Grand Rounds

Elliot J. Roth, MD, Editor

Urinary Incontinence After Stroke: Does Rehabilitation Make a Difference? A Systematic Review of the Effectiveness of Behavioral Therapy
Chantale Dumoulin, Nicol Korner-Bitensky, and Cara Tannenbaum
This study uses a comprehensive review of the literature to assess the scientific evidence for the effectiveness of behavioral therapies to treat urinary incontinence (UI) post stroke. Evidence for the different behavioral therapies was critically appraised to achieve a level of evidence based on Foleys classification of levels of evidence. Only four randomized clinical trials (RCTs), one cohort study, and recommendations from three clinical practice guidelines were found. There is limited evidence that bladder retraining with urge suppression in combination with pelvic floor exercises results in reduction of UI in male individuals with stroke. Further research is urgently needed to elucidate clinical recommendations about the efficacy of behavioral approaches. Key words: bladder neurogenic, bladder training, cerebrovascular accident, pelvic floor exercises, polyuria, prompted voiding, timed voiding, urinary incontinence, urinary retention, urination disorder

n often forgotten but serious consequence of stroke is new onset urinary incontinence (UI). The prevalence of UI post stroke ranges from 37% to 79% in the days and weeks immediately following the event.1,2 Upon admission to the rehabilitation facility, 26% to 44% of individuals referred for stroke rehabilitation programs report persistent UI.3 Although the prevalence continues to decrease over time,2,4,5 as many as one third of individuals are still incontinent 1 year post stroke.2,6 UI is a strong predictor of functional recovery. In a population-based cohort study, Taub et al.7 found that incontinence in first-time stroke survivors younger than 75 years was the best single predictor of disability at 3 months, with a sensitivity of 60% and specificity of 78%. Discharge destination post stroke is also related to incontinence.8 Ween and colleagues9 found that only 46% of 145 incontinent individuals with stroke returned home after rehabilitation hospitalization compared to 79% of 278 who were continent. UI has a known association with low self-esteem, social isolation, and depression.10 Medically, UI predisposes individuals to urinary tract infections, nephritis, fungal dermatitis, and an increased risk for falls.311 For

persons requiring rehabilitation therapy, UI affects therapy time, concentration, and participation in treatment.12 Addressing UI post stroke is therefore an integral aspect of the post stroke rehabilitation process. There are multiple etiologies for UI post stroke. Symptoms reflect the underlying cause. UI may result from infarction or cerebral edema affecting central micturition pathways. When frontal lobe damage occurs, symptoms include frequency, urChantale Dumoulin, PT, PhD, is a post-doctoral fellow, School of Physical and Occupational Therapy, McGill University, Center for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), Montreal, Quebec. Nicol Korner-Bitensky, OT, PhD, is Associate Professor, School of Physical and Occupational Therapy, Center for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), McGill University, Montreal, Quebec. Cara Tannenbaum, MD, MSc, is Assistant Professor, Faculty of Medicine, University of Montreal, and Director of the Geriatric Incontinence Clinic at the McGill University Health Centre, Montreal, Quebec.
Top Stroke Rehabil 2005;12(3):6676 2005 Thomas Land Publishers, Inc. www.thomasland.com

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gency, incontinence, and possibly nocturia.13 With strokes affecting the brainstem, individuals commonly experience hesitancy, bladder dyssynergia, and urinary retention due to the inability to achieve simultaneous bladder contraction and urethral sphincter relaxation to empty the bladder in a coordinated and timely fashion.13 Disruption of the neuromicturition pathways has also been shown to result in bladder hyperreflexia and urgency incontinence.14 Alternatively, stress UI with urine leakage may be exacerbated by frequent coughing from dysphagia. Impairments of consciousness or of motor, sensory, cognitive, or language function can also affect toileting, despite normal bladder function.14 The presence of preexisting peripheral neuropathies from diabetes may result in bladder hyporeflexia and overflow incontinence.14 Other important contributing factors include the patients medications (antihypertensives, diuretics)314; the presence of depression,15 constipation, 15 or environmental factors that impede toileting15; or preexisting UI.25 In most cases, a combination of factors contributes to UI post stroke,1 making the treatment more challenging. Management of UI takes many forms including behavioral, pharmacological, surgical, and supportive devices.16 The present systematic review focuses on the behavioral management of UI in individuals who have experienced a stroke. Behavioral management in this group includes timed voiding, prompted voiding, bladder retraining with urge suppression, and pelvic floor muscle exercises. 3 Behavioral techniques are recommended as the first-line treatment for UI in adults by the Agency for Health Care Policy and Research Clinical Practice Guidelines16,17 and by the 2nd International Consultation on Incontinence.18 The objective of this systematic and comprehensive review is to assess the scientific evidence for the effectiveness of various behavioral therapies for the treatment of UI post stroke, specifically, timed voiding, prompted voiding, bladder retraining with urge suppression, and pelvic floor muscle exercises. The following questions were posed using the PICO (Population, Intervention, Control, and Outcome) concept19: In the adult stroke population, is a behavioral

