Políticas de uso de sondas para el tratamiento de problemas de evacuación a largo plazo en pacientes adultos con trastornos por vejiga neurogénica
Resumen
Antecedentes
El tratamiento de la vejiga neurogénica tiene como objetivos primarios mantener la continencia, asegurar una presión vesical baja (para evitar el daño renal) y evitar o minimizar la infección. Las opciones incluyen sonda uretral intermitente, sonda uretral o suprapúbica permanente, evacuación cronometrada, uso de sonda externa (para los hombres), tratamiento farmacológico, cistoplastia de aumento y desviación urinaria.
Objetivos
El objetivo primario fue determinar los efectos de diferentes métodos de tratamiento de los problemas de evacuación a largo plazo (que se prolongan después de tres meses) con sondas en pacientes con vejiga neurogénica.
Las hipótesis específicas para considerar incluyeron:
1. que la sonda intermitente es mejor que la sonda permanente;
2. que la sonda uretral permanente es mejor que la sonda suprapúbica;
3. que las sondas externas (vainas) son mejores que las sondas uretrales permanentes o intermitentes;
4. que las sondas externas (vainas) son mejores que las sondas suprapúbicas;
5. que la sonda intermitente es mejor que la evacuación cronometrada.
Métodos de búsqueda
Se hicieron búsquedas en el registro especializado del Grupo Cochrane de Incontinencia (Cochrane Incontinence Group) (búsqueda 3 julio 2013), que contiene ensayos identificados del Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials) (CENTRAL), MEDLINE y MEDLINE in process, y se hicieron búsquedas manuales en revistas y actas de congresos. Se realizaron búsquedas de ensayos adicionales de otras fuentes como las listas de referencias de los artículos relevantes y mediante el contacto con los consultores de los Spinal Cord Injury Centres en todo el Reino Unido.
Criterios de selección
Todos los ensayos controlados aleatorios y cuasialeatorios que compararan métodos de uso de sondas para el tratamiento de los problemas de evacuación urinaria en pacientes con vejiga neurogénica.
Obtención y análisis de los datos
Los resúmenes fueron examinados de forma independiente por los autores de la revisión y se obtuvieron los artículos completos cuando fue necesario.
Resultados principales
Se examinaron aproximadamente 400 estudios. No se encontraron ensayos que cumplieran con los criterios de inclusión y se excluyeron cinco estudios de la revisión.
Conclusiones de los autores
A pesar de una búsqueda exhaustiva, no se encontraron pruebas de ensayos controlados aleatorios o cuasialeatorios. No fue posible establecer conclusiones con respecto al uso de diferentes tipos de sonda para el tratamiento de la vejiga neurogénica.
Resumen en términos sencillos
Políticas de uso de sondas para el tratamiento de los problemas de evacuación a largo plazo en adultos con daño nervioso que afecta la vejiga
Los pacientes con daño nervioso que afecta la vejiga pueden presentar incontinencia (pérdida de orina) o incapacidad para vaciar la vejiga (problemas de evacuación). Esto puede causar infecciones o daños en los riñones. Los tratamientos incluyen el uso de una sonda urinaria permanente; el uso intermitente de una sonda cuando necesita realizarse el vaciamiento de la vejiga; una sonda externa con vaina colocada en el pene; o evacuación cronometrada, que incluye el vaciamiento regular de la vejiga a intervalos cronometrados. Aunque todos estos métodos se utilizan en la práctica, la revisión halló que no se han realizado ensayos aleatorios para aportar pruebas convincentes y sugerir cuál es el mejor método y en qué circunstancias.
Authors' conclusions
Background
Neurogenic bladder comprises any dysfunctional condition of the urinary bladder caused by a spinal cord injury (SCI) or other lesion or disease of the central nervous system (CNS). The prevalence of the condition is unknown, but the estimated annual incidence of acute SCI is 40 per million population (Bracken 1981). Multiple sclerosis is a common neurological disease. A joint World Health Organization (WHO)/Multiple Sclerosis International Federation (MSIF) survey, conducted during 2005 to 2007, estimated a worldwide median prevalence of 30 per 100 000 (range 5‐80) (WHO 2008).
