Policies for replacing long‐term indwelling urinary catheters in adults

Fergus PM Cooper; Cameron Edwin Alexander; Sanjay Sinha; Muhammad Imran Omar

doi:10.1002/14651858.CD011115.pub2

Normas para el reemplazo de sondas urinarias permanentes de largo plazo en adultos

Declaraciones de intereses de los autores

Versión publicada: 26 julio 2016 Historial de versiones

https://doi.org/10.1002/14651858.CD011115.pub2

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Resumen

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Antecedentes

Las sondas permanentes de largo plazo se utilizan con frecuencia en pacientes con trastornos de las vías urinarias bajas en el entorno doméstico, hospitalario o en la atención sanitaria especializada. Existen muchos efectos adversos y complicaciones potenciales asociados con el uso de sondas a largo plazo. No queda claro qué efecto tienen las normas sanitarias relacionadas con el reemplazo de las sondas urinarias a largo plazo en las medidas de resultado del paciente.

Objetivos

Determinar la efectividad de las diversas normas para reemplazar las sondas urinarias permanentes de largo plazo en adultos.

Métodos de búsqueda

Se hicieron búsquedas en el Registro Especializado de Ensayos del grupo Cochrane de Incontinencia (Cochrane Incontinence Specialised Trials Register), que contiene ensayos identificados del Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials) (CENTRAL), MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP y búsquedas manuales de revistas y actas de congresos (búsqueda 19 mayo 2016), y en listas de referencias de artículos relevantes.

Criterios de selección

Se incluyeron todos los ensayos controlados aleatorios que investigaron las normas para el reemplazo de sondas urinarias permanentes de largo plazo en adultos.

Obtención y análisis de los datos

Al menos dos autores de la revisión realizaron de forma independiente la extracción de datos y evaluaron el riesgo de sesgo de todos los ensayos incluidos. La calidad de las pruebas se evaluó mediante el enfoque GRADE. Las discrepancias se resolvieron mediante discusión entre los autores de la revisión o un árbitro independiente. Se estableció contacto con los autores de los ensayos incluidos para obtener aclaraciones cuando fue necesario.

Resultados principales

Tres ensayos cumplieron los criterios de inclusión, con 107 participantes en tres entornos diferentes de atención sanitaria: Una residencia de ancianos del Departamento de Asuntos de Veteranos de los EE. UU.; un centro geriátrico en Israel; y un servicio comunitario de enfermería de Hong Kong. Estaban disponibles los datos de tres comparaciones declaradas anteriormente. Priefer y cols. evaluaron diferentes intervalos de tiempo entre los reemplazos de las sondas (n = 17); Firestein y cols. evaluaron el consumo preventivo de antibióticos en el momento del reemplazo (n = 70); y Cheung y cols. compararon dos tipos diferentes de soluciones de limpieza (n = 20).

Todos los ensayos incluidos eran pequeños y no tenían suficiente poder estadístico. El informe de los ensayos fue inapropiado y, en consecuencia, se determinó que la evaluación del riesgo de sesgo era poco clara en la mayoría de los dominios de dos de los tres ensayos. Las pruebas eran insuficientes para indicar que (i) hubo una menor incidencia de IU sintomática en los pacientes a quienes se les cambió la sonda tanto en forma mensual como por indicación clínica (cociente de riesgos [CR ] 0,35; intervalo de confianza del 95% [IC] 0,13 a 0,95; pruebas de muy baja calidad) comparado con los casos en que se realizó exclusivamente por indicación clínica, (ii) no hubo suficientes pruebas para evaluar el efecto de la prevención con antibióticos en la reducción de: cultivos de orina positivos a los siete días (CR 0,91; IC del 95%: 0,79 a 1,04); infección (CR 1,41; IC del 95%: 0,55 a 3,65); o mortalidad (CR 2,12; IC del 95%: 0,20 a 22,30; pruebas de muy baja calidad), (iii) no hubo diferencias estadísticamente significativas en la incidencia de bacteriuria asintomática a los siete días (CR 0,80; IC del 95%: 0,42 a 1,52) entre los pacientes tratados con agua o solución de clorhexidina para la limpieza periuretral, en el momento de reemplazar la sonda. Sin embargo, ninguno de los 16 participantes presentó infección sintomática de las vías urinarias (ISVU) asociada con la sonda el día 14.

Los siguientes resultados se consideraron críticos para la toma de decisiones y también se seleccionaron para la tabla "Resumen de los hallazgos": (i) satisfacción del participante, (ii) calidad de vida específica de la enfermedad, (iii) traumatismo de las vías urinarias y (iv) análisis económico formal. Sin embargo, ninguno de los ensayos informó estos resultados.