intervention more effective than no intervention or placebo/alternative intervention in the management of UI? In the adult stroke population, is a combination of behavioral interventions more effective than no intervention or placebo/alternative intervention in the management of UI? Research evidence was combined in these different areas to achieve a level of evidence using Foleys levels of evidence.20 These are based on the original Sacketts levels of evidence21 but are modified to account for physiotherapy evidence database (PEDro) scoring. Five levels of evidence were considered: strong, moderate, limited, consensus, and conflicting (Appendix A).20 Method
Systematic review of the literature

A comprehensive review of the English-language medical literature was performed covering the period from January 1966 to July 2004 using the electronic MEDLINE database and covering the period from January 1982 to July 2004 with the CINAHL database to search for articles relating to UI in individuals with stroke. The following key terms were used: urination disorder, bladder neurogenic, and cerebrovascular accident. In a first search, the term urination disorder, which explodes to polyuria, urinary incontinence, and urinary retention, was used together with cerebrovascular accident. In the second search, the term bladder neurogenic was used together with cerebrovascular accident. In addition, a comprehensive review of the English-language literature was performed covering the period from January 1980 to July 2004 using EMBASE with the following key terms: micturition disorder, bladder neurogenic and cerebrovascular accident. In a first search, the term micturition disorder, which explodes to polyuria, urinary incontinence, and urinary retention, was used together with cerebrovascular accident. In the second search, the term bladder neurogenic was used together with cerebrovascular accident. All randomized clinical trials (RCTs) and cohort studies related to behavioral treatment were con-

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sidered for inclusion. In addition, the reference lists of retrieved articles were reviewed to identity additional references that may not have been found in the preliminary search. Next, two evidence-based databases, the Cochrane database of systematic review22 and PEDro23 were explored for systematic reviews and RCTs using stroke and incontinence as key terms. In addition, the Cochrane central register of controlled trials (CENTRAL)24 was searched for RCTs using the same key terms. All major authors working in the area of UI in individuals with stroke were also sought in citation indexes using the ISI Web of Science database to verify that all publications relevant to UI in individuals with stroke were obtained.25 Eight major stroke clinical practice guidelines (CPGs)2633 and two major UI CPGs17,18 were searched for recommendations regarding behavioral approaches for the management of UI in individuals with stroke and for references to RCTs. Although we recognize that the AHCPR guidelines have not been updated, we decided to include them in the review because there are so few guidelines making recommendations about incontinence. Finally, unpublished trial data were searched for on national and international databases including the Canadian Institute of Health Research Institute of Gender and Health (IGH) National Research Registry,34 Computer Retrieval of Information on Scientific Projects (CRISP) generated in the United States,35 and the National Research Register and the Department of Health Research Finding electronic Register (ReFeR) from the United Kingdom (UK).36 The flow chart of the review process is presented in Figure 1. For the purpose of this literature review, only peer-reviewed articles were considered. Abstracts and proceedings were excluded.
Data abstraction and analysis

affect its internal validity such as randomization; concealed allocation; baseline comparability; blinding of the subjects, assessors, and therapists; intention-to-treat analysis; and adequacy of follow-up. Two reviewers rated each RCT independently, and discrepancies in scoring were then discussed between the two reviewers. When agreement on certain points could not be reached, a third reviewer, a senior researcher with experience in RCTs methodology, was consulted. Where an RCT already had a PEDro score in the PEDro database, the existing score was used. PEDro scale results of individual studies were interpreted following Foleys quality assessment20 where studies scoring 9 to10 were considered methodologically excellent, 6 to 8 were considered good , 4 to 5 was fair, and below 4 was poor.20 Cohort studies were considered as an inferior form of evidence.
Data retrieved

