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National Clinical Guideline Centre (UK). Infection: Prevention and Control of Healthcare-Associated Infections in Primary and Community Care: Partial Update of NICE Clinical Guideline 2. London: Royal College of Physicians (UK); 2012 Mar. (NICE Clinical Guidelines, No. 139.)

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Infection: Prevention and Control of Healthcare-Associated Infections in Primary and Community Care: Partial Update of NICE Clinical Guideline 2.

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10Long term urinary catheters

10.1. Introduction

The updated review questions in this chapter are:

  • types of catheter
  • bladder instillations and washouts
  • antibiotic use when changing long-term indwelling catheters.

These review questions were prioritised as it was considered that new evidence had emerged since the 2003 guideline.

The evidence and text from the previous guideline that has been superseded by this update is included in Appendix D.6. and D.9. No new review questions are included in this chapter.

Sections not updated in this chapter are:

  • education of patients, carers and healthcare workers
  • assessing the need for catheterisation
  • catheter drainage options
  • catheter insertion
  • catheter maintenance (closed systems).

The GDG recognised that hand decontamination is an important part of catheter management. See Section 6 for further details.

In addition the GDG acknowledged that Medical Device Regulations169 implement the EC Medical Devices Directives into UK law. They place obligations on manufacturers to ensure that their devices are safe and fit for their intended purpose before they are CE marked and placed on the market in any EC member state. The GDG noted that guidance168 on the MHRA's adverse incident reporting system is available for reporting adverse incidents involving medical devices.

The GDG has prioritised three recommendations in this chapter as a key priorities for implementation, see recommendations 39, 42 and 58.

In the community and primary healthcare settings, long-term (>28 days) urinary catheterisation (LTC) is most commonly used in the management of the elderly and patients with neurological conditions. The prevalence of LTC in the United Kingdom (UK) has been estimated as 0.5 percent in those over 75 years old135 and 4 percent in people undergoing domiciliary care.98 Some patients may require continuous bladder drainage using urethral or suprapubic catheters. Alternatively, patients or carers may insert and remove urethral catheters at regular intervals (intermittent catheterisation).

Catheter care in the community is time consuming and expensive.98,135,230 LTC should be regarded as a ‘method of last resort’ in the management of urinary problems as the burden both to the health service and to individual patients is high.84 However, there will remain a group of patients for whom LTC is the best option.

The method of catheterisation will depend on each patient’s individual requirements, available clinical expertise and services. Infection is a major problem in LTC although there are other non-infectious complications associated with LTC, including physiological/structural damage,271 urological cancer61 and psycho-social problems.209 In selecting particular strategies to manage urinary problems, healthcare practitioners must take account of all of these complications. These guidelines focus on preventing infection. However, because infection has a complex inter-relationship with encrustation and blockage, these aspects of catheter management are also addressed.

These guidelines apply to adults and children and should be read in conjunction with the guidance on Standard Principles (see chapters 7 to 8). These recommendations are broad principles of best practice and are not detailed procedural protocols. They need to be adapted and incorporated into local practice guidelines. The recommendations are divided into five distinct interventions:

  1. Education of patients, their carers and healthcare workers
  2. Assessing the need for catheterisation
  3. Selection of catheter type and system
  4. Catheter insertion
  5. Catheter maintenance.

The systematic review process is described in Appendix D.1.

10.2. Education of patients, carers and healthcare workers

Given the prevalence of LTC and the associated risk of clinical urinary tract infection, it is important that everyone involved in catheter management is educated about infection prevention. As many people, including children, will manage their own catheters, they must be confident and proficient in the procedure, aware of the signs and symptoms of clinical infection and how to access expert help when difficulties arise.79,97,140,283

10.2.1.1. Recommendations

30.

Patients and carers should be educated about and trained in techniques of hand decontamination, insertion of intermittent catheters where applicable, and catheter management before discharge from hospital. [2003]

31.

Community and primary healthcare workers must be trained in catheter insertion, including suprapubic catheter replacement and catheter maintenance. [2003]

32.

Follow-up training and ongoing support of patients and carers should be available for the duration of long-term catheterisation. [2003]

10.3. Assessing the need for catheterisation

Catheterising patients increases the risk of acquiring a urinary tract infection. The longer a catheter is in place, the greater the danger.

The highest incidence of healthcare-associated infection is associated with indwelling urethral catheterisation.247 Many of these infections are serious and lead to significant morbidity. In acute care facilities, 20–30% of catheterised patients develop bacteriuria, of whom 2–6 percent develop symptoms of urinary tract infection (UTI).247 The risk of acquiring bacteriuria is approximately 5 percent for each day of catheterisation,92,94 and therefore most patients with LTC are bacteriuric after 20 days of catheterisation.272

A study of patients in long-term care facilities demonstrated significantly higher morbidity and mortality in catheterised patients than in matched non-catheterised controls.140 Duration of catheterisation is strongly associated with risk of infection, i.e., the longer the catheter is in place, the higher the incidence of UTI.247

Best practice emphasises that all procedures involving the catheter or drainage system and the related batch codes of these devices are recorded in the patient's records.283 Patients should be provided with adequate information in relation to the need, insertion, maintenance and removal of their catheter by the person planning their care.283

10.3.1.1. Recommendations

33.

Indwelling urinary catheters should be used only after alternative methods of management have been considered. [2003]

34.

The patient’s clinical need for catheterisation should be reviewed regularly and the urinary catheter removed as soon as possible. [2003]

35.

Catheter insertion, changes and care should be documented. [2003]

10.4. Catheter drainage options

10.4.1. How to select the right system

Choosing the right system for any given patient will depend on a comprehensive individual patient assessment.

Our search identified one systematic review239 concerning the approaches to catheterisation. This reported a higher rate of infection associated with indwelling rather than intermittent catheterisation. This finding is reflected in a recent position paper189 on urinary tract infections in long-term care facilities by the Society for Healthcare Epidemiology of America (SHEA) who recommended that “where clinically appropriate, intermittent catheterisation should be used for urinary drainage rather than a chronic indwelling catheter.”

Two studies were identified in our search which compared catheter options.125,258 The first focussed on the risk of Meticillin-resistant Staphylococcus aureus (MRSA) colonisation and infection in nursing home patients.258 This study concluded that indwelling catheters posed a greater risk of infection than intermittent catheters. The second studied men with prostatic enlargement and reported a significantly lower rate of infection in those with suprapubic rather than urethral catheters, despite the former being used for two weeks longer.125 A non-comparative study of patients with neuropathic bladder demonstrated a low rate of infection (6 percent) associated with the use of long-term suprapubic catheters.240 However, 30% of patients in this study reported other catheter-related complaints. Economic opinion suggests that if staff and resource use are the same, suprapubic catheterisation is more cost effective.229,240

Eight studies were identified which focussed exclusively on the use of intermittent catheterisation. The study populations encompassed a wide range of patient groups and ages.1719,42,79,174,200,274 One theme emerging from these studies was that the prevalence of bacteriuria is equal between men and women17,18 though the incidence of clinical UTI appears to be higher in women.18,19 There is also some evidence that bacteriuria rates are similar between adults and children.57

Generally, large studies indicated that the rates of infection associated with intermittent catheterisation were low,200,274 1 per 87 months,274 and that hydrophilic catheters were associated with a further reduction in infection risk.19,42

A possible alternative to indwelling and intermittent catheterisation is the penile sheath (condom catheter). Whilst our systematic review did not include a specific question related to the use of penile sheath catheters, there is evidence that this type of device may be preferable in men who are able to empty their bladder and are unlikely to manipulate the system.57,229 To date there are no controlled studies comparing penile sheaths with indwelling devices.

10.4.1.1. Recommendations

36.

Following assessment, the best approach to catheterisation that takes account of clinical need, anticipated duration of catheterisation, patient preference and risk of infection should be selected. [2003]

37.

Intermittent catheterisation should be used in preference to an indwelling catheter if it is clinically appropriate and a practical option for the patient. [2003]

10.5. Types of long-term catheters

10.5.1. Review question – intermittent catheters

Long-term urinary catheterisation is considered an important area where updated guidance is required.

The following two questions both address the clinical and cost effectiveness of intermittent self-catheterisation. They were addressed independently for the clinical evidence review, but incorporated into the same economic model.

  1. What is the clinical and cost effectiveness of different types of long-term intermittent urinary catheters (non-coated, hydrophilic or gel reservoir) on symptomatic urinary tract infections, bacteraemia, mortality, and patient preference?
  2. In patients performing intermittent catheterisation, what is the clinical and cost effectiveness of non-coated catheters reused multiple times compared to single-use on urinary tract infections, bacteraemia, mortality, and patient preference?

10.5.1.1. Clinical evidence

Question 1. Non-coated vs. hydrophilic vs. gel reservoir catheters

Six studies were identified, five of which investigated hydrophilic catheters compared to non-coated catheters35,59,193,254,265 and one that compared non-hydrophilic gel reservoir catheters to non-coated catheters.99 None of the studies from the previous 2003 guideline met the inclusion criteria for this review question.

The non-coated catheters were used as a single-use product in Cardenas et al., 2009,35 as a multi use product (reused up to 5 times a day, with a new catheter used each day) in Vapnek et al., 2003265 and Pachler et al., 1999193 and not stated in Gianntoni et al., 200199 and Sutherland et al., 1996254 and DeRidder et al., 2005.59 In order to allow accurate incorporation of the data from these studies into the economic model, the authors of these studies were contacted for clarification. DeRidder et al., replied that the catheters used in the study were single-use. No reply was obtained from Giantonni et al., and Sutherland et al., it was assumed that these studies also used single-use non-coated catheters.

See Evidence Table G.5.2, Appendix G, Forest Plots in Figure 33–40, Appendix I.

Table 46Hydrophilic coated vs. non-coated catheters for long term intermittent self catheterisation – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Mean monthly urinary tract infection - 12 months2651RCTSerious limitations(a)No serious inconsistencyNo serious indirectnessNo serious imprecision
Total urinary tract infections - 1 year 351RCTSerious limitations (b)No serious inconsistencyNo serious indirectnessNo serious imprecision
Patients with ≥ 1 urinary tract infection – 1 year35,592RCTSerious limitations (b, d)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Patients/helpers very satisfied with the catheter – 6 months 591RCTSerious limitations (d)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Patients/helpers very satisfied with the catheter – 1 year 591RCTSerious limitations (d)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Patient satisfaction 254(visual analogue scale, 10 = least favourable)1RCTSerious limitations (e, g)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Problems introducing catheter1931RCTSerious limitations (f)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Burning sensation when introducing the catheter1931RCTSerious limitations (f)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Pain when introducing the catheter1931RCTSerious limitations (f)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Burning sensation or pain after removal of the catheter1931RCTSerious limitations (f)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Bacteraemia0RCT
Mortality0RCT
a

Method of randomisation not stated. Number of urinary tract infections at baseline is higher in intervention compared to the control. Catheters re-used up to 5 times a day for control, where as intervention did not reuse catheters.

b

Method of randomisation not stated and unclear allocation concealment. Higher number of women in control group compared to the intervention35.

c

The relatively few events and few patients give wide confidence intervals around the estimate of effect. This makes it difficult to know the true effect size for this outcome.

d

High dropout rate in DeRidder et al., 200559 (54%) due to restored urinary function and thus no further need for catheterisation, change of bladder management to an indwelling catheter and withdrawal of consent.

e

Sutherland et al., 1996254 population is all male mean age 12 years old.

f
g

Crossover study. No details of allocation concealment or assessor blinding.