Ninguno de los ensayos realizó las siguientes comparaciones: (i) reemplazo de la sonda versus otras normas como lavados, (ii) reemplazo en el entorno doméstico versus entorno clínico, (iii) técnica limpia versus aséptica para el reemplazo de sondas, (iv) lubricante A versus lubricante B o sin lubricante y (v) procedimiento de reemplazo de la sonda realizado por el usuario de la sonda versus el cuidador versus un profesional sanitario.

Conclusiones de los autores

Las pruebas actuales no son suficientes para evaluar la importancia de diferentes normas de reemplazo de sondas urinarias a largo plazo en las medidas de resultado del paciente. En especial, existe un número de normas acerca de las cuales no se dispone de ensayos; y una cantidad de medidas de resultado importantes que no fueron evaluadas, incluida la satisfacción del paciente, la calidad de vida, el traumatismo de las vías urinarias y los resultados económicos. Existe una necesidad inmediata de ensayos controlados aleatorios rigurosos y con un adecuado poder estadístico que evalúen medidas de resultado clínicas importantes y que cumplan con los principios y las recomendaciones de la declaración CONSORT.

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Resumen en términos sencillos

disponible en

Normas para el reemplazo de sondas urinarias permanentes de largo plazo en adultos

Antecedentes

Una sonda urinaria es un tubo que se inserta en la vejiga desde el extremo de la uretra para drenar la orina de la vejiga. Por lo general, las sondas urinarias solamente se requieren durante unos pocos días, por ejemplo, después de una cirugía. Sin embargo, hay ciertos trastornos médicos que podrían requerir el drenaje vesical durante un período prolongado. Existen muchas formas de cuidar y mantener una sonda urinaria de largo plazo. En esta revisión, se hará referencia a estos diferentes métodos de cuidado como "normas" de atención sanitaria. Entre los ejemplos de las normas relacionadas con el reemplazo de la sonda a largo plazo, se incluyen: tiempo entre los reemplazos de las sondas; administración de antibióticos durante el reemplazo; utilización de soluciones de limpieza o de lubricantes durante el reemplazo; y personal, entorno y técnicas utilizadas durante el reemplazo. Esta revisión trató de identificar qué normas resultaron más efectivas en el momento del reemplazo de la sonda de largo plazo respecto de una mejor atención del paciente.

Principales hallazgos de la revisión

Esta revisión identificó que actualmente no se cuenta con suficientes pruebas de alta calidad que evalúen la efectividad de las diferentes normas de reemplazo de sondas urinarias de largo plazo. Sólo tres ensayos clínicos aleatorios, que incluyeron un total de 107 participantes, fueron elegibles y se incluyeron en esta revisión.

Estos ensayos evaluaron: (i) diferentes intervalos de tiempo para el reemplazo de las sondas, (ii) administración de antibióticos para prevenir infecciones y (iii) utilización de diferentes soluciones de limpieza. Las pruebas no eran suficientes para sugerir que el reemplazo de las sondas en forma mensual o por un motivo clínico redujera las bacterias en la orina en comparación con el reemplazo de la sonda exclusivamente por un motivo clínico. Sin embargo, no hubo pruebas suficientes para determinar si la administración de antibióticos en el momento del reemplazo de la sonda para prevenir infecciones era efectivo, o si el uso de agua como enjuague durante el reemplazo de la sonda fue tan efectivo como el uso de una solución de lavado antibacteriana.

Efectos adversos

Ninguno de los ensayos informó efectos adversos relacionados con las normas investigadas.

Posibles limitaciones de la revisión

Los tres ensayos incluidos en esta revisión fueron muy pequeños y presentaban defectos metodológicos. Por lo tanto, se necesitan nuevos ensayos para dar una respuesta definitiva a esta pregunta de investigación. Las pruebas de esta revisión están actualizadas hasta el 19 de mayo de 2016.

Authors' conclusions

Implications for practice

There is insufficient evidence to support catheter replacement monthly as well as when clinically indicated compared to only when clinically indicated. Further research with a larger number of participants could turn an insignificant reduction in symptomatic CAUTIs in the monthly replacement group to a significant reduction. It is unclear which policy is more favourable economically, as performing monthly replacements in addition to replacements when clinically indicated incurs more replacements, but less irrigations. As these figures were also insignificant further research is needed, particularly including the need for treatment of any symptomatic CAUTI.

There is not enough evidence to suggest whether antibiotics should be used at catheter replacement in patients with long‐term catheters. However, not all variants of this intervention or outcomes have been assessed.

