37750674
DOI: 10.1021/acs.langmuir.3c01451 -
Clinica Chimica Acta; International... Oct 2023Urinalysis is essential for diagnosing kidney-related medical conditions. Urine test strip analysis serves as an initial and efficient screening method for reflex...
INTRODUCTION
Urinalysis is essential for diagnosing kidney-related medical conditions. Urine test strip analysis serves as an initial and efficient screening method for reflex testing with accurate quantitative methods.
MATERIALS AND METHODS
Freshly voided urines (n = 206) were analysed using two urine test strip brands on UC-MAX (Menarini) and cobas u 601 (Roche Diagnostics) instruments. Ordinal scale categories and reflectance signals (if available) were both used for the comparison with reference quantitative methods for glucose, proteins and albumin (cobas 503). Samples were considered positive when glucose > 15 or ≥ 54 mg/dL, proteins ≥ 200 mg/L and albumin ≥ 10 mg/L. Optimized reflectance thresholds were calculated by ROC curve analysis. Analytical performance specifications (APS) for trueness of test strip were gathered from the EFLM guideline (FP, FN, FN).
RESULTS
Reflectance signals were significantly lower in urine samples considered positive by the reference method (p < 0.0001). Reflectance signals were also correlated with quantitative measurements, showing strong correlation (0.754 to 0.969). Only the use of optimized reflectance thresholds on cobas u 601 achieved at least the minimum EFLM APS (FP < 20%, FN < 50% and FN < 10%).
CONCLUSION
The use of reflectance signals from urine test strips enhanced accuracy for glucose, proteins, and albumin measurement and may contribute to improve diagnosis of diverse kidney-related conditions.
Topics: Humans; Reagent Strips; Urinalysis; Glucose; Proteins; Albumins
PubMed: 37739023
DOI: 10.1016/j.cca.2023.117534 -
Lancet (London, England) Sep 2023Chronic kidney disease (CKD) has a rising global prevalence and is expected to become the fifth leading cause of death by 2030. Increased albuminuria defines the early... (Randomized Controlled Trial)
Randomized Controlled Trial
Participation rate and yield of two home-based screening methods to detect increased albuminuria in the general population in the Netherlands (THOMAS): a prospective, randomised, open-label implementation study.
BACKGROUND
Chronic kidney disease (CKD) has a rising global prevalence and is expected to become the fifth leading cause of death by 2030. Increased albuminuria defines the early stages of CKD and is among the strongest risk factors for progressive CKD and cardiovascular disease. The value of population screening for albuminuria to detect CKD in an early phase has yet to be studied. We aimed to evaluate the effectiveness of two home-based albuminuria population screening methods.
METHODS
Towards Home-based Albuminuria Screening (THOMAS) was a prospective, randomised, open-label implementation study that invited Dutch adults aged 45-80 years for albuminuria screening. Individuals were randomly assigned (1:1) to screening by applying either a urine collection device (UCD) that was sent by post to a central laboratory for measurement of the albumin-to-creatinine ratio (ACR) by immunoturbidimetry or to screening via a smartphone application that measures the ACR with a dipstick method at home. Randomisation was done with a four-block method via a web-based system and was stratified by age, sex, and socioeconomic status. If two or more individuals per household were invited to participate, these individuals were randomly assigned to the same group. In case of confirmed increased albuminuria at home, participants were invited for an elaborate screening in a regional hospital (Amphia Hospital, Breda, Netherlands) for CKD and cardiovascular risk factors. When abnormalities were found, participants were referred to their general practitioner for treatment. The primary outcomes were the participation rate and yield of the home-based screening and elaborate screening. Participation rate was assessed in the intention-to-screen population (ie, all participants who were invited for the home-based screening or elaborate screening). Yield was assessed in the per-protocol population (ie, all individuals who participated in the home-based screening or elaborate screening). An exploratory analysis assessed the sensitivity and specificity of both home-based screening methods. To this end, an additional quantitative ACR test was performed among people participating in the elaborate screening, and a substudy was performed among participants with a first negative home-based screening test, who were invited for an additional test. The study is registered with ClinicalTrials.gov, NCT04295889.
