Prevention and treatment of urinary incontinence after stroke in adults
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The objective of this review is to determine the optimal methods for promoting urinary continence after stroke in adults.
The following hypotheses will be tested:
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intervention is more effective than no intervention;
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intervention is more effective than placebo;
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a specific intervention is more effective in comparison with another intervention;
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combined interventions are more effective than single interventions.
Background
Up to two thirds of people admitted to hospital after a stroke can have problems with urinary incontinence. A quarter of stroke survivors still have problems on hospital discharge, with around 15% remaining incontinent after one year (Barrett 2001).
The more severe the stroke, the greater is the likelihood of urinary incontinence (Burney 1996a). Other risk factors include older age, female sex, speech difficulties, motor weakness, visual field defects or cognitive impairment (Barrett 2001). The problems experienced may range from urinary retention to complete incontinence. The most likely pattern of incontinence is urinary frequency, urgency and urge incontinence (Marinkovic 2001), generally the result of neurogenic detrusor overactivity (Arunabh 1993), although these depend on the site of the stroke lesion (Burney 1996b).
The symptoms of urinary incontinence are reported to have more of an effect on the lives of stroke survivors, because of their severity (Brittain 2000) when compared with other types of people with incontinence. Incontinence is not just a physical problem, but impacts on what people can do and how they feel. It is distressing for both those affected and their carers (Williams 1993), with depression being twice as common in stroke survivors who are incontinent (Brittain 1998). Continuing incontinence is associated with poor outcome in both stroke survivor and carer (Nakayama 1997), and conversely, stroke outcome is better in those survivors who remain continent or regain continence (Barer 1989). Factors predicting early improvements in continence status are less impairment on admission, and the site of the stroke lesion (Ween 1996). Factors associated with poor recovery of continence include stroke type and being aged 75 or over (Patel 2001). However, improvement is common over time (Marinkovic 2001), which suggests that problems with continence may be transient in some stroke survivors, and/or amenable to intervention.
Incontinence is a strong predictor of stroke functional outcome (Meijer 2003). While there are problems with attributing better stroke outcome to improvements in continence, it is possible that recovery from incontinence may improve morale and self‐esteem and thereby speed overall stroke recovery (Patel 2001). While differences in incontinence rates between centres will reflect differences in the the mix of patients and the methods of reporting (Barrett 2001), they might also indicate variations in continence assessment and management.
It is known that early intervention in stroke results in better outcome overall (Cifu 1999). Some of the studies on which this conclusion is based have included incontinence as a measure of functional outcome. For example, a trial of a multidisciplinary rehabilitation intervention aiming to improve functional independence after stroke showed a positive impact on incontinence rates (Wikander 1998). Methods of promoting continence in people who have not had a stroke might also be useful after stroke (Brittain 1999). Recent systematic reviews indicate that bladder training may be helpful for urge incontinence (Roe 2003), with possible short term benefit from prompted voiding (Eustice 2003). Other incontinence management techniques include biofeedback, pelvic floor muscle training, electrical stimulation, drug treatments, surgical interventions and mechanical devices.
Current guidelines for the management of urinary incontinence recommend an assessment to guide management (Thuroff 1999). This begins with physical assessment and history‐taking including identification of urological problems before the stroke occurred, such as bladder outlet obstruction in men or stress incontinence in women. The choice of method to promote continence will then depend on the individual patient's history and type of incontinence. Bladder training and/or anticholinergic drugs may be appropriate for urge incontinence, while problems with retention may require intermittent clean bladder catheterisation. Alternatively, incontinence associated with memory loss or restriction of movement may benefit more from toileting assistance programmes, such as prompted (Eustice 2003) or timed voiding or habit retraining (Ostaszkiewicz 2003).
Other interventions which appear to be potentially beneficial for stroke patients, based on non‐randomised studies include transurethral resection of the prostate (Moisey 1978; Lum 1982; Natsume 1992; Shiomi 1992), biofeedback (Middaugh 1989), a combination of drug therapy, bladder training and/or surgical intervention (Gotoh 1992; Gelber 1997), and a behavioural management programme (Owen 1995). The conclusions that can be drawn from these studies are limited by their research designs and sample sizes.
A systematic review of methodologically more robust studies ‐ randomised controlled trials ‐ is needed to identify interventions to promote continence that are effective in the stroke population. Trials which have evaluated different management strategies also need to be reviewed in relation to sub‐groups of stroke patients with specific patterns of incontinence because the effects of management are likely to depend on the type of stroke that a person has suffered and the urinary problems they experienced.
Objectives
The objective of this review is to determine the optimal methods for promoting urinary continence after stroke in adults.
The following hypotheses will be tested:
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intervention is more effective than no intervention;
-
intervention is more effective than placebo;
-
a specific intervention is more effective in comparison with another intervention;
-
combined interventions are more effective than single interventions.
Methods
Criteria for considering studies for this review
Types of studies
All randomised and quasi‐randomised controlled trials evaluating the effects of interventions designed to promote continence in people who have had a stroke.
Types of participants
Adults (i.e. 18 years of age and over) with a diagnosis of stroke within the previous 12 months, including people who have had a stroke identified as a sub‐group within a larger group for whom relevant outcome data are reported.