Table 47Hydrophilic coated vs. non-coated catheters for long term intermittent self catheterisation - Clinical summary of findings

OutcomeHydrophilicNon-coatedRelative riskAbsolute effectQuality
Mean monthly urinary tract infection - 12 months3131-MD 0.01 lower (0.11 lower to 0.09 higher)MODERATE
Total urinary tract infections - 1 year2223-MD 0.18 higher (0.5 lower to 0.86 higher)MODERATE
Patients with 1 or more urinary tract infection – 1 year51/83 (61.4%)65/85 (76.5%)RR 0.8 (0.65 to 0.99)153 fewer per 1000 (8 fewer to 268 fewer)LOW
Patients/helpers very satisfied with the catheter – 6 months10/55 (18.2%)6/59 (10.2%)RR 1.79 (0.7 to 4.59)80 more per 1000 (31 fewer to 365 more)LOW
Patients/helpers very satisfied with the catheter – 1 year9/55 (16.4%)7/59 (11.9%)RR 1.38 (0.55 to 3.45)45 more per 1000 (53 fewer to 291 more)LOW
Patient satisfaction (visual analogue scale, 10 = least favourable)1716-MD 0.6 lower (2.36 lower to 1.16 higher)LOW
Problems introducing catheter1/32 (3.1%)2/32 (6.3%)RR 0.5 (0.05 to 5.24)31 fewer per 1000 (59 fewer to 265 more)LOW
Burning sensation when introducing the catheter2/32 (6.3%)1/32 (3.1%)RR 2 (0.19 to 20.97)31 more per 1000 (25 fewer to 624 more)LOW
Pain when introducing the catheter3/32 (9.4%)2/32 (6.3%)RR 1.5 (0.27 to 8.38)31 more per 1000 (46 fewer to 461 more)LOW
Burning sensation or pain after removal of the catheter2/32 (6.3%)2/32 (6.3%)RR 1 (0.15 to 6.67)0 fewer per 1000 (53 fewer to 354 more)LOW

Table 48Gel reservoir vs. non-coated catheters for long term intermittent self catheterisation – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Patients with ≥ 1 urinary tract infection – 7 weeks991RCTVery serious(a)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Patient comfort (visual analogue scale, low = more comfortable)991RCTVery serious(b)No serious inconsistencyNo serious indirectnessNo serious imprecision
Bacteraemia0RCT
Mortality0RCT
a

Crossover study, the outcomes measured 3 times per patient and reported for 3× the number of total patients in the group i.e. 54 instead of 18. No details of allocation concealment or assessor blinding.

b

Crossover study. No details of allocation concealment or assessor blinding. Small number of patients in each arm.

c

The relatively few events and few patients give wide confidence intervals around the estimate of effect. This makes it difficult to know the true effect size for this outcome.

Table 49Gel reservoir vs. non-coated catheters for long term intermittent self catheterisation - Clinical summary of findings

OutcomeGel reservoirNon-coatedRelative riskAbsolute effectQuality
Patients with 1 or more urinary tract infection – 7 weeks4/54 (7.4%)12/54 (22.2%)RR 0.33 (0.11 to 0.97)149 fewer per 1000 (7 fewer to 198 fewer)VERY LOW
Patient comfort (visual analogue scale, low = more comfortable)1818-MD 2.39 higher (1.29 to 3.49 higher)VERY LOW
Question 2. Single-use non-coated vs. multiple-use non-coated catheters (see section 10.5.1)

Two RCTs were identified for inclusion comparing multiple-use non-coated catheters to single-use catheter for intermittent catheterisation, where the multiple-use arm had new catheters once a week79 or every 24 hours.134 None of the studies from the previous 2003 guideline met the inclusion criteria for this review question.

See Evidence Table G.5.2, Appendix G, Forest Plots in Figure 41–42, Appendix I.

Table 50Non-coated catheters reused multiple times vs. single-use – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Symptomatic UTI79,1342RCTSerious limitations(a)No serious inconsistencyNo serious indirectnessNo serious imprecision
Frequency of catheterisations per day 791RCTSerious limitations(a)No serious inconsistencyNo serious indirectnessSerious imprecision(b)
Bacteraemia0RCT
Mortality0RCT
Patient preference and comfort0RCT
a

Unclear randomisation, allocation concealment and blinding. The length of follow up varied from 1–107 days.

b

The relatively few events and few patients give wide confidence intervals around the estimate of effect. This makes it difficult to know the true effect size for this outcome.

Table 51Non-coated catheters reused multiple times vs. single use - Clinical summary of findings

OutcomeReusedSingle-useRelative riskAbsolute effectQuality
Symptomatic UTI34/61 (55.7%)38/65 (58.5%)RR 0.98 (0.77 to 1.25)12 fewer per 1000 (134 fewer to 146 more)MODERATE
Frequency of catheterisations per day3842-MD 0.2 higher (0.28 lower to 0.68 higher)LOW

10.5.1.2. Cost-effectiveness evidence

No cost-effectiveness evidence was identified in the update search.

No cost-effectiveness studies were identified in the previous 2003 guideline.

This question was identified as a high priority area for economic modelling and an original cost-utility model was developed to inform the cost-effectiveness evidence for this question.

10.5.1.3. Cost-effectiveness evidence – original economic model

Methods

A cost-utility analysis was undertaken to evaluate the cost-effectiveness of different types of intermittent catheters. A Markov model was used to estimate the lifetime quality-adjusted life years (QALYs) and costs from a UK NHS and personal social services perspective. Both costs and QALYs were discounted at a rate of 3.5% per annum in line with NICE methodological guidance. The model was built probabilistically to take into account uncertainty surrounding each of the model input parameters.

Population & comparators

The population evaluated in the base case analysis was people with bladder dysfunction caused by spinal cord injury (SCI). This population was chosen for the base case as it most closely matched the population considered by the majority (4/5) of the RCTs included in the clinical review and because this group of patients is one of the largest users of intermittent catheters. The average age of the population entering the model was 40 years and 80% were assumed to be male; this is the average age at injury and gender composition of the UK population of people with SCI.

A similar model exploring the cost-effectiveness of intermittent catheterisation in patients with bladder dysfunction not due to SCI was considered as part of the sensitivity analysis.

The comparators selected for the model were the types of intermittent catheter available to patients living or being cared for in the community:

The GDG indicated that there may be situations in which it would not be practical or advisable for patients to wash and reuse catheters (such as when facilities are not available or patients are unable to wash and dry catheters, or if patients are catheterised by others). Therefore, two models were constructed; they varied only in the inclusion/exclusion of clean multiple-use non-coated catheters as a comparator.

The GDG also noted that in children and young people (≤ 16 years old), symptomatic UTI can cause progressive renal scarring which may lead to renal failure later in life. Renal failure carries a high risk of mortality and morbidity, is associated with very high cost and decreased quality of life. The most recent NICE guideline for Urinary Tract Infection in Children181 concluded that it was not possible to estimate the true risk of renal failure as a result of childhood UTI, did not identify any quality of life values for children with UTI, and did not consider economic modelling a valid option in this population. The current GDG agreed with this decision and noted that none of the studies included in the clinical review which contained symptomatic UTI as an outcome were conducted in children. Given the uncertain risk of harm as a result of symptomatic UTI in childhood, the GDG decided to employ the precautionary principle in their approach to intermittent self-catheterisation (ISC) in children. Therefore, only single-use catheters were considered an option for ISC in children and modelling was not explicitly undertaken in this population.

Approach to modelling

Symptomatic UTI was considered the most important outcome for evaluating the efficacy of different types of intermittent catheters. The GDG also considered the costs and consequences arising from antimicrobial resistant UTIs and catheter-associated bacteraemia to be an important factor to include when assessing the downstream effects of symptomatic UTI. In the absence of any comparative clinical evidence, in the base case analysis it was assumed that urethral complications do not vary between catheter types. This assumption was explored in sensitivity analysis.

The main simplifying assumption of the model was that the probability of antibiotic resistance does not change over time. This assumption was necessary due to a lack of available data about current and historical resistance rates, the complexity of forecasting antibiotic resistance trends over time and within populations, and a lack of examples on which to base methodological approaches.49 Different rates of resistance were explored in sensitivity analysis.

Results

This analysis found that clean multiple-use non-coated catheters are the most cost-effective type of intermittent catheter. Although gel reservoir catheters were found to be slightly more effective than clean non-coated catheters, they were associated with a much greater cost. Dividing the incremental cost by the incremental effectiveness results gives a cost-effectiveness ratio of £51,345 per QALY gained. This value far exceeds the £20,000 per QALY threshold set by NICE. By taking into account the standard error of each model input, probabilistic analysis revealed that clean multiple-use non-coated catheters are the most cost-effective option in 99.6% of model iterations.

In patients who are unable to use clean non-coated catheters, gel reservoir catheters were found to be the most cost-effective option, at approximately £3,270 per QALY gained. Compared to hydrophilic catheters, gel reservoir catheters are most cost-effective in 84.2% of model iterations.

In both scenarios, hydrophilic catheters were found to be slightly less effective than gel reservoir catheters. They are also less costly, although their incremental cost is still much greater than the cost of clean non-coated multiple-use catheters. Therefore, hydrophilic catheters are excluded from the further considerations due to extended dominance. Single-use non-coated catheters were found to be slightly less effective and more costly than multiple-use non-coated catheters. They are therefore said to be ‘dominated’ by the more effective, less costly alternatives under consideration.

Figure 2. Base case analysis results (probabilistic).

Figure 2Base case analysis results (probabilistic)

Results for each subgroup are plotted on the incremental cost-effectiveness ratio axis. The non-coated multi-use catheter is the least costly strategy and has been used as the baseline comparator. Therefore, it is plotted at the axis. The slope of the line is the ICER.

Table 52Base case analysis results (probabilistic)

CatheterTotal costTotal QALYsIncremental cost*Incremental QALYs*ICERProbability CE
In cases where non-coated catheters can be washed and reused
Non-coated used multiple times£11, 98411.896BaselineBaselineBaseline99.6%
Hydrophilic£38, 88312.005£26, 8990.109ED0.00%
Gel reservoir£40, 34612.449£28, 3260.552£51, 3450.4%
Non-coated used once only£43, 61111.882£31, 627−0.014D0.00%
In cases where non-coated catheters cannot be washed and reused
Hydrophilic£38, 93612.002BaselineBaselineBaseline15.1%
Gel reservoir£40, 39112.446£1, 4540.445£3, 27084.2%
Non-coated used once only£43, 64211.879£4, 705−0.122D0.7%

The health gain to individuals using ISC is presented in terms of total and incremental QALYs. Cost is presented as total and incremental cost per catheter strategy. These values are used to calculate the ICER. Because single-use non-coated catheters are less effective and more expensive than non-coated catheters used multiple times, they are said to be dominated and are eliminated from further analysis. Similarly, hydrophilic catheters are excluded by extended dominance. QALYs = quality adjusted life years; ICER = incremental cost-effectiveness ratio; ED = extended dominated; D = dominated; CE = cost-effective at a threshold of £20,000.

