UroShield for preventing catheter-associated urinary tract infections

4.1 The patient expert and patient survey comments described UroShield as simple and easy to use. The patient expert reported several benefits from using UroShield in the past 3 years. These included a significant reduction in urinary tract infections (UTIs) and no catheter blockages. They liked that UroShield was not a drug and said that since using the device they no longer needed to take prophylactic antibiotics. The committee heard during consultation several comments strongly supporting these patient benefits. UroShield was described by the patient expert, patient survey, and several consultees as life changing and transformational. The committee heard how recurrent UTIs can have a devastating impact on a person's quality of life. It considered that preventing catheter-associated UTIs and blockages is a significant unmet need, especially in people in the community with long-term catheters. It concluded that UroShield showed promise in addressing this unmet need and strongly encouraged further research in this patient population.

4.2 The committee considered that the clinical evidence showed that UroShield had promise for reducing bacteriuria, infection, and catheter-related complaints including blockages. However, it considered that the limited clinical evidence raised uncertainties about the effectiveness of UroShield in preventing catheter-associated UTIs. The 2 key studies (da Silva et al. 2021, Markowitz et al. 2018) had methodological concerns. While Markowitz et al. (2018) was a double-blinded randomised controlled trial, it was limited by a small sample size (n=55), risk of multiplicity in the data analysis, and its reporting of significant improvement in bacterial load to a threshold of 100,000 colony forming units (CFU). The committee also noted the limitations of the study by da Silva et al. (2021), such as the small sample size (n=23), and the uncontrolled before-and-after study design. This meant it could not control for other potential changes to standard care with the introduction of UroShield, such as increased catheter care and attention.

4.3 Markowitz et al. (2018) reported continued positive effects of UroShield on bacterial load and the number of new UTIs requiring antibiotics for up to 60 days after stopping its use. The committee considered that this prolonged effect did not align with the instructions for use, which specify that the device should be used continuously. The company said that, while it advised continuous use of the device for optimal effects, real-world use may differ. It reported that laboratory testing suggested it took some time for bacteria to re-establish on catheters after people stopped using UroShield. The company attributed this prolonged effect to changes in the quorum sensing (cell-to-cell communication) of the bacteria. The committee considered that more information into the prolonged effect of UroShield would be valuable and may help patients better understand how to use the device effectively.

4.4 Bacteriuria was the most reported outcome in the clinical evidence. The clinical experts said that bacteria are the root cause of both catheter-associated UTI and blockages. But they advised that bacteriuria only indicates the presence of bacteria in the urine and not catheter-associated UTI, and it may not cause symptoms in everyone. The committee recognised that bacteriuria is easy to measure but considered that the presence of a catheter-associated UTI is a more reliable outcome. It acknowledged that symptoms from other health conditions may present similarly to the symptoms of a UTI. Therefore, for the purposes of further research on UroShield, the committee considered a pragmatic definition of catheter-associated UTI would be a reasonable choice to reflect how it is captured in clinical practice, that is, clinical judgement of UTI symptoms, visual inspection of urine, and microbiological inspection of bacteriuria.

4.5 The committee heard during consultation and from the clinical experts that catheter blockages are a major source of patient complaints and unscheduled healthcare visits, which may affect around 33% to 50% of people with long-term catheters. Catheters can become blocked with or without an associated UTI. The committee recognised that the patient and clinical experts and several consultees strongly supported using UroShield to prevent or reduce catheter blockages. It considered that UroShield had the potential to address an important unmet need and that its use could result in cost savings associated with a reduction in blockages. But there is little clinical evidence on the effect of UroShield on blockages, with only 1 study (da Silva et al. 2021) reporting catheter blockages as an outcome. The committee therefore considered that more evidence was needed on the effectiveness of UroShield in preventing catheter blockages independent of catheter-associated UTI.

4.6 The main challenge reported by the patient expert and patient survey was UroShield's battery life, which lasts around 6 to 7 hours. The patient expert said that they charged it overnight from the mains electricity. They also recharged the device during the day as needed using either the mains electricity or a rechargeable battery pack they had bought themselves. The company said that it was planning to improve battery life.

4.7 The evidence and comments from the patient and clinical experts and several consultees showed that most people have positive experiences of using UroShield. But the device may not suit everyone. Some people may have difficulty handling the device, for example people with neurological conditions that affect manual dexterity. Some people may also find the hum emitted from the device annoying. The patient expert said that this low-level hum is less noticeable with time. The company said that the hum may reassure people that the device is still working, and believed it is hardly noticeable once the device is worn under clothes. The committee accepted that patient preferences and their capacity to manage the device are important considerations.

4.8 The evidence on UroShield included people with short- and long-term catheterisation in hospital and community care. Only 1 study was in the UK (da Silva et al. 2021). The clinical experts said that the evidence was broadly generalisable to the NHS but noted a few differences in practice, such as the frequency of catheter changes. The company said that the instructions for use recommend the actuator is changed every 30 days to align with practice in the US. The patient expert noted that their catheter and actuator are changed every 6 weeks. The company said that it is continuing work on the technology to make it more country specific. The committee considered that more evidence for using UroShield in addition to standard care in the NHS was needed.

4.9 The clinical experts said that people in long-term care in the community who have a long-term catheter have the highest rates of catheter-associated UTIs and catheter blockages. They said that UroShield would most benefit people with a high risk of catheter-associated UTI. Some factors related to increased risk of catheter-associated UTIs were:

4.10 UroShield has only been used by about 80 patients in the NHS. The clinical experts said that patient education and counselling is important to understand how to wear and use the device. This may be especially important for people who use it outside their home. Healthcare professionals may also need training because most would be unfamiliar with the technology. Training and support are available through the company, including online training sessions, a specialist nurse adviser, and a helpdesk team.

4.11 The evidence did not identify any device-related adverse events. Clinical and patient experts, and the patient survey, did not attribute any adverse events to UroShield. The committee noted that some patients could use UroShield for years and it considered that real-world evidence on using UroShield for longer periods would be valuable.

4.12 The committee considered that the economic case for UroShield was uncertain because the effectiveness of UroShield relied on the findings of the meta-analysis. The committee had notable concerns with the meta-analysis, including the quantity and quality of the evidence used, the heterogeneity of the studies, and the use of bacteriuria as a proxy for catheter-associated UTIs.

4.13 The committee considered that the results from the cost models suggested that UroShield could be cost saving in hospital, and in the community for people with recurrent infection or blockages. But it noted that this depends on whether it is effective in preventing catheter-associated UTIs or blockages.

4.14 The committee concluded that more research is needed on the effectiveness of UroShield in preventing catheter-associated UTIs and blockages. There is an ongoing non-comparative study by the University of Southampton (National Institute for Health Research clinical research network [NIHR CRN] portfolio CPMS ID 48290) in 30 people with long-term catheters in the community who have frequent infection or blockages. The committee considered that while this study may provide additional evidence on patient experiences and the effect of UroShield on the microbiota in the urine, it will not resolve the uncertainties in effectiveness. A randomised controlled trial (at the individual or group level) is considered to be the most robust and efficient design to confirm the promising results of the studies presented. The external assessment centre (EAC) advised that a well-designed before and after study may also be appropriate. The committee considered that the study should be powered to detect statistically significant differences in clinically confirmed catheter-associated UTIs (see section 4.4). Secondary outcomes of interest should include catheter blockages and bacteriuria. Patient-reported outcomes and resource utilisation outcomes would also be welcomed.