Specialist commentator comments
Comments on this technology were invited from clinical specialists working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
Two out of 4 of the specialists were familiar with or had used this technology before.
All the commentators considered UroShield to be an innovative or novel concept or design. None of the commentators was aware of any competing or alternative technologies available to the NHS that have similar function or mode of action to UroShield. One commentator noted that there are other devices available that aim to reduce urinary tract infections in indwelling catheters for example Farco-Fill and polyhexanide. However, these are installed using a catheter balloon or are inserted directly into the bladder. UroShield is the first device developed to be fitted externally.
Reduced blockages and catheter-associated urinary tract infections (CAUTIs), potentially resulting in better patient quality of life, less pain and discomfort, and fewer hospitalisations and acute settings visits for some people were identified by commentators as the potential benefits to patients from using UroShield. A reduced need for antibiotics and reduced risk of antimicrobial resistance was also identified by 1 of the commentators. People with indwelling urethral catheters who have blockages and recurrent CAUTIs despite current management, and patients with autoimmune suppressive conditions such as multiple sclerosis were identified by commentators as people who would particularly benefit from UroShield. One commentator said the technology appeared relevant to all catheterised patients.
Reduced use of antibiotics, fewer hospital admissions and fewer visits by community staff having to either unblock or change catheters, as well as fewer emergency admissions because of CAUTIs were identified by commentators as the potential benefits to the NHS from using UroShield. One commentator noted that UroShield may help reduce the risk of E. Coli, which is now a recordable bacteria target for the NHS. All of the commentators thought that UroShield would be an addition to current standard care. One commentator thought there would be little cost improvement based on the studies done so far. Another commentator thought that UroShield would cost more than current practice, which involves changing catheters (costing £8 to £10 each) every 12 weeks or more often if a patient has CAUTIs, or silver-coated catheters (costing around £11 each) every 4 weeks.
One commentator responded that based on experience in their trust, there would be a cost saving for some patients with just over half of patients having a cost-neutral impact. The remaining commentator said that cost savings would be dependent on achieving reductions in blockages or infections. None of the commentators identified any facility or infrastructure changes needed to adopt this technology. One commentator said that adopting the technology may increase demands on care staff, in terms of fitting the device and trouble-shooting non-function issues. Two commentators noted that product-specific training would be needed for healthcare professionals. None of the commentators were aware of any safety concerns or regulatory issues surrounding the technology.
According to 2 of the commentators, UroShield is not yet widely used in the NHS. One of the commentators said that UroShield is very easy to use, and that patients and their families have been able to remove and replace the device and attach the battery charger without difficulty. One commentator felt that the device may be inconvenient for users because of its size and location. According to 1 commentator, UroShield, would not be needed for every patient with an indwelling urethral or suprapubic catheter, but only for those with recurrent infections or blockages. One comment highlighted that, according to the instructions for use, UroShield cannot be used with 12-French Gauge (FG) catheters; adding that this is the most commonly used catheter size in most healthcare settings. The company has since confirmed that although not in the instructions for use, the technology can be used with12-FG catheters. Initial problems with the battery pack failing to keep its charge were mentioned by 1 commentator, however they added that the company had been very quick in replacing the defective packs. Commentators thought that the following research would be needed to strengthen the evidence base: data from a UK healthcare setting, data on device-related adverse events and possible contraindications to use, medium-term data (1 year) on CAUTI and blockage rates, and efficacy data comparing UroShield with other available catheters (such as silver-coated catheters and antibiotic-impregnated catheters). One commentator did not consider the current body of evidence robust enough to recommend routine use of UroShield in the NHS. They highlighted that some of the studies relied on patient-reported outcomes and involved the use of urinalysis and the treatment of suspected CAUTIs, which are not recommended in the UK.