IAA - Urinostics

Project: Research council

Project Details


Preamble: The team have provisional HRA / LREC approvals for this study – which was due to start in March 2019 but was delayed by Covid-19. The team will submit minor amendments to the trial protocol through IRAS as soon as a clear start date can be identified. However, the delay has allowed us to improve the trial protocol, and bring our industry partner, Mediplus formally into the team, thus allowing us to identify a clear route to market.

The University of Bath team (UoB) developed a patented prototype diagnostic ‘lozenge’ which, when placed in a patient’s urine drainage bag, gives early warning (approximately 6.5 hours) of potential catheter blockage onset caused by a Catheter Associated Urinary Tract Infection (CAUTI) [1]. Catheter blockage from CAUTI, the most serious consequence of Proteus mirabilis infection, can quickly lead to sepsis, kidney infection and death in vulnerable (mostly elderly) patients [2]. In the UK, approximately 15-25% of patients admitted to NHS hospitals each year will require urethral catheterisation. CAUTIs, the most common cause of hospital-acquired infection, account for approximately 80% of hospital-acquired infections worldwide, resulting in 45 717 excess bed days in NHS hospitals during 2016-2017, and costing the NHS £1.5-2.25 billion/year [3].

The aim was to carry out a pilot clinical study by recruiting 48 catheterised patients over 6 months and asking them to donate their used catheter drainage bags (removed in the clinic at the Urology department at the Royal United Hospital in Bath). The urine (in drainage bags) was taken to the lab at the UoB for evaluation of urine microbiology, and to test the prototype diagnostic lozenge (that, in future, will be inserted into the urine-containing drainage bags).
Effective start/end date1/07/2130/04/22


  • Engineering and Physical Sciences Research Council


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