*

Incremental costs and QALYs are calculated compared to the option with the lowest cost – non-coated multiple-use catheters and hydrophilic catheters, respectively.

Scenario and sensitivity analyses
Intermittent self-catheterisation (ISC) in patients with bladder dysfunction not due to spinal cord injury

A separate set of probabilities and utilities was collected in order to run a scenario analysis for patients with bladder dysfunction that is not caused by SCI. Assuming that each type of catheter exhibits the same relative efficacy in this population, the conclusion of this scenario analysis is the same as that for patients with SCI: where it is possible to wash and re-use non-coated catheters (in this population gel reservoir catheters are associated with a cost of £149, 559 per QALY gain and so do not represent an efficient use of NHS resources); however, when re-use of non-coated catheters is not an option, gel reservoir catheters represent the most cost-effective option. In both cases, single-use non-coated catheters are excluded from the analysis by dominance and hydrophilic catheters by extended dominance.

Urethral complications

When the relative risk of urethral complications associated with each type of coated catheter is reduced to zero and the cost of complications is doubled (i.e. hydrophilic catheters prevent 100% of urethral complications and those that occur with the use of other catheter types are twice as expensive as assumed in the base case), the conclusion of the analysis is unchanged. This is true regardless of whether or not multiple-use non-coated catheters are considered an option.

Antimicrobial resistance

The conclusions of the model were robust to simultaneously varying the probability of the risk of treatment failure and multidrug resistant UTI to the upper limit of each input’s 95% confidence interval. This shows that given current understanding of the scope of antibiotic resistance, multiple-use non-coated catheters are the most cost cost-effective option for ISC.

This analysis did not take into account the dynamic and extremely complex nature of antimicrobial resistance. Although the GDG sought to use the most current, relevant estimates to inform this analysis, data about the prevalence and mortality associated with antibiotic resistant UTI is limited and it is impossible to predict the future of this phenomenon. If the prevalence, clinical and economic impact of antimicrobial resistance increases beyond the extreme values used in this model, then the cost-effectiveness of clean intermittent catheterisation in this population may have to be re-visited.

Number of non-coated catheters used

The number of clean non-coated catheters used per year was varied between an average of 60 per year (average 5 per month) and 1825 per year (average 5 per day) in a threshold analysis. Clean ISC ceases to be the most cost-effective option when an average of 208 non-coated catheters is used per year; this equivalent to approximately 17.3 catheters per month or 4 per week.

Interpretation and limitations

This analysis combines the best available evidence about the costs and consequences of each type of catheter used for intermittent catheterisation. Based on the results of the model, we can conclude that the small decrease in symptomatic infections associated with single-use gel reservoir and hydrophilic catheters is not enough to justify the large increase in the cost of these catheters compared to multiple-use non-coated catheters. As a result, clean multiple-use non-coated catheters represent the most cost-effective type of catheter for ISC. This conclusion was robust to a wide range of sensitivity analyses, including the increased probability of urethral complications that may be associated with the use of non-coated catheters. However, multiple-use non-coated catheters cease to be the most cost-effective choice when patients use an average of more than two catheters per day. Compliance and behaviour are therefore important factors for healthcare workers to consider when prescribing an ISC regime.

Healthcare workers must also consider other patient-specific situations when deciding which catheter to prescribe. Under the current decision rule, the recommended treatment is identified as that with the highest ICER that falls below the cost-effectiveness threshold. Preferences are incorporated into the cost-utility analysis through the values that are attached to each health state; these values represent the average weight attached to each health state by the general population and are assumed to be independent of factors related to the health care process.

The use of societal values creates the potential for conflict where individual patients hold a strong preference for a particular treatment that is not reflected in the decision made at the societal level.26 It has been suggested that one way to incorporate individual patient preference into cost-effectiveness decisions would be to adopt a two-part decision process which gives the patient the choice of the most cost-effective treatment plus all cheaper options.77

Of the five RCTs included in our review of clinical efficacy, three included a measure of patient preference and comfort; none found any difference between catheter types. Nevertheless, it is still possible that patients may find one type of catheter more comfortable or easier to use than another and therefore derive a benefit from the catheter that is not captured in the model.76 When deciding between gel reservoir and hydrophilic catheters for patients who cannot use multiple-use non-coated catheters, the GDG did not wish to force the consumption of more costly gel reservoir catheters. If a patient has a strong preference for hydrophilic catheters then the GDG agreed that they should be able to choose this less costly option.

10.5.1.4. Evidence statements

ClinicalQuestion 1. Non-coated vs. hydrophilic vs. gel reservoir catheters
It is unlikely that there is any difference in mean monthly urinary tract infections or total urinary tract infections at 1 year for hydrophilic coated catheters compared to non-coated catheters for long-term intermittent catheterisation (MODERATE QUALITY).
It is uncertain whether there is any difference in patient/helper satisfaction with catheters and catheter preference for hydrophilic coated catheters compared to non-coated catheters for long-term intermittent catheterisation (LOW QUALITY).
There is a statistically significant decrease of uncertain clinical importance in the number of patients with 1 or more urinary tract infection(s) at 1 year with hydrophilic coated catheters compared to non-coated catheters for long-term intermittent catheterisation (LOW QUALITY).
There is a statistically significant decrease of uncertain clinical importance in the number of patients with 1 or more urinary tract infection(s) at 7 weeks for gel reservoir catheters compared to non-coated catheters for long-term intermittent catheterisation (VERY LOW QUALITY).
There is a statistically significant increase of uncertain clinical importance in patient comfort for gel reservoir catheters compared to non-coated catheters for long-term intermittent catheterisation (VERY LOW QUALITY).
No studies were identified that reported bacteraemia or mortality.
Question 2. Single-use non-coated vs. multiple-use non-coated catheters
It is unlikely that there is any difference in symptomatic urinary tract infections with clean vs. sterile uncoated catheters for long-term intermittent catheterisation (MODERATE QUALITY).
It is uncertain whether there is any difference in frequency of catheterisations per day with clean vs. sterile non-coated catheters for long-term intermittent catheterisation (LOW QUALITY).
No studies were identified that reported bacteraemia, mortality or patient preference and comfort.
EconomicNew economic analyses comparing single-use hydrophilic, single-use gel reservoir, single-use non-coated, and clean multiple-use non-coated catheters found that washing and re-using non-coated catheters is the most cost-effective option for intermittent self-catheterisation. In situations where it may not be feasible or appropriate to wash and reuse non-coated catheters, gel reservoir catheters appear to be the most cost-effective catheter type. However, if patients prefer hydrophilic catheters to gel reservoir catheters, they may also be considered cost-effective. Single-use non-coated catheters are never a cost-effective option for intermittent self-catheterisation. The conclusion was robust to a wide range of scenario and sensitivity analyses, including varying the probability and cost of urethral complications (MINOR LIMITATIONS AND DIRECTLY APPLICABLE).

10.5.1.5. Recommendations and link to evidence

Recommendations
38.

Offer a choice of either single-use hydrophilic or gel reservoir catheters for intermittent self-catheterisation. [new 2012]