Abstracts and references were reviewed to identify RCTs and control studies evaluating behavioral interventions for UI and including human subject data. RCTs were appraised for methodological quality using the PEDro Scale, developed by the Center for Evidence-Based Physiotherapy in Australia.37 The PEDro score provides a nominative description of the aspects of a clinical trial that

In the first search, 35 citations were retrieved in MEDLINE and 62 in CINAHL. From these, two RCTs were found.38,39 By reviewing the reference lists of retrieved articles, we identified two additional RCTs40,41 and one additional cohort study.42 In the second search, we retrieved nine citations in MEDLINE and five citations in CINHAL. No new RCTs or cohort studies were found. In EMBASE, we retrieved 43 citations in the first search and one additional citation in the second. No new RCTs or cohort studies were found. In ISI Web of Science database,25 no new RCTs citing major authors working in the area of UI in individuals with stroke were found. In the Cochrane database of systemic reviews,22 one systematic review43 has been proposed but is not yet published. In the PEDro database,23 two RCTs already found in MEDLINE had PEDro scores.3840 In CENTRAL,24 no RCT related to individuals with stroke and behavioral treatments were found. Finally, no unpublished trials were found in the Canadian Institute of Health Research Institute, IGH national research registry,34 in the American CRISP,35 or in the UK National Research register and the ReFeR.36 Table 1 summarizes the four RCTs3841 and the only prospective cohort study42 found in the databases. Recommendations regarding behavioral man-

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Figure 1. Flow chart of the review process.

agement of UI in individuals with stroke were found in one major stroke CPG32 and two major CPGs on UI.17,18 Recommendations were extracted and are presented in Table 2. Results Of the four RCTs, one cohort study and the three CPGs where recommendations were found, five major subtopics emerged: timed voiding and prompted voiding, bladder retraining with urge suppression, pelvic floor exercises alone, pelvic floor exercises in combination with bladder retraining, and stroke rehabilitation approaches.
Timed voiding or prompted voiding

Timed voiding is a fixed time interval toileting assistance program that has been promoted for the

management of people with UI who cannot participate in independent toileting.44 Prompted voiding is a behavioral intervention that teaches people with or without cognitive impairment to initiate their own toileting through requests for help in combination with positive reinforcement from care providers when voiding is successfully accomplished.45 Prompted voiding is different from timed voiding because the individual actively participates in initiation and maintenance of the voiding process. Considering that timed and prompted voiding have been shown to be effective for improving dryness in the frail elderly population,46 is timed voiding more effective than no intervention/ placebo intervention or an alternative intervention in the management of UI in the adult stroke population? There is no RCT addressing these comparisons. Is prompted voiding more effective than no intervention/placebo intervention or an alternative

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Table 1. Characteristics of the randomized and nonrandomized trials on the effects of behavioral treatment on UI in stroke patients
Intervention Change All subjects achieved and maintained continence No score 4 weeks schedule-voiding + 25 sessions biofeedback assisted bladder retraining Continence: number of leakage/week at 6 and 12 months Outcome measures PEDro score

Author year

Study design

Population characteristics

Middaugh, 198942

One-group pretest/ posttest design

4 male stroke patients living in the community with a clear history of persistent UI associated with stroke (aged 5275) Treatment group: compensatory rehab approach vs. control group: remedial rehabilitation approach - Urinary continence - Katz ADL index - FIM-G 7 - PGWB index - Mobility score Continence 20/21 in the treatment group vs. 3/13 in the control group Greater improvement in all outcome measures in the compensatory rehabilitation approach group 75% reduction in UI episode in treatment group 6.4% reduction in UI episode in control group 8-week long prompted voiding intervention performed every 2 hours % reduction daytime UI episode 60% reduction in daytime UI episode in treatment group 37% reduction in daytime UI episode in control group SF-36 IIQ 12 weeks of standardized PFM exercises vs. no specific treatment for incontinence No difference in QOL scores between the 2 groups after treatment 6 5

