Intermittent catheterization is the gold standard method for bladder management in individuals with urinary retention and/or incontinence. It is therefore important to understand the performance of urinary catheters, especially on parameters associated to risks of developing urinary tract infections, and that may impact the quality of life for urinary catheter users. Examples of such parameters include, urine flowrate, occurrence of flow-stops, and residual urine left in the bladder after flow-stop. Reliable in-vitro and/or ex-vivo laboratory models represent a strong asset to assess the performance of urinary catheters, preceding and guiding in-vivo animal studies and/or human clinical studies. Existing laboratory models are generally simplified, covering only portions of the catheterization process, or poorly reflect clinical procedures. In this work, we developed an ex-vivo porcine lower urinary tract model that better reflects the catheterization procedure in humans and allows to investigate the performance of standard of care catheters. The performance of three standard of care catheters was investigated in the developed model showing significant differences in terms of flowrate. No differences were detected in terms of residual volume in the bladder at first flow-stop also when tuning the abdominal pressure to mimic a sitting down and standing up position. A newly discovered phenomenon named hammering was detected and measured. Lastly, mucosal suction was observed and measured in all standard of care catheters, raising the concern for microtrauma during catheterization and a need for new and improved urinary catheter designs. Results obtained with the ex-vivo model were compared to in-vivo studies, highlighting similar concerns.
The original version of this Article contained a repeated error, where the pressure unit was incorrectly given as 'mbar' instead of 'mmHg' .In the Results and discussion section, under the subheading 'Intra-catheter pressure' , "The average pressure variation for Brand A was − 364 ± 42 mbar, − 248 ± 81 mbar for Brand B and − 272 ± 59 mbar for Brand C at 20 cmH 2 O. When the abdominal pressure was adjusted to 50 cmH 2 O, the average pressure for Brand A was − 383 ± 50 mbar, − 323 ± 47 mbar for Brand B and − 330 ± 93 mbar for Brand C. " now reads: "The average pressure variation for Brand A was − 364 ± 42 mmHg, − 248 ± 81 mmHg for Brand B and − 272 ± 59 mmHg for Brand C at 20 cmH 2 O. When the abdominal pressure was adjusted to 50 cmH 2 O, the average pressure for Brand A was − 383 ± 50 mmHg, − 323 ± 47 mmHg for Brand B and − 330 ± 93 mmHg for Brand C. " Additionally, "The measured intra-catheter pressure variation for Brand B at 20 cmH 2 O was equal to − 296 ± 56 mbar (N = 9, SD) for the tests where mucosal suction was perceived by the operator. Conversely, the intra-catheter pressure variation that could be measured at the first flow-stop for Brand B at 20 cmH 2 O when mucosal suction was not detected by the operator was equal to − 180 ± 64 mbar (N = 6, SD). A similar scenario was seen for Brand C at 50 cmH 2 O, where the measured intra-catheter pressure variation was equal to − 373 ± 62 mbar (N = 11, SD) when mucosal suction was perceived by the operator, and to − 212 ± 45 mbar (N = 4, SD) when mucosal suction was not perceived by the operator. " now reads: "The measured intra-catheter pressure variation for Brand B at 20 cmH 2 O was equal to − 296 ± 56 mmHg (N = 9, SD) for the tests where mucosal suction was perceived by the operator. Conversely, the intra-catheter pressure variation that could be measured at the first flow-stop for Brand B at 20 cmH 2 O when mucosal suction was not detected by the operator was equal to − 180 ± 64 mmHg (N = 6, SD). A similar scenario was seen for Brand C at 50 cmH 2 O, where the measured intra-catheter pressure variation was equal to − 373 ± 62 mmHg (N = 11, SD) when mucosal suction was perceived by the operator, and to − 212 ± 45 mmHg (N = 4, SD) when mucosal suction was not perceived by the operator. " Furthermore,
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