Relative values of different outcomesThe GDG considered the most important outcomes to be symptomatic UTIs (recurrent and total), patient preference or comfort and mortality. The risk of long-term complications as a result of childhood UTI was considered the most important outcome in people under 16. Other outcomes also searched for were allergic reactions and bacteraemia.
Trade off between clinical benefits and harmsBased on the evidence included in the clinical review, different types of intermittent catheters are associated with slightly different rates of symptomatic urinary tract infection. Although some of these differences are statistically significant, all are associated with wide and overlapping confidence intervals, conferring a degree of uncertainty as to whether the effect is of clinical significance. The risk ratio for one or more UTIs for hydrophilic vs. single-use non-coated is 0.80 (95% CI 0.65 – 0.99);35,59 gel reservoir vs. single-use non coated is 0.33 (95% 0.11 – 0.97);99 and multiple-use non-coated vs. single-use non-coated is 0.98 (95% 0.77 – 1.25).79,134
Although there was a statistically significant increase in scores for comfort using gel reservoir catheters compared to single-use non-coated catheters,99 it is uncertain if this is clinically important as the scores are un-validated. No difference was reported between hydrophilic and single-use non-coated catheters;59,193,254 and there was no evidence for single-use non-coated compared to multiple-use non-coated catheters in terms of patient comfort or preference.
A probabilistic model was constructed to take into account the uncertainty surrounding the relative efficacy of each catheter at preventing infection, the cost of each type of catheter regime, the cost of catheter-associated infections, and quality of life associated with catheter-associated urinary tract infection.
The GDG considered that there may be situations in which it is difficult for patients to wash, dry and store multiple-use non-coated catheters, for example patients with communal washing facilities. On this basis, the GDG agreed that there are situations in which it is not appropriate for patients to use multiple-use non-coated catheters. For patients in whom single-use catheters represent the most appropriate option, the strategy for multiple-use non coated catheters was removed from the model.
The GDG noted that symptomatic UTI in childhood carries the risk of serious kidney damage in the long-term. In light of the absence of evidence related to the use of single- vs. multiple-use non-coated catheters in children, and the uncertainty surrounding the real lifetime risk of established renal failure as a result of childhood UTI, the GDG decided to adopt a precautionary approach when making this recommendation.
The GDG discussed the health economic evidence at length and acknowledged the model findings. The GDG felt it important to reflect the strength of the low quality clinical evidence in drafting their recommendation for consultation.
They felt it appropriate to recommend that this choice of catheter was therefore ‘considered’ rather than ‘offered’ in line with advice that is defined in the NICE guidelines manual (2009)182 for ‘recommendations on interventions that ‘could’ be used, i.e. the GDG is confident that the intervention will do more good than harm for most patients, and will be cost effective’.
The consultation recommendation stated that those patients in residential or nursing homes should be offered a choice of single-use hydrophilic or gel reservoir catheters and not be offered single-use non-coated catheters. There may be a higher risk of infections in settings where patients share facilities and as such the GDG considered that a cautionary approach be followed. The GDG considered that in residential or nursing homes the healthcare workers care for many patients during their work and there is consequently a greater risk of infection and reusable catheters would therefore not be appropriate. The GDG felt that healthcare workers should consider using single-use intermittent catheters in this setting.
The GDG discussed the clinical and cost-effectiveness evidence and acknowledged the model findings. The GDG drafted the recommendation for consultation which reflected the results of the clinical review and cost-effectiveness evaluation. This recommendation proposed that non-coated intermittent catheters for multiple-use be prescribed providing the following conditions were met: this is considered clinically appropriate after assessment; the patient is aged 16 years or over; the patient is able to wash and dry catheters; suitable facilities to wash, dry and store catheters are readily available; catheterisation is performed by the patient or a close family member; and the patient is not in a residential or nursing home.
Following stakeholder consultation, the GDG reviewed their recommendation in light of comments received. Stakeholders expressed concern that it would not be possible to implement the recommendation due to the single-use logo on intermittent catheters. Despite legal advice received in advance of consultation that this recommendation was acceptable, stakeholders were concerned that the re-use of these items would make practitioners liable for any catheter-associated infections caused by the multiple-use of a catheter intended for single-use (see other considerations below). There was also concern that recommending that patients disregard the single-use symbol for this device may lead to confusion and safety implications in other areas. Therefore, it was agreed that this recommendation would be amended for the final guideline publication, as the GDG feel that too many barriers remain in practice to achieve successful implementation of the consultation recommendation at this time.
Multiple-use catheters remain in the clinical and health economic write up of this guideline and were considered by the GDG when developing the consultation recommendation.
Reusing a device labelled as single-use in this context is considered similar to making an “off label” recommendation where robust clinical and cost-effectiveness evidence is required. The GDG noted that although the results of the cost-effectiveness evaluation suggest that multiple-use catheters are the most cost effective option for ISC, the model was based on low or very low quality clinical evidence.
In addition to concerns regarding the single-use symbol, two other areas (frequency of catheter change and cleaning and drying of catheters for reuse) which were not included within the scope of this update were highlighted as relevant to the implementation of this recommendation. Further work is required in future updates of this guidance to clarify some of the 2003 recommendations related to catheters. For example, the original 2003 recommendations state that ‘catheters should be changed only when clinically necessary or according to manufacturer’s current recommendations [2003]’, but the GDG are aware that manufacturer’s instructions vary. This is also the case with the recommendation that states ‘reusable intermittent catheters should be cleaned with water and stored dry in accordance with the manufacturer’s instructions [2003]’. As such the GDG feel it important at this time to remove the recommendation about cleaning and storing reusable catheters from this update, to minimise confusion in practice.
A research recommendation has been made to gain higher quality clinical evidence in this area (see section 10.12). If the results of additional research support the conclusions reached by the current clinical and cost-effectiveness evaluation, then the use of non-coated catheters for multiple-use represents a significant cost saving to the NHS.
Economic considerationsThis section reports directly the development and findings of the health economic model that informed the consultation recommendation.
Based on the results of the original economic model developed for this update review, gel reservoir catheters are associated with an incremental cost per QALY gain of £51, 345. Because this exceeds the NICE cost-effectiveness threshold of £20, 000 (and given that hydrophilic catheters and single-use non-coated catheters are excluded by extended dominance and dominance, respectively), clean multiple-use non-coated catheters are the most cost-effective type of intermittent catheter. This conclusion was robust to a wide range of sensitivity analyses, including exploratory analysis surrounding the issue of urethral trauma and strictures. The base case model assumed that patients use an average of five catheters per month (1.2 per week). When a threshold analysis was run for this parameter, multiple-use non-coated catheters cease to be the most cost effective option when patients use more than an average of 17.3 per month (4 per week).
In situations where multiple-use non-coated catheters are not considered a valid option, gel reservoir catheters may be most cost-effective with an incremental cost per QALY gain of £3, 270 compared to hydrophilic catheters. However, not all patients find gel reservoir catheters suitable, so flexibility is needed to allow the use of hydrophilic catheters in this situation. The NICE guideline ‘Urinary Tract Infection in Children’181 concluded that it is currently impossible to accurately establish the risk of long-term complications as a result of childhood UTI. The GDG considered that given the current level of understanding of the long-term risks of childhood UTI and the lack of evidence about quality of life in children with UTI, it would be invalid to attempt to model this process. The GDG for this partial update agreed with this decision and noted that none of the studies included in the clinical review which contained symptomatic UTI as an outcome were conducted in children. Given the uncertain risk of harm as a result of symptomatic UTI in childhood, the GDG decided to employ the precautionary principle in their approach to ISC in children. Therefore, only single-use catheters were considered an option for ISC in children and modelling was not explicitly undertaken in this population.
Quality of evidenceThis section reports the clinical evidence that informed the consultation recommendation.
Two RCTs were identified investigating single-use versus multiple-use non-coated catheters that were of low to moderate quality. These studies varied in length of follow up between patients and had unclear randomisation, allocation concealment and blinding.
Five RCTs and one crossover trial looked at hydrophilic coated or gel reservoir catheters versus single-use non-coated catheters for intermittent catheterisation. The quality of the evidence is low to moderate.
Several of the outcomes for this recommendation were imprecise and although, for example, there is a statistically significant decrease in the number of patients with 1 or more urinary tract infection at 1 year with hydrophilic coated catheters compared to non-coated catheters, there is uncertainty whether this is clinically important because of the wide confidence intervals for this outcome. The 95% confidence interval for the reduction of number of patients with 1 or more urinary tract infection ranged from 6 to 268 fewer in the hydrophilic catheter group. It was difficult to interpret the meaning of the increase in patient comfort score because invalidated tools were used. For example, it is unclear what it means for patients when the score for patient comfort increased 2.39 points, 95% CI of 1.29 to 3.49) for non-hydrophilic gel reservoir catheter compared to non coated catheters, and whether this is of clinical importance.
No clinical evidence was found for multiple versus single-use catheters in children and adolescents. UTIs were not reported in the single study identified in children254 which investigated hydrophilic catheters versus non-coated PVC catheters in children (mean age 12 years).254 This study did suggest that there is no difference in patient satisfaction between the catheter types although this evidence was low quality. In the absence of evidence, the GDG made a consensus recommendation for consultation that people under 16 should not use non-coated catheters.
Other considerationsThis section provides detail on the recommendation amended following consultation.
The GDG were aware that the majority of non-coated intermittent catheters bear a symbol on their packaging indicating that they are single-use devices.
This symbol means that the manufacturer:
  • Intends the device to be used once and then discarded
  • Considers that the device is not suitable for use on more than one occasion
  • Has evidence to confirm that re-use would be unsafe.
However, the GDG considered this to be contradictory for several reasons:
  • Some manufacturers provide instructions for cleaning non-coated catheters.
  • There is no evidence to suggest that re-use of non-coated catheters is unsafe. On the contrary, the only direct evidence suggests that single-use non-coated catheters are associated with a non-significant increase in symptomatic urinary tract infections compared to multiple-use non-coated catheters.
  • The NHS Drug Tariff states that non-coated catheters can be re-used for up to one week. The GDG did not feel that there was any further evidence that would support a recommendation on the guidance of frequency of change of multiple-use catheters outside of the existing drug tariff.
Discussion of these issues informed the GDG’s consultation recommendation for multiple-use of non-coated intermittent catheters. Following the stakeholder consultation and the NICE guideline review panel feedback (GRP) the GDG reviewed their recommendation for non-coated intermittent catheters for multiple-use and made revisions. The reasons for this are discussed in the trade off between clinical benefits and harms section above.
If the single-use logo on these intermittent catheters is removed or if higher quality clinical evidence is published prior to the next scheduled review for update, then this recommendation may warrant an exceptional update, as described in the NICE guidelines manual:182 “Exceptionally, significant new evidence may emerge that necessitates a partial update of a clinical guideline before the usual 3-year period… This evidence must be sufficient to make it likely that one or more recommendations in the guideline will need updating in a way that will change practice significantly.“
In drafting the revised recommendation, the GDG noted the following issues of importance:
The GDG feel it important to consider privacy and dignity issues when recommending a type of intermittent catheter and considered issues such as shared toilets in work places or other public spaces.
The GDG considered that during the healthcare worker’s assessment of the patient (see recommendation 36), they would discuss the choice of catheter that would appropriately maintain their patient’s independence and not restrict their everyday activities.
The GDG thought the patient’s physical ability, including problems with manual dexterity or mobility, including wheelchair users, should be taken into consideration. Other equality issues such as cognitive and visual impairment would be taken into consideration prior to selecting an intermittent catheter, when assessing the patient for type of catheterisation,(see recommendation 36: ‘Following assessment, the best approach to catheterisation that takes account of clinical need, anticipated duration of catheterisation, patient preference and risk of infection should be selected’ [2003]).The GDG acknowledged that patient preference is an important issue and this was clearly highlighted as an important outcome in the evidence review; and that recommendation 36 is worded to prompt discussion between clinician and patient so that they may both decide which type of catheter is best suited to an individual’s needs and circumstances. Patient preference, clinical assessment, clinical and cost effectiveness should all be considered when selecting an intermittent catheter.
Although the results of the economic model indicate that gel reservoir catheters are more cost effective than hydrophilic, the GDG considered that patients should be able to choose a less effective, less expensive option if it is their preference. The GDG have therefore recommended that healthcare workers ‘offer a choice of single-use hydrophilic or gel reservoir catheters’. This is in line with the NHS constitution which details that patients “have the right to make choices about [their] NHS care and to information to support these choices. The options available to you will develop over time and depend on your individual needs.”69 The GDG also took this into account when cross referring to an earlier recommendation about clinician assessment, which includes patient preference (see recommendation 36).
No evidence was reviewed regarding the frequency of change for non-coated catheters. The GDG did not feel it was appropriate to make a recommendation regarding the frequency of change of catheters as this was likely to be influenced by other factors such as comfort or efficacy which would be routinely discussed as part of the normal patient-clinician interaction.
Patient compliance was also identified as an important factor when deciding which type of intermittent catheter to recommend. No clinical evidence was identified regarding this; however it was felt that this could also form part of the discussion with the patient regarding clinically appropriate options.
Urinary tract infection in childhood may carry special significance, as discussed in the Urinary Tract Infection in Children guideline.181 This includes the risks of acute clinical deterioration and long-term renal damage. Although the vast majority of children who have a urinary tract infection recover promptly and do not have any long-term complications, there is a small subgroup at risk of significant morbidity, including children with congenital abnormalities of the urinary tract.
The GDG also considered the social impact upon children and young people of non-coated catheters for multiple-use. Children and young people requiring intermittent self-catheterisation may have difficulties accessing adequate facilities to wash, dry and store their catheters. The GDG recognised the difficulties in ensuring privacy and dignity where shared toilet facilities are used, such as in schools and colleges. Even where these facilities are provided and accessed, issues such as peer pressure and embarrassment in schools could have an adverse impact on the child or young person’s self-esteem, and potentially reduce compliance with intermittent catheterisation and appropriate hygiene. The revised recommendation also applies to children.
The GDG have also made a research recommendation in this area, see section 10.12.

10.5.2. Review question – long-term indwelling catheters

What is the clinical and cost effectiveness of different types of long-term indwelling urinary catheters (non-coated silicone, hydrophilic coated, or silver or antimicrobial coated/impregnated) on urinary tract infections, bacteraemia, frequency of catheter change, encrustations and blockages, mortality, and patient preference?

10.5.2.1. Clinical evidence

One RCT was identified, which investigated hydrophilic catheters compared to silicone elastomer catheters.32 None of the studies from the previous 2003 guideline met the inclusion criteria for this review question.

See Evidence Table G.5.2, Appendix G, Forest Plots in Figure 30–32, Appendix I.

Table 53Hydrophilic coated vs. silicone catheters for long term indwelling catheterisation – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Mean catheter time in situ321RCTSerious limitations(a)No serious inconsistencyNo serious indirectnessNo serious imprecision
Encrustations leading to catheter change321RCTSerious limitations (a)No serious inconsistencyNo serious indirectnessSerious imprecision(b)
Catheter related adverse events321RCTSerious limitations (a)No serious inconsistencyNo serious indirectnessSerious imprecision(b)
Symptomatic UTI0RCT
Bacteraemia0RCT
Frequency of catheter change0RCT
Mortality0RCT
Patient preference and comfort0RCT
a

Unclear allocation concealment and selective outcome reporting where full data is not provided.

b

The relatively few events and few patients give wide confidence intervals around the estimate of effect. This makes it difficult to know the true effect size for this outcome.