FINDINGS
15 074 participants were enrolled between Nov 14, 2019, and March 19, 2021. 7552 (50·1%) were randomly assigned to home-based albuminuria screening by the UCD method and 7522 (49·9%) were assigned to albuminuria screening by the smartphone application method. The participation rate of the home-based screening was 4484 (59·4% [95% CI 58·3-60·5]) of the 7552 invited individuals for the UCD method and 3336 (44·3% [43·2-45·5]) of 7522 invited individuals for the smartphone application method (p<0·0001). Increased ACR was confirmed by home-based testing in 150 (3·3% [95% CI 2·9-3·9]) of 4484 individuals for the UCD method and 171 (5·1% [4·4-5·9]) of 3336 indivduals for the smartphone application method. 124 (82·7% [95% CI 75·8-87·9]) of 150 individuals assigned to the UCD method and 142 (83·0% [76·7-87·9]) of 171 participants assigned to the smartphone application method attended the elaborate screening. Sensitivity to detect increased ACR was 96·6% (95% CI 91·5-99·1) for the UCD method and 98·1% (89·9-99·9) for the smartphone application method, and specificity was 97·3% (94·7-98·8) for the UCD method and 67·9% (62·0-73·3) for the smartphone application method, indicating that the test characteristics of only the UCD method were sufficient for screening. Albuminuria, hypertension, hypercholesterolaemia, and decreased kidney function were newly diagnosed in 77 (62·1%), 44 (35·5%), 30 (24·2%), and 27 (21·8%) of 124 participants for the UCD method, respectively. Of the 124 participants assigned to the UCD method who completed elaborate screening, 111 (89·5%) were referred to their general practitioner for treatment because of newly diagnosed CKD or cardiovascular disease risk factors or known risk factors outside the target range.
INTERPRETATION
Home-based screening of the general population for increased ACR using a UCD had a high participation rate and correctly identified individuals with increased albuminuria and yet unknown or known but outside target range CKD and cardiovascular risk factors. By contrast, the smartphone application method had a lower at-home participation rate than the UCD method and the test specificity was too low to accurately assess individuals for risk factors during the elaborate screening. The UCD screening strategy could allow for an early start of treatment to prevent progressive kidney function loss and cardiovascular disease in patients with CKD.
FUNDING
Dutch Kidney Foundation, Top Sector Life Sciences & Health of the Dutch Ministry of Economic Affairs.
Topics: Humans; Albuminuria; Cardiovascular Diseases; Creatinine; Netherlands; Prospective Studies; Renal Insufficiency, Chronic; Middle Aged; Aged; Aged, 80 and over
PubMed: 37597522
DOI: 10.1016/S0140-6736(23)00876-0 -
Clinica Chimica Acta; International... Aug 2023To address the situation that the accuracy of concentration intervals (CI) corresponding to dipstick grades is not given by the manufacturers or literature, we developed...
BACKGROUND
To address the situation that the accuracy of concentration intervals (CI) corresponding to dipstick grades is not given by the manufacturers or literature, we developed a method that determined reasonable dipstick grades with concentration intervals (GCIs) based on the percent agreement (PA) and discussed the GCI application to comparability among currently dipstick tests.
METHODS
By comparing the results of 2 dipstick tests (iChem and KU-500) with the quantitative test (AU5800), the GCIs were verified and established based on the PAs, which were calculated and used as an indicator of GCI's accuracy. The overlap (percent) between the 2 GCIs with the same grade (2 dipstick devices), was calculated and used to evaluate the agreement between their test results.
RESULTS
After verification and adjustment, the GCI and PA combinations for iChem Velocity were as follows: - (<0.1 g/l, 85 %), ± (0.1-0.3 g/l, 66 %), 1+ (0.3-1 g/l, 78 %), 2+ (1-3 g/l, 74 %), 3+ (3-6 g/l, 77 %), and 4+ (≥6 g/l, 84 %). The determined GCI and PA combinations for KU-500 were: - (<0.1.2 g/l, 75 %), ± (0.12-0.5 g/l, 63 %), 1+ (0.5-1.2 g/l, 69 %), 2+ (1.2-3.2 g/l, 76 %), and 3+ (≥3.2 g/l, 82 %). The GCI overlaps between the 2 dipstick devices were - (83 %), ± (45 %), 1+ (56 %), 2+ (82 %), and 3+ or ≥3+ (94 %). The overall overlap was 72 %. Since the overlaps ± (45 %) and 1+ (56 %) were within the overlap reject limit for any grade (70 %), and the overall overlap (72 %) was within the overall overlap reject limit (80 %), the test results of the 2 devices were not comparable.
CONCLUSIONS
GCIs can be verified and established correctly based on PAs, and industry standards for dipstick tests can be established based on GCIs and PAs. Comparability between dipstick devices, historical data, and literature data can be roughly determined based on the overlap.
Topics: Humans; Sensitivity and Specificity; Urinalysis; Reagent Strips
PubMed: 37500032
DOI: 10.1016/j.cca.2023.117500 -
Scientific Reports Jul 2023Lyme disease, one of the most common tickborne diseases, has been rapidly spreading in parallel with the expansion of the range of its tick vector. Better tick...
