DOI: 10.1111/ajag.12047
Review Article Do continence management strategies reduce falls? A systematic review Frances A Batchelor National Ageing Research Institute, Melbourne, Victoria, Australia
Briony Dow and May-Ann Low National Ageing Research Institute and University of Melbourne, Melbourne, Victoria, Australia
Urinary incontinence is associated with increased fall risk, and fall prevention programs include recommendations to manage continence as one component of fall reduction. However, the evidence to support this recommendation is unclear. The aim of this study was to identify continence management interventions that are effective in decreasing falls. A systematic review of the literature was conducted. Studies were included if they evaluated the effect of any type of continence management strategy on falls in older adults. The included studies were assessed for quality, and data relating to participants, interventions and outcomes were extracted by two independent reviewers. Four articles met the inclusion criteria. Two studies were randomised controlled trials, one a retrospective cohort study and one an uncontrolled intervention study. Interventions included pharmacological agents, a toileting regime combined with physical activity and an individualised continence program. Only the study evaluating the combination of physical activity and prompted voiding found an effect on falls. It is surprising that there has been so little research into continence management interventions that include fall outcomes. A toileting regime combined with physical activity may reduce falls in residential care. There is a need for further studies investigating the impact of continence management on falls. Key words: accidental falls, geriatrics, review, systematic, urinary incontinence.
Introduction Falls and incontinence are common health issues in older people. For example, in Australia, approximately one in three people over the age of 65 experience at least one fall each year [1]. This rate of falls further increases with age [2]. Falls cause 80% of injury-related hospital admissions in people aged 65 and over [3] and result in high total healthcare costs [4]. Worldwide rates of urinary incontinence in older people have been reported to range from 4.4 to 34.1% in men and from 4.8 to 55.1% in women [5], with this rate Correspondence to: Dr Frances Batchelor, National Ageing Research Institute, PO Box 2127, The Royal Melbourne Hospital. Email: [email protected] Australasian Journal on Ageing, Vol 32 No 4 December 2013, 211–216 © 2013 The Authors Australasian Journal on Ageing © 2013 ACOTA
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increasing with age [6]. Urinary incontinence may be due to physical stress causing leakage (e.g. coughing, jumping) or symptoms of urgency and nocturia (waking during the night because of the need to void) associated with an overactive bladder. Urinary incontinence is one of the recognised risk factors for falls [7–9]. A systematic review by Chiarelli et al. [10] identified increased odds of falling of 1.45 (95% confidence interval 1.36–1.54) in the presence of any type of urinary incontinence. Incontinence is also a risk factor for recurrent falls [11]. A lower risk of falls exists in the presence of stress incontinence compared to urge incontinence; however, a mix of the two poses the greatest risk [10]. Incontinence may lead to a fall through various mechanisms including slips on wet surfaces; rushing to the toilet resulting in tripping; symptoms of a urinary tract infection that predispose an individual to falls, such as delirium, drowsiness, urinary frequency; and nocturia in conjunction with impaired vision and balance, as well as postural hypotension due to medication [12,13]. A significant amount of research has been conducted into interventions that promote continence. Pelvic floor muscle training (PFMT) involves strengthening the muscles of the pelvic floor to increase urethral closure pressure and thus prevent urine leakage. It is a conservative intervention recommended as first line of management for urinary incontinence, although it seems that those with stress incontinence benefit the most [14]. Feedback or biofeedback may be used as an adjunct to PFMT, as more patients tend to report an improvement with its use [15]. Other forms of conservative management include bladder or habit training in which patients are given scheduled voiding (to improve bladder capacity, aiming for 3–4 hours of intervals). However, there is limited evidence for effectiveness of these interventions in treating urinary incontinence [16,17]. Lifestyle changes may also be recommended to improve continence, such as weight loss, fluid management, cessation of smoking and reduced strenuous activity [18]. While the association between continence problems and falls is well established, it is unlikely that the relationship is causative, particularly as both incontinence and falls are associated with other factors such as cognitive impairment and mobility problems. However, it is still unclear whether improving continence through the application of any continence management interventions would also lead to a decrease in falls. The aim of this study, therefore, was to identify continence management interventions in older adults (from community 211
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and residential care settings) that were effective in decreasing fall incidence by systematically reviewing the current literature.
resolved by consensus and a third independent reviewer was available to be consulted if disagreements could not be resolved.
Materials and methods
Data synthesis Because of the heterogeneity across studies, this systematic review is presented as a narrative summary. This allowed for initial data exploration and identification of gaps in research. A meta-analysis was not conducted as results were not able to be combined.
Identification and selection criteria A systematic search of the following databases was conducted: MEDLINE, CINAHL, PsycINFO, Web of Science, PEDro and Scopus. All databases were examined from their date of inception until March 2012. Search terms consisted of ‘falls, accidental falls’, and ‘continence’, ‘incontinence, urinary incontinence’ with MeSH headings as appropriate. A secondary search through the reference lists of relevant studies was also conducted. From the initial search, titles and abstracts were reviewed to determine if a study was suitable for inclusion. Full articles were retrieved for studies that were not clearly excluded from review of the title and abstract, and they were reviewed to determine eligibility for inclusion. Inclusion criteria Study design • Intervention studies Participants • Aged ⱖ65 years • Any type of incontinence Intervention • Any continence management intervention
Results Description of studies The primary search strategies yielded 1328 studies that were potentially relevant. These were then screened by title and abstract and 1313 studies were rejected. The full texts of the remaining 18 potentially relevant articles were retrieved for further screening. Of these, 14 articles did not meet the inclusion criteria (refer to Figure 1 for details). A total of four studies were therefore deemed appropriate for review [20–23]. Characteristics of studies Table 1 summarises the characteristics and results of the included studies. Participant characteristics Participants in the included studies were aged 65 or older (as per inclusion criteria). Although the search strategy was not
Figure 1: Search results.
