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CADTH Health Technology Review
Authors; Qiukui Hao, and Quenby Mahood.
In Canada, the population is rapidly aging; 1 in 10 people living in Canada will be aged 65 or older by 2036. For adults at the age of 65, life expectancy for males is 17.4 years and 20.8 years for females.1 The demand for personal care homes or nursing for older adults has been steadily increasing and new residents in these facilities were older and had more comorbidities and functional impairment.2 Many residents in these long-term care facilities are not born in Canada and did not speak English as their first language, which makes the health care in these facilities more complex and challenging.3
Personal care homes generally provide comprehensive care for older adults with disability, cognitive impairment, and other chronic illnesses, but they receive far less attention than other acute health care settings.4 At least 50% of residents in these facilities experience urinary incontinence,5,6 which is an essential indicator of the quality of life in older adults.7,8 Older adults with incontinence are at a relatively higher risk of acute urinary retention that needs to be addressed in the emergency department due to lower abdominal pain and distress.9,10
Traditionally, medical history and physical examinations are important for the diagnosis of acute urinary retention and conventional prompted voiding care was used for urinary incontinence management by prompting older residents to void after regularly asking the older adults every 2 or 3 hours whether they had the desire to void. Ultrasound plays an important role in the management of urinary tract diseases as a diagnostic aid or care assistant,11 particularly for individuals who may not be able to respond to prompted voiding and provide accurate medical history. For example, either bladder ultrasound or catheterization is required for the diagnosis of acute urinary retention.12 If a bladder ultrasound is immediately available, bladder ultrasound is a good first choice over catheterization, as it is noninvasive and more comfortable for people and if the results are normal, catheterization could be avoided.12
Bladder scanners are portable ultrasound devices and can be used to measure bladder volume, including postvoid residual (PVR) volume, and provide 3-dimensional bladder images. A health technology assessment published in 2006 by Health Quality Ontario suggested that portable bladder scanners were acceptable in the older population; however, evidence regarding the clinical effectiveness of bladder scanners for long-term care facility settings was limited.13 Previous studies determined that using bladder scanners had acceptable sensitivity, specificity and excellent test-retest and interrater reliability for obtaining the PVR among nursing home residents with incontinence.14
The cost of bladder scanners might be a barrier to their application in the long-term care setting.14 Furthermore, nursing knowledge, training, scopes of practice, and related education also affect its widespread use in these settings.15-17 To support the decision-making about bladder scanners in personal care homes, we prepared this Rapid Response report to summarize available studies and evidence-based guidelines regarding the clinical effectiveness and cost-effectiveness of bladder scanners in these specific settings.
A limited literature search was conducted by an information specialist on key resources including MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Database of Systematic Reviews, the International HTA Database, the websites of Canadian and major international health technology agencies, as well as a focused internet search. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were bladder and scans and portability or personal care homes. CADTH-developed search filters were applied to limit retrieval to guidelines for an additional search of the concepts bladder and scans. The search was completed on January 19, 2023 and limited to English-language documents published since January 1, 2013. Conference abstracts were omitted from the search results.
One reviewer screened citations and selected studies. In the first level of screening, titles, and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.
Selection Criteria.
Publications were excluded if they did not meet the eligible criteria outlined in Table 1. Duplicate publications, studies published before 2013, or non-English publications were excluded. Studies with unclear settings, expert opinions or guidelines with unclear methodology were also excluded.
One reviewer critically appraised the included studies using the Downs and Black checklist18 for randomized and nonrandomized studies. Summary scores were not calculated for the included studies; rather, the strengths and limitations of each included publication were described narratively.
A total of 549 citations were identified in the literature search. Following the screening of title and abstracts, 507 citations were excluded and 42 potentially relevant reports from the electronic search were retrieved for full-text screening. Sixteen potentially relevant publications were retrieved from the grey literature search for full-text screening. Of these 58 potentially relevant articles, 56 were excluded for various reasons. This report includes 2 primary studies (one randomized controlled trial [RCT] and 1 before-and-after study).19,20 Appendix 1 presents the PRISMA flow chart21 of the study selection. Additional references of potential interest are provided in Appendix 5.
This report included 2 primary clinical studies.19,20 We did not identify any systematic reviews, health technology assessments, economic evaluation reports or evidence-based guidelines that met inclusion criteria. Additional details regarding the characteristics of included publications are provided in Appendix 2 (Table 2).