Lyme disease, one of the most common tickborne diseases, has been rapidly spreading in parallel with the expansion of the range of its tick vector. Better tick surveillance efforts are needed to accurately estimate disease risk and to guide public health and clinical management. We have developed two multiplex loop-mediated isothermal amplification (LAMP) reactions coupled with oligonucleotide strand displacement (OSD) probes to identify the tick host, Ixodes scapularis, and the Lyme disease pathogen, Borrelia burgdorferi, they carry. In each multiplex LAMP-OSD assay the co-presence of two target sequences is computed at the DNA level by linking the two corresponding amplicons and detecting the co-product on colorimetric lateral flow dipsticks. In tests with synthetic DNA, the co-presence of as few as four copies of input DNA could be detected, without producing spurious signals. Most importantly, though, the LAMP-OSD assay is amenable to being carried out directly with macerated tick samples, without any sample preparation. In such field conditions, assays performed robustly and demonstrated 97-100% sensitivity and 100% specificity with both field-collected and lab-raised artificially infected ticks. Such easy-to-use, arthropod and pathogen-specific assays would be well suited to field and near patient use without relying on complex instrumentation or infrastructure.
Topics: Animals; Humans; Ixodes; Borrelia; Colorimetry; Lyme Disease; Borrelia burgdorferi; Nucleic Acids
PubMed: 37454160
DOI: 10.1038/s41598-023-38452-8 -
Talanta Dec 2023Dipstick-type lateral flow immunosensors are used widely for on-site detection of food allergens. The weakness of the immunosensors of this type, however, is their low...
Dipstick-type lateral flow immunosensors are used widely for on-site detection of food allergens. The weakness of the immunosensors of this type, however, is their low sensitivity. Contrary to current methods, that focus on improving detection capability through the introduction of novel labels or multistep protocols, this work exploits macromolecular crowding to modify and regulate the microenvironment of the immunoassay, thus promoting the interactions that are responsible for allergen recognition and signal generation. The effect of 14 macromolecular crowding agents was explored using, as a model, commercially available and widely applied dipstick immunosensors, which are already optimized in terms of reagents and conditions for peanut allergen detection. An about 10-fold improvement in detection capability was achieved by using polyvinylpyrrolidone, Mr 29,000, as a macromolecular crowder without compromising simplicity and practicality. The proposed approach is complementary to other methods of improving the sensitivity by using novel labels. Because biomacromolecular interactions have a fundamental role in all types of biosensors, we foresee that the proposed strategy will also find applications in other biosensors and analytical devices.
Topics: Allergens; Biosensing Techniques; Immunoassay; Macromolecular Substances
PubMed: 37421795
DOI: 10.1016/j.talanta.2023.124899 -
The Journal of Antimicrobial... Aug 2023Given the lack of accurate rapid diagnostics for urinary tract infection (UTI) in women, many countries have developed guidelines aiming to support appropriate... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
Given the lack of accurate rapid diagnostics for urinary tract infection (UTI) in women, many countries have developed guidelines aiming to support appropriate antibiotic prescribing, but some guidelines have not been validated. We performed a diagnostic accuracy validation study of two guidelines: Public Health England (GW-1263) and Scottish Intercollegiate Guidelines Network (SIGN160).
METHODS
We used data from women with symptoms suggestive of uncomplicated UTI from a randomized controlled trial comparing urine collection devices. Symptom information was recorded via baseline questionnaire and primary care assessment. Women provided urine samples for dipstick testing and culture. We calculated the number within each risk category of diagnostic flowcharts who had positive/mixed growth/no significant growth urine culture. Results were presented as positive/negative predictive values, with 95% CIs.
RESULTS
Of women aged under 65 years, 311/509 (61.1%, 95% CI 56.7%-65.3%) classified to the highest risk category (recommended to consider immediate antibiotic prescribing) and 80/199 (40.2%, 95% CI 33.4%-47.4%) classified to the lowest risk category (recommended to reassure that UTI is less likely) by the GW-1263 guideline (n = 810) had positive culture. For the SIGN160 guideline (n = 814), the proportion with positive culture ranged from 60/82 (73.2%, 95% CI 62.1%-82.1%) in those for whom immediate treatment was indicated to 33/76 (43.4%, 95% CI 32.3%-55.3%) in those recommended a self-care/waiting strategy.
CONCLUSIONS
Clinicians should be aware of the potential for diagnostic error when using diagnostic guidelines for managing uncomplicated UTI and making antimicrobial prescribing decisions. Infection cannot be excluded on the basis of symptoms and dipstick testing alone.
Topics: Humans; Female; Urinalysis; Urinary Tract Infections; Anti-Bacterial Agents; Predictive Value of Tests; Primary Health Care
PubMed: 37401673
DOI: 10.1093/jac/dkad212