Outcome measures • Fall-related outcomes (e.g. fall rate, proportion of falls) Exclusion criteria • Papers written in languages other than English • Studies where continence management strategies were not the main component of the intervention
Method of review Quality appraisal All articles retrieved that satisfied the criteria stated above were assessed independently by two reviewers with any disagreements being resolved by consensus or through consultation with a third independent reviewer, if necessary. The quality of each study was appraised using a critical review form and guidelines for quantitative studies developed by Law et al. [19]. Data extraction Two reviewers independently extracted relevant data including participant inclusion and exclusion criteria, setting, intervention and control protocols, outcome measures, and results using a customised table. All disagreements were 212
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Aged ⱖ66, commenced treatment with oxybutynin or tolterodine for pharmaceutical management of urinary incontinence in Ontario, Canada, between 1 April 2002 and 31 December 2008. Female, average age 80, incontinent of urine and/or had urgency related to an overactive bladder, 55% had dementia
Gomes et al. (2011) [22]
Australasian Journal on Ageing, Vol 32 No 4 December 2013, 211–216 © 2013 The Authors Australasian Journal on Ageing © 2013 ACOTA
Incontinence of urine (as identified by nursing home staff and verified by checks for wetness); free of catheter; ability to follow a simple one-step instruction; not being on Medicare Part A reimbursement for post-acute skilled care or terminal illness
Schnelle et al. (2003) [20]
Terminal illness; bed bound; non-communicative; delirium; Lewy body dementia; history of ⱖ3 UTIs in previous year or current infection; post-void residual urine volume ⱖ150 mL; urethral diverticulum; bladder tumour or stone; severe pelvic organ prolapse or vaginitis; genitourinary surgery within past 6 months; hepatic disease; severe CVD; myasthenia gravis; SCI; bowel movement < every 3 days; history of gastrointestinal obstruction or decreased motility; current drug therapy for urinary incontinence; current use of acetylcholinesterase inhibitor or bisphosphonate; investigational drug, systemic or ophthalmic cholinomimetic drug, diphenhydramine, or gastrointestinal antispasmodic within 2 weeks before trial NA
Male, patients with terminal illness
NA
Exclusion criteria
4 nursing homes (one non-profit, 3 propriety), USA
Twelve skilled nursing homes, USA
Long-term care facility, USA
Canada
Setting
Research staff implemented the intervention 5 days a week, every 2 hours, between 08.00 and 16.00 hours for 8 months. Patients were prompted to toilet and change if they were wet. Before or after this, they were encouraged to walk or, if not ambulatory, to wheel their chairs and to repeat sit-to-stands up to eight times using minimum assistance. During one trial each day, upper body resistance training was performed. Before and after each trial, patients were offered fluids with a prompting protocol that significantly increased fluid intake. Target goals for the exercise were set individually and adjusted on a weekly basis. (n = 92)
Individualised treatment plan by continence care nurse including anticholinergics, topical oestrogen, PFMT +/- biofeedback administered by registered nurses, dietary changes (elimination of caffeine and increased daily fluid and fibre intakes), prompted toileting (n = 27) 4 weeks of treatment with once-daily oral extended-release oxybutynin 5 mg (n = 26)
Patients prescribed with oxybutynin (n = 40 563) Patients prescribed with tolterodine (n = 40 563)
Intervention/s
Usual care from nursing home staff (n = 98)
Placebo (n = 24)
NA
NA
Control
People who had fallen during 8 months of intervention period, as documented in records. Compared to 6 months baseline measurement pre intervention.
Fall incidence during the 3 months prior, during (4 weeks) or 3 months after the trial, as documented in incident reports and progress notes
Hospital visit for a fall within 90 days of drug initiation (identified on the Canadian Institute for Health Information Discharge Abstract Database and National Ambulatory Care Reporting System) Fall incidence over 1-year intervention period as documented in medical record
Outcome measure
Control group: 14 at baseline; 21 at follow-up. Intervention group: 11 at baseline; 13 at follow-up. Authors report a significant difference between groups when comparing the change in number of people who had fallen pre and post intervention.
No differences between groups in the 3 months prior to trial (27%, 33%; P = 0.62), during (19.2%, 16.7%; P = 0.81) or 3 months after (30.8%, 41.7%; P = 0.42). No difference in median change in number of falls per month (P = 0.24–0.66). No treatment or period effect for the number of falls per month over time of observation (treatment effect, P = 0.24; period effect, P = 0.51).
321 (0.79%) tolterodine users compared with 294 (0.72%) oxybutynin users experienced a fall-related hospital visit within 90 days of drug initiation. No difference in risk. Falls decreased from 18 to 7 (61% decrease) compared to 1 year prior to intervention.
Result
i n t e r v e n t i o n s a n d
CVD, cardiovascular disease; GDS, Global Deterioration Scale; MMSE, Mini-Mental State Examination; PFMT, pelvic floor muscle training; SCI, spinal cord injury; UTI, urinary tract infection; NA, not addressed.