There is not enough evidence to suggest whether sterile water is as effective as 0.05% CHG solution for periurethral cleansing between catheter replacements for reducing rates, and delaying onset, of bacteruria and symptomatic CAUTIs. However, other factors such as patient comfort remain unexplored. A formal economic analysis should be performed to determine whether this is a more cost‐effective approach.

Implications for research

Randomised controlled trials with higher numbers of participants and of higher quality are required in order to make recommendations for changing policies for replacing long‐term catheters. Further research into the areas studied by the trials featured in this review would help strengthen the evidence to support their conclusions. Different types of antibiotics, different cleaning solutions and different periods between replacements could also be studied in addition to the interventions described in this protocol where no trials were found. Future research should aim to explore additional outcomes to asymptomatic bacteruria and symptomatic CAUTI such as participant satisfaction and cost‐effectiveness. A validated questionnaire should be developed for assessing participant satisfaction and quality of life measures in order to reduce heterogeneity across trials. It is also important to identify which of these outcomes not yet studied are most crucial to decision making regarding policies for replacing long‐term catheters in order to guide future research. Sub‐group analysis would give valuable data as to whether certain policies are more effective in sub‐groups such as females or younger participants. We did not identify any long‐term follow‐up data. It is paramount that future trials report long‐term follow‐up data as this is also valuable evidence.

Summary of findings

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Summary of findings for the main comparison. Monthly & PRN catheter replacement versus PRN catheter replacement for replacing long‐term indwelling urinary catheters in adults

Monthly & PRN catheter replacement versus PRN catheter replacement for replacing long‐term indwelling urinary catheters in adults
Patient or population: adults with replacing long‐term indwelling urinary catheters Settings: USA veterans administration nursing home Intervention: Monthly & PRN catheter replacement versus PRN catheter replacement
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Monthly & PRN catheter replacement versus PRN catheter replacement
Symptomatic CAUTI as defined by trialists	857 per 1000	300 per 1000 (111 to 814)	RR 0.35 (0.13 to 0.95)	17 (1 study)	⊕⊝⊝⊝ very low^1,2
Participant satisfaction ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Condition‐specific quality‐of‐life measures ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Adverse effects (Urinary tract trauma) ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Adverse effects (Death) ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Formal economic analysis ‐ not reported	See comment	See comment	Not estimable	‐	See comment
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Downgraded two levels: Sequence generation, allocation concealment and blinding of outcome assessment was judged to be unclear. Blinding of participants and personnel was judged to be at high risk of bias.The outcome was reported by one under‐power study. ² Downgraded one level: As the sample size and the event rate is small. PRN: from the Latin "pro re nata", meaning " as needed".

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Summary of findings 2. Antibiotics at time of replacement versus no antibiotics at time of replacement for replacing long‐term indwelling urinary catheters in adults

Antibiotics at time of replacement versus no antibiotics at time of replacement for replacing long‐term indwelling urinary catheters in adults
Patient or population: adults with replacing long‐term indwelling urinary catheters Settings: Geriatric Centre in Israel Intervention: Antibiotics at time of replacement versus no antibiotics at time of replacement
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Antibiotics at time of replacement versus no antibiotics at time of replacement
Symptomatic CAUTI ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Participant satisfaction ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Condition‐specific quality of life measures ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Adverse effects (Urinary tract trauma) ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Adverse effects (Death)	28 per 1000	59 per 1000 (6 to 619)	RR 2.12 (0.20 to 22.20)	70 (1 study)	⊕⊝⊝⊝ very low^1,3
Formal economic analysis ‐ not reported	See comment	See comment	Not estimable
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Downgraded two levels: Sequence generation, allocation concealment and blinding of outcome assessment was judged to be unclear. Blinding of participants and personnel, and incomplete outcome data was judged to be at high risk of bias. ² Downgraded one level: 95% CI is wide (0.79 to 1.04) ³Downgraded one level: As the sample size and the event rate is small.