SCI primarily affects young males, whereas young women are more likely to develop multiple sclerosis (female : male sex ratio 1 : 4 and 2.5 : 1, respectively). The permanent paralysis that often results leads to major disability and significant economic cost (Berkowitz 1992). Life expectancy may be reduced, particularly in the absence of optimal medical care. As well as respiratory and cardiovascular problems, and pressure sores, long‐term consequences of damage to the CNS include urinary tract complications (loss of bladder control leading to infections and impaired renal function). Even in developed countries where those affected have access to advanced treatment and management options, social problems can arise from difficulties in maintaining bladder function.
The effects of SCI on bladder function depend on the location of the injury on the spinal cord. Two types of bladder dysfunction may occur, automatic (hyperreflexic) bladder and flaccid (areflexic) bladder.
Automatic (hyperreflexic) bladder (detrusor overactivity)
When injury occurs above the reflex voiding centre in the sacral portion of the spinal cord (effectively at T12 or above), hyperreflexic paralysis of the bladder (also known as 'automatic bladder') usually results. The person loses both the sensation that they need to void and their voluntary, co‐ordinated control over the reflex voiding centre. When the bladder becomes sufficiently full for the stretch receptors in the detrusor muscle to be activated, uncontrolled, spontaneous bladder contraction is stimulated through the simple reflex arcs. The automatic bladder often does not empty efficiently. Spasm of the bladder outlet muscle (sphincter) can prevent the complete expulsion of urine, resulting in bladder overextension. Detrusor sphincter dyssynergia (DSD) is a combination of detrusor hyperreflexia and sphincteric hypertonicity. While the latter can be alleviated by sphincterotomy (an operation to cut the external sphincter of the bladder outlet), this can increase the risk of incontinence and compromise sexual function in males.
Flaccid (areflexic) bladder (acontractile detrusor)
Areflexic or flaccid paralysis of the bladder is usually caused by a lower motor neurone lumbosacral lesion, with damage to the reflex voiding centre in the sacral portion of the spinal cord. Reflex activity and bladder activity are diminished and overdistension of the bladder usually results.
Management of the neurogenic bladder
Problems arising from detrusor and/or sphincter dysfunction in addition to urinary incontinence can include recurrent kidney infections and high back pressure on the kidneys. Ultimately, both of these can lead to serious renal disease.
Management of the neurogenic bladder, therefore, has the primary objectives of maintaining continence, ensuring low bladder pressure (to avoid renal damage) and avoiding or minimising infection. Management options include intermittent urethral catheterisation, indwelling urethral or suprapubic catheterisation, timed voiding, use of an external catheter (for men), augmentation cystoplasty and urinary diversion. A number of pharmacological interventions including anticholinergic drugs are also used (Vickrey 1999), particularly in people with multiple sclerosis. The type, site and extent of neurological impairment, and the type of help available, will clearly influence the choice of management option.
Some of the above options have already been or are the subject of other Cochrane reviews (Brosnahan 2004; Niel‐Weise 2003a; Niel‐Weise 2003b; Yong 2003). The current review was therefore confined to the use of urinary catheters and external (sheath) catheters by people with neurogenic bladder dysfunction.
The aim of our review was to compare the effectiveness of these different management options for the neurogenic bladder in terms of urinary function (in both the short and long term), but taking account of other factors such as ease of use, comfort and cost, which may influence choice of catheter policy. Provided that a sufficient number of trials of adequate quality has been conducted, the most reliable evidence is likely to come from the consideration of all well‐designed randomised controlled trials.
We hoped that providing an easily accessible, periodically updated, comprehensive systematic review of such trials would help not only to identify optimal practice, but to also highlight gaps in the evidence base.
Objectives
The primary objective was to determine the effects of different methods of managing long‐term voiding problems (persisting after three months) with catheters in patients with neurogenic bladder.
Specific hypotheses to be addressed included:
1. that intermittent catheterisation is better than indwelling catheterisation;
2. that indwelling urethral catheterisation is better than suprapubic catheterisation;
3. that external (sheath) catheters are better than indwelling or intermittent urethral catheters;
4. that external (sheath) catheters are better than suprapubic catheters;
5. that intermittent catheterisation is better than timed voiding.
