Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

Three studies are summarised in this briefing. The evidence base for UroShield comprises 2 randomised controlled studies and 1 prospective non-randomised comparative study involving a total of 182 patients with indwelling urinary catheters.

Further studies are publicly available but were excluded from this briefing because they were either laboratory studies not involving patients, animal studies or they involved a previous prototype of the device (Kopel et al. 2011; Hazan et al. 2006; Ikinger et al. 2007).

Table 1 summarises the clinical evidence as well as its strengths and limitations.

Overall assessment of the evidence

Although the evidence base comprises comparative studies (2 of which were randomised controlled studies), the peer-reviewed published evidence for UroShield is limited to 1 study funded by the company (Markowitz et al. 2018). The remaining studies were available as an abstract or as information published on the company's website. Moreover, the quality of some of the studies was difficult to assess given the limited information available. Overall, the evidence available suggests that when applied to urinary catheters UroShield has the potential to help reduce the incidence of CAUTI and bacterial load and may help decrease catheter-related pain. Studies are limited in their generalisability to the NHS given that none of the studies were done in the UK. Further UK-based studies would be helpful to understand the frequency of blockages and premature catheter removals with UroShield compared with standard care, as well as the number of emergency hospital admissions because of blocked catheters and any differences in nursing time. Further evidence on the incidence of device-related complications with UroShield, on patient quality of life, and on the potential for the technology to reduce antibiotic use in those with a history of symptomatic urinary tract infections in line with NICE guidelines, would also be helpful.

Table 1 Summary of selected studies

Markowitz et al. (2018)

Study size, design and location

Double-blind, randomised controlled trial involving 55 patients with long-term indwelling catheters in a skilled nursing facility being treated with long-term indwelling catheters.

Jerusalem, Israel.

Intervention and comparator(s)

UroShield

Sham UroShield

Key outcomes

All patients in the study had an indwelling urinary or suprapubic catheter for over a year and had had treatment for a UTI in the 90 days before study enrolment. Of the 55 patients enrolled, 26 were randomised to the control group and 29 to the treatment group. The UroShield was shown to be effective in significantly reducing the number of CFUs in patients with indwelling catheters. Compared with the sham control, UroShield resulted in a mean decrease of 87,200 CFUs at day 30, 87,500 at day 60 and 79,300 at day 90 (all p<0.001). UroShield was also shown to be effective in reducing the number of treated UTIs. At day 90, the number of reported infections was 3 in the UroShield group and 14 needing antimicrobial therapy in the control group (p=0.001).

Strengths and limitations

This was a randomised, double-blind study with a follow-up period that extended 60 days after treatment. The study included patients with both suprapubic and urethral catheters (proportion of patients for each catheter type was not reported). The study only evaluated the distal tip of the catheter and retained urine. It did not evaluate the entire catheter. The study was funded by the company.

Zillich et al. (2014)

Study size, design and location

Prospective randomised 2-arm study involving 40 patients with urinary catheter after radical prostatectomy.

Heidelberg, Germany.

Intervention and comparator(s)

Post-operative single dose of Ceftriaxon 2 g and active UroShield (treatment group)

Post-operative dose of Ceftriaxon 2 g on days 1 to 3 and trimetoprim 2×200 mg per day until the end of the study (control group).

Key outcomes

Of the 40 patients recruited, 20 were randomised to the treatment group and 20 to the control group. The average age was 66.7 and 60.7 years for the treatment group and the control group, respectively. The average catheter days was 8.4 days and 8.3 days for the treatment group and the control group, respectively. In the treatment group, there was 1 case of bacteriuria at the end of the study (bacteriuria rate=5%). In the control group there were 4 cases of bacteriuria at the end of the study (bacteriuria rate=20%).

Strengths and limitations

This was a randomised 2-arm study. However, it has not been peer-reviewed and results are available on the company's website only. Full study details, patient baseline demographics and statistical analyses were limited or lacking. The catheter dwell time was short (8 days for each group) and reasons for removal were not reported. Results may be limited in their generalisability to the NHS, because routine use of prophylactic antibiotics is not recommended by NICE for catheter changes.

Nagy et al. (2011)

Study size, design and location

Prospective non-randomised comparative study involving a total of 27 patients having long-term urinary catheterisation between August 2009 and September 2010.

Budapest, Hungary.

Intervention and comparator(s)

UroShield

Urinary catheters without UroShield devices

Key outcomes

Of the 27 patients recruited, 14 had a UroShield device for 8 weeks and 13 patients had urinary catheters without a UroShield device (control group) for 8 weeks. At the time of catheter insertion and after every 2 weeks, urine cultures were taken, and health condition checked. Catheter-related pain was also documented on a numerical scale of 1 to 10. More than 10×5 CFU/ml of 1 organism was defined as significant bacteriuria. At the end of week 8 a small piece of the catheter was sent to electromicroscopy to determine the rate of biofilm formation and incrustation. At the end of week 8, significant bacteriuria was detected in 4 patients (33%) in the UroShield group and in 9 patients (81%) in the control group. No significant biofilm producing P. aeruginosa bacteria were detected in the UroShield group, while P. aeruginosa bacteria rate was 27% in the control group. In the UroShield group, significant E. coli bacteriuria was half that in the control group. Catheter-related pain scores decreased by 1.6 in the UroShield group, while they increased by 1.3 in the control group. In patients with at least moderate symptoms (≥3) at baseline, there was a decrease of 2.4 points in the UroShield group and a 2.0 increase point increase in pain scores in the control group.

Strengths and limitations

This study reported patient outcomes for pain and evaluated the long-term (8 weeks) use of UroShield. However, the study was a non-randomised study that did not use a sham device as a control. No statistical analyses were done on outcomes between groups and there was no follow-up after treatment. The results were presented in a conference poster to the Annual Congress of the European Association of Urology and have not been published in a peer-reviewed journal.

Abbreviations: CFU, colony-forming unit; UTI, urinary tract infection.

Recent and ongoing studies