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4 Committee discussion

Unmet need

UroShield is potentially life changing and could address an unmet need among people with long-term catheters in the community

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 reported that since using the device they were no longer taking prophylactic antibiotics. UroShield was described by the patient expert and patient survey 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 other catheter-related problems is a significant unmet need, especially in people with long-term catheters in the community. It concluded that UroShield showed promise in addressing this unmet need.

Clinical-effectiveness overview

The evidence shows that UroShield may reduce bacteriuria, infection, and catheter-related complaints but there are considerable uncertainties

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. The committee considered that, 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.

More information is needed about whether UroShield's effect is maintained after people stop using it

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.

Outcome measures

There is uncertainty about using bacteriuria as a proxy outcome for catheter-associated UTI

4.4 Bacteriuria was the most reported outcome in the clinical evidence. The clinical experts noted that bacteriuria only indicates the presence of bacteria in the urine and not catheter-associated UTI, and it may not cause symptoms. The committee recognised that bacteriuria is easy to measure but considered that the presence of a catheter-associated UTI is a more reliable outcome. For the purposes of further research on UroShield, it considered a pragmatic definition of catheter-associated UTI would be a reasonable choice to reflect how it is captured in clinical practice i.e. clinical judgement of UTI symptoms and visual inspection of bacteriuria.

More evidence is needed on the effect of UroShield on catheter blockages independent of catheter-associated UTI

4.5 The clinical experts said 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. Only 1 study (da Silva et al. 2021) reported 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.

Other patient benefits or issues

The main challenge to using UroShield is its short battery life

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 recharge the device during the day as needed using either the mains electricity or a rechargeable battery pack they bought themselves. The company said that it is planning to improve battery life.

Relevance to the NHS

The evidence is broadly generalisable to NHS practice

4.7 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 of using UroShield in addition to standard care in the NHS was needed.

NHS considerations overview

UroShield may most benefit people who need a long-term catheter in community care

4.8 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 who could be identified by their healthcare team. Some factors related to increased risk of catheter-associated UTIs were long-term catheterisation; genetic predisposition to UTI; history of catheterisation or UTI; comorbidities such as neurogenic bladder, diabetes, and multiple sclerosis; and female sex. Also, UTIs are a noted cause of morbidity and antibiotic use in older people. The clinical experts advised that catheter-associated UTI may present differently in elderly people and may be associated with confusion. This can affect the presentation and self-reporting of UTIs so additional steps to prevent morbidity is especially important. The clinical and patient experts believed people with recurrent UTIs would be highly motivated to use UroShield. The committee considered that people with a long-term catheter at high risk of catheter-associated UTIs and other catheter-related problems are likely to benefit most from UroShield. It understood that high risk of catheter-associated UTIs and catheter-related problems is not clearly defined and concluded that patient selection criteria would be valuable.

UroShield is not widely used in the NHS so healthcare professionals and patients may need support

4.9 UroShield has only been used by about 50 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.

Side effects and adverse events

Evidence shows UroShield is safe but more information on its long-term use would be valuable

4.10 The evidence did not identify any significant 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 many months and it considered that real-world evidence on using UroShield for periods of at least 6 months would be valuable.

Cost modelling

The meta-analysis data on UroShield's effectiveness is too uncertain to use in the cost modelling

4.11 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 use of a fixed effects model given the heterogeneity of the studies, and the use of bacteriuria as a proxy for catheter-associated UTIs.

Cost savings

UroShield has the potential to be cost saving if it is effective

4.12 The committee considered that the results from the cost models suggested that UroShield could be cost saving in hospital and in some community settings but noted that this depends on whether it is effective in preventing catheter-associated UTIs.

Further research

Further research is needed on the effectiveness of UroShield

4.13 The committee concluded that more research is needed on the effectiveness of UroShield in preventing catheter-associated UTIs and catheter-related complaints. 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 committee considered that the trial 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, unscheduled healthcare visits, and bacteriuria. Patient-reported outcomes would also be welcomed and helpful.