Methods
Criteria for considering studies for this review
Types of studies
All randomised and quasi‐randomised controlled trials comparing methods of using catheters to manage urinary voiding in people with neurogenic bladder.
Types of participants
Adults in hospitals, nursing homes and the community with neurogenic bladder persisting after three months for whom catheters are an option for long‐term management, whether or not they have had surgery or another invasive procedure.
Types of interventions
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Indwelling urethral catheter
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Intermittent urethral catheter
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Indwelling suprapubic catheter
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Intermittent suprapubic catheter
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Timed voiding
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External (sheath) catheter
Types of outcome measures
The primary outcomes were episodes of urinary incontinence, urinary retention, urinary tract infection and long‐term renal function. Other outcomes were as follows.
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Subjective/objective factors
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Patient comfort
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Patient satisfaction
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Ease of use for patient
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Ease of use for carer
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Sexual function
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Incontinence/bypass leakage
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Need to use supplementary pads/bed pads
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Ease of use for practitioner
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Need to change catheter/sheath
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Number of catheters/sheaths used
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Length of time each catheter/sheath used
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Compliance
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Quality of life
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Generic QoL measures (eg MOS 36‐item Short Form Health Survey (Ware 1992))
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Psychological outcome measures (eg Hospital Anxiety and Depression Scale (Zigmond 1983))
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Complications/adverse effects
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Asymptomatic bacteriuria
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Symptomatic urinary tract infections
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Use of prophylactic antibiotics
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Use of rescue antibiotics
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Urethral strictures
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Bladder or kidney stones
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Urgency/bladder spasms/detrusor overactivity
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Creation of false passages in urethra
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Trauma to skin or urethra
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Other (other than urinary tract infection)
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Economic outcomes
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Costs of intervention(s)
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Resource implications of differences in outcomes
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Formal economic analysis (cost effectiveness, cost utility)
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Other outcomes
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Non‐prespecified outcomes judged important when performing the review
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Search methods for identification of studies
We imposed no language or other limits on the searches.
Electronic searches
This review has drawn on the search strategy developed for the Cochrane Incontinence Group. Relevant trials were identified from the Group's Specialised Register of controlled trials, which is described, along with the search strategy, under the Incontinence 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, CINAHL and the handsearching of journals and conference proceedings. The Cochrane Incontinence Group's trials register was searched using the Group's own keyword system. The search terms used were:
({design.cct*} OR {design.rct*})
AND
({intvent.mech.cath*} OR {intvent.mech.device*} OR {intvent.mech.sheaths.} OR {intvent.prevent.antibiotics*} OR {intvent.prevent.antifect.*} OR {intvent.prevent.antiinfect.periurethralcare.} OR {intvent.prevent.AntiInfect.UrethralMeatusCare.} OR {intvent.prevent.antiInfection.} OR {intvent.prevent.cath.stricture.} OR {intvent.prevent.cleaning fluids*})
(All searches were of the keyword field of Reference Manager 12, Thomson Reuters).
The date of the most recent search of the Register for this review: 3 July 2013.
The trials in the Cochrane Incontinence Group Specialised Register are also partially contained in CENTRAL.
Searching other resources
For this review, extra, specific searches were performed. These are detailed below.
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The reference lists of relevant articles were searched for other possible relevant trials.
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Consultants in Spinal Cord Injury Centres throughout the United Kingdom were contacted to ask for information about other possible relevant trials, published or unpublished.
In addition, it was intended that the files of the National Acute Spinal Cord Injury Study (NASCIS) in the USA would be searched for trials, along with any neurology‐related abstracts presented at urology conferences (eg AUA, EAU, ICS). In the event, we discovered that the NASCIS covers only research into the treatment of spinal cord injury per se. We were advised by experts in the field that searching the neurological abstracts was therefore unlikely to uncover trials fulfilling our inclusion criteria.
Data collection and analysis
The lead reviewer (JJ) and one of the coreviewers (JMcC) independently assessed all titles and abstracts identified by the search. Where there was any possibility that the study might be included, the full paper was obtained.