Female, aged ⱖ65, resident for ⱖ3 months in long-stay nursing home unit, MMSE score 5–23, GDS score 3–6, urinary incontinence, ability to swallow medication intact, medication adherence rate ⱖ80% during week before screening
Lackner et al. (2008) [23]
Klay & Marfyak (2005) [21]
Inclusion criteria
Study
Table 1: Summary of included studies
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limited to urinary incontinence, all the included studies targeted only those with urinary incontinence. One study [21] also included participants with symptoms of urgency from an overactive bladder. Two of the studies included female participants only [21,23]. Three of the trials were conducted in nursing homes [20,21,23], and the study by Gomes et al. [22] was not restricted to a particular setting. Interventions Two studies investigated the effect of pharmacological agents: Gomes et al. [22] compared oxybutynin with tolterodine within a 90-day period, and Lackner et al. [23] investigated the effect of 5-mg extended-release oxybutynin administered once daily for 4 weeks compared to a placebo. One study implemented prompted toileting every 2 hours between 08.00 and 16.00 hours in conjunction with a lowintensity exercise program over 8 months (also known as functional incidental training) [20]. Klay & Marfyak [21] investigated the use of a continence specialist nurse in designing an individualised treatment plan from a range of interventions including the use of anticholinergics, topical oestrogen, PFMT with or without biofeedback administered by registered nurses, dietary changes (elimination of caffeine and increased daily fluid and fibre intakes) and prompted toileting over the course of 1 year. Outcome measures Three studies reported the number of falls as an outcome measure but across varying time periods [21–23]. Gomes et al. [22] recorded falls that resulted in a hospital visit within 90 days from drug administration from data collected from relevant emergency department and hospital admission databases. Two of the studies [21,23] calculated the number of falls throughout the intervention period, which ranged from 4 weeks [23] to 1 year [21]. Lackner et al. [23] also compared fall incidence 3 months post intervention. Data were collected from documentation in the patients’ medical records. Lackner et al. [23] used incidence reports in addition to medical records for data collection. One study reported the number of people who had fallen only, comparing the difference pre-post intervention [20]. Effectiveness Of the three studies that used statistical tests to evaluate differences between groups [20,22,23], only the study by Schnelle et al. found a significant difference [20]. They found a difference between control and intervention groups for proportion of people who had fallen but not fall rate when comparing pre and post intervention. Lackner et al. [23] reported no difference in falls either during the intervention or in the 3 months post intervention, compared to the placebo group. Klay & Marfyak [21] administered a patientspecific program from a range of interventions designed by a continence nurse specialist and reported a post-intervention decrease in falls of 61% compared to pre-intervention; however, no statistical analysis was reported. 214
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Methodological quality The methodological quality of studies is summarised in Table 2. Of the four studies examined, two trials [20,23] were randomised controlled trials (RCTs). However, there was lack of therapist blinding and the study by Schnelle et al. [20] lacked participant blinding and intention-to-treat analysis. One study [22] was a retrospective, population, cohort study design. This allowed a large sample size to be investigated; however, lack of features such as a comparison group, randomisation and blinding resulted in unknown biases in patient selection and data analysis. Patient characteristics were not adequately described. Klay & Marfyak [21] conducted a preand post-study without a control group, comparing number of falls in the year prior to the year after intervention. The difference in the outcome was not examined statistically. There was generally a lack of justification of sample size, with only one study [20] doing so (see Tables 1 and 2).
Discussion This review found very few studies that investigated the impact of continence management interventions on falls, with only one intervention found to produce a statistically significant reduction in people who had fallen [20]. This intervention consisted of a regime of prompted toileting and a physical activity component undertaken every 2 hours with long-term care residents. In addition to the decrease in the proportion of people who had fallen seen in the intervention group, the study authors also reported differences in favour of the intervention group in frequency of urinary incontinence, physical activity and mobility endurance [20]. It is therefore difficult to isolate the effect of the continence management strategy on falls. The study by Klay & Marfyak [21] involved a multifactorial intervention. In this study, the intervention was individually tailored and therefore different for each of the 27 participants. Although they reported a reduction in fall incidence, the methodological quality of this study was poor. The small sample size and lack of a control group limited the validity and generalisability of these findings. However, the positive finding suggests that future studies might benefit from an individually tailored, multifactorial approach. It is important to note that the primary aim of the studies included in this review was not to investigate fall occurrence, and thus the study designs were not targeted directly at this outcome. The studies investigating the use of anticholinergics [22,23] sought to determine any adverse effects of these medications within this population, including a potential increase in falls due to the anticholinergic effects [24]. The use of antimuscarinics (e.g. oxybutynin, tolterodine) has been found to reduce the incidence of incontinence when compared to placebo or no treatment [25], thereby possibly decreasing falls. However, because of the anticholinergic side effects of these medications, they may also contribute to increased fall risk. This may have countered any benefits of improving continence on the incidence of falls, thereby limiting study findings. A scoping review examining the use of Australasian Journal on Ageing, Vol 32 No 4 December 2013, 211–216 © 2013 The Authors Australasian Journal on Ageing © 2013 ACOTA
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✓ ✗ ✓ ✓
antimuscarinic medications found insufficient evidence to conclude whether this form of treatment positively or adversely affected falls [26].
✓ NA ✓ ✓
✓ ✓ ✓ ✓
✓ ✗ ✓ ✓
The study by Gomes et al. [22] investigated only the occurrence of falls that resulted in an emergency department or hospital admission, and thus falls of less severity may have gone undetected. The validity of databases used in this study was not determined. It is therefore uncertain whether there was an effect on overall fall incidence, with the lack of a placebo group further preventing conclusions from being drawn.
