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. 2023 Aug 13;12(16):5266.
doi: 10.3390/jcm12165266.

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

Malene Hornbak Landauro  1 , Lotte Jacobsen  1 , Fabio Tentor  1 , Troels Pedersen  1 , Cecilie Rovsing  2 , Omar Feix do Nascimento  1 , Michael Kennelly  3
Affiliations

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

Malene Hornbak Landauro et al. J Clin Med. .

Abstract

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.

Keywords: intermittent urethral catheterisation; micro-hole drainage zone; urinary bladder disease; urinary flow-stop; urinary retention; urinary tract infection.

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Conflict of interest statement

The study was financially supported by Coloplast A/S. Cecilie Rovsing was paid a fixed price by Coloplast to conduct the study and took part in reviewing the manuscript. Michael Kennelly has received honoraria for participating in a Coloplast NeuroUrology Advisory Board and took part in the design of the study and review of the manuscript. Malene Hornbak Landauro, Lotte Jacobsen, Fabio Tentor, Troels Pedersen, and Omar Feix do Nascimento were Coloplast A/S employees during the study, and all took part in the interpretation and writing of the manuscript.

Figures

Figure 1
Figure 1
Two different types of flexible intermittent urinary catheters and their drainage zones: (a) a conventional eyelet catheter, with two eyelets at the catheter tip; (b) the micro-hole zone catheter, with 120 micro-holes extending from the tip down the tube of the catheter, creating a long drainage zone.
Figure 2
Figure 2
Example of the catheterisation profiles from one participant with the drained urine (mL) and intra-catheter pressure * (cmH2O) as a function of time (seconds) for the micro-hole zone catheter (MHZC, blue) and conventional eyelet catheter (CEC, orange). The solid line represents the intra-catheter pressure (P) measured with a fibre optic sensor and the dotted line represents the drained urine (RV) (mL). * Corrected for atmospheric pressure.
Figure 3
Figure 3
Haematuria assessment from the MultiStix 10 SG Urinalysis Test Strips.
Figure 4
Figure 4
Flow diagram of subjects randomised into two different intervention sequence groups.
Figure 5
Figure 5
Frequency plots for the residual volume at the first flow-stop, flow-stop episodes, and haematuria after catheterisation with both the MHZC and CEC: (a) a scatter plot depicting the distribution of the residual volume (mL) at the first flow-stop upon catheterisations with the CEC (grey) and MHZC (turquoise) and horizontal lines at 10 mL, 50 mL, and 100 mL; (b) number of flow-stop episodes during catheterisations with the CEC and MHZC categorised into 0–4 episodes (0 flow-stops = grey; 1 flow-stops = turquoise; 2 flow-stops = white; 3 flow-stops = light blue; 4 flow-stops = dark blue); (c) proportions of positive (turquoise) and negative (grey) haematuria post-catheterisation measured with a dipstick after catheterisations with the CEC and MHZC. MHZC = micro-hole zone catheter; CEC = conventional eyelet catheter.
See this image and copyright information in PMC

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