Two primary clinical studies conducted in Japanese personal care homes (study authors originally used “nursing home” to describe study setting) were included in this report.19,20 One study was a cluster RCT published in 201919; the other was an uncontrolled before-and-after study published in 2016.19 The cluster RCT randomized 13 personal care homes into the intervention (n = 7) and the control group (n = 6) with a ratio of 1:1 in western and eastern parts of Japan.19 Two of the 13 personal care homes did not provide eligible older residents (one each for the intervention and the control group), leaving 11 eligible personal care homes (n = 5 for the intervention group and n = 6 for the control group) in this study.
Both eligible studies were conducted in Japan.19,20 The cluster RCT enrolled 13 personal care homes from the western and eastern parts of Japan.19 The uncontrolled before-and-after study included 6 personal care homes in the Kanto area of Japan.20
The publications identified for this report included older adults (65 years or older) with urinary incontinence residing in personal care homes. For patients in the cluster RCT, 62/80 (77.5%) of patients were female with a median age of 85 years, a median Carlson comorbidity index of 3, a median mini-mental state examination score (MMSE) of 15, and 40 of 80 (50%) of patients were almost fully dependent and required extensive assistance in daily activities from their caregiver.19 For patients in the uncontrolled before-and-after study, 59 of 77 (76.6%) were female with a mean age of 84.1 years, and 41 of 77 (53%) of patients were almost fully dependent on their caregiver.19 The caregivers of patients also participated in the 2 studies with a median age of 42 in the RCT intervention group and a median age of 36 years in the RCT control group; and a mean age of 36 years in the before-after study; their professional career was around 11 years in the cluster RCT and 6 years in the uncontrolled before-and-after study.19,20
The intervention was ultrasound-assisted prompted voiding (USAPV) care using a portable ultrasound device for 8 weeks in the cluster RCT.19 First, caregivers calculated the patient participant’s optimal intravesical urine volume for voiding by the sum of the mean values of voided volume and residual volume. Then, caregivers used the portable ultrasound device regularly to monitor the urine volume in the bladder every 2 to 3 hours and prompted the patients to void when the intravesical urine volume was more than 75% of the individually precalculated bladder capacity. The comparator was the conventional prompted voiding care without residual urine volume measurement. Patients in the comparator group were regularly asked every 2 to 3 hours by their caregiver if they desired to void and prompted patients to void when the response was yes. The uncontrolled before-and-after study used a similar intervention to the cluster RCT for 12 weeks and compared the outcomes to baseline values in the same group.20
The cluster RCT19 reported the following as their primary outcome measures for efficacy: the change in the amount of urine loss during the day measured by weighing the incontinence pads and quality of life (QoL) measured by EQ-5D (ranging from −0.59 to 1.00 with higher scores indicating better QoL)22 from baseline to the end of the intervention. The secondary outcomes in this study included the score of mental state measured by MMSE (ranging from 0 to 30 with higher scores indicating better function),23 depression measured by the Geriatric Depression Scale (GDS, ranging from 0 to 30, with higher scores indicating greater severity of depression),24 physical function measured by the Barthel index (ranging from 0 to 100, with higher scores indicating greater physical function)25 and “level of motivation” measured by the vitality index (ranging from 0 to 10 with higher scores indicating greater motivation level).26 The study also reported the change in caregivers’ QoL measured by SF-12v2 (ranging from 0 to 100, with higher scores indicating better QoL)27 and mental stress for care burden with the visual analogue scale (ranging from 0: not stressful at all to 100: very stressful).
The primary outcome of the uncontrolled before-and-after study20 was the change in absorbent cost from the week before baseline to the end of the study. Absorbent cost (the cost to the facility for incontinence pads) was used as a surrogate measure of incontinence; a reduction in cost would be interpreted as a reduction in the use of incontinence pads and associated incontinence (urine loss). The activities of daily living (ADL) of patients were measured by the vitality index, which is a validated tool consisting of 5 subscales: walking, communication, feeding, toileting, and rehabilitation (total score: 0 to 10 with higher scores indicating greater ADL). The study also reported the change in the QoL of caregivers measured by SF-36 with 8 subscales (ranging from 0 to 100 with higher scores indicating better QoL).
The cluster RCT clearly reported study objectives and process, inclusion and exclusion criteria, intervention and comparator, participant characteristics, outcome measures, and the main findings.19 The RCT did not have patients lost to follow-up during the intervention and indicated good adherence to the intervention. The study assessed the impacts of the intervention on QoL and care burdens, which may be important outcomes to consider for decision-making. The cluster RCT was a preregistered clinical trial (No. UMIN000017963) with the study protocol available for the public28 and reported all planned outcomes in the protocol. In the analysis, to adjust for some potential confounding factors, the researchers calculated a propensity score and adjusted the score in the final model. The study was funded by an academic association in Japan, which may have little influence on potential publication bias. Additionally, the RCT included 13 personal care homes in the geographical cluster of western and eastern parts of Japan, which probably had a good representation for Japanese personal care homes.
