On Medicine Pilot clinical trial to test the function of a diagnostic sensor in predicting impending urinary catheter blockage in long-term catheterized patients

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In an On Medicine blog post, Rachel Heylen discusses a new medical device developed to help predict urinary catheter blockage and the pilot study to test the sensor before the design of a larger randomized trial.

Doctor holding a urine sampleGladkovPhoto / Stock.adobe.com A diagnostic sensor to detect impending catheter blockage has been developed as a medical device to aid long-term urinary catheter users. Urinary catheter blockage can occur because of urease-positive infections – the urease metabolizes urea into two molecules of ammonia and carbonic acid.

No device currently exists to predict catheter blockage. The sensor described in this study can be used by individuals with no existing medical knowledge. Placed within the catheter drainage bag, it provides a colorimetric indication of impending catheter blockage, allowing the user or carer to change the catheter themselves; or flush the catheter using a maintenance solution thus reducing the risk of blockage.

The figure below shows the colorimetric change when the sensor indicates that catheter blockage is likely to occur. Conclusions The sensor can predict participants more prone to catheter blockage, and it is accurate in detecting urine with a pH over 7. Owing to the small sample number of this trial, the results are not statistically powered. However, the data can be used to improve the design of the sensor and inform the design of a larger, randomized clinical trial.

We would like to thank Mrs Annette Moreton at the Royal United Hospitals Bath for her support during the trial. We also thank our funders: Urology Foundation, the University of Bath Impact Acceleration Account and the EPSRC IAA Seed Grant.

 

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