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 (HCP) and by 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.

Background/Objectives: To perform a physicochemical characterization of urine and sediment in intermittent catheterization (IC) users and evaluate the impact of IC with micro-hole zone catheters (MHZC) and conventional two-eyelet catheters (CEC). Methods: Analysis of anonymized urine samples collected from four IC user groups with lower urinary tract dysfunction (LUTD): Newly diagnosed individuals with spinal cord injury (SCI) from an inpatient SCI clinic (A), and community-based IC users with SCI (B), multiple sclerosis (MS) (C), or other conditions than SCI or MS (D). Urine analysis included physicochemical properties, bacterial load, and sediment size, both after collection and following passage through MHZC and CEC. Results: Urine samples from 53 participants were analyzed (groups A: 11, B: 11, C: 9, D: 22). The physicochemical properties of urine were similar to reference values despite the prevalence of bacteriuria ranging from 54.5% to 77.3%. The median [99th percentile] sediment size in the total group was 8.6 µm [50.7 µm] and 8.5 µm [54.1 µm] for group A, 9.2 µm [40.3 µm] for group B, 7.9 µm [48.3 µm] for group C, and 8.9 µm [50.3 µm] for group D. Following catheter passage, the median sediment size for the total group was 8.9 µm with the MHZC and 8.9 µm with the CEC. Conclusions: This two-part study initially presented a novel approach to characterizing urine samples, including sediment from IC users, and, thereafter, an in vitro experiment using the samples to test sediment passage through MHZC and CEC. The results indicated similar urine properties and sediment sizes across groups and did not suggest differences or issues relating to urine and sediment passage through these IC technologies for these groups.

PURPOSE: The purpose of this study was to assess sediments in complicated and uncomplicated urine samples and the ability of conventional and micro-hole intermittent catheters to drain these sediments. DESIGN: Randomized, single-blinded, cross-over study. SUBJECTS AND SETTING: Adult healthy volunteers (male and female) and patients regularly using intermittent catheterization were enrolled. Urine samples from these study participants were collected with a conventional eyelet catheter and a micro-hole zone catheter, on separate days. In addition, complicated urine samples defined as urine containing large numbers of visible casts and mucus collected from patients visiting a urology department in Copenhagen Denmark were collected with a conventional catheter with extra-large eyelets. METHODS: All urine samples from patients and healthy volunteers were analyzed within 48 hours of collection. The number and size distribution of sediments in uncomplicated urine was evaluated using automated light microscopy. Sediments in complicated urine also were assessed with conventional light microscopy. Laboratory-based drainage tests were performed for complicated urine using both types of catheters. RESULTS: Similar types of sediments were found in all urine samples, with sizes from 2 to 195 μm in clear urine and 2 to 131 μm in cloudy urine. More sediments were found in cloudy and complicated urine compared with clear samples. In complicated urine, the number of sediments in some instances was large enough to obstruct flow in some micro-hole catheters, and a few conventional catheters as well. CONCLUSIONS: Most urine samples can be successfully drained through micro-hole zone catheters, but care should be exercised in recommending these catheters to patients with complicated urine, containing large numbers of visible sediments.