Table 54Hydrophilic coated vs. silicone catheters for long term indwelling catheterisation - Clinical summary of findings

OutcomeHydrophilicSiliconeRelative riskAbsolute effectQuality
Mean catheter time in situ (days)3633-MD 32.91 higher (15.14 to 50.68 higher)MODERATE
Encrustations leading to catheter change11/36 (30.6%)9/33 (27.3%)RR 1.12 (0.53 to 2.36)33 more per 1000 (128 fewer to 371 more)LOW
Catheter related adverse events1/36 (2.8%)7/33 (21.2%)RR 0.13 (0.02 to 1.01)185 fewer per 1000 (208 fewer to 2 more)LOW

10.5.2.2. Cost-effectiveness evidence

No cost-effectiveness evidence was identified in the update search.

No cost-effectiveness evidence was identified in the previous 2003 guideline.

In the absence of any published cost-effectiveness analyses, current UK catheter and infection-related costs were presented to the GDG to inform decision making. The GDG were also presented with the costs and quality of life associated with UTI and UTI-associated complications (see economic model in Appendix J and K).

Table 55Cost of long-term indwelling urinary catheters

Foley catheter typeProduct descriptionAverage cost (£)
PTFE coated latexSelf-retaining 2-way long-term PTFE coated latex connected to 2 litre drainage bag3.87
Non-coated siliconeSelf-retaining 2-way long-term silicone connected to 2 litre drainage bag4.87
Hydrophilic coated siliconeSelf-retaining 2-way long-term hydrogel coated silicone connected to 2 litre drainage bag4.95
Silver coated siliconeSelf-retaining 2-way long-term silicone hydromer coated silver connected to 2 litre drainage bag7.17

Source: Based on average 2010 Supply Chain187 prices.

Abbreviations: PTFE = polytetrafluoroethylene

10.5.2.3. Evidence statements

ClinicalThere is a statistically significant and clinically important increase in mean catheter time in situ for hydrophilic catheters compared to silicone catheters for long-term indwelling catheterisation (MODERATE QUALITY).
It is uncertain whether there is any difference in encrustations leading to catheter change for hydrophilic catheters compared to silicone catheters for long-term indwelling catheterisation (LOW QUALITY).
It is unlikely that there is any difference in catheter related adverse events for hydrophilic catheters compared to silicone catheters for long-term indwelling catheterisation (LOW QUALITY).
No studies identified reported symptomatic urinary tract infections, bacteraemia, frequency of catheter change, mortality or patient preference and comfort.
EconomicNo relevant economic studies were identified.

10.5.2.4. Recommendations and link to evidence

Recommendations
39.

Select the type and gauge of an indwelling urinary catheter based on an assessment of the patient’s individual characteristics, including:

  • age
  • any allergy or sensitivity to catheter materials
  • gender
  • history of symptomatic urinary tract infection
  • patient preference and comfort
  • previous catheter history
  • reason for catheterisation. [new 2012]
Relative values of different outcomesPrevention of urinary tract infections was considered the most important outcome. Encrustations and blockages were also seen as an important outcome.
Trade off between clinical benefits and harmsThe GDG considered the trade off in time involved in selecting an appropriate catheter and the benefit of increased patient satisfaction. The GDG also considered the risk of infection if choosing an inappropriate catheter balanced against the need for patient comfort and choice. The GDG discussed the clinical and economic evidence, but felt that there was not sufficient evidence to recommend one type of catheter over another. The GDG discussions centred around the key factors that would influence choice of catheter in practice and chose to make a recommendation based on a consensus agreement of these factors, which are discussed under other considerations.
Economic considerationsIn the absence of high-quality evidence of effectiveness, there is little on which to assess the relative cost-effectiveness of different types of long-term indwelling catheters.
Quality of evidenceOnly one RCT was identified for types of indwelling catheters. The evidence was of low to moderate quality. There were serious study limitations (unclear allocation concealment and selective outcome reporting, where full data was not provided).
Other considerationsHealthcare workers must be competent to assess the need for catheterisation (see Assessing the need for catheterisation) and select the appropriate catheter. The factors within the current recommendation are listed in alphabetical order rather than by order of priority and should not be considered an exhaustive list.
This list was largely made by GDG consensus and the reasoning behind the inclusion of each factor is discussed below:
  • Age – the length and gauge of the catheter should be appropriate for the patient. For example, the size should be appropriate for the age or size of the child.
  • Catheter material sensitivity/allergy – latex-containing catheters are inappropriate for patients with latex allergies.
  • Gender – males and females require catheters of different length.
  • History of symptomatic UTI – a previous history of a symptomatic UTI with a certain type of catheter may influence selection.
  • Patient preference/comfort –many patients find that a small catheter gauge is more comfortable than a large gauge. A larger catheter gauge may be used if the patient has a specific catheter need.
  • Previous catheter history – a previous history of catheter related complications (discomfort or blockage) with a certain type of catheter may influence selection.
  • Reason for catheterisation – the type of catheter should be based on clinical reason for catheterisation, such as bladder cancer or chronic retention.
The GDG have prioritised this recommendation as a key priority for implementation as they considered that it has a high impact on outcomes that are important to patients, has a high impact on reducing variation in care and outcomes, leads to a more efficient use of NHS resources, promotes patient choice and means that patients reach critical points in the care pathway more quickly, see section 4.1.

10.5.3. Is one catheter better than another?

There is some evidence that the balloon material on all silicone Foley catheters has a greater tendency to “cuff” on deflation than latex catheters, particularly when used suprapubically. Cuffing can cause distress and injury to patients when the catheter is removed.165 Our systematic review showed that smaller gauge catheters (12–14 Ch) with a 10 ml balloon minimise urethral trauma, mucosal irritation and residual urine in the bladder, all factors which predispose to catheter-associated infection.220,229 A non-systematic review of the literature confirmed this.248 For suprapubic catheterisation, a 16 Ch gauge catheter is usually preferable to avoid blockage.162 Where there is no difference in the quality of the catheter, the least expensive option should be used.73

One study280 identified by our systematic review compared the use of catheter valves with a standard drainage system and found no significant difference in urinary tract infection but a patient preference for the catheter valve. The Medical Device Agency (now Medicines and Healthcare products Regulatory Agency) suggests patients need to be assessed for their mental acuity, manual dexterity, clothing preferences and use of night drainage bags when considering using catheter valves.164

10.5.3.1. Recommendations

40.

In general, the catheter balloon should be inflated with 10 ml of sterile water in adults and 3–5 ml in children. [2003]

41.

In patients for whom it is appropriate, a catheter valve can be used as an alternative to a drainage bag. [2003]

10.6. Asepsis

The following question was asked as this was not included in the previous guideline and it was highlighted by stakeholders during the scoping consultation that where aseptic techniques were referred to in recommendations the terminology may be out-of-date. Asepsis is also covered in the PEG and VAD chapters (see chapters 11 and 12).

10.6.1. Review question

What is the most clinically and cost effective technique (aseptic technique, non-touch, aseptic non touch technique or a clean technique) when handling long-term urinary catheters to reduce colony forming units, urinary tract infections, compliance, MRSA or C. diff reduction and mortality?

10.6.1.1. Clinical evidence

No clinical evidence was identified. No clinical evidence was identified in the previous 2003 guideline.

10.6.1.2. Cost-effectiveness evidence

No cost-effectiveness evidence was identified. No cost-effectiveness evidence was identified in the previous 2003 guideline.

10.6.1.3. Recommendations

The GDG decided not to make any new recommendations or to change any other specific recommendations in this chapter relating to aseptic or clean techniques. Also see recommendations in section 10.7.1.1.

10.7. Catheter Insertion

10.7.1. Catheterisation is a skilled procedure

Principles of good practice, clinical guidance270,284 and expert opinion74,75,131,141,247 agree that urinary catheters must be inserted using sterile equipment and an aseptic technique. Expert opinion indicates that there is no advantage in using antiseptic preparations for cleansing the urethral meatus prior to catheter insertion.93,139 Urethral trauma and discomfort will be minimised by using an appropriate sterile, single-use lubricant or anaesthetic gel. The insertion of urinary catheters by healthcare workers who are competent in the procedure will minimise trauma, discomfort and the potential for catheter-associated infection.75,93,141,270

With regard to self-catheterisation, our systematic review found that in a study examining the safety of clean versus sterile intermittent catheterisation in male adults aged 36–96 years, no significant differences were found in infection rates, time to first infection or number of episodes.79 A systematic review identified three controlled trials regarding the benefits of sterile or “non-touch techniques” for intermittent catheterisation vs. conventional clean intermittent catheterisation.239 Data “neither supports nor refutes the need to utilize sterile, as opposed to clean, intermittent catheterisation.” Economic analysis suggests that clean intermittent catheterisation is unlikely to lead to additional infections and the additional cost of sterile catheterisation is unlikely to be justified.79,274

10.7.1.1. Recommendations

42.

All catheterisations carried out by healthcare workers should be aseptic procedures. After training, healthcare workers should be assessed for their competence to carry out these types of procedures. [2003]

43.

Intermittent self-catheterisation is a clean procedure. A lubricant for single-patient use is required for non-lubricated catheters. [2003]

44.

For urethral catheterisation, the meatus should be cleaned before insertion of the catheter, in accordance with local guidelines/policy. [2003]

45.

An appropriate lubricant from a single-use container should be used during catheter insertion to minimise urethral trauma and infection. [2003]

10.8. Catheter Maintenance

10.8.1. Leave the closed system alone!

Maintaining a sterile, continuously closed urinary drainage system is central to the prevention of catheter-associated infection.75,101,141,261,270,284 The risk of infection reduced from 97% with an open system to 8–15% when a sterile closed system was employed as standard practice.93,100,139 However, breaches in the closed system such as unnecessary emptying of the urinary drainage bag or taking a urine sample increase the risk of catheter-related infection and should be avoided.139,208,270 Hands must be decontaminated and healthcare workers should wear clean, non-sterile gloves before manipulation.

Reflux of urine is associated with infection and, consequently, best practice suggests catheters are secured to avoid trauma and drainage bags should be positioned in a way that prevents back-flow of urine.75,270 Expert opinion also recommends that urinary drainage bags should be supported in such a way that prevents contact with the floor.139 For night drainage, a link system should be used to maintain the original closed system, i.e., a bag attached to the end of the day system.249

Drainable urinary drainage bags should be changed in line with the manufacturer’s recommendations, generally every 5–7 days, or sooner if clinically indicated, e.g. malodorous or damaged. Bags that are non-drainable should be used once, e.g., overnight, and emptied before disposal.

10.8.1.1. Recommendations

46.

Indwelling catheters should be connected to a sterile closed urinary drainage system or catheter valve. [2003]

47.

Healthcare workers should ensure that the connection between the catheter and the urinary drainage system is not broken except for good clinical reasons, (for example changing the bag in line with manufacturer’s recommendations). [2003]

48.