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Summary of findings 3. Sterile water versus 0.05% chlorohexidine gluconate for periurethral cleansing during replacement for replacing long‐term indwelling urinary catheters in adults

Sterile water versus 0.05% chlorohexidine gluconate for periurethral cleansing during replacement for replacing long‐term indwelling urinary catheters in adults
Patient or population: adults with replacing long‐term indwelling urinary catheters Settings: Hong Kong Community Nursing Service Intervention: Sterile water versus 0.05% chlorohexidine gluconate for periurethral cleansing during replacement
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Sterile water versus 0.05% chlorohexidine gluconate for periurethral cleansing during replacement
Symptomatic CAUTI at 14 days after replacement	Study population		Not estimable	16 (1 study)	⊕⊝⊝⊝ very low^1,2
Symptomatic CAUTI at 14 days after replacement	0 per 1000	0 per 1000 (0 to 0)	Not estimable	16 (1 study)	⊕⊝⊝⊝ very low^1,2
Participant satisfaction ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Condition‐specific quality of life measures ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Adverse effects (Urinary tract trauma) ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Adverse effects (Death) ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Formal economic analysis ‐ not reported	See comment	See comment	Not estimable	‐	See comment
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Downgraded two levels: Allocation concealment, and blinding of outcome assessment was judged to be unclear. Blinding of participants and personnel was judged to be at high risk of bias.The outcome was reported by one under‐power study. ²Downgraded one level: As the sample size and the event rate is small.

Background

Description of the condition

Long‐term indwelling urinary catheters can be used in the care of people with urinary incontinence or urinary retention. These conditions can arise from a variety of underlying pathologies that cause dysfunction of bladder storage or emptying, such as multiple sclerosis and benign prostatic hyperplasia. The prevalence of long‐term catheter use varies between countries and health‐care settings (Stensballe 2005). A study by Sørbye and colleagues found that, in Italy, 35.9% of male and 27.4% of female elderly home care clients used either an indwelling, intermittent or condom catheter. However, rates of use of these catheters were lower in men in Finland (2.9%) and in women in the Czech Republic (0.6%) (Sørbye 2009). There are many well recognised and common complications associated with the use of long‐term urinary catheters, including urinary tract infections, encrustation due to mineral deposits, and peri‐catheter leakage. The majority of micro‐organisms that cause catheter‐associated urinary tract infections (CAUTIs) are derived from the patient’s own colonic and perineal flora and the hands of health‐care professionals involved in catheter insertion or management (Maki 2001). Studies have shown a 5% to 8% increase in the risk of developing bacteruria for each day following catheterisation, and that almost all users will have bacteruria four weeks after long‐term catheter insertion (Gould 2010; Nicolle 2001; Stamm 1991). Leakage, blockage, pain and dislodgement of long‐term catheters are also recognised as commonly occurring problems that often require additional use of health‐care resources and services (Wilde 2013). These complications will undoubtedly have an impact on patient quality of life and satisfaction.

Description of the intervention

A number of different policies can be employed during the time of catheter replacement. These policies are described below.

Time between replacements

The recommended time between catheter replacement depends on local policies and varies significantly between centres (Palka 2014; Willson 2009). This discrepancy in clinical practice reflects a lack of evidence to support the early or late replacement of long‐term urinary catheters in the reduction of adverse outcomes. The Infectious Diseases Society of America (IDSA) states there is currently insufficient data to recommend a specific time interval between long‐term catheter or suprapubic catheter replacement (Hooton 2010). A shorter time interval between catheter replacements may reduce the development of a biofilm that can act to harbour bacteria, and may also reduce the likelihood of mechanical blockage. However, the tissue disruption caused by more frequent catheter replacement could contribute to the development of CAUTI and other adverse outcomes.

Antibiotics as prophylaxis

For people requiring a long‐term indwelling catheter, antibiotics may be given prophylactically in an attempt to prevent CAUTI development or at the time of developing the symptoms associated with CAUTI. However, prophylactic antibiotics have been shown to permit the development of resistant organisms (Hooton 2010). A comparison of prophylactic, clinically indicated and microbiologically indicated antibiotics has been previously explored in another Cochrane Review (Lusardi 2013). This concluded that data was limited and that there was insufficient evidence to determine best practice.

Catheter replacement environments, personnel and techniques

Long‐term indwelling urinary catheters can be replaced by personal carers, health‐care professionals or by the catheter users themselves. Furthermore, the procedure may be carried out by the catheter user in their own home, by a health‐care professional visiting the user at home, or by a health‐care professional in a clinical environment or nursing home. Catheter replacement can be performed using either a clean or an aseptic approach. A clean approach involves the use of non‐sterile gloves and the cleansing of the external urethral meatus and surrounding area with a non‐antiseptic solution. An aseptic approach involves the use of sterile gloves, sterile barriers, antiseptic cleaning solutions and a non‐touch technique. Clinical practice worldwide varies according to local policies, individual preferences and the specific clinical setting (Willson 2009). A previous Cochrane Reviewconcluded that existing data does not provide convincing evidence that any specific technique (aseptic or clean), catheter type (coated or uncoated), method (single use or multiple use), or person (self or other) can be considered as the gold standard in the use of intermittent catheters (Moore 2007) .