✓ ✗ ✓ ✓
✓ NA ✓ NA
✓ NA NA NA
It is possible that the use of interventions with greater efficacy such as PFMT may have an identifiable impact on falls. An RCT by Kim and colleagues [27] demonstrated the effectiveness of PFMT as part of a 3-month multidimensional exercise program, with urinary incontinence decreasing 43.4% post intervention. Although significant improvements in functional decline were also noted (both of which are known risk factors for falls), the incidence of falls specifically was not included as an outcome measure, and thus direct conclusions cannot be drawn. Future studies could therefore implement a similar intervention in comparison to a control group, but include a fall-related outcome measure.
NA NA NA NA
✗ NA ✓ NA
One limitation of this review was that only English studies were included. The two studies that were excluded based on language may have provided additional insight into this area.
Conclusions
✓ ✓ ✓ ✓
✗ ✗ ✓ ✗
✓ ✗ ✓ ✓
NA ✗ ✓ ✓
Despite the evidence demonstrating an association between urinary incontinence and falls, there has been little research targeting continence as an intervention to reduce falls. We found it surprising, given the known relationship between these two factors, that there is not much research either into continence that includes falls as an outcome or into fall prevention that targets continence.
NA, not addressed.
✓ ✓ ✓ ✓ Gomes et al. (2011) [22] Klay & Marfyak (2005) [21] Lackner et al. (2008) [23] Schnelle et al. (2003) [20]
Clinical Drop outs Appropriate Purpose Relevant Participant Similarity Justification Outcome Outcome Intervention Contamination Co-intervention Results stated background characteristics at baseline of sample size measures measures described avoided avoided reported importance reported conclusions literature described reliable valid in detail in statistical reported significance
Table 2: Quality appraisal
C o n t i n e n c e
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Clearly, there is a need for a well-designed intervention study that specifically targets continence as one of the components and includes falls as a primary outcome [28]. Future research should include older people who have both high fall risk and incontinence, which include multifactorial interventions and interventions that are individually tailored to maximise adherence and efficacy. It is also important to clearly document what interventions are undertaken by individual older people in order to determine the effectiveness of specific interventions. Further research in this area could also include the investigation of the effects such interventions have in specific population groups (e.g. stroke, dementia) which have been found to have an increased incidence of incontinence [29,30]. In the interim, given the evidence supporting the association between urinary incontinence and fall risk, clinicians should seek to address this problem as part of their treatment plans 215
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and consider combining interventions aimed at improving continence with physical activity, as interventions aimed at improving functional mobility are likely to be beneficial for both falls and continence. This should include a thorough assessment of the nature of the continence difficulty and tailoring of interventions to take into account the associated fall risk.
10 11
12 13
Acknowledgement This study was funded by the Scobie Mackinnon Trust Fund.
14 15
16
Key Points • Urinary incontinence is a recognised risk factor for falls. • Combining incidental physical activity with a toileting regime may help reduce falls in people living in residential care. • It is still unclear whether interventions improving continence will also reduce the risk of falls in community-dwelling older adults.
17 18 19
20 21
References 1 2
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Watson W, Clapperton A, Mitchell R. The Incidence and Cost of Falls Injury Among Older People in New South Wales 2006/2007. Sydney: NSW Department of Health, 2010. Lord SR, Tiedemann A, Chapman K et al. The effect of an individualized fall prevention program on fall risk and falls in older people: A randomized, controlled trial. Journal of the American Geriatrics Society 2005; 53: 1296–1304. Kannus P, Kahn KM, Lord SR. Preventing falls among elderly people in the hospital environment. Medical Journal of Australia 2006; 184: 372– 373. Moller J. Projected Costs of Fall Related Injury to Older Persons Due to Demographic Change in Australia. Canberra: Department of Health and Ageing, 2003. Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. International Journal of Gynecology & Obstetrics 2003; 82: 327–338. Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU International 2001; 87: 760–766. Brown JS, Vittinghoff E, Wyman JF et al. Urinary incontinence: Does it increase risk for falls and fractures? Study of Osteoporotic Fractures Research Group. Journal of the American Geriatrics Society 2000; 48: 721–725. Teo JSH, Briffa NK, Devine A, Dhaliwal SS, Prince RL. Do sleep problems or urinary incontinence predict falls in elderly women? The Australian Journal of Physiotherapy 2006; 52: 19–24. Hasegawa J, Kuzuya M, Iguchi A. Urinary incontinence and behavioral symptoms are independent risk factors for recurrent and injurious falls, respectively, among residents in long-term care facilities. Archives of Gerontology and Geriatrics 2010; 50: 77–81.