Healthcare workers must decontaminate their hands and wear a new pair of clean, non-sterile gloves before manipulating a patient’s catheter, and must decontaminate their hands after removing gloves. [2003]

49.

Patients managing their own catheters, and their carers, must be educated about the need for hand decontaminationii before and after manipulation of the catheter, in accordance with the recommendations in the standard principles section (chapter 6.). [2003, amended 2012]

50.

Urine samples must be obtained from a sampling port using an aseptic technique. [2003]

51.

Urinary drainage bags should be positioned below the level of the bladder, and should not be in contact with the floor. [2003]

52.

A link system should be used to facilitate overnight drainage, to keep the original system intact. [2003]

53.

The urinary drainage bag should be emptied frequently enough to maintain urine flow and prevent reflux, and should be changed when clinically indicated. [2003]

10.8.2. Appropriate maintenance minimises infections

10.8.2.1. Meatal cleansing with antiseptic solutions is unnecessary

One systematic review considered six acceptable studies that compared meatal cleansing with a variety of antiseptic/antimicrobial agents or soap and water.211 No reduction in bacteriuria was demonstrated when using any of these preparations for meatal care compared with routine bathing or showering. Expert opinion75,139,284 and another systematic review229 support the view that vigorous meatal cleansing is not necessary and may increase the risk of infection. Washing the meatus with soap and water during daily routine bathing or showering is all that is needed.

10.8.2.2. Recommendation

54.

The meatus should be washed daily with soap and water. [2003]

10.9. Do bladder instillations or washouts reduce catheter associated symptomatic urinary tract infections?

The terminology regarding bladder instillations, irrigations and washouts can be confusing. Bladder irrigation refers to the continuous introduction of a sterile fluid into the bladder for the purpose of draining blood and debris; bladder instillation refers to the introduction of a sterile fluid into the bladder and leaving it there for a variable period of time in order to dissolve encrustations, alter bladder pH, or suppress bacterial growth; bladder washout refers to the introduction of a sterile fluid which is allowed to drain immediately for the purpose of diluting bladder contents or unblocking an obstruction. Bladder irrigation is not performed in primary and community settings and is therefore outside the scope of this guideline. However, in the literature the term ‘irrigation’ is sometimes used to refer to what is actually an instillation. Therefore, the term ‘irrigation’ was included as a search term to ensure that studies in which the terminology may have been confused were identified. These papers were also reviewed by a GDG member to ensure that only studies reporting on bladder instillations were included.

10.9.1. Review question

What is the clinical and cost effectiveness of bladder instillations or washouts on reduction of catheter associated symptomatic urinary tract infections and encrustations and blockages?

10.9.1.1. Clinical evidence

Four studies were identified. The terms instillations, washouts and irrigations were not defined or used consistently in the studies. The studies have been categorised into those that compare one type of washout to another and those that compare a washout to no washout.

One randomised crossover trial, which was included in the previous guideline, compared saline, Solution G (active ingredients: citric acid, magnesium oxide and sodium bicarbonate) and Solution R (active ingredients: citric acid, magnesium carbonate and gluconolactone)133 instillations/washouts twice a week. One RCT compared saline and acetic acid instillations/washouts twice a week.269 One RCT compared Solution G and saline instillations/washouts once a week to no instillation/washout.173 One randomised crossover trial compared saline once a day to no instillation/washout.176

Only one study133 from the previous 2003 guideline met the inclusion criteria for this review question.

See Evidence Tables G.5.3, Appendix G, Forest Plots in Figure 43–59, Appendix I.

Comparison of solutions for instillation/washout

Table 56Solution G vs. saline washout (twice a week) – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Catheter blockage 1331RCTSerious limitations(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Partially blocked catheter 1331RCTSerious limitations(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Catheters not encrusted 1331RCTSerious limitations(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Catheter removal/replacement 1331RCTSerious limitations(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Symptomatic UTI0RCT
Bacteraemia0RCT
Mortality0RCT
Patient preference and comfort0RCT
a

Crossover trial. Allocation concealment and blinding not reported

b

Randomised catheters rather than patients, therefore patients were included in the study more than once.

c

Wide confidence intervals crossing MID. This makes it difficult to know the true effect size for this outcome.

Table 57Solution G vs. saline washout (twice a week) - Clinical summary of findings

Outcome(a)Solution GSalineRelative riskAbsolute effectQuality
Catheter blockage14/29 (48.3%)18/44 (40.9%)RR 1.18 (0.7 to 1.98)74 more per 1000 (123 fewer to 401 more)LOW
Partially blocked catheter12/29 (41.4%)14/44 (31.8%)RR 1.3 (0.71 to 2.4)95 more per 1000 (92 fewer to 445 more)LOW
Catheters not encrusted3/29 (10.3%)12/44 (27.3%)RR 0.38 (0.12 to 1.23)169 fewer per 1000 (240 fewer to 63 more)LOW
Catheter removal/replacement14/84 (16.7%)16/84 (19%)RR 0.88 (0.46 to 1.68)23 fewer per 1000 (103 fewer to 130 more)LOW
a

Catheters outcomes reported per number of catheters rather than number of study participants

Table 58Solution R vs. saline washout (twice a week) – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Catheter blockage 1331RCTSerious limitations(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Partially blocked catheter1331RCTSerious limitations(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Catheters not encrusted1331RCTSerious limitations(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Catheter removal/replacement1331RCTSerious limitations(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Symptomatic UTI0RCT
Bacteraemia0RCT
Mortality0RCT
Patient preference and comfort0RCT
a

Crossover trial. Allocation concealment and blinding not reported.

b

Randomised catheters rather than patients, therefore patients were included in the study more than once.

c

Wide confidence intervals crossing MID. This makes it difficult to know the true effect size for this outcome.

Table 59Solution R vs. saline washout (twice a week) - Clinical summary of findings

Outcome(a)Solution RSalineRelative riskAbsolute effectQuality
Catheter blockage7/27 (25.9%)18/44 (40.9%)RR 0.63 (0.31 to 1.31)151 fewer per 1000 (from 282 fewer to 127 more)LOW
Partially blocked catheter10/27 (37%)14/44 (31.8%)RR 1.16 (0.6 to 2.24)51 more per 1000 (from 127 fewer to 395 more)LOW
Catheters not encrusted10/27 (37%)12/44 (27.3%)RR 1.36 (0.68 to 2.7)98 more per 1000 (from 87 fewer to 464 more)LOW
Catheter removal/replacement14/84 (16.7%)16/84 (19%)RR 0.88 (0.46 to 1.68)23 fewer per 1000 (from 103 fewer to 130 more)LOW
a

Catheters outcomes reported per number of catheters rather than number of study participants.

Table 60Solution G vs. solution R washout (twice a week) – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Catheter blockage1331RCTSerious(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Partially blocked catheter1331RCTSerious(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Catheters not encrusted1331RCTSerious(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Catheter removal/replacement1331RCTSerious(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Symptomatic UTI0RCT
Bacteraemia0RCT
Mortality0RCT
Patient preference and comfort0RCT
a

Crossover trial. Allocation concealment and blinding not reported.

b

Randomised catheters rather than patients, therefore patients were included in the study more than once.

c

Wide confidence intervals crossing MID. This makes it difficult to know the true effect size for this outcome.

Table 61Solution G vs. solution R washout (twice a week) - Clinical summary of findings

Outcome(a)Solution GSolution RRelative riskAbsolute effectQuality
Catheter blockage14/29 (48.3%)7/27 (25.9%)RR 1.86 (0.89 to 3.9)223 more per 1000 (29 fewer to 752 more)LOW
Partially blocked catheter12/29 (41.4%)10/27 (37%)RR 1.12 (0.58 to 2.15)44 more per 1000 (156 fewer to 426 more)LOW
Catheters not encrusted3/29 (10.3%)10/27 (37%)RR 0.28 (0.09 to 0.91)267 fewer per 1000 (33 fewer to 337 fewer)LOW
Catheter removal/replacement14/84 (16.7%)14/84 (16.7%)RR 1 (0.51 to 1.97)0 fewer per 1000 (82 fewer to 162 more)LOW
a

Catheters outcomes reported per number of catheters rather than number of study participants.

Table 62Acetic acid vs. saline washout (twice a week) – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Symptomatic UTI2691RCTSerious limitations(a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Adverse effects2691RCTSerious limitations (a, b)No serious inconsistencyNo serious indirectnessSerious imprecision(c)
Encrustations and blockages0RCT
Bacteraemia0RCT
Mortality0RCT
Patient preference and comfort0RCT
Encrustations and blockages0RCT
a

Randomised non-controlled trial. Sequence generation not clear and allocation concealment not reported.

b

Blinding not clear.

c

Wide confidence intervals crossing MID. This makes it difficult to know the true effect size for this outcome.

Table 63Acetic acid vs. saline washout (twice a week) - Clinical summary of findings

OutcomeAcetic acidSalineRelative riskAbsolute effectQuality
Symptomatic UTI6/30 (20%)1/29 (3.4%)RR 5.8 (0.74 to 45.26)166 more per 1000 (9 fewer to 1526 more)LOW
Adverse effects1/30 (3.3%)0/29 (0%)RR 2.9 (0.12 to 68.5)0 more per 1000 (0 fewer to 0 more)LOW

Table 64Solution G vs. saline washout (once a week) – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Symptomatic UTI1731RCTVery serious limitations (a)(b)No serious inconsistencyNo serious indirectnessVery serious imprecision(c)
Mean time to first catheter change (weeks)1731RCTVery serious limitations (a)No serious inconsistencyNo serious indirectnessVery serious imprecision (c)
Encrustations and blockages0RCT
Bacteraemia0RCT
Mortality0RCT
Patient preference and comfort0RCT
Encrustations and blockages0RCT
a

Open label study. Blinding not possible due to nature of sterile packaging.

b

2–3 patients in each group did not complete data collection due to self reported UTI and initiation of antibiotic treatment, but none met study criteria for symptomatic UTI.

c

Very low number of patients in each study arm, likely to be underpowered.

Table 65Solution G vs. saline washout (once a week) - Clinical summary of findings

OutcomeSolution GSalineRelative riskAbsolute effectQuality
Symptomatic UTI0/17 (0%)0/16 (0%)not pooledN/AVERY LOW
Mean time to first catheter change (weeks)1716-MD 0.43 lower (2.32 lower to 1.46 higher)VERY LOW
Comparison of solutions for instillation/washout vs. no instillation/washout

Table 66Solution G (once a week) vs. no washout – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Symptomatic UTI1731RCTVery serious limitations (a)No serious inconsistencyNo serious indirectnessVery serious imprecision (b)
Mean time to first catheter change (weeks)1731RCTVery serious limitations (a)No serious inconsistencyNo serious indirectnessVery serious imprecision (b)
Encrustations and blockages0RCT
Bacteraemia0RCT
Mortality0RCT
Patient preference and comfort0RCT
a

Open label study - blinding not possible due to nature of sterile packaging

b

Very low number of patients in each study arm, likely to be underpowered.