Types of interventions
One arm of the study must use an intervention designed to promote urinary continence. Trials evaluating any of the following will be included in the review:
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drugs e.g. anticholinergics, adrenergics, antibiotics;
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physical therapy e.g. pelvic floor muscle training, electrical stimulation, biofeedback;
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physical aids e.g. catheters, pads, pessaries, other appliances;
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behavioural interventions e.g. prompted or scheduled voiding, bladder training, habit retraining (i.e. identification of voiding pattern and development of an individualised toileting schedule), or other behavioural management programmes;
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environmental or lifestyle interventions e.g. voiding position, diet and fluid management, alternative communication devices;
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specialised professional input interventions e.g. provision of information or education, assessment schedules, generic multidisciplinary rehabilitation programmes, Continence Advisors, home‐support programmes, nurse practitioners;
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complementary interventions e.g. homeopathy, acupuncture.
Trials relating solely to surgical or physical interventions for pre‐existing continence problems that are not associated with stroke (e.g. transurethral resection of the prostate, pelvic floor muscle training) will not be included, unless it is a co‐intervention in a wider trial testing an included method of continence promotion. Trials relating to urological diagnosis, or to the management of incontinence or retention of urine in the acute phase of stroke (i.e. under one month post stroke) will not be considered in this review.
Types of outcome measures
To be included, the trial has to report an outcome measure reflecting the presence or degree of continence after stroke. The primary outcome of interest is therefore incontinence/continence, measured by:
1. Patient symptoms
Number of patients regaining continence
Number of incontinent episodes over 24 hours (indicated from bladder charts, total number of episodes and mean)
Severity of incontinence e.g. index score
Perception of improvement or cure (as reported by patient or caregiver)
2. Physical measures
Pad tests of quantified leakage (volume of urine loss, self‐reported number of pads used, total number and mean)
Data will also be collected on secondary outcomes which may include:
Patient or carer report of other urinary symptoms including frequency, urgency, dysuria, polyuria, nocturia, discomfort, pain
Physical measures of post‐void retention of urine, time to voiding onset, void volume
3. Health status or measures of psychological health
Impact of incontinence e.g. Incontinence Impact Questionnaire, functional ability, knowledge, satisfaction, quality of life.
4. Economic outcomes
Impact of continence promotion interventions on cost or service use.
5. Other outcomes
Any other outcomes subsequently deemed appropriate to the review.
Search methods for identification of studies
The review will initially draw on a combination of the search strategies developed for the Cochrane Incontinence and Stroke Groups. Trials identified in this way will be found in the specialised registers held by the two review groups. The registers are described, including the search strategies under both Group's details in The Cochrane Library. For this review, unpublished trial data will be searched for on additional national and international databases: CRISP (Computer Retrieval of Information on Scientific Projects) (USA), UK National Research Register, ReFeR (The Department of Health Research Findings electronic Register) (UK) and in journals and conference proceedings not already being searched by the Cochrane Collaboration. This will be done by adapting terms drawn from the existing search strategies of the Incontinence and Stroke Review Groups developed for other databases. The citations of all relevant reviews and trial reports will be searched to identify further relevant studies. Major researchers in the field will be contacted to ascertain details of further unpublished studies. In addition, contact will be made with the authors of other relevant Cochrane reviews and Cochrane Review Groups to ascertain whether defined sub‐groups of stroke patients are identified in trials testing methods of promoting continence in a general population. No language or other restrictions will be imposed on these searches.
Contact with the pharmaceutical companies will be made. Because the nursing and allied health literature is not as well indexed or searched as the medical literature, the review will be publicised on appropriate websites e.g. Notice Board of Joanna Briggs Institute, Pedro, RCN Research Society, RCN Continence Interest Group, Association of Continence Advisors, Sigma Theta Tau, etc. The advice of the Trials Search Coordinators will be sought regarding searching and translation of the Asian and South American literature.
Data collection and analysis
The identified references, with abstracts where available, will be assessed against the inclusion criteria independently by two reviewers and the full text obtained for potentially relevant studies. If assessment using the title and abstract is inconclusive the full text will be obtained for further assessment. Studies formally considered will be listed, with reasons for exclusion given. Data extraction and review of the methodological quality of the eligible studies will be independently performed by two reviewers using the quality assessment tool described by the Incontinence Group.
Data extraction forms will be piloted using a representative sample of studies and inter‐rater reliability will be checked for the recording of outcome data and the coding of quality assessment. Extracted data will be cross checked and any disagreements will be discussed and if necessary resolved by a third person. If data are missing or where data may have been collected but not reported, attempts will be made to contact the authors. The permission of the principal investigator would be sought for inclusion of any unpublished data.
Subgroup analyses for the effect of urological diagnosis (e.g. detrusor overactivity versus other) and time from stroke onset (1‐6months, >7months) will be considered, dependent on the availability of data in the original studies.
Outcomes will be presented for unfavourable events and where appropriate data will be combined quantitatively using the Cochrane statistical package MetaView. The studies will first be assessed for clinical heterogeneity by considering the populations, interventions, outcomes and settings. If synthesis is inappropriate, a narrative overview will be undertaken by reporting the processes and outcomes as they were reported in the original papers, and by classification and comparison of the variability of outcome according to client group, type of intervention, context and study quality. Otherwise, synthesis will use a fixed effect model. We shall report relative risks (RR) for dichotomous data and weighted mean differences (WMD) for continuous data, accompanied by 95% confidence intervals (CI). Evidence for statistical heterogeneity will be assessed using the chi squared test and if heterogeneity is suspected (at 10%), a random effects model may be used for combining data and the sensitivity of the results to the choice of model will be discussed.
The sensitivity of the conclusions to missing data will also be considered by reanalysing the data, imputing a reasonable range of values. Other sensitivity analyses will be applied if deemed appropriate (for example, when there is uncertainty about the impact of: clinical heterogeneity, variable inclusion criteria, varying study quality, and possible effect modifiers, eg. gender, stroke type, stroke severity).