Several methodology limitations need to be mentioned in the cluster RCT.19 First, the study may have been underpowered in detecting an important difference in QoL. The study authors also did not consider intracluster correlation for sample size calculation, which underestimated the required sample size for the daytime urine loss outcome. According to the underestimated calculation based on relative rate of urine loss reduction, the study required 92 patients. However, the study only included 80 patients who met the eligibility criteria and reported results for absolute daytime urine loss. Second, this study was an open-label study, which did not attempt to use blinding during the study. Considering the practical issues of the study, blinding patients and caregivers would be difficult to achieve. To help reduce the performance bias, the outcome assessors should have been blinded to treatment allocation. Third, the study randomized at the cluster level, but their analysis was based on the individual patients and did not assess the cluster mean for outcomes at baseline across different clusters, which was recommended for the analysis of cluster randomized trials.29 The daytime urine loss at baseline was significantly higher in the intervention group than in the control group (median 300 mL versus 150 mL, P < 0.05), which suggests that patients in the intervention group experienced more incontinence at baseline. This may result in a bias to favour the intervention. Fourth, the final logistic regression model to evaluate the effect of the intervention (the propensity score-adjusted odds ratio) needed to be clarified. The dependent variable in the model seems to be individuals whose daytime urine loss decreased by more than 25%, but the independent variable was unclear in the model. The study authors did not report the propensity score-adjusted odds ratio for improving urine loss in the result section.
The uncontrolled before-and-after study clearly reported study objectives, inclusion and exclusion criteria, intervention details, participant characteristics, outcome measures and the main findings.20 The study did not have patients lost to follow-up during the intervention and indicated good adherence to the intervention. The study assessed the impact of the intervention on caregivers’ QoL and ADL for patients, which may be important considerations for decision-making. The study was funded by an academic association in Japan, which may have little influence on potential publication bias.
There are several methodology limitations in the before-and-after study.20 First, the sampling methods needed to be clearer. The study seems to have used convenience sampling of personal care homes, which may have reduced sample generalizability to other settings. Second, the study did not report the sample size calculation. It is unclear whether the study had enough power to detect statistically significant changes in patients’ ADL and caregivers’ QoL. Third, due to the nature of the study, the study did not have a control group. It is difficult to attribute the before-and-after changes to the effect of the intervention. The study reported the absorbent cost as their primary outcome, which was a surrogate outcome for the effectiveness of using a bladder scanner for the management of incontinence. It is possible that factors beyond the amount or severity of patient incontinence could have contributed to levels of incontinence pad use or purchasing. Fourth, the study used the paired t-test to compare the weekly absorbent cost across baseline, 4 weeks, 8 weeks and 12 weeks, which would increase the type I error. For repeat measures without missing data, a better statistical method would be repeat repeated measures ANOVA.
Additional details regarding the strengths and limitations of included publications are provided in Appendix 3 (Table 3).
A cluster RCT and an uncontrolled before-and-after study reported the clinical effectiveness of using bladder scanners (portable ultrasound devices) to assist conventional urinary incontinence care for older personal home residents and assess the impact on their caregivers.19,20 No relevant evidence was available for the cost-effectiveness of bladder scanners for personal care homes and no eligible guidelines were identified in this report.
Appendix 4 presents the main study findings.
A cluster RCT included older personal home residents (n = 80) with urinary incontinence and compared the changes in daytime urine loss between intervention and control groups as 1 of the primary outcomes.19 The study found that the absolute decrease from baseline in daytime urine loss at the end of treatment (8 weeks) was statistically significantly greater in the USAPV group than conventional prompted voiding (CVP) group, in both adjusted and unadjusted analyses (Table 4).
One uncontrolled before-and-after study 20 evaluated absorbent costs incurred by a personal care home before and after the implementation of a USAPV protocol as a surrogate measure of USAPV effectiveness to manage urinary incontinence. This study reported a statistically significant reduction of 11.8% in weekly absorbent cost from baseline to the end of the USAPV intervention. The study also reported 40 of 77 (51.9%) patients with reduced absorbent cost and 3 of 77 (3.9%) patients being pad-free at the end of the USAPV intervention. Patients with fair bladder function showed statistically significantly greater cost reduction from baseline than patients with poor bladder function. Patients with care-needs levels 1 to 3 tended to have a greater relative cost reduction than patients with care-needs levels 4 to 5 (almost dependent in physical function), but the difference was not statistically significant (Table 5).
