PICO question | Population: People performing intermittent self catheterisation in the community.
This heterogeneous population should include: People aged 16 and over, wheelchair users, people with spinal cord injuries, older people, males and females.
This population should not include: People living in residential care
Interventions: Multiple-use non-coated catheters, single use non-coated catheters, single use gel reservoir catheters and single use hydrophilic catheters.
Comparisons: Multiple-use non-coated catheters, single use non-coated catheters, single use gel reservoir catheters and single use hydrophilic catheters.
Outcomes: Symptomatic urinary tract infection, bacteraemia, mortality, patient comfort & preference, clinical symptoms of urethral damage quality of life and costs .
Trial duration: Follow-up should be a minimum of 1 year |
Importance to patients or the population | Catheter-associated UTIs are the most common type of healthcare-acquired infection in the world. While most urinary tract infections (UTIs) are mild and easily resolved with appropriate antibiotic treatment, more severe infections can be devastating, resulting in bacteraemia, sepsis and death. ISC is an intimate procedure which is often associated with anxiety and discomfort; compliance and patient acceptability are key considerations informing the choice of catheter.
It is important that high quality clinical evidence is available to determine which type of intermittent catheter is the most effective for preventing catheter-associated infections and urethral damage and which represents the most acceptable option for patients. |
Relevance to NICE guidance | Currently, all non-coated intermittent catheters are considered as single use devices as they have a single use logo on them. This is in contrast to the Department of Health, who recommend that five non coated catheters represents one month’s supply and require that manufacturers provide instructions for cleaning these items. Due to the uncertain legal status of these devices, concerns raised by stakeholders, and the low to very low quality clinical evidence base, non coated catheters were not recommended for multiple-use in the current guideline.
NICE consider the reuse of these items to be ‘off-licence’. In order to make an ‘off-licence’ recommendation, NICE requires sound clinical and cost-effectiveness evidence. The current clinical evidence base is of low to very low quality and better quality evidence is needed. If the results of the proposed research are found to contradict the current recommendation, the recommendation may be put forward for rapid update. |
Relevance to the NHS | The uncertainty inherent in the current recommendation represents a large opportunity cost for patients within the NHS. The results of this trial have the potential to change this recommendation. A change in this recommendation would represent a significant cost savings and would result in a more efficient use of resources across the NHS. |
National priorities | This research is relevant to two key national priority areas: reducing healthcare-associated infections and identifying efficiency savings as set out in the Operating Framework for the NHS in England in 2010/11. |
Current evidence base | The current clinical evidence base consists of five randomised controlled trials: one comparing single use gel reservoir to single use non-coated catheters; two comparing single use hydrophilic to single use non-coated catheters; and two comparing re-used single use catheters to single use non-coated catheters. These studies varied in length of follow up between patients and had unclear randomisation, allocation concealment, and blinding. All were assigned a GRADE rating of low to very low quality. The cost-effectiveness model developed for this guideline combined evidence of clinical effectiveness, costs, and quality of life of symptomatic UTI and its associated complications. The results of this analysis showed that in 100% of model simulations, non-coated catheters used multiple times are the most cost-effective option for ISC. This conclusion was robust to a wide range of sensitivity analyses, including exploratory analysis of the impact of urethral strictures to cost and quality of life and varying levels of use of non-coated catheters. |
Study design | This research should be a randomised controlled trial with a minimum follow-up of one year. Although blinding will not be possible, the trial should have good randomisation and allocation concealment. Sample size should be calculated using appropriate statistical methods. It is important that the study is adequately powered to detect a clinically important effect size. ISC technique (including the use of lubricant for non coated catheters) and patient characteristics should be clearly reported. The trial should include a diverse community-based population who regularly self catheterise. The primary outcome measures should be symptomatic urinary tract infections, UTI-associated bacteraemia, mortality, patient comfort & preference, quality of life, clinical symptoms of urethral damage, and costs. Clinical results should be fully reported and uncertainty surrounding cost-effectiveness should be explored using appropriate bootstrap analyses.
The criteria for symptomatic UTI, UTI-associated bacteraemia and mortality should be clearly defined, consistently applied and clearly reported. Clinical symptoms of urethral damage could include stricture, epididymitis and urethritis; these outcomes should be confirmed in a clinically appropriate manner and be clearly described. Patient comfort and preference should be measured using a validated score or scale. At a minimum, quality of life should be captured using the EQ-5D. If other measures of quality of life are also thought to be appropriate these could also be included. Costs should be measured from the NHS and personal social services perspective and should include both the cost associated with each type of catheter (and lubricant for non-coated catheters) and costs associated with treating UTI, urethral damage and any other catheter-associated complications. In order to ‘future proof’ this research, cost data could also be collected from a societal perspective; however these costs should be reported and analysed separately. |
Economic considerations | See “current evidence base” above. There is a proportion of the community that require long-term intermittent catheterisation. The net gain of finding the most cost effective catheter that minimises the risks of catheter associated urinary tract infection and bacteraemia would be of ongoing benefit. |
Feasibility | It should be possible to undertake this trial within a realistic timescale and at reasonable cost. |
Equalities | Equality considerations apply regarding patients’ physical abilities, such as problems with manual dexterity or mobility, including wheelchair users. Other equality issues such as cognitive and visual impairment would be taken into consideration prior to selecting an intermittent catheter. |
Other comments | The research is of high priority. The results of this research have the potential to alter future guidance on the use of intermittent urinary catheters. If the results of this research are found to contradict the current recommendation, the recommendation may be put forward for rapid update. |