Cleaning solutions

There are various cleaning solutions which can be used when replacing catheters, including sterile water, chlorhexidine gluconate and povidone‐iodine. The cleaning procedure may include cleaning the perineal area as well as the periurethral area. Catheters may also be cleaned instead of replaced. Washout policies for catheters have been evaluated by a previous Cochrane review (Hagen 2010). The review indicated that "the evidence was too scanty to conclude whether or not washouts were beneficial".

Lubricants

Lubricants are commonly used in most types of urethral catheterisation to allow for easier insertion and patient comfort and typically contain local anaesthetic and antiseptic. The administration of lubricants can be incorporated into either a clean or an aseptic catheterisation technique.

Other catheter reviews

This review is one of a series of Cochrane Reviews addressing different issues in the use of catheters for long‐term management of catheter users for a variety of conditions. These include:

Washout policies in long‐term indwelling urinary catheterisation in adults (Hagen 2010)
Types of indwelling urinary catheters for long‐term bladder drainage in adults (Jahn 2007)
Long‐term bladder management by intermittent catheterisation in adults and children (Moore 2007)
Urinary catheter policies for long‐term bladder drainage (Niël‐Weise 2005).

Why it is important to do this review

Long‐term indwelling urinary catheters are used commonly in health care. Guidelines and protocols exist worldwide but are not supported by extensive or high‐quality evidence. It is important that policies for replacing long‐term indwelling urinary catheters are updated based on all of the existing high‐quality evidence. There is an immediate need to improve the rates of adverse effects and optimise patient quality of life, patient and carer satisfaction and resource management associated with long‐term catheter use. The review will also identify the specific needs for future research in this area.

Objectives

To determine the effectiveness of different policies for replacing long‐term indwelling urinary catheters in adults.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs) or quasi‐RCTs.

Types of participants

Adults (over the age of 18 years) with long‐term (> 14 days) indwelling urinary or suprapubic catheters that are anticipated to require replacement.

Types of interventions

The following types of interventions were compared with each other:

One interval versus another interval between catheter replacement
Antibiotic prophylaxis versus no prophylaxis at the time of catheter replacement
Replacing catheter versus other policy e.g. washouts
Replacing in home environment versus clinical environment
Clean versus aseptic technique for replacing catheter
Cleaning solution A versus cleaning solution B
Lubricant A versus lubricant B or no lubricant
Catheter users versus carer versus health professional performing the catheter replacement procedure

This review did not include: type/material of catheter (Jahn 2007), washout versus no washout in long‐term indwelling urinary catheters (Hagen 2010), long‐term antibiotics (Niël‐Weise 2005), and the use of intermittent catheters (Moore 2004), as these areas have been addressed in other Cochrane Reviews.

Types of outcome measures

Primary outcomes

Participant satisfaction
Symptomatic catheter‐associated urinary tract infection (CAUTI) as defined by trialists

Secondary outcomes

Participant‐reported quality of life

Generic quality‐of‐life measures
Condition‐specific quality‐of‐life measures
Psychological outcome measures

Clinician‐reported outcomes

Clinician satisfaction
Number of participants requiring more frequent replacements (than per protocol)
Duration of use of single catheter

Carer‐reported outcomes

Carer satisfaction

Adverse effects

Urinary tract trauma
Pain/discomfort
Haematuria
Asymptomatic bacteruria
Systemic infection (septicaemia)
Encrustation/breakdown of catheter
Pericatheter leakage
Stricture formation
Failure to achieve catheter replacement
Hospitalisation
Bladder calculi
Bladder cancer

Economic outcomes

Cost of intervention
Resource implications
Formal economic analysis (cost effectiveness)

Other outcomes

Any other outcomes considered to be important if reported in trials.

Search methods for identification of studies

We did not impose any restrictions, for example language or publication status, on the searches described below.

Electronic searches

This review drew on the search strategy developed for Cochrane Incontinence. We identified relevant trials from the Cochrane Incontinence Specialised Trials Register. For more details of the search methods used to build the Specialised Register please see the Group's module in The Cochrane Library. The Register contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP , UK Clinical Research Network Portfolio and handsearching of journals and conference proceedings. Many of the trials in the Cochrane Incontinence Specialised Register are also contained in CENTRAL. The date of the last search was 19 May 2016.

The terms used to search the Cochrane Incontinence Specialised Register are given in Appendix 1.

Searching other resources

We searched the reference lists of relevant articles.