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Chiarelli PE, Mackenzie LA, Osmotherly PG. Urinary incontinence is associated with an increase in falls: A systematic review. The Australian Journal of Physiotherapy 2009; 55: 89–95. van Nieuwenhuizen RC, van Dijk N, van Breda FG et al. Assessing the prevalence of modifiable risk factors in older patients visiting an ED due to a fall using the CAREFALL Triage Instrument. The American Journal of Emergency Medicine 2010; 28: 994–1001. Lord SR, Sherrington C, Menz HB. Falls in Older People: Risk Factors and Strategies for Prevention, 2nd edn. Cambridge: Cambridge University Press, 2007. Australian Commission on Safety and Quality in Health Care. Best Practice Guidelines for Australian Hospitals. Sydney: Commonwealth of Australia, 2009. Dumoulin C, Hay-Smith J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database of Systematic Reviews 2010: CD005654. Herderschee R, Hay-Smith EJ, Herbison GP, Roovers JP, Heineman MJ. Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women. Cochrane Database of Systematic Reviews 2011: CD009252. Wallace SA, Roe B, Williams K, Palmer M. Bladder training for urinary incontinence in adults. Cochrane Database of Systematic Reviews 2004: CD001308. Ostaszkiewicz J, Johnston L, Roe B. Habit retraining for the management of urinary incontinence in adults. Cochrane Database of Systematic Reviews 2010: CD002801. Gungor I, Beji NK. Lifestyle changes for the prevention and management of lower urinary tract symptoms in women. International Journal of Urological Nursing 2011; 5: 3–13. Law M, Stewart D, Pollock N, Letts L, Bosch J, Westmorland M. Critical Review Form – Quantitative Studies. 1998. [Cited 13 March 2012.] Available from URL: http://www.srs-mcmaster.ca/Default.aspx?tabid =630 Schnelle JF, Kapur K, Alessi C et al. Does an exercise and incontinence intervention save healthcare costs in a nursing home population? Journal of the American Geriatrics Society 2003; 51: 161–168. Klay M, Marfyak K. Use of a continence nurse specialist in an extended care facility. Urologic Nursing 2005; 25: 101–102, 107–8. Gomes T, Juurlink DN, Ho JM, Schneeweiss S, Mamdani MM. Risk of serious falls associated with oxybutynin and tolterodine: A population based study. The Journal of Urology 2011; 186: 1340–1344. Lackner TE, Wyman JF, McCarthy TC, Monigold M, Davey C. Randomized, Placebo-Controlled Trial of the Cognitive Effect, Safety, and Tolerability of Oral Extended-Release Oxybutynin in Cognitively Impaired Nursing Home Residents with Urge Urinary Incontinence. Journal of the American Geriatrics Society 2008; 56: 862–870. Berdot S, Bertrand M, Dartigues J-F et al. Inappropriate medication use and risk of falls – A prospective study in a large community-dwelling elderly cohort. BMC Geriatrics 2009; 9: 30. Nabi G, Cody JD, Ellis G, Herbison P, Hay-Smith J. Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database of Systematic Reviews 2006: CD003781. Hunter KF, Wagg A, Kerridge T, Chick H, Chambers T. Falls Risk Reduction and Treatment of Overactive Bladder Symptoms With Antimuscarinic Agents: A Scoping Review. Neurourology and Urodynamics 2011; 30: 490–494. Kim H, Yoshida H, Suzuki T. The effects of multidimensional exercise on functional decline, urinary incontinence, and fear of falling in communitydwelling elderly women with multiple symptoms of geriatric syndrome: A randomized controlled and 6-month follow-up trial. Archives of Gerontology and Geriatrics 2011; 52: 99–105. Morris V, Wagg A. Lower urinary tract symptoms, incontinence and falls in elderly people: Time for an intervention study. International Journal of Clinical Practice 2007; 61: 320–323. Brittain KR, Perry SI, Peet SM et al. Prevalence and impact of urinary symptoms among community-dwelling stroke survivors. Stroke 2000; 31: 886–891. Byles J, Millar CJ, Sibbritt DW, Chiarelli P. Living with urinary incontinence: A longitudinal study of older women. Age and Ageing 2009; 38: 333–338; discussion 251.
Australasian Journal on Ageing, Vol 32 No 4 December 2013, 211–216 © 2013 The Authors Australasian Journal on Ageing © 2013 ACOTA
Review Article Do continence management strategies reduce falls? A systematic review Frances A Batchelor National Ageing Research Institute, Melbourne, Victoria, Australia
Briony Dow and May-Ann Low National Ageing Research Institute and University of Melbourne, Melbourne, Victoria, Australia
Urinary incontinence is associated with increased fall risk, and fall prevention programs include recommendations to manage continence as one component of fall reduction. However, the evidence to support this recommendation is unclear. The aim of this study was to identify continence management interventions that are effective in decreasing falls. A systematic review of the literature was conducted. Studies were included if they evaluated the effect of any type of continence management strategy on falls in older adults. The included studies were assessed for quality, and data relating to participants, interventions and outcomes were extracted by two independent reviewers. Four articles met the inclusion criteria. Two studies were randomised controlled trials, one a retrospective cohort study and one an uncontrolled intervention study. Interventions included pharmacological agents, a toileting regime combined with physical activity and an individualised continence program. Only the study evaluating the combination of physical activity and prompted voiding found an effect on falls. It is surprising that there has been so little research into continence management interventions that include fall outcomes. A toileting regime combined with physical activity may reduce falls in residential care. There is a need for further studies investigating the impact of continence management on falls. Key words: accidental falls, geriatrics, review, systematic, urinary incontinence.
