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Cochrane Database of Systematic Reviews Protocol - Intervention

Techniques and strategies for long‐term bladder management by intermittent catheterisation in adults and children

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To determine if certain intermittent catheters, catheterisation techniques, or catheter‐cleaning strategies are better than others in terms of bladder drainage, complications, quality of life and cost‐effectiveness, for adults and children whose long‐term (with no predicted endpoint) bladder management is by intermittent catheterisation

Note: Uncoated catheters (designated 'u') may be made of PVC or other material such as red rubber and have no lubricated coating. When used only once they are defined as 'sterile', when reused they are defined as 'clean'. Coated catheters (designated 'c') have a hydrophilic coating, or other lubricant intended to replace the use of separate lubricant. Coated catheters are not intended for reuse and are therefore defined as sterile (i.e. there is no category of 'clean' coated catheter).

Specific comparisons to be addressed include:
1. sterile uncoated catheter with sterile technique (SuS) versus sterile uncoated catheter with clean technique (SuC);
2. sterile uncoated catheter with clean technique (SuC) versus clean uncoated catheter with clean technique (CuC);
3. sterile uncoated catheter with sterile technique (SuS) versus clean uncoated catheter with clean technique (CuC);
4. sterile coated catheter with sterile technique (ScS) versus sterile coated catheter with clean technique (ScC);
5. sterile coated catheter with sterile technique (ScS) versus sterile uncoated catheter with sterile technique (SuS);
6. sterile coated catheter with clean technique (ScC) versus clean uncoated catheter with clean technique (CuC);
7. sterile coated catheter with clean technique (ScC) versus sterile uncoated catheter with sterile technique (SuS);
8. self‐catheterisation versus catheterisation by health professional or other carer;
9. comparisons of different catheter cleaning and storage strategies eg. soap and water, boiling, disinfectants, microwave.

Background

Intermittent catheterisation (IC) is the act of passing a catheter into the bladder to drain urine via the urethra, (or occasionally another catheterisable channel such as a Mitrofanoff continent urinary diversion). The catheter is removed immediately after urine drainage.

Intermittent catheterisation was originally advocated by Lapides et al (Lapides 1972) and is widely for urinary drainage by people with neurogenic bladder dysfunction or incomplete bladder emptying. The technique avoids or reduces many of the risks associated with indwelling catheters, such as urinary tract infection (UTI).

Intermittent catheterisation can be taught to people of all ages who have sufficient manual dexterity and motivation to manage the technique. This includes very elderly people and children as young as four years old with parental supervision (Eckstein 1982). Carers can also be taught the procedure where this is acceptable to both patient and carer. Disabilities such as blindness, lack of perineal sensation, tremor, mental disability and paraplegia do not necessarily preclude people from mastering the technique if they have sufficient manual dexterity and motivation.

An individualised care plan is developed to identify an appropriate catheterisation frequency, based on assessment of their voiding problem through discussion, frequency‐volume charts and ultrasound bladder scans for residual urine. Some people need to catheterise several times per day, others only infrequently. Advantages of intermittent catheterisation over indwelling catheterisation include:

  • greater opportunity for individuals to reach their own potential in terms of self‐care and independence;

  • reduced risk of common catheter‐associated complications;

  • better protection of upper urinary tract from reflux;

  • reduced need for equipment and appliances eg. drainage bags;

  • greater freedom for expression of sexuality;

  • potential for improved continence between catheterisations.

Catheterisation techniques vary as follows:
(i) Sterile catheter (single‐use) with sterile (no‐touch) catheterisation technique (SS).
(ii) Sterile catheter (single‐use) with clean technique (SC).
(iii) Clean catheter (reusable) with clean technique (CC).

There is variation in the types and characteristics of catheters used in IC techniques and this adds complexity to the selection of products and to comparative analysis of performance. Plain uncoated catheters are packed singly in sterile packaging and are sometimes reused after cleaning. The success of cleaning is affected by the method used (eg. soap & water, boiling, disinfectants, microwave) and by the method of storage of cleaned catheter. Some catheters are coated, most commonly with a hydrophilic coating designed to aid lubrication and comfort in use, although catheters are also available with coatings containing an antibiotic element. Coated catheters are intended for single use only, and therefore over time they are more expensive than plain, uncoated reusable catheters. Also available are pre‐lubricated catheters and sterile packs containing a coated catheter along with sterile water for soaking and/or an integral drainage bag, intended to allow the user greater freedom in terms of where and when he or she catheterises. Some products are also designed to facilitate a 'sterile' no‐touch technique. There is also variation in the design of catheters themselves in terms of material, length, flexibility, and whether drainage eyes are polished or unpolished. Although these characteristics may be important for individual users they are not addressed in this review.

Complications of intermittent catheterisation
Wyndaele (Wyndaele 2002) reviewed 82 studies of complications of intermittent catheterisation. Urinary tract infection (UTI) was the most common complication and catheterisation frequency and the avoidance of bladder over‐filling were recognised as important prevention measures. Prostatitis was an identified risk in men. Epididymitis and urethritis were relatively rare. Trauma from catheterisation was noted to occur regularly but lasting effects were limited. Estimates of the prevalence of urethral strictures and false passages increased with longer use of IC but the study concluded that the most important preventative measures were good education of all involved in IC, good patient compliance, use of an appropriate catheter material, and good catheterisation technique. Similar findings were recently reported by Campbell et al (Campbell 2004) in a follow‐up of children with spina bifida who had used intermittent catheterisation with an uncoated PVC catheter for at least 5 years. The incidence of urethritis, false passage, or epididymitis was very low while compliance with the protocol was excellent.

Nevertheless, concern remains about the long‐term implications of routine intermittent catheterisation and recent innovations have attempted to address this issue. Hydrophilic polymers which can bind lubricating liquids have been shown to reduce friction during catheter insertion but any relationship to catheter‐associated infection is less clear (Cottenden 2005). Vaidyanathan et al (Vaidyanathan 1994) studied the degree of urethral inflammation by urethral cytology in two groups on IC: one using uncoated PVC catheters with lubricant; the other using hydrophilic coated catheters. The group using hydrophilic coated catheters had significantly less urethral inflammation. However, they are more expensive in the long‐term and questions about whether better patient satisfaction and decreased urethral irritation can justify the greater expense remain largely unanswered. Hydrophilic catheters themselves vary in type and degree of coating (Fader 2001) and, may cause urethral or meatal irritation. Hedlund et al (Hedlund 2001) reviewed the literature on IC (28 studies) and called for a prospective, randomised, long‐term, multi‐centre study to address cost‐benefit and cost effectiveness. A further aspect of the cost‐effectiveness debate relates to whether catheters designated for single use by manufacturers should only be used once or whether 'single use' can be interpreted as re‐use by a 'single patient' in the case of patients who are self‐caring at home.

A recent trial by De Ridder et al (De Ridder 2005) suggests that UTI is reduced in hydrophilic catheter users compared to uncoated PVC users, a finding that deserves further exploration. It is difficult to know the prevalence of UTIs associated with intermittent catheterisation as the reports vary widely. This is, at least partially, due to the various definitions of UTI based on bacteriuria alone (asymptomatic) or symptomatic UTI (with or without clearly defined criteria); evaluation methods used; different catheterisation techniques; different frequencies of urine analysis; the administration or not of prophylactic antibiotics; the group of patients studied (including sex, functional ability and other behavioural and personal hygiene factors).

This review has two primary aims. The first is to assess whether and under what circumstances, clean catheterisation is as good as sterile catheterisation. The second is to determine if coated catheters are better than uncoated catheters in relation to defined outcome measures. A further aim is to compare different catheter cleaning strategies. It must be recognised that IC takes place in a range of settings (e.g. hospital or community) and this will be taken into account where possible. Comparisons between different types of bladder drainage will not be addressed as this has been examined in existing Cochrane Reviews including: 'Catheter policies for management of long‐term voiding problems in patients with neurogenic bladder '(Jamison 2004); and 'Urinary catheter policies for long‐term bladder drainage' (Niel‐Weise 2005).

Objectives

To determine if certain intermittent catheters, catheterisation techniques, or catheter‐cleaning strategies are better than others in terms of bladder drainage, complications, quality of life and cost‐effectiveness, for adults and children whose long‐term (with no predicted endpoint) bladder management is by intermittent catheterisation

Note: Uncoated catheters (designated 'u') may be made of PVC or other material such as red rubber and have no lubricated coating. When used only once they are defined as 'sterile', when reused they are defined as 'clean'. Coated catheters (designated 'c') have a hydrophilic coating, or other lubricant intended to replace the use of separate lubricant. Coated catheters are not intended for reuse and are therefore defined as sterile (i.e. there is no category of 'clean' coated catheter).

Specific comparisons to be addressed include:
1. sterile uncoated catheter with sterile technique (SuS) versus sterile uncoated catheter with clean technique (SuC);
2. sterile uncoated catheter with clean technique (SuC) versus clean uncoated catheter with clean technique (CuC);
3. sterile uncoated catheter with sterile technique (SuS) versus clean uncoated catheter with clean technique (CuC);
4. sterile coated catheter with sterile technique (ScS) versus sterile coated catheter with clean technique (ScC);
5. sterile coated catheter with sterile technique (ScS) versus sterile uncoated catheter with sterile technique (SuS);
6. sterile coated catheter with clean technique (ScC) versus clean uncoated catheter with clean technique (CuC);
7. sterile coated catheter with clean technique (ScC) versus sterile uncoated catheter with sterile technique (SuS);
8. self‐catheterisation versus catheterisation by health professional or other carer;
9. comparisons of different catheter cleaning and storage strategies eg. soap and water, boiling, disinfectants, microwave.

Methods

Criteria for considering studies for this review

Types of studies

Randomised and quasi‐randomised trials comparing techniques and policies for long‐term bladder management by intermittent catheterisation.

Types of participants

Adults or children requiring intermittent catheterisation for long‐term bladder management.

Types of interventions

Comparisons of intermittent catheterisation techniques including sterile versus clean, different catheter materials and/or coatings, single or multiple use.

Types of outcome measures

1. Catheter‐associated infection (definition of infection as used in trial reports)

  • Asymptomatic UTI

  • Symptomatic UTI. For the purposes of this review, UTI will be defined as positive urine culture plus one or more systemic symptoms (fever, loin pain, dysuria, urgency, haematuria, temperature, pyuria ‐ (NIDRR 1992)

  • Use of antibiotics

2. Other complications/adverse effects

  • Urethral trauma

  • Abnormal cytology

  • Stricture formation

3. Patient outcomes

  • Patient comfort, including ease of insertion and removal

  • Patient satisfaction

  • Patient preferences

  • Quality of life measures

4. Economic outcomes

  • Catheter and equipment costs

  • Frequency of catheterisation

  • Resource implications (personnel and other costs to services)

  • Formal economic analysis (cost‐effectiveness, cost utility)

5. Other outcomes

  • Microbiological culture of catheter surfaces

  • Additional outcomes judged to be important when performing the review

Search methods for identification of studies

The search strategy will draw on the guidance provided by the Cochrane Incontinence Review Group. Relevant trials will be identified from the Cochrane Incontinence Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL. Further searching will interrogate reference lists of all identified trials, relevant conference proceedings and hand searching of key journals. We will not impose any language or other limitations.

Data collection and analysis

Study selection
Two reviewers will assess the titles and abstracts of studies identified by the search strategy. Full reports of all potentially relevant randomised and quasi‐randomised trials will be obtained and assessed for eligibility, based on defined inclusion criteria. Any disagreement will be resolved by discussion or where agreement cannot be reached, by consultation with an independent third person.

Methodological quality assessment
The quality of eligible trials will be assessed independently by the two reviewers using a pre‐defined quality assessment form (Cochrane Incontinence Review Group). This will include quality of random allocation and concealment, description of drop‐outs and withdrawals, analysis by intention to treat, blinding during intervention and at outcome assessment. Disagreements between reviewers will be resolved by discussion or will be referred to the coordinating editor of the Cochrane Incontinence Review Group.

Data abstraction
Relevant data regarding inclusion criteria (study design, participants, interventions, and outcomes), quality criteria (randomisation, blinding, and control) and results will be extracted independently by the two reviewers using a data abstraction form developed specifically for this review. In cases where insufficient data were reported (e.g. method of randomisation, statistical methods) authors will be contacted for further information. Excluded studies and reasons for exclusion will be detailed in the 'Characteristics of Excluded Studies' table.

Data analysis
Data will be processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Deeks 2005). For dichotomous outcomes relative risks and 95% confidence intervals (CI) will be derived. For continuous outcomes mean differences and 95% CI will be calculated. Where appropriate, results from included studies will be combined for each outcome to give an overall estimate of treatment effect. Fixed effect methods will be applied, with relative risk or weighted mean differences used as appropriate. A random effects model may be applied if there are concerns that heterogeneity may be complicating an analysis. Sub‐group analysis will be considered for different diagnostic groups or according to sex and age of participants, where possible.

If data cannot be combined, a qualitative synthesis of results of included studies will be presented.