Data collection and analysis

Selection of studies

We included only randomised and quasi‐randomised controlled trials. At least two review authors independently screened the list of titles and abstracts generated by our search. We retrieved full‐text articles of potentially relevant studies. At least two review authors independently assessed the full‐text articles for eligibility. We contacted study investigators for additional information when required. We resolved any differences of opinion by discussion or involvement of a third party. We listed studies formally considered for the review that were subsequently excluded along with the reasons for their exclusion.

Data extraction and management

Two of the review authors independently extracted data of the included studies by using a standardised form. Any disagreement was resolved by discussion or by consulting a third party. We contacted study authors when there was insufficient information regarding the primary outcome in the published reports or when additional information was required. We used Review Manager software (RevMan 5.3) for data entry. We processed the included trial data according to the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Assessment of risk of bias in included studies

We assessed the risk of bias in the included studies using the Cochrane 'Risk of bias' assessment tool (Higgins 2011). This included assessment of:

sequence generation
allocation concealment
blinding of participants or therapists
blinding of outcome assessors
completeness of outcome data
selective outcome reporting
other potential sources of bias

Two of the review authors independently assessed these domains and rated each as ‘high risk’, ‘low risk’ or ‘unclear risk’. We resolved any differences of opinion by consensus or by consulting a third party.

Measures of treatment effect

We based analysis on available data from all included trials relevant to the comparisons and outcomes of interest. For trials with multiple publications, only the most up‐to‐date or complete data for each outcome were included.

For categorical outcomes we related the numbers reporting an outcome to the numbers at risk in each group to calculate a risk ratio (RR) with 95% confidence interval (CI). For continuous variables we planned to use means and standard deviations to calculate a mean difference (MD) with 95% CI; however no continuous variables were encountered.

If we had found similar outcomes reported on different scales, we would have calculated the standardised mean difference (SMD). We would have reversed the direction of effect, when necessary, to ensure consistency across trials. If data to calculate RRs or MDs were not given, we would have utilised the most detailed numerical data available to calculate the actual numbers or means and standard deviations (for example test statistics, P values).

Unit of analysis issues

In simple parallel group designs, when participants are individually randomised, the primary analysis was per participant randomised. We analysed studies with multiple treatment groups by treating each pair of arms as a separate comparison, as appropriate. We planned to undertake analysis of studies with non‐standard designs, such as cross‐over trials and cluster‐randomised trials, as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011); however no such trials were included.

Dealing with missing data

We analysed data on an intention‐to‐treat basis, as far as possible, meaning that all participants were analysed in the groups to which they are randomised. We made attempts to obtain missing data from the original trialists. Where this was not possible, we reported the data as given in the studies.

If trials had reported sufficient detail to calculate MDs but gave no information on associated standard deviations (SD), we would have assumed the outcome had an SD equal to the highest SD from other trials within the same analysis. We did not need to do this as meta‐analysis was not performed.

Assessment of heterogeneity

We did not perform any assessment of heterogeneity as none of the pre‐specified comparisons were addressed by more than one trial. We had intended to combine trials only if they were thought to be clinically similar. We would have assessed heterogeneity between studies by visual inspection of the plots of data, the Chi² test for heterogeneity and the I²statistic (Higgins 2011). We would have defined the thresholds for interpretation of the I² statistic according to the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Assessment of reporting biases

In view of the difficulty of detecting and correcting for publication bias and other reporting biases, we aimed to minimise their potential impact by ensuring a comprehensive search for eligible studies and by being alert to duplication of data. We encountered no duplication of data as no comparison was investigated by more than one trial.

Data synthesis

We intended to combine trials if interventions were similar, based on clinical criteria; however we did not find more than one study addressing any pre‐specified comparison. We would have conducted a meta‐analysis with a fixed‐effect model to combine trial data unless there had been evidence of heterogeneity across studies.

Subgroup analysis and investigation of heterogeneity

We intended to perform sub‐group analysis in order to explore the impact of these sub‐groups on the interventions. We selected the following sub‐groups:

1. Different catheter materials

Catheter material is a key determinant of encrustation (and presumably blockage) and this is directly linked to the interval between replacements. Antimicrobial impregnation of the catheter or use of special low‐friction catheters could impact the need for antibiotic prophylaxis or a lubricant.

2. Participants over 75 versus participants under 75

Elderly people have unique anatomical and functional changes, both local and systemic. Elderly individuals are more likely to have voiding dysfunction, altered lower urinary tract anatomy, co‐morbidities, impaired immune function and poor local hygiene. These could have an impact on antimicrobial policy, health‐care setting for catheter change or use of an aseptic technique. The authors have chosen 75 years as a marker for the age at which these issues would likely be most relevant.