Introduction Falls and incontinence are common health issues in older people. For example, in Australia, approximately one in three people over the age of 65 experience at least one fall each year [1]. This rate of falls further increases with age [2]. Falls cause 80% of injury-related hospital admissions in people aged 65 and over [3] and result in high total healthcare costs [4]. Worldwide rates of urinary incontinence in older people have been reported to range from 4.4 to 34.1% in men and from 4.8 to 55.1% in women [5], with this rate Correspondence to: Dr Frances Batchelor, National Ageing Research Institute, PO Box 2127, The Royal Melbourne Hospital. Email: [email protected] Australasian Journal on Ageing, Vol 32 No 4 December 2013, 211–216 © 2013 The Authors Australasian Journal on Ageing © 2013 ACOTA
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increasing with age [6]. Urinary incontinence may be due to physical stress causing leakage (e.g. coughing, jumping) or symptoms of urgency and nocturia (waking during the night because of the need to void) associated with an overactive bladder. Urinary incontinence is one of the recognised risk factors for falls [7–9]. A systematic review by Chiarelli et al. [10] identified increased odds of falling of 1.45 (95% confidence interval 1.36–1.54) in the presence of any type of urinary incontinence. Incontinence is also a risk factor for recurrent falls [11]. A lower risk of falls exists in the presence of stress incontinence compared to urge incontinence; however, a mix of the two poses the greatest risk [10]. Incontinence may lead to a fall through various mechanisms including slips on wet surfaces; rushing to the toilet resulting in tripping; symptoms of a urinary tract infection that predispose an individual to falls, such as delirium, drowsiness, urinary frequency; and nocturia in conjunction with impaired vision and balance, as well as postural hypotension due to medication [12,13]. A significant amount of research has been conducted into interventions that promote continence. Pelvic floor muscle training (PFMT) involves strengthening the muscles of the pelvic floor to increase urethral closure pressure and thus prevent urine leakage. It is a conservative intervention recommended as first line of management for urinary incontinence, although it seems that those with stress incontinence benefit the most [14]. Feedback or biofeedback may be used as an adjunct to PFMT, as more patients tend to report an improvement with its use [15]. Other forms of conservative management include bladder or habit training in which patients are given scheduled voiding (to improve bladder capacity, aiming for 3–4 hours of intervals). However, there is limited evidence for effectiveness of these interventions in treating urinary incontinence [16,17]. Lifestyle changes may also be recommended to improve continence, such as weight loss, fluid management, cessation of smoking and reduced strenuous activity [18]. While the association between continence problems and falls is well established, it is unlikely that the relationship is causative, particularly as both incontinence and falls are associated with other factors such as cognitive impairment and mobility problems. However, it is still unclear whether improving continence through the application of any continence management interventions would also lead to a decrease in falls. The aim of this study, therefore, was to identify continence management interventions in older adults (from community 211
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and residential care settings) that were effective in decreasing fall incidence by systematically reviewing the current literature.
resolved by consensus and a third independent reviewer was available to be consulted if disagreements could not be resolved.
Materials and methods
Data synthesis Because of the heterogeneity across studies, this systematic review is presented as a narrative summary. This allowed for initial data exploration and identification of gaps in research. A meta-analysis was not conducted as results were not able to be combined.
Identification and selection criteria A systematic search of the following databases was conducted: MEDLINE, CINAHL, PsycINFO, Web of Science, PEDro and Scopus. All databases were examined from their date of inception until March 2012. Search terms consisted of ‘falls, accidental falls’, and ‘continence’, ‘incontinence, urinary incontinence’ with MeSH headings as appropriate. A secondary search through the reference lists of relevant studies was also conducted. From the initial search, titles and abstracts were reviewed to determine if a study was suitable for inclusion. Full articles were retrieved for studies that were not clearly excluded from review of the title and abstract, and they were reviewed to determine eligibility for inclusion. Inclusion criteria Study design • Intervention studies Participants • Aged ⱖ65 years • Any type of incontinence Intervention • Any continence management intervention
Results Description of studies The primary search strategies yielded 1328 studies that were potentially relevant. These were then screened by title and abstract and 1313 studies were rejected. The full texts of the remaining 18 potentially relevant articles were retrieved for further screening. Of these, 14 articles did not meet the inclusion criteria (refer to Figure 1 for details). A total of four studies were therefore deemed appropriate for review [20–23]. Characteristics of studies Table 1 summarises the characteristics and results of the included studies. Participant characteristics Participants in the included studies were aged 65 or older (as per inclusion criteria). Although the search strategy was not
Figure 1: Search results.
Outcome measures • Fall-related outcomes (e.g. fall rate, proportion of falls) Exclusion criteria • Papers written in languages other than English • Studies where continence management strategies were not the main component of the intervention
Method of review Quality appraisal All articles retrieved that satisfied the criteria stated above were assessed independently by two reviewers with any disagreements being resolved by consensus or through consultation with a third independent reviewer, if necessary. The quality of each study was appraised using a critical review form and guidelines for quantitative studies developed by Law et al. [19]. Data extraction Two reviewers independently extracted relevant data including participant inclusion and exclusion criteria, setting, intervention and control protocols, outcome measures, and results using a customised table. All disagreements were 212
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Aged ⱖ66, commenced treatment with oxybutynin or tolterodine for pharmaceutical management of urinary incontinence in Ontario, Canada, between 1 April 2002 and 31 December 2008. Female, average age 80, incontinent of urine and/or had urgency related to an overactive bladder, 55% had dementia
Gomes et al. (2011) [22]
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Incontinence of urine (as identified by nursing home staff and verified by checks for wetness); free of catheter; ability to follow a simple one-step instruction; not being on Medicare Part A reimbursement for post-acute skilled care or terminal illness
Schnelle et al. (2003) [20]
Terminal illness; bed bound; non-communicative; delirium; Lewy body dementia; history of ⱖ3 UTIs in previous year or current infection; post-void residual urine volume ⱖ150 mL; urethral diverticulum; bladder tumour or stone; severe pelvic organ prolapse or vaginitis; genitourinary surgery within past 6 months; hepatic disease; severe CVD; myasthenia gravis; SCI; bowel movement < every 3 days; history of gastrointestinal obstruction or decreased motility; current drug therapy for urinary incontinence; current use of acetylcholinesterase inhibitor or bisphosphonate; investigational drug, systemic or ophthalmic cholinomimetic drug, diphenhydramine, or gastrointestinal antispasmodic within 2 weeks before trial NA
Male, patients with terminal illness
NA
Exclusion criteria
4 nursing homes (one non-profit, 3 propriety), USA
Twelve skilled nursing homes, USA
Long-term care facility, USA
Canada
Setting
Research staff implemented the intervention 5 days a week, every 2 hours, between 08.00 and 16.00 hours for 8 months. Patients were prompted to toilet and change if they were wet. Before or after this, they were encouraged to walk or, if not ambulatory, to wheel their chairs and to repeat sit-to-stands up to eight times using minimum assistance. During one trial each day, upper body resistance training was performed. Before and after each trial, patients were offered fluids with a prompting protocol that significantly increased fluid intake. Target goals for the exercise were set individually and adjusted on a weekly basis. (n = 92)
Individualised treatment plan by continence care nurse including anticholinergics, topical oestrogen, PFMT +/- biofeedback administered by registered nurses, dietary changes (elimination of caffeine and increased daily fluid and fibre intakes), prompted toileting (n = 27) 4 weeks of treatment with once-daily oral extended-release oxybutynin 5 mg (n = 26)
Patients prescribed with oxybutynin (n = 40 563) Patients prescribed with tolterodine (n = 40 563)
Intervention/s
Usual care from nursing home staff (n = 98)
Placebo (n = 24)
NA
NA
Control
People who had fallen during 8 months of intervention period, as documented in records. Compared to 6 months baseline measurement pre intervention.