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Wilkander, 199838

RCT

34 stroke patients with UI following stroke 19 females/15 males (mean age 74)

5 as per PEDro database score

McDowell, 199940 Biofeedback assisted pelvic floor muscle training vs socialization visit % reduction in UI episode

RCT

105 homebound older adults with UI (aged 6096) 28/105 with a stroke

6 as per PEDro database score

Engberg, 200241

RCT

16 homebound cognitively impaired older adults with UI (aged 60 years and older)

Tibaeck, 200339

RCT

26 female stroke patients with UI closely associated with the cerebrovascular accident (aged 5275)

Note: UI = urinary incontinence; RCT = randomized clinical trial; ADL = activities of daily living; PGWB = psychological general well-being index; QOL = quality of life; PFM = pelvic floor muscle; IIQ = Incontinence Impact Questionnaire.

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Table 2. Synthesis of the recommendations specific to behavioral approaches emitted by international clinical practice guidelines
Clinical Practice Guideline/ Group Post-stroke Rehabilitation CPG #16/ Agency for Health Care Policy and Research (AHCPR)26 *Disclaimer not to use for clinical practice at this time. UI in Adults CPG #2/ AHCPR17 *Disclaimer not to use for clinical practice at this time. Recommendations specific to behavioral approaches for UI Management of incontinence should follow the AHCPR guidelines on UI in Adults CPG #2.

-The least invasive or dangerous procedures should be tried first. Behavioral management (pelvic muscle rehabilitation and/or behavioral therapies) meets this criterion. (Research evidence from RCTs in adult population, expert opinions) -For patients who have not been successfully treated, management plans must be developed to maximize their well being. Techniques such as scheduled toileting and prompted voiding may be useful in reducing the impact of the patients incontinence. (Research evidence from RCTs in adult population, expert opinions) No specific comments on behavioral techniques for UI

Recommendations for stroke management/European Stroke Initiative27 Best Practice Guidelines for Stroke Care/ Heart and Stroke Foundation of Ontario28 The Italian Guidelines for Stroke Prevention/ The Stroke Prevention and Awareness Diffusion (SPREAD) collaboration 29 National Clinical Guidelines for Stroke, 2nd ed./ Royal College of Physicians, London, UK 30 Life after Stroke: New Zealand guideline for management of stroke/Stroke Foundation of New Zealand33 Management of Patient with Stroke/ Scottish Intercollegiate Guidelines Network 31 Veterans Affairs/Department of Defense (VADOD) CPG for the management of stroke rehabilitation in the primary care setting/VADOD32

No specific comments on behavioral techniques for UI

No specific comments on behavioral techniques for UI

No specific comments on behavioral techniques for UI

No specific comments on behavioral techniques for UI

No specific comments on behavioral techniques for UI

Consider an individual bladder-training program that is developed and implemented for patients who are incontinent of urine (systematic review supporting management of urge UI in general population). Recommend the use of prompted voiding in stroke patients with UI (systematic review evidence supporting short-term improvement of incontinence symptoms in general population).

2nd International Consultation on Incontinence/ Abrams et al.18

Behavioral modification (timed voiding) for the cooperative mobile patient (evidence from randomized and nonrandomized trials on nonstroke-specific neurogenic UI).

xx

intervention in the management of UI in the adult stroke population? One RCT has evaluated prompted voiding in cognitively impaired homebound individuals, 20% of whom experienced a stroke.41 No results specific to the stroke subjects were reported, thus it was not possible to determine the effect on this subgroup. Based on recommendations from three CPGs,17,18,32 there is consensus opinion that timed voiding or

prompted voiding should be implemented for urinary retention or incontinence in cooperative and mobile individuals with stroke.
Bladder retraining with urge suppression

Bladder retraining with urge suppression involves three components: educating patients about the mechanisms underlying incontinence and con-