Table 67Solution G (once a week) vs. no washout - Clinical summary of findings

OutcomeSolution GNo washoutRelative riskAbsolute effectQuality
Symptomatic UTI0/17 (0%)0/20 (0%)not poolednot pooledVERY LOW
Mean time to first catheter change (weeks)1720-MD 0.2 higher (1.58 lower to 1.98 higher)VERY LOW

Table 68Saline washout (once a week) vs. no washout – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Symptomatic UTI1731RCTVery serious limitations (a, b)No serious inconsistencyNo serious indirectnessVery serious imprecision(c)
Mean time to first catheter change (weeks)1731RCTVery serious limitations (a)No serious inconsistencyNo serious indirectnessVery serious imprecision(c)
Encrustations and blockages0RCT
Bacteraemia0RCT
Mortality0RCT
Patient preference and comfort0RCT
a

Open lable study - blinding not possible due to nature of sterile packaging.

b

2–3 patients in each group did not complete data collection due to self reported UTI and initiation of antibiotic treatment, but none met study criteria for symptomatic UTI.

c

Very low number of patients in each study arm, likely to be underpowered.

Table 69Saline washout (once a week) vs. no washout - Clinical summary of findings

OutcomeSaline washoutNo washoutRelative riskAbsolute effectQuality
Symptomatic UTI0/16 (0%)0/20 (0%)not pooledN/AVERY LOW
Mean time to first catheter change (weeks)1620-MD 0.63 higher (1.28 lower to 2.54 higher)VERY LOW

Table 70Saline washout (once a day) vs. no washout – Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Catheter replacement per 100 days of catheterisation1761RCTSerious limitations(a, b, c)No serious inconsistencyNo serious indirectnessSerious imprecision(d)
Encrustations and blockages0RCT
Bacteraemia0RCT
Mortality0RCT
Patient preference and comfort0RCT
Symptomatic UTI0RCT
a

Crossover trial. Sequence generation and allocation concealment not clear.

b

23 patients participated in full duration of trial, but 32 patients (crossover and partial crossover patients) included in analysis.

c

Blinding not reported.

d

Wide confidence intervals crossing MID. This makes it difficult to know the true effect size for this outcome.

Table 71Saline washout (once a day) vs. no washout - Clinical summary of findings

OutcomeSalineNo washoutRelative riskAbsolute effectQuality
Catheter replacement per 100 days of catheterisation5.5
N = 32
4.7
N = 32
N/A(a)N/A(a)LOW
a

Value not estimated as SD not reported.

10.9.1.2. Cost-effectiveness evidence

No cost-effectiveness evidence was identified.

No cost-effectiveness evidence was identified in the previous 2003 guideline.

In the absence of any published cost-effectiveness analyses, the current UK cost of bladder instillations and washouts, nurse time, and catheter-related infections were presented to the GDG to inform decision making.

Table 72Cost of bladder instillation and washout solutions

SolutionDoseAverage cost (£)
3.23% Citric Acid100 ml3.35
6.00% Citric Acid100 ml3.35
0.9% Saline100 ml3.26
Sterile water100 ml3.30

Source: NHS Drug Tariff 2010186; Infection-related costs – see economic model in Appendix J. Acetic acid (used in the included clinical trials) was not identified in either the BNF or NHS Drug Tariff and was therefore not included in this table.

10.9.1.3. Evidence statements

Clinical It is uncertain whether there is any difference between saline, Solution G or Solution R washout (twice a week) for catheter encrustations, catheter blockage and catheter removal or replacement (LOW QUALITY).
It is uncertain whether there is any difference between saline and acetic acid (twice a week) for symptomatic UTI or adverse effects (LOW QUALITY).
It is uncertain whether there is any difference between saline washout and Solution G (once a week) and no washout for symptomatic UTI and mean time to first catheter change (VERY LOW QUALITY).
It is uncertain whether there is any difference between saline washout (daily) and no washout in the number of catheter replacements per 100 days of catheterisation (VERY LOW QUALITY).
No studies were identified that reported bacteraemia, mortality and patient preference or comfort.
EconomicNo evidence of the cost-effectiveness of instillations or washouts was identified.
There is little cost difference between different types of solutions. It is more expensive (in terms of solution cost and nurse time) to use an instillation or washout than to not use an instillation or washout.

10.9.1.4. Recommendations and link to evidence

Recommendations
55.

To minimise the risk of blockages, encrustations and catheter-associated infections for patients with a long-term indwelling urinary catheter:

  • develop a patient-specific care regimen
  • consider approaches such as reviewing the frequency of planned catheter changes and increasing fluid intake
  • document catheter blockages. [new 2012]
Relative values of different outcomesThe number of symptomatic UTIs was considered the primary outcome of interest. Catheter replacement/frequency of catheter change, encrustations, and blockages were also considered important outcomes.
Trade off between clinical benefits and harmsThe GDG considered a trade off between the potential for instillations/washouts to reduce the incidence of blockages and encrustations and the increased risk of infection associated with breaking a closed system. The GDG considered the potential for increased fluid intake to reduce encrustations, blockages and UTIs, and the risk of fluid overload (i.e. excessive fluid consumption) that may occur as a result of patients being encouraged to increase fluid intake.
The GDG considered that the use of bladder instillations and washouts as a prophylactic measure to prevent infections was not appropriate. After careful consideration, the GDG acknowledged that there is insufficient evidence to make a recommendation regarding the use of instillations and washouts to minimise the risk of blockages and encrustations.
Economic considerationsThe GDG considered the cost of bladder instillation and washout solutions as well as the nurse time needed to perform these procedures. They also took into account the cost and QALY loss associated with UTIs, risk of fluid overload, and the resource use associated with catheter changes resulting from encrustations and blockages.
The GDG thought that performing bladder instillations and washouts is likely to lead to an increase in infections due to the risk associated with breaking a closed system. It is also more expensive to administer an instillation or washout than to not administer an instillation or washout. Instillations and washouts are therefore very unlikely to be cost-effective as a prophylactic measure to prevent infections.
The GDG thought that taking the time to develop patient-specific care plans, reviewing the frequency of planned catheter changes, and encouraging an increase in fluid intake would likely be a more cost-effective use of nurse time.
Quality of evidenceThis recommendation was based on GDG consensus, as the evidence was deemed poor quality due to study limitations and inconclusive outcomes.
Other considerationsThe GDG considered approaches other than instillations and washouts that could be effective in reducing blockages, encrustations and catheter associated infections. These approaches included the development of patient specific care regimens, reviewing the frequency of planned catheter changes, and encouraging increased fluid intake. The GDG considered these approaches to be good practice for the care of patients using long-term indwelling catheters. The GDG acknowledged that therapeutic intervention, such as instillations for patients undergoing chemotherapy, was an area beyond the scope of the guideline.
Patient preference and quality of life were considered important.
56.

Bladder instillations or washouts must not be used to prevent catheter-associated infections. [2003]

10.9.2. Changing catheters

There is no definitive evidence as to the optimal interval for changing catheters in patients undergoing long-term urinary drainage via either the urethral or suprapubic route. Our search identified a study which suggested that a higher rate of infection was associated with frequent catheter changes, though evidence is not definitive.277 Expert opinion suggests changing the catheter according to the clinical needs of the patient or as recommended by the catheter manufacturer (usually every 12 weeks).270,284 Our systematic review identified a study that showed if catheter blockage occurs within a shorter interval, catheters should be changed more frequently to avert a future clinical crisis.97 An economic analysis suggested that there may be a cost saving in changing a catheter at six weeks when there is an increased likelihood of blockage (>50%).185

10.9.2.1. Recommendations

57.

Catheters should be changed only when clinically necessary, or according to the manufacturer’s current recommendations. [2003]

10.10. Use of antibiotics when changing long-term urinary catheters

Antibiotic use when changing indwelling catheters is considered an area of disparity and associated with mixed views regarding antibiotic resistance and patient safety. This update aims to determine the need for prophylactic antibiotics and their impact on the reduction of urinary tract infections.

10.10.1. Review question

In patients with long-term urinary catheters (more than 28 days), what is the clinical and cost effectiveness of prophylactic antibiotics (single dose or short course) during catheter change on reduction of urinary tract infections?

10.10.1.1. Clinical evidence

One RCT conducted in elderly patients using an open urinary collecting catheter system and silicone coated catheters was identified.89 No studies from the previous 2003 guideline met the inclusion criteria for this review question.

See Evidence Table G.5.1, Appendix G, Forest Plots in Figure 60–62, Appendix I.

Table 73Antibiotic prophylaxis vs. no treatment - Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Antibiotic resistance891RCTSerious limitations(a)No serious inconsistencySerious indirectness(b)Very serious imprecision(c)
Mortality891RCTSerious limitations(a)No serious inconsistencySerious indirectness(b)Very serious imprecision(c)
Bacteraemia891RCTSerious limitations(a)No serious inconsistencySerious indirectness(b)Very serious imprecision(c)
Symptomatic UTI0RCT
Upper UTI (pylonephritis)0RCT
Patient preference0RCT
a

Randomisation allocation and concealment method not reported. Not double blinded.

b

The patients in the study were elderly in a home, and used an open urinary collecting catheter system; the antibiotic prophylaxis used was meropenem (1gm given intravenously 30 minutes prior to catheterisation). Meropenem is a broad spectrum antibiotic normally reserved as a second line treatment in the UK. It is highly uncertain whether this evidence is applicable to prophylaxis in the community for UK patients.

c

Sparse data and confidence intervals crossed MID. Sample size was too small to detect statistical significance for rare events.

Table 74Antibiotic prophylaxis vs. no treatment - Clinical summary of findings

OutcomeIV meropenemNo treatmentRelative riskAbsolute effectQuality
Antibiotics resistance0/36 (0%)0/34 (0%)Not estimable0 fewer per 1000 (0 fewer to 0 fewer)VERY LOW
Mortality1/36 (2.8%)2/34 (5.9%)RR 0.47 (0.04 to 4.97)31 fewer per 1000 (56 fewer to 234 more)VERY LOW
Bacteraemia0/36 (0%)0/34 (0%)Not estimable0 fewer per 1000 (0 fewer to 0 fewer)VERY LOW

10.10.2. Cost-effectiveness evidence

No cost-effectiveness evidence was identified. No cost effectiveness evidence was identified in the previous 2003 guideline.

From an economic perspective, questions surrounding the use of antibiotic prophylaxis are very complex. A recent Health Technology Assessment performed a literature search in order to develop a conceptual evaluative framework for the economic evaluation of policies against MRSA49. Many of the considerations discussed within this review were relevant to the current question and provided a useful background for GDG discussions related to the cost-effectiveness of antibiotic prophylaxis for changing long-term indwelling urethral catheters.

The GDG were also presented with current UK antibiotic and infection-related costs (see economic model in Appendix J).

Table 75Cost of antibiotics commonly used for prophylaxis when changing long-term indwelling urinary catheters

AntibioticStandard prophylactic doseCost per dose (£)
Gentamicin80mg intramuscular1.48
Ciprofloxacin20mg × 2 per oral0.22
Nitrofuratonin50mg × 4 per oral0.38
Trimethoprim200mg × 2 per oral0.02

Source: Drug and dosing data based on expert advice; costs obtained from the NHS Drug Tariff186 prices.