3. Sex: male versus female

Sex of the individual can influence the interventions under study. The unique anatomy of the female perineum makes women more prone to urinary infections but also renders catheter change technically easy. Men with gross prostatic enlargement could pose technical problems in catheter change demanding greater skill and a hospital setting.

4. Level of care: community/self‐care versus residential/assisted living

The level of care such as community care, self care or an assisted facility could potentially have an impact on the policies chosen with regard to catheter change in people requiring long‐term urinary catheters.

5. Condition requiring catheterisation

Non‐neurological versus neurological reason for indwelling catheter

The underlying condition could have an impact on the chosen policy. For example catheter change in people with neurogenic lower urinary tract dysfunction could be associated with distinct challenges. People with neurogenic bladder on long‐term indwelling catheters are usually clinically advised to receive intermittent catheterisation. Many of these people have poor hand function, quadriplegia or impaired cognition and these factors are more likely to be associated with poor local hygiene, impaired nutrition and immunity. Some people with neurogenic dysfunction might have elevated bladder pressures in the form of severe neurogenic detrusor overactivity or poor compliance with consequent risk to the upper urinary tracts. This could conceivably make them more prone to sepsis during urethral manipulations.

People with retention versus those with incontinence

People with incontinence requiring an indwelling catheter are more likely to have cognitive impairment, limited ambulation or neurological disease such as Parkinsonism or stroke; while those with intractable retention are more likely to be suffering from severe cardiovascular or pulmonary disease. All these can influence the interventions under study in unique ways.

However, subgroup analysis could not be performed due to the lack of included trials.

Sensitivity analysis

We intended to conduct sensitivity analyses by including or excluding trials we judged as high risk of bias. We did not conduct sensitivity analyses because meta‐analysis was not performed.

Quality of evidence

Primary and secondary outcomes, as defined above, were classified by the review authors as 'critical', 'important' or 'not important' for decision making from the patients' perspective (Gould 2010; Guyatt 2011a; Guyatt 2011b; Guyatt 2013a; Guyatt 2013b). The GRADE Working Group recommend including up to seven outcomes in a systematic review. In this systematic review, GRADE methodology was adopted for assessing the quality of the evidence for the following outcomes classified as critical:

Symptomatic CAUTI as defined by trialists
Participant satisfaction
Condition‐specific quality‐of‐life measures
Adverse effects (urinary tract trauma)
Adverse effects (death)
Formal economic analysis

Results

Description of studies

Results of the search

We screened a total of 1125 records, identified by the literature search, for this review. From these records, we considered 61 for full text screening, of which we deemed three were suitable for inclusion in this review (Cheung 2008; Firestein 2001; Priefer 1982). The flow of literature through the assessment process is shown in the PRISMA flowchart (Figure 1).

Figure 1

PRISMA study flow diagram

Included studies

Cheung 2008 randomised 20 subjects (6 males, 14 females) in a Hong Kong community nursing service to either sterile water or conventional 0.05% chlorhexidine gluconate for periurethral cleansing prior to insertion of a replacement of long‐term urinary catheter. Subjects were excluded if they had a symptomatic UTI at the time of the replacement, were on antibiotic treatment or if they had only been using a long‐term catheter for less than one month. The mean age of the subjects was 78.4 (SD = 11.8) years, and 55% lived in a nursing home. Urine cultures were taken from participants at baseline and then 1, 7 and 14 days after catheter replacement. Reported outcomes were colonisation counts greater than 10⁵ cfu/mL and incidence of symptomatic CAUTIs.

Firestein 2001 randomised 70 subjects (21 males, 49 females) in a geriatric centre in Israel to receive either 1 g of intravenous meropenem 30 minutes before long‐term catheter replacement or no antibiotic before replacement. Subjects were excluded if their urinary catheter had been in place for less than 4 weeks or if there had been antibiotic use within the 2‐week period before enrolment. The mean age of the subjects was 79.3 (SD = 9.6) years. Urine cultures were taken from participants at baseline and then 3, 7, 14 and 28 days after catheter replacement. Reported outcomes were positive urine cultures, incidence of infection, incidence of bacteraemia and death.

Priefer 1982 randomised 17 men in a USA veterans administration nursing home to catheter replacements either: only for obstruction and/or infection or monthly as well as when indicated by obstruction and/or infection. Subjects who required transfer to a hospital for acute problems unrelated to the urinary tract were excluded. The mean age of subjects was 77.1 (SD = 16.3) years in the control group and 83.4 (SD = 7.9) years in the intervention group. Participants were observed over a six‐month period and the following outcomes were reported: total number of irrigations required; number of catheter changes per month required; incidence of symptomatic CAUTI over the six months.