The other primary outcome for the eligible cluster RCT was patients’ QoL measured by EQ-5D.19 The study found that there was no statistically significant change in patients’ QoL from baseline within the USAPV group (P = 0.42) and within the CPV group (P = 0.72) (Table 6). The study also reported that the changes from baseline in patients’ mental state (measured by MMSE), depression level (measured by GDS) and physical function (measured by Barthel index) were not statistically significant within either the USAPV group or the CPV group (Table 7, Table 8, Table 9).19 Both included studies evaluated patients’ motivation and ADL (measured by the vitality index) and reported no statistically significant differences from baseline within the USAPV group19,20 or within the CPV group19 (Table 10).
Two studies19,20 reported the impacts of USAPV on caregivers’ QoL measured by SF-12v2 or SF-36. The uncontrolled before-and-after study20 reported that the management of urinary incontinence using USAPV statistically increased care worker’s QoL in role emotional and mental health subscales of SF-36 from baseline to the end of treatment. However, the cluster RCT did not find statistically significant changes from baseline to the end of treatment within the USAPV group and within the CPV group19 (Table 11).
A cluster RCT19 reported that there was no statistically significant increase in caregivers’ care burden (measured by a visual analogue scale [VAS], 0 to 100, a higher score indicated more care burden) from baseline within the USAPV group; whereas, there was a statistically significant increase in caregivers’ care burden from baseline within the control group. However, the change in caregivers’ care burden from baseline was not statistically significantly different between the USAPV group and the CPV group (Table 12).
No cost-effectiveness evidence regarding bladder scanners for personal care homes was identified; therefore, no summary can be provided.
No evidence-based guidelines regarding bladder scanners for personal care homes was identified; therefore, no summary can be provided.
The body of evidence that was identified to address the clinical effectiveness research question was limited, consisting of 1 cluster RCT and 1 uncontrolled before-and-after study.19,20 All participants in the 2 eligible studies were from Japanese personal care homes and the uncontrolled before-and-after study was the precursor to the RCT. Both studies were conducted by the same Japanese research team. It seems that both studies included personal care homes in which all caregivers had adequate knowledge of portable bladder scanners and with good resources for potential ultrasound training or supervision; similar results may not be expected for other settings with fewer resources. Certainty in the effectiveness findings for the intervention from the uncontrolled before-and-after study was limited due to the study design.20 Only 1 RCT was identified to examine the effectiveness of the intervention in this report.19 All available evidence was limited to Japan. The generalizability to personal care homes or other settings in Canada was also unclear.
All eligible patients for the included studies had urinary incontinence and most of them (more than 70%) were female.19,20 The generalizability of findings to populations with other conditions (e.g., urinary retention) or to older males was unclear. Both studies followed patients up to the end of the treatment (either 8 or 12 weeks). The long-term effects of using portable ultrasound or whether the effects of the intervention can be maintained were not assessed.
When interpreting the evidence, only statistical significance was identified and considered; minimal important differences for all outcome measures were not reported. No evidence was identified that evaluated bladder scanners with respect to potential harms (e.g., patient discomfort, urinary tract infection, health care-acquired infection) and for preventing emergency department visits or catheterization. Finally, no evidence for the cost-effectiveness of bladder scanners for personal care homes and evidence-based guidelines regarding bladder scanners for personal care homes were identified.
A cluster RCT19 and an uncontrolled before-and-after study20 were identified to address the clinical effectiveness of bladder scanners for personal care homes. The 2 studies provided limited evidence suggesting that using a bladder scanner to assist prompted voiding care to manage urinary incontinence (for 8 weeks or 12 weeks) reduces patients’ daytime urine loss and absorbent cost without increasing caregivers’ care burden. However, there were no statistically significant differences in any patient important outcome measures (QoL, mental state, depression, physical function and level of motivation) between baseline and the end of the treatment or between the intervention and control groups. The uncontrolled before-and-after study had significant limitations in study design and the methodologies, such as convenience sampling, and inappropriate statistical analysis methods.20
All studies were conducted in Japan, and the generalizability of the evidence to Canadian personal care homes was unclear. No evidence was identified for potential harms or for preventing emergency department visits or catheterization. No evidence regarding the cost-effectiveness and evidence-based guideline of bladder scanners for personal care homes was identified that met the inclusion criteria for this report.
Indirect evidence from hospital or postoperative settings may be helpful for decision-making. For example, Donaldson and colleagues reported that PVR volume measured by bladder scanners can be used for decision-making and cost-effectiveness analysis for health care utilization (ambulatory office emergency visits) among postoperative patients.30 Chen and colleagues reported that using portable bladder scanