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Cochrane Database of Systematic Reviews Protocol - Intervention

Types of urinary catheters for management of long‐term voiding problems in adults

Authors' declarations of interest

Version published: 18 October 2004 Version history

https://doi.org/10.1002/14651858.CD004997

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view the current version 17 October 2012
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Abstract

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

To determine which is the best type of urinary catheter to use in the long‐term management of voiding problems in adults.

We wish to test the following hypotheses.

1. Antiseptic impregnated urethral catheters are better than standard urethral catheters.
2. Antibiotic impregnated urethral catheters are better than standard urethral catheters.
3. Antibiotic impregnated catheters are better than antiseptic impregnated catheters.
4. One type of standard urethral catheter is better than another.
5. One type of antiseptic impregnated urethral catheter is better than another.
6. One type of antibiotic impregnated urethral catheter is better than another.
7. One type of intermittent catheter is better than another.

Background

Long‐term urinary catheterisation is common amongst people in long‐term care settings, e.g. nursing homes or home care. Common reasons for chronic urinary catheterisation are urinary incontinence, urinary retention (physical or neurogenic), and wound‐management, which may have a specific underlying cause such as multiple sclerosis, spinal cord injury, or enlarged prostate, and for patient comfort (Gammack 2003; Wilde 1986). In the USA 4% to 15% of long‐term care residents have used urinary catheters for more than 30 days (Gammack 2003; Getliffe 1990).

The urinary tract is the most common site (30% to 40%) of nosocomial infections and this is almost always associated with indwelling urinary catheters (NINSS 2002; NNIS 2003; RKI 2002). The incidence for catheter‐associated bacteriuria is about 3% to 10% per day a catheter is in situ. Therefore, most users of catheters will have a detectable bacteriuria within 30 days (Warren 1992; Warren 1997). The main criterion for urinary tract infection is generally agreed to be bacteriuria with 105 or more colony forming units per ml (CFU/ml) (Garner 1996). Catheter‐related infection is more common in women, the elderly and patients with co‐morbidities (Stamm 1998).

An estimated two‐thirds of catheter‐associated urinary tract infections in hospitalised patients are extraluminal (bacteria ascending from the meatus along the catheter urethral interface). One third are intraluminal (bacteria migrating into the catheter lumen as a result of disconnecting the catheter system) (Stamm 1998; Tambyah 1999). The micro‐organism species responsible for the catheter‐associated urinary tract infections vary widely between hospitals and within hospitals. Escherichia coli remains to be the most common pathogen causing urinary tract infection, and other important organisms are Enterococci, Pseudomonas aeruginosa, Klebsiella spp. and Candida spp. (Jarvis 1992; NINSS 2002; RKI 2002).

The most frequent complications associated with chronic catheterisation are symptomatic or asymptomatic bacteriuria, encrustation, irritation of the urethra tissue and leaking of urine due to blockage of the catheter itself. Less common are bacteraemia and renal disease (Warren 1997).

Urinary catheters are of varying design and material. The most common standard catheters include polyvinyl chlorine (PVC), plain latex, polytetrafluoroethylene (PTFE), and particularly for long‐term use silicone‐elastomer, hydrogel, polymer hydromer and pure silicone (CF 2004; Pomfret 2000, Robinson 2001). Catheters may be impregnated with antiseptic or antibiotic agents; the most common bactericidal agent is silver (Saint 1998). Catheters for intermittent catheterisation (single use) have either a hydrophilic or gel coating. Reusable catheters are usually made of polyvinyl chlorine and non‐coated (CF 2004).

This review will investigate which type of urinary catheter minimises the catheter‐associated infection rate and related complications during long‐term catheterisation in adults. Other factors that may influence the choice of catheter will also be examined. These include ease of use, comfort and handling for the caregivers and patients, and cost‐effectiveness.

Objectives

To determine which is the best type of urinary catheter to use in the long‐term management of voiding problems in adults.

We wish to test the following hypotheses.

1. Antiseptic impregnated urethral catheters are better than standard urethral catheters.
2. Antibiotic impregnated urethral catheters are better than standard urethral catheters.
3. Antibiotic impregnated catheters are better than antiseptic impregnated catheters.
4. One type of standard urethral catheter is better than another.
5. One type of antiseptic impregnated urethral catheter is better than another.
6. One type of antibiotic impregnated urethral catheter is better than another.
7. One type of intermittent catheter is better than another.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs) of parallel or crossover design evaluating the effectiveness of alternative types of urinary catheters in adults with long‐term voiding problems persisting more than thirty days.

Types of participants

Adults with indwelling urethral or suprapubic catheters, or using catheters for intermittent catheterisation, all for more than thirty days, irrespective of primary disease and care setting will be included. Patients with pre‐existing urinary tract infections will be excluded.

Types of interventions

Clearly described types of urinary catheter. These may be:

  • indwelling urethral catheters (standard or antiseptic coated or antibiotic coated);

  • suprapubic catheters (standard or antiseptic coated or antibiotic coated);

  • catheters suitable for intermittent catheterisation (standard or hydrophilic/gel coated).

Types of outcome measures

The primary outcome is catheter‐associated urinary tract infection (definitions of infection will be those used in the trial reports). Secondary outcomes are:

Complications/adverse effects:

  • asymptomatic bacteriuria;

  • symptomatic urinary tract infection;

  • other adverse effects of the intervention (e.g. encrustation, blockage, stone formation, retention).

Co‐interventions:

  • use of prophylactic antibiotics;

  • use of rescue antibiotics.

Patient reported:

  • patient satisfaction;

  • patient comfort.

Clinician reported:

  • practitioners' satisfaction;

  • length of time catheters used.

Quality of life:

  • generic quality of life measures (e.g. SF 36, Ware 1992);

  • psychological outcome measures (e.g. HADS, Zigmond 1983).

Economic outcomes:

  • costs of the intervention;

  • costs implications of differences in outcomes;

  • formal economic evaluation, such as cost‐effectiveness.

Search methods for identification of studies

The Specialised Register of Randomised Controlled Trials of the Cochrane Incontinence Review Group as a part of The Cochrane Central Register of Controlled Trials (CENTRAL) will be searched for reports of trials about problems occurring with long‐term catheterisation of adults. The Trials Register has been developed and is maintained by regular searches. It is regularly updated using a maximally sensitive search strategy for retrieving randomised controlled trials of electronic databases, as well as handsearching of journals and conference proceedings. In addition to The Cochrane Library, MEDLINE via PubMed and CINAHL will be searched using free text and MeSH terms. Some of the search terms to be tested will be: urinary catheter, urethral, suprapubic, indwelling, intermittent, urinary tract infection, bacteriuria. These search terms will be combined with the Cochrane Highly Sensitive Search Strategy phases one and two to identify randomised controlled trials (Alderson 2004). The listed databases will be searched by the authors for eligible studies for the earliest entrance date possible until the latest search date. For this review there will be no restrictions on date of publication, language of publication, or publication status (published or unpublished work). Experts in the field such as scientific societies for continence and urology will be contacted and asked whether they have been involved in any further potentially eligible studies or are aware of recent or ongoing studies about problems occurring with long‐term catheterisation of adults. The reference lists of all retrieved studies will be scanned for additional studies.
Catheter manufacturers will also be contacted, e.g. Wirutec, Urotech, Braun.
Handsearching
The following handsearching is planned. Exact volumes and years to be searched will be finalised in liaison with the New England Cochrane Centre and the Trials Search Co‐ordinator of the Incontinence Group.
A handsearch of the following conference proceedings will be conducted to identify any research or relevant studies:

  • International Continence Society (ICS)

  • International Urogynecological Association (IUGA)

  • American Urogynecological Society

  • Kongress der Deutschen Gesellschaft für Urologie e.V.

The following journals will be searched by hand:

  • Aktuelle Urologie

  • AUAA Journal (Official Journal of the American Urological Association Allied)/Urologic Nursing

  • British Journal of Urology

  • Contemporary Urology

  • Current Opinion in Urology

  • Current Urology Reports

  • Der Urologe

  • European Urology

  • Excerpta Medica, Section 28, Urology and Nephrology

  • Geriatric Nephrology and Urology

  • International Journal of Urology

  • International Urology and Nephrology

  • Investigative Urology

  • Scandinavian Journal of Urology and Nephrology

  • Scandinavian Journal of Urology and Nephrology / Supplement

  • Seminars in Urology

  • Techniques in Urology

  • The Canadian Journal of Urology

  • The Japanese Journal of Urology

  • The Journal of Urology

  • Urological Research

  • Urological Survey

  • Urology

  • World Journal of Urology

Data collection and analysis

Results from the search will be assessed for potential eligibility by two people independently and disagreement will be resolved by discussion with a third reviewer. Potentially relevant studies will be retrieved in full and two reviewers will decide independently whether they meet the inclusion criteria. Details of eligible studies will be extracted and summarised by two reviewers using a data extraction sheet. Studies that have been published in duplicate will be included only once using the most up to date data available for each outcome.

All studies that meet the selection criteria will be assessed for methodological quality. The system for classifying methodological quality of controlled trials will be based on an assessment of the three principal potential sources of bias. These are:

(1) selection bias from insecure random allocation of treatments;
(2) attrition bias from dropouts or losses to follow‐up, particularly if there is a differential dropout rate between groups;
(3) biased ascertainment (detection bias) of outcome where knowledge of the allocation might have influenced the measurement of outcome.

Data extraction will be undertaken by two reviewers independently and simultaneously. Any disagreement will be resolved by a third reviewer.

The included trial data will be handled according to the description of the Cochrane Collaboration Reviewers' Handbook (Alderson 2004). When appropriate, a meta‐analysis will be undertaken. Categorical outcomes will be expressed as relative risk with 95% confidence intervals. Continuous data will be presented using weighted mean difference. If quantitative synthesis is appropriate the pooled relative risks, weighted mean differences and their 95% confidence intervals will be calculated using a fixed effects model.

Differences between trials will be investigated when apparent from either visual inspection of the results or when statistically significant heterogeneity is demonstrated by using the chi‐squared test at the 10% probability level or assessment of the I‐squared statistic (Higgins 2003). If there is no obvious reason for the heterogeneity (after consideration of populations, interventions, outcomes and settings of the individual trials) or it persists despite the removal of outlying trials, a random effects model may be used. Sensitivity analysis will be considered to test the effects of including studies of poorer methodological quality e.g. quasi‐randomised studies.

If the data allows, subgroup analyses will be considered for the following groups:

  • male versus female;

  • duration of catheter use;

  • diagnostic groups;

  • immunodeficiency patients.