Excluded studies

We have listed the excluded studies along with reasons for exclusion in the Characteristics of excluded studies table. The most common reason for excluding studies was that the intervention did not relate to replacing long‐term catheters.

Risk of bias in included studies

Detailed results of the 'Risk of bias' assessment are provided in Figure 2; Figure 3 and judgement of individual domains are summarised below.

Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Allocation

Random sequence generation

Cheung 2008 provided details of sequence generation and was judged to be at low risk of bias. We judged the two remaining trials to be unclear (Firestein 2001; Priefer 1982)

Concealment of allocation

Methods of allocation concealment were inadequately described in all three trials and we judged them to be unclear (Cheung 2008; Firestein 2001; Priefer 1982)

Blinding

Blinding of participants and personnel in two studies are not described and are assumed to be impossible due to the nature of the interventions (Firestein 2001; Priefer 1982).

Blinding participants in one study to their method of periurethral cleansing would be possible, but is not described and therefore assumed not to occur (Cheung 2008). Additionally, this study provides no information on blinding of personnel. We assumed the outcomes in these studies were reported by the same unblinded personnel administering the intervention and they are therefore also classed as high risk.

Microbiological outcomes for the three studies are classed as low risk, as we assumed microbiologists analysing urine cultures to be blind to participants.

Incomplete outcome data

We judged two studies to be at low risk of bias (Cheung 2008; Priefer 1982). We judged Firestein 2001 to be at high risk of bias for this domain.

Selective reporting

All three trials reported all outcomes intended to be investigated by the trial and have been classed as low risk. Priefer 1982 does not report microbiological outcome, but this was not possible as urine cultures were not taken during this trial. Firestein 2001 reports incidence of CAUTI in the two groups, but not number of CAUTIs per subject over the time period.

Other potential sources of bias

We classed two studies as high risk for other areas of bias. In one study, the participants were all male (Priefer 1982). This was unavoidable due to the nature of the study setting and this could have an impact on the outcome and therefore it was judged to be high risk. There is also a wide age range in participants. In the other study, there is a calculation error, inconsistent data and a positive urine culture is not defined (Firestein 2001). We tried to contact the author but did not receive any response.

Effects of interventions

See: Summary of findings for the main comparison Monthly & PRN catheter replacement versus PRN catheter replacement for replacing long‐term indwelling urinary catheters in adults; Summary of findings 2 Antibiotics at time of replacement versus no antibiotics at time of replacement for replacing long‐term indwelling urinary catheters in adults; Summary of findings 3 Sterile water versus 0.05% chlorohexidine gluconate for periurethral cleansing during replacement for replacing long‐term indwelling urinary catheters in adults

1. One interval versus another interval between catheter replacement

One small trial found that replacing the catheter monthly as well as when clinically indicated resulted in fewer symptomatic CAUTIs than replacing the catheter monthly (RR 0.35, 95% CI 0.13 to 0.95; very low quality evidence; Analysis 1.1) (Priefer 1982). However, when expressed as number of symptomatic CAUTIs per subject over the six months, there was no significant difference between the two interventions. Participants in the 'monthly as well as clinically indicated' group required more catheter replacements but fewer irrigations than those in the clinically indicated group. However, the trial was too small (hence under‐powered) to be reliable.

2. Antibiotic prophylaxis versus no prophylaxis at the time of catheter replacement

One small trial found that there was no statistically significant difference in incidence of positive urine culture between giving 1 g of intravenous meropenem 30 minutes before catheter replacement and no antibiotic: (i) 3 days after replacement (RR 0.95, 95% CI 0.80 to 1.13); (ii) 7 days after replacement (RR 0.91, 95% CI 0.79 to 1.04); (iii) 14 days after replacement (RR 0.94, 95% CI 0.85 to 1.04); or (iv) 28 days after replacement (RR 0.94, 95% CI 0.84 to 1.05; Analysis 2.1) (Firestein 2001). Additionally, there was no statistically significant difference in incidence of infection including urosepsis, soft tissue, pneumonia and unknown infection (RR 1.41, 95% CI 0.55 to 3.65; Analysis 2.2); bacteraemia (Analysis 2.3); or death (RR 2.12, 95% CI 0.20 to 22.30; very low quality evidence; Analysis 2.4) between the two groups. However, the trial was too small (hence under‐powered) to be reliable.