It was planned that these two reviewers would independently assess each report for inclusion and methodological quality using the Cochrane Incontinence Group's quality assessment tool.
Data were to be extracted by two reviewers and cross‐checked. If the data in trials had not been fully reported, clarification was to be sought directly from the trialists.
It was planned that included trial data would be processed as described in the Cochrane Reviewers' Handbook (Clarke 2003). When appropriate, meta‐analysis was to have been undertaken. For categorical outcomes, we were to relate the numbers reporting an outcome to the numbers at risk in each group to derive a relative risk (RR). For continuous variables, we were to use means and standard deviations to derive a mean difference (MD). A fixed‐effect model was to have been used for calculations of pooled estimates and their 95% confidence intervals. If the data allowed, sensitivity analyses were to have been performed to assess the impact of study quality (eg quality of randomisation at allocation). Analyses of subgroups (eg males/females, different medical diagnostic groups or individuals who had/had not undergone previous surgery or other invasive procedures for bladder outlet obstruction) were also to have been undertaken, if appropriate.
It was planned that trials would be compared to assess and investigate the likelihood of important clinical heterogeneity. This would also take into account the results of the Chi2 test for heterogeneity at the 10% level and the I2 statistic (Higgins 2003). Consideration was to have been given to using a random‐effects model where there were concerns that heterogeneity might be complicating an analysis.
Results
Description of studies
Results of the search
In total, 806 records were assessed for eligibility for this review. The flow of the literature through the assessment process is shown in Figure 1.
PRISMA study flow diagram.
1. Excluded studies
Six studies appeared to fulfil the eligibility criteria and the full‐text articles were retrieved and given particular consideration. However, they failed to meet the inclusion criteria and were excluded (Faure 1980; Grundy 1983; Khan 2010; Piergiovanni 1991; Sethia 1987; Vandoni 1994). Descriptions of these studies with reasons for exclusion are given in the Characteristics of excluded studies table.
2. Studies awaiting assessment
One study (Turi 2006) is awaiting assessment. The details of the study are unclear and the authors have been contacted for further information.
3. Ongoing studies
No ongoing studies were identified.
4. Included studies
No studies meeting the a priori inclusion criteria were identified.
Risk of bias in included studies
No randomised or quasi‐randomised controlled trials were found and therefore no studies were assessed for methodological quality.
Effects of interventions
No randomised or quasi‐randomised controlled trials were found and therefore no analyses were carried out.
Discussion
This review has highlighted a lack of research in the area of catheter policies for people with neurogenic bladder. We found no randomised or quasi‐randomised controlled trials comparing catheter methods for managing voiding problems experienced by such people. There were a number of trials comparing intermittent and urethral catheterisation in patients who had undergone surgery or who were in the acute phase following SCI. There were also trials comparing clean and sterile means of undertaking urethral catheterisation. However, none of these trials provided any evidence in relation to the topic of this review.
We found a systematic review of risk factors for urinary tract infection in adults with spinal cord dysfunction (Shekelle 1999). This review included controlled clinical trials, and cohort and cross‐sectional studies, and included method of drainage as a risk factor. Three controlled clinical trials (including two randomised controlled trials) were found relating to method of drainage. However, these were comparisons of types of intermittent catheter or of clean versus sterile catheterisation.
The Shekelle 1999 review found eight prospective cohort studies comparing catheter policies in adults with spinal cord dysfunction (eg bladder retraining versus intermittent catheterisation, indwelling versus intermittent catheterisation, use of condom catheter versus intermittent catheterisation). The review noted that seven of these studies found that persons using intermittent catheterisation had fewer urinary tract infections than those with indwelling catheters. However, none of these studies had adjusted for differences in baseline characteristics.
We found a small number of trials comparing surgical and other invasive interventions (eg sphincterotomy) for DSD in people with neurogenic bladder. The choice of drainage method in such people is heavily dependent on whether any previous intervention has been undertaken, and this indicates that a systematic review of evidence relating to these interventions and associated catheter use should be carried out.
PRISMA study flow diagram.