Fall incidence during the 3 months prior, during (4 weeks) or 3 months after the trial, as documented in incident reports and progress notes
Hospital visit for a fall within 90 days of drug initiation (identified on the Canadian Institute for Health Information Discharge Abstract Database and National Ambulatory Care Reporting System) Fall incidence over 1-year intervention period as documented in medical record
Outcome measure
Control group: 14 at baseline; 21 at follow-up. Intervention group: 11 at baseline; 13 at follow-up. Authors report a significant difference between groups when comparing the change in number of people who had fallen pre and post intervention.
No differences between groups in the 3 months prior to trial (27%, 33%; P = 0.62), during (19.2%, 16.7%; P = 0.81) or 3 months after (30.8%, 41.7%; P = 0.42). No difference in median change in number of falls per month (P = 0.24–0.66). No treatment or period effect for the number of falls per month over time of observation (treatment effect, P = 0.24; period effect, P = 0.51).
321 (0.79%) tolterodine users compared with 294 (0.72%) oxybutynin users experienced a fall-related hospital visit within 90 days of drug initiation. No difference in risk. Falls decreased from 18 to 7 (61% decrease) compared to 1 year prior to intervention.
Result
i n t e r v e n t i o n s a n d
CVD, cardiovascular disease; GDS, Global Deterioration Scale; MMSE, Mini-Mental State Examination; PFMT, pelvic floor muscle training; SCI, spinal cord injury; UTI, urinary tract infection; NA, not addressed.
Female, aged ⱖ65, resident for ⱖ3 months in long-stay nursing home unit, MMSE score 5–23, GDS score 3–6, urinary incontinence, ability to swallow medication intact, medication adherence rate ⱖ80% during week before screening
Lackner et al. (2008) [23]
Klay & Marfyak (2005) [21]
Inclusion criteria
Study
Table 1: Summary of included studies
C o n t i n e n c e f a l l s
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limited to urinary incontinence, all the included studies targeted only those with urinary incontinence. One study [21] also included participants with symptoms of urgency from an overactive bladder. Two of the studies included female participants only [21,23]. Three of the trials were conducted in nursing homes [20,21,23], and the study by Gomes et al. [22] was not restricted to a particular setting. Interventions Two studies investigated the effect of pharmacological agents: Gomes et al. [22] compared oxybutynin with tolterodine within a 90-day period, and Lackner et al. [23] investigated the effect of 5-mg extended-release oxybutynin administered once daily for 4 weeks compared to a placebo. One study implemented prompted toileting every 2 hours between 08.00 and 16.00 hours in conjunction with a lowintensity exercise program over 8 months (also known as functional incidental training) [20]. Klay & Marfyak [21] investigated the use of a continence specialist nurse in designing an individualised treatment plan from a range of interventions including the use of anticholinergics, topical oestrogen, PFMT with or without biofeedback administered by registered nurses, dietary changes (elimination of caffeine and increased daily fluid and fibre intakes) and prompted toileting over the course of 1 year. Outcome measures Three studies reported the number of falls as an outcome measure but across varying time periods [21–23]. Gomes et al. [22] recorded falls that resulted in a hospital visit within 90 days from drug administration from data collected from relevant emergency department and hospital admission databases. Two of the studies [21,23] calculated the number of falls throughout the intervention period, which ranged from 4 weeks [23] to 1 year [21]. Lackner et al. [23] also compared fall incidence 3 months post intervention. Data were collected from documentation in the patients’ medical records. Lackner et al. [23] used incidence reports in addition to medical records for data collection. One study reported the number of people who had fallen only, comparing the difference pre-post intervention [20]. Effectiveness Of the three studies that used statistical tests to evaluate differences between groups [20,22,23], only the study by Schnelle et al. found a significant difference [20]. They found a difference between control and intervention groups for proportion of people who had fallen but not fall rate when comparing pre and post intervention. Lackner et al. [23] reported no difference in falls either during the intervention or in the 3 months post intervention, compared to the placebo group. Klay & Marfyak [21] administered a patientspecific program from a range of interventions designed by a continence nurse specialist and reported a post-intervention decrease in falls of 61% compared to pre-intervention; however, no statistical analysis was reported. 214
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Methodological quality The methodological quality of studies is summarised in Table 2. Of the four studies examined, two trials [20,23] were randomised controlled trials (RCTs). However, there was lack of therapist blinding and the study by Schnelle et al. [20] lacked participant blinding and intention-to-treat analysis. One study [22] was a retrospective, population, cohort study design. This allowed a large sample size to be investigated; however, lack of features such as a comparison group, randomisation and blinding resulted in unknown biases in patient selection and data analysis. Patient characteristics were not adequately described. Klay & Marfyak [21] conducted a preand post-study without a control group, comparing number of falls in the year prior to the year after intervention. The difference in the outcome was not examined statistically. There was generally a lack of justification of sample size, with only one study [20] doing so (see Tables 1 and 2).