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tinence, a scheduled voiding regimen with gradually progressive voiding intervals, and an urgency control strategy using distraction and relaxation techniques.47,48 Bladder retraining requires patients to be independent of caregiver support and motivated to participate actively in treatment.49 Considering that there is strong evidence that bladder retraining with urge suppression is an effective treatment for adult women with urge, stress, and mixed symptom UI,48 is bladder training with urge suppression more effective than no intervention/ placebo intervention or an alternative intervention in the management of UI in the adult stroke population? There are no RCTs investigating this question. There is consensus opinion from one CPG32 that a bladder training program with urge suppression should be implemented in individuals with symptoms of urge incontinence post stroke.
Pelvic floor exercises

outcome can be questioned as it may not have been sensitive enough to detect changes in UI QOL in a clientele where the disability associated with the condition already impacts considerably on health-related QOL. Thus, this first RCT allows no conclusion regarding the effects of pelvic floor exercises in incontinent adults with stroke. Furthermore, there is no CPG that addresses the use of pelvic floor exercises for the treatment of UI in individuals with stroke. There is no evidence that pelvic floor exercises should be recommended for individuals with UI post stroke.
Bladder retraining with urge suppression in combination with pelvic floor muscle exercises

Pelvic floor exercises consist of a program of repeated voluntary pelvic floor muscle contractions taught by a health care professional.48 These exercises aim to improve strength and/or timing of the pelvic floor contraction in the management of stress incontinence and to inhibit detrusor contraction in the management of urge incontinence.48 There is strong evidence that pelvic floor exercises reduce UI in cognitively intact but frail elderly individuals.46 Are pelvic floor strengthening exercises more effective than no intervention/placebo intervention or an alternative intervention in the management of UI in the adult stroke population? There is one RCT that investigated the use of pelvic floor exercises in a stroke population.39 Twenty-six men and women were randomized to a 12-week program of standardized pelvic floor strengthening exercises or no treatment.39 After treatment, no difference in continence-specific quality of life (QOL) (measured using the Incontinence Impact Questionnaire) or general QOL (based on SF-36 scores) between the two groups was observed.39 No direct measurement of UI was used. While rating 6 on the PEDro scale, the very small sample size of 24 participants (12 in each group) highly increased the likelihood of a type 2 error. In addition, the choice of a QOL measure as a primary

Bladder retraining with urge suppression has been used in combination with pelvic floor muscle exercises (inhibition of detrusor contractions) for UI in adults without neurological disease.18 It has demonstrated effectiveness in reducing incontinence episodes 3 months after randomization, as compared to bladder retraining with urge suppression alone.50 Is bladder retraining with urge suppression in combination with pelvic floor exercises more effective than no intervention/placebo intervention or an alternative intervention in the management of UI in the adult stroke population? There is one fair RCT40 and one nonrandomized study 42 that address these comparisons. In Middaughs quasi-experimental study,42 using a single-group pretest/posttest design, four male subjects with chronic post stroke UI (average 1.6 to 7.5 involuntary voids per week for at least 8 months) participated in two to five training sessions with pelvic floor muscle exercises, urge suppression, and home pelvic floor exercises. All four were evaluated for incontinence episodes prior to treatment, after treatment, and at 6-month followup. All achieved and maintained continence at the 6-month follow-up evaluation.42 Although this study provides evidence that there are individuals with persistent UI post stroke who can regain continence following a program of pelvic floor muscle exercises, urge suppression, and home pelvic floor exercises, it is not possible to tell how typical these four subjects were or whether other individuals with UI post stroke would benefit similarly from

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this treatment. Such additional information requires more extensive RCTs. McDowell et al.40 randomized 105 older adults (60 years and older) with UI to a biofeedbackassisted pelvic floor muscle training group (n = 53) or to a control group (n = 52) that received no specific UI treatment.40 Twenty-eight participants (26%) had experienced a stroke (15 in the treatment group and 13 in the control group). High levels of comorbidity and functional impairment such as heart failure, diabetes, and Parkinsons disease were found in the majority of participants. The treatment consisted of eight weekly sessions of biofeedback-assisted pelvic floor exercises and bladder retraining with urge suppression strategies together with a daily home pelvic floor exercise program. Participants in the treatment group with complete postcontrol data (n = 48) achieved a median 75% reduction in incontinence episodes as opposed to 6.4% in the control group with complete postcontrol follow-up (n = 45) despite high levels of comorbidity. Again, no results specific to the participants with stroke were reported. There is limited evidence from one nonrandomized study42 that bladder retraining with urge suppression in combination with pelvic floor exercises results in reduction of UI in male individuals with stroke. Further research is necessary before more definitive conclusions can be reached.
Rehabilitation approaches to neurological impairment