10.10.3. Evidence statements

ClinicalIt is uncertain whether there are any differences between providing single dose antibiotics vs. not providing antibiotics in mortality, bacteraemia and antibiotic resistance when changing urinary catheters (VERY LOW QUALITY).
No studies were identified that reported symptomatic lower UTI, symptomatic upper UTI, or patient preference.
EconomicNo evidence comparing the cost-effectiveness of providing antibiotic prophylaxis vs. not providing prophylactic antibiotics while changing urinary catheters was identified.

10.10.3.1. Recommendations and link to evidence

Recommendations
58.

When changing catheters in patients with a long-term indwelling urinary catheter:

  • do not offer antibiotic prophylaxis routinely
  • consider antibiotic prophylaxisjj for patients who:
    1. have a history of symptomatic urinary tract infection after catheter change or
    2. experience traumakk during catheterisation. [new 2012]
Relative values of different outcomesPrevention of symptomatic UTI was considered the most important outcome. UTI-associated mortality, bacteraemia and pylonephritis or upper UTIs were also considered important outcomes.
Trade off between clinical benefits and harmsSymptomatic UTI carries the risk of serious complications such as bacteraemia and death. There is a clear clinical benefit to be gained from the prevention of symptomatic UTI in patients with long-term indwelling catheters. However, the risk of using antibiotics as a form of prophylaxis is that it may lead to an increase in resistance to that drug which, in turn, may reduce the available treatments for patients with clinical infections in the future.
Antibiotics also carry a risk of adverse reaction in individual patients.
The recommendation was based on GDG consensus as the strength of evidence was insufficient to indicate an overall benefit from routine antibiotic prophylaxis.
Economic considerationsAssessing the cost-effectiveness of antibiotic prophylaxis is very complex. Within the past decade there has been a large increase in the prevalence of multi-drug resistant UTIs in the community. The use of antibiotics is undoubtedly a factor in this phenomenon. There is a need to consider the potential economic consequences across the patient population rather than simply considering the cost-effectiveness for individuals. However, predicting the development of antibiotic resistance within individuals and between populations is an area characterised by extreme uncertainty.
The GDG thought that is likely that the effect of antibiotic prophylaxis on antibiotic resistance will depend on the extent of usage. Given the high cost and QALY loss associated with UTI and UTI-associated complications, the GDG thought that among patients at higher risk of UTI during catheter change, and the low cost of a single dose of antibiotics, prophylactic antibiotic use for indwelling catheter change would likely be cost-effective. Given the long-term risks to the patient and the population associated with antibiotic resistance, the GDG decided that the routine use of antibiotic prophylaxis would likely represent an inefficient use of resources.
Quality of evidenceThe evidence was of very low quality; any estimates of effect sizes obtained were highly uncertain. Only one small RCT conducted in elderly patients using an open urinary collecting catheter system and silicone coated catheters was identified. This study had serious limitations. There was serious imprecision and indirectness of the population (i.e. applicability to the guideline population), type of intervention used (meropenem, which is normally a second-line therapy antibiotic) and type of catheterisation used in the study. This recommendation is based on GDG consensus and input of expert advisors on the interpretation of the evidence.
No cost-effectiveness evidence was identified.
Other considerationsThe GDG considered the opinion of the microbiologist expert advisor who worked with the GDG to interpret the evidence and provide advice on the current practices in this area.
Although there was no evidence of effectiveness for short course/single dose antibiotic prophylaxis, the GDG thought that antibiotics may be considered in certain groups (where there is a high risk of UTI or the consequences of complications from UTI are particularly high).
The GDG felt that in these groups, the potential benefit of risk reduction from antibiotic prophylaxis may outweigh the potential disadvantages associated with its use.
  • Both groups are at an increased risk of getting UTI during catheter change. The numbers needed to treat in order to prevent infections in this group may be lower if their baseline risks are higher. This would tip the balance of benefits vs. harms to favour considering antibiotics.
  • Prophylactic antibiotics are normally offered as a single dose (and very rarely, as a short course). Adequate efforts to ensure appropriate use and good adherence may be helpful to minimise the risk of bacterial resistance.
For these groups, the concerns about patient safety were paramount.
There is no existing widely accepted definition of “trauma” from repeated or difficult catheterisation. The definition provided (frank haematuria following catheterisation or two or more attempts of catheterisation) is formed by GDG consensus, with expert input, and intended to capture the concern that traumatic catheterisation led to tissue damage which could increase the risk of infection becoming systemic.
The GDG also discussed patients with a high risk of bacteraemia, such as immunosuppressed patients, and that they could also be considered for antibiotic prophylaxis.
The choice of antibiotics has not been specified because resistance patterns could vary based on locality and over time. It is assumed that clinicians will follow local guidance and prescribe an effective antibiotic with the lowest acquisition cost unless otherwise indicated.
None of the antibiotics are licensed for single dose or short course prophylaxis of urinary tract infections when changing long-term urinary catheter. It is important to fully inform patients about the advantages and disadvantages of using antibiotics for their individual circumstances, and the importance of fully adhering to the antibiotic prophylaxis regimen to reduce the risk of bacterial resistance. Patients should be asked their preference and to consent on the course of antibiotic prophylaxis prescribed.
Other linked recommendations:
Prophylaxis against infective endocarditis: antimicrobial prophylaxis against infective endocarditis in adults and children undergoing interventional procedures CG 64 (http://guidance​.nice.org.uk/CG64).
The GDG have also made a research recommendation in this area, see section 10.12.
The GDG have prioritised this recommendation as a key priority for implementation as they consider that it has a high impact on outcomes that are important to patients, has a high impact on reducing variation in care and outcomes and leads to a more efficient use of NHS resources, see section 4.1.
jj

At the time of publication of the guideline (March 2012), no antibiotics have a UK marketing authorisation for this indication. Informed consent should be obtained and documented.

kk

The GDG defined trauma as frank haematuria after catheterisation or two or more attempts of catheterisation.

10.11. Areas for Further Research

In developing the recommendations we identified several areas that were inadequately addressed in the literature. The following recommendations for research are therefore made.

Assessing the need for catheterisation

Epidemiological studies of the prevalence and incidence of bacteriuria/clinical urinary tract infection during long-term catheterisation in different populations and different care settings. These should at least encompass the predominant populations; older people and those with neurological deficits in both institutional and domiciliary settings. There needs to be clear definition of the ‘cases’ and the populations from which they are drawn.

Catheter drainage options

Randomised controlled trials of different approaches to urinary drainage. These should compare urethral indwelling catheterisation with and without a drainage bag (i.e., a valve); urethral intermittent catheterisation; suprapubic catheterisation; penile sheath drainage and incontinence pads in appropriate populations. Outcome measures need to include rates of bacteriuria/clinical UTI; tissue damage; patient/carer satisfaction; and cost-benefit.

Randomised controlled trials of the efficacy of antimicrobial impregnated urethral catheters for long-term use.

Catheter maintenance

Randomised controlled trials of strategies to reduce/prevent/manage encrustation and blockage. These need to determine whether catheter maintenance solutions (washouts/installations) are effective in reducing encrustation; blockage; urethral trauma; frequency of catheter replacement; and interventions/visits by healthcare practitioners. The rates of these complications when catheter valves are used in place of drainage bags also needs to be compared.

Cohort studies to determine whether monitoring of urinary pH can be used to predict time to blockage. These need to be undertaken in defined and representative groups.

Randomised controlled trials to establish the optimum time interval between changing equipment. There is a particular need to determine whether the frequency of changing leg bags or catheter valves influences the rates of bacteriuria/clinical UTI.

10.12. Research Recommendations

3. For patients performing intermittent self-catheterisation over the long term, what is the clinical and cost effectiveness of single-use non-coated versus single-use hydrophilic versus single-use gel reservoir versus reusable non-coated catheters with regard to the following outcomes: symptomatic urinary tract infections, urinary tract infection-associated bacteraemia, mortality, patient comfort and preference, quality of life, and clinical symptoms of urethral damage?

Why is this important?

Long-term (more than 28 days) intermittent self-catheterisation is performed by many people living in the community. It is important that the choice between intermittent catheters is informed by robust evidence on clinical and cost effectiveness.

The cost-effectiveness model developed for this guideline combined evidence of clinical effectiveness, costs and quality of life with respect to symptomatic urinary tract infection and associated complications. The results of the analysis showed that reusable non-coated catheters were the most cost-effective option for intermittent self-catheterisation. However, the clinical evidence informing this model was of low to very low quality. Currently, non-coated catheters are considered to be single-use devices. In order to make an ‘off-licence’ recommendation for the use of these catheters, better quality evidence is needed.

A four-arm randomised controlled trial is required. The trial population should be diverse, including wheelchair users, people with spinal cord injuries and people over 16 who regularly self-catheterise. The primary outcome measures should be incidence of symptomatic urinary tract infections, urinary tract infection-associated bacteraemia, mortality, patient comfort and preference, quality of life, clinical symptoms of urethral damage, and costs.

4. For patients using a long-term indwelling urinary catheter, what is the clinical and cost effectiveness of impregnated versus hydrophilic versus silicone catheters in reducing symptomatic urinary tract infections, encrustations and/or blockages?

Why is this important?

Long-term indwelling catheters (both urethral and suprapubic) are commonly used in both hospital and community care settings. Long-term catheterisation carries a significant risk of symptomatic urinary tract infection, which can lead to more serious complications. Several different types of impregnated and hydrophilic long-term indwelling catheters on the market claim to be more effective than non-coated catheters, but are also more expensive.

The clinical evidence review for the guideline revealed an absence of evidence for the effectiveness of indwelling catheters over the long-term. A comparison of impregnated (for example, with silver) catheters, hydrophilic catheters and silicone catheters is needed. The primary outcome measures should be symptomatic urinary tract infections, encrustations, blockages, cost/resource use and quality of life. Secondary outcome measures should include the mean number of days the catheter remains in situ (mean dwell time) and patient comfort.

5. When recatheterising patients who have a long-term indwelling urinary catheter, what is the clinical and cost effectiveness of single-dose antibiotic prophylaxis in reducing symptomatic urinary tract infections in patients with a history of urinary tract infections associated with catheter change?

Why is this important?

The immediate clinical and economic impact of urinary tract infection is so great that patients at risk of infection are sometimes offered the option to receive prophylactic antibiotics. However, the widespread use of antibiotics, including their prophylactic use, has been identified as a major factor in the increasing levels of antibiotic resistance observed across England and Wales. There is currently an absence of evidence about the short-term and long-term effects of prophylactic antibiotic use during catheter change. The GDG identified this as an important area for research to establish the benefits and harms of this practice in order to develop future guidance (the recommendation on this topic in the current guideline was based on GDG consensus).

A randomised controlled trial or cohort trial to compare single-dose antibiotic prophylaxis with selected major antibiotic groups is needed. The primary outcome measures should be symptomatic urinary tract infection, cost and quality of life. This is an important area for patients as it could minimise the inappropriate use of antibiotics.

Footnotes

ii

The text ‘Patients managing their own catheters, and their carers, must be educated about the need for hand decontamination…’ has replaced ‘Carers and patients managing their own catheters must wash their hands…’ in the 2003 guideline.

Copyright © 2012, National Clinical Guideline Centre.

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Bookshelf ID: NBK115272

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