Urinostics - catheter infection diagnostics v1.1
Research type
Research Study
Full title
A study to test a sensor for giving early warning of urinary catheter blockage
IRAS ID
261065
Contact name
June Mercer-Chalmers
Contact email
Sponsor organisation
University of Bath
Duration of Study in the UK
0 years, 3 months, 13 days
Research summary
In the UK, approximately 15-25% of patients admitted to NHS hospitals each year will require urethral catheterisation. Foley catheters are often used on a long-term (≥30 days) indwelling basis, as a common management technique for urinary incontinence or retention and carry an approximate 5% per day risk of developing bacterial infections. These infections usually manifest as catheter blockages, resulting in painful bladder distention of the bladder, and can lead to serious symptomatic episodes such as acute pyelonephritis and septicaemia.
Catheter-associated urinary tract infection (CAUTI) is the second most common cause of hospital-acquired infection, accounting for approximately 80% of hospital-acquired infections worldwide, and its prevention is an important part of patient safety initiatives in many countries. Development of CAUTI is likely to prolong a patient’s hospital stay by an estimated 0.5 days to 5 days, and suffering CAUTI adversely affects quality of life. In the US alone, CAUTIs result in approximately $425 million in excess health care costs and 13,000 deaths.
The aim is to carry out a pilot study by recruiting around 48 catheterized patients over 5 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) will be taken to the lab, at the University of Bath, for evaluation of urine microbiology and to test a new diagnostic lozenge (that will be inserted into the urine-containing drainage bags). The diagnostic lozenge has been designed to give the patient, or carer, an early warning (of approximately 14 hours) of the onset of infection or potential catheter blockage.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/LO/0094
Date of REC Opinion
9 Mar 2020
REC opinion
Further Information Favourable Opinion