population, does a specific rehabilitation approach have an effect on UI? One RCT of fair quality was found: Wilkander et al.38 randomized 34 patients with stroke to rehabilitation based on a compensatory rehabilitation approach or remedial approach. No specific UI treatment was given. A significantly greater proportion of the compensatory group regained continence (20/21) as compared to the remedial group (3/13). In addition, significantly greater improvement in activities of daily living, in psychological well-being, and in mobility was observed in the compensatory group compared to the remedial group. These results can potentially be explained by the inherent philosophy of the compensatory approach in which the patients independence in mobility and transfers is encouraged more rapidly. There is moderate evidence from the results of one fair RCT38 that a functionally oriented rehabilitation approach results in less incontinence than the conventional approach in individuals with stroke. A second RCT is needed to constitute a strong level of evidence. Discussion Despite the high prevalence of persistent UI in individuals with stroke, and a growing recognition of the importance of using behavioral approaches as first-line treatment for managing UI, evidence specific to the treatment of UI in individuals with stroke remains extremely limited. Evidence-based practice is the judicious use of current best evidence in making decisions about the care of individual patients.52 In the case of UI, this must be integrated with clinical expertise and available research to provide rehabilitation professionals with the information they need to improve the quality of care of UI post stroke. At the current time, evidence-based recommendations for rehabilitation specialists to improve the quality of care of UI post stroke include timed voiding for cooperative and mobile stroke individuals unaware of their bladder status and experiencing urinary retention or UI; prompted voiding for cooperative and mobile individuals aware of their bladder status and experiencing urinary retention or UI; and bladder retraining with urge suppression for those with urge symptoms who are independent of caregiver

There are two basic approaches to the rehabilitation of individuals with stroke. One approach, the remedial approach, involves use of neuro-developmental techniques that are directed at improving the impairment and attempts to restore the stroke patients physical functioning as close to normal as possible.51 The compensatory approach is not focused on the return to normal physical functioning as much as it is focused on optimization of function regardless of how it is accomplished.51 Currently, clinicians use both methods, and there is no consensus on which is more effective.51 However, the choice of rehabilitation approach may have an impact on the evolution of UI in stroke patients. The following question arises: In the adult stroke

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support and motivated to participate actively in treatment. Although there is moderate evidence that a functionally oriented rehabilitation approach results in reduced incontinence, the absence of level 1 evidence suggests that therapists consider combining the two approaches (functionally oriented and conventional rehabilitation approach) in treating individuals with stroke, thereby encouraging independence in mobility and transfers. Finally, specific to male individuals post stroke who have urge symptoms and who are independent of caregiver support and motivated to participate actively in treatment, bladder retraining with urge suppression together with pelvic floor muscle exercises is recommended. Conclusion The effectiveness of various behavioral approaches in the management of UI in individuals

post stroke is not well studied. Preliminary research suggests that important improvements in UI can be achieved using a number of behavioral strategies for UI that are employed for nonstroke patients. Further research is urgently needed, because UI is a strong predictor of functional recovery and discharge destination. Acknowledgments C. Dumoulin was supported by a postdoctoral fellowship from the Fond de la Recherche en Sant du Qubec (FRSQ) and from infrastructure support from the Canadian Stroke Network and CRIR.

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APPENDIX A
Summary of the Definition of Evidences20
Strong Moderate Limited Consensus Conflicting The findings were supported by the results of two or more RCTs of at least fair quality. The findings were supported by a single RCT of at least fair quality. The findings were supported by at least one nonexperimental study (non-RCT, cohort studies, etc.). In the absence of evidence, agreement was reached by a group of experts on the appropriate treatment course. There was disagreement between the findings of at least two RCTs. Where there were more than four RCTs and the results of only one was conflicting, the conclusion was based on the results of the majority of the studies, unless the study with conflicting results was of higher quality.

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