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.

New Intermittent Urinary Micro-Hole Zone Catheter Shows Enhanced Performance in Emptying the Bladder: A Randomised, Controlled Crossover Study.

Urinary tract infections (UTIs) are common and troublesome complications of clean intermittent catheterisation (CIC) in individuals suffering from incomplete bladder emptying, which may exacerbate the underlying disease and lead to hospitalisation. Aside from the design of the intermittent catheter and its handling, a recent review highlighted residual urine as one of several UTI risk factors. A new urinary intermittent catheter with multiple micro-holes has been developed for improved bladder emptying. In a controlled crossover study, adult male CIC users were randomised for a health care professional-led catheterisation with the new micro-hole zone catheter (MHZC) and a conventional eyelet catheter (CEC) in two individual test visits to compare the number of flow-stops and the residual urine at the first flow-stop as co-primary endpoints. In 42 male CIC users, the MHZC resulted in significantly fewer flow-stop episodes compared to the CEC (mean 0.17, 95% CI [0.06, 0.45] vs. mean 1.09, 95% CI [0.75, 1.6], respectively; p < 0.001) and significantly less residual urine at the first flow-stop (mean 5.10 mL, SE [1.14] vs. mean 39.40 mL, SE [9.65], respectively; p < 0.001). No adverse events were observed in this study. The results confirm the enhanced performance of the MHZC compared to a CEC, ensuring an uninterrupted free urine flow with no need to reposition the catheter until the bladder is thoroughly empty.

Deep Breathing Increases Heart Rate Variability in Patients With Rheumatoid Arthritis and Systemic Lupus Erythematosus.

BACKGROUND/OBJECTIVE: Autoimmune diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) have been associated with an impaired function of the autonomic nervous system and reduced vagus nerve (VN) tone measured through lower heart rate variability (HRV). Targeting the VN through electrical stimulation has been proposed as a treatment strategy with promising results in patients with RA. Moreover, it has been suggested that the VN can be stimulated physiologically through deep breathing. In this study, the aim was to investigate if the VN can be stimulated through deep breathing in patients with RA and SLE, as measured by HRV. METHODS: Fifty-seven patients with RA and SLE performed deep breathing exercises for 30 minutes in this explorative study. Before the breathing exercise, 2 electrocardiogram recordings were obtained to determine the patient's baseline HRV during rest. After the 30-minute breathing exercise, 5 minutes of electrocardiogram recordings were obtained to determine postintervention HRV and used as a measure of vagal activity. RESULTS: No change was observed in the HRV between the 2 recordings prior the exercise, but the heart rate and HRV significantly decreased and increased, respectively, after the deep breathing exercise. CONCLUSIONS: HRV can be modulated in patients with RA and SLE; this may have implications for future treatment with medications in conjunction with deep breathing. However, the biological and clinical effect of deep breathing must be investigated in future studies.

Classification of Hand Grasp Kinetics and Types Using Movement-Related Cortical Potentials and EEG Rhythms.

Detection of single-trial movement intentions from EEG is paramount for brain-computer interfacing in neurorehabilitation. These movement intentions contain task-related information and if this is decoded, the neurorehabilitation could potentially be optimized. The aim of this study was to classify single-trial movement intentions associated with two levels of force and speed and three different grasp types using EEG rhythms and components of the movement-related cortical potential (MRCP) as features. The feature importance was used to estimate encoding of discriminative information. Two data sets were used. 29 healthy subjects executed and imagined different hand movements, while EEG was recorded over the contralateral sensorimotor cortex. The following features were extracted: delta, theta, mu/alpha, beta, and gamma rhythms, readiness potential, negative slope, and motor potential of the MRCP. Sequential forward selection was performed, and classification was performed using linear discriminant analysis and support vector machines. Limited classification accuracies were obtained from the EEG rhythms and MRCP-components: 0.48 ± 0.05 (grasp types), 0.41 ± 0.07 (kinetic profiles, motor execution), and 0.39 ± 0.08 (kinetic profiles, motor imagination). Delta activity contributed the most but all features provided discriminative information. These findings suggest that information from the entire EEG spectrum is needed to discriminate between task-related parameters from single-trial movement intentions.

Quantification of Movement-Related EEG Correlates Associated with Motor Training: A Study on Movement-Related Cortical Potentials and Sensorimotor Rhythms.

The ability to learn motor tasks is important in both healthy and pathological conditions. Measurement tools commonly used to quantify the neurophysiological changes associated with motor training such as transcranial magnetic stimulation and functional magnetic resonance imaging pose some challenges, including safety concerns, utility, and cost. EEG offers an attractive alternative as a quantification tool. Different EEG phenomena, movement-related cortical potentials (MRCPs) and sensorimotor rhythms (event-related desynchronization-ERD, and event-related synchronization-ERS), have been shown to change with motor training, but conflicting results have been reported. The aim of this study was to investigate how the EEG correlates (MRCP and ERD/ERS) from the motor cortex are modulated by short (single session in 14 subjects) and long (six sessions in 18 subjects) motor training. Ninety palmar grasps were performed before and after 1 × 45 (or 6 × 45) min of motor training with the non-dominant hand (laparoscopic surgery simulation). Four channels of EEG were recorded continuously during the experiments. The MRCP and ERD/ERS from the alpha/mu and beta bands were calculated and compared before and after the training. An increase in the MRCP amplitude was observed after a single session of training, and a decrease was observed after six sessions. For the ERD/ERS analysis, a significant change was observed only after the single training session in the beta ERD. In conclusion, the MRCP and ERD change as a result of motor training, but they are subject to a marked intra- and inter-subject variability.