Discussion This review found very few studies that investigated the impact of continence management interventions on falls, with only one intervention found to produce a statistically significant reduction in people who had fallen [20]. This intervention consisted of a regime of prompted toileting and a physical activity component undertaken every 2 hours with long-term care residents. In addition to the decrease in the proportion of people who had fallen seen in the intervention group, the study authors also reported differences in favour of the intervention group in frequency of urinary incontinence, physical activity and mobility endurance [20]. It is therefore difficult to isolate the effect of the continence management strategy on falls. The study by Klay & Marfyak [21] involved a multifactorial intervention. In this study, the intervention was individually tailored and therefore different for each of the 27 participants. Although they reported a reduction in fall incidence, the methodological quality of this study was poor. The small sample size and lack of a control group limited the validity and generalisability of these findings. However, the positive finding suggests that future studies might benefit from an individually tailored, multifactorial approach. It is important to note that the primary aim of the studies included in this review was not to investigate fall occurrence, and thus the study designs were not targeted directly at this outcome. The studies investigating the use of anticholinergics [22,23] sought to determine any adverse effects of these medications within this population, including a potential increase in falls due to the anticholinergic effects [24]. The use of antimuscarinics (e.g. oxybutynin, tolterodine) has been found to reduce the incidence of incontinence when compared to placebo or no treatment [25], thereby possibly decreasing falls. However, because of the anticholinergic side effects of these medications, they may also contribute to increased fall risk. This may have countered any benefits of improving continence on the incidence of falls, thereby limiting study findings. A scoping review examining the use of Australasian Journal on Ageing, Vol 32 No 4 December 2013, 211–216 © 2013 The Authors Australasian Journal on Ageing © 2013 ACOTA
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f a l l s
✓ ✗ ✓ ✓
antimuscarinic medications found insufficient evidence to conclude whether this form of treatment positively or adversely affected falls [26].
✓ NA ✓ ✓
✓ ✓ ✓ ✓
✓ ✗ ✓ ✓
The study by Gomes et al. [22] investigated only the occurrence of falls that resulted in an emergency department or hospital admission, and thus falls of less severity may have gone undetected. The validity of databases used in this study was not determined. It is therefore uncertain whether there was an effect on overall fall incidence, with the lack of a placebo group further preventing conclusions from being drawn.
✓ ✗ ✓ ✓
✓ NA ✓ NA
✓ NA NA NA
It is possible that the use of interventions with greater efficacy such as PFMT may have an identifiable impact on falls. An RCT by Kim and colleagues [27] demonstrated the effectiveness of PFMT as part of a 3-month multidimensional exercise program, with urinary incontinence decreasing 43.4% post intervention. Although significant improvements in functional decline were also noted (both of which are known risk factors for falls), the incidence of falls specifically was not included as an outcome measure, and thus direct conclusions cannot be drawn. Future studies could therefore implement a similar intervention in comparison to a control group, but include a fall-related outcome measure.
NA NA NA NA
✗ NA ✓ NA
One limitation of this review was that only English studies were included. The two studies that were excluded based on language may have provided additional insight into this area.
Conclusions
✓ ✓ ✓ ✓
✗ ✗ ✓ ✗
✓ ✗ ✓ ✓
NA ✗ ✓ ✓
Despite the evidence demonstrating an association between urinary incontinence and falls, there has been little research targeting continence as an intervention to reduce falls. We found it surprising, given the known relationship between these two factors, that there is not much research either into continence that includes falls as an outcome or into fall prevention that targets continence.
NA, not addressed.
✓ ✓ ✓ ✓ Gomes et al. (2011) [22] Klay & Marfyak (2005) [21] Lackner et al. (2008) [23] Schnelle et al. (2003) [20]
Clinical Drop outs Appropriate Purpose Relevant Participant Similarity Justification Outcome Outcome Intervention Contamination Co-intervention Results stated background characteristics at baseline of sample size measures measures described avoided avoided reported importance reported conclusions literature described reliable valid in detail in statistical reported significance
Table 2: Quality appraisal
C o n t i n e n c e
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Clearly, there is a need for a well-designed intervention study that specifically targets continence as one of the components and includes falls as a primary outcome [28]. Future research should include older people who have both high fall risk and incontinence, which include multifactorial interventions and interventions that are individually tailored to maximise adherence and efficacy. It is also important to clearly document what interventions are undertaken by individual older people in order to determine the effectiveness of specific interventions. Further research in this area could also include the investigation of the effects such interventions have in specific population groups (e.g. stroke, dementia) which have been found to have an increased incidence of incontinence [29,30]. In the interim, given the evidence supporting the association between urinary incontinence and fall risk, clinicians should seek to address this problem as part of their treatment plans 215
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and consider combining interventions aimed at improving continence with physical activity, as interventions aimed at improving functional mobility are likely to be beneficial for both falls and continence. This should include a thorough assessment of the nature of the continence difficulty and tailoring of interventions to take into account the associated fall risk.
10 11
12 13
Acknowledgement This study was funded by the Scobie Mackinnon Trust Fund.
14 15
16
Key Points • Urinary incontinence is a recognised risk factor for falls. • Combining incidental physical activity with a toileting regime may help reduce falls in people living in residential care. • It is still unclear whether interventions improving continence will also reduce the risk of falls in community-dwelling older adults.
17 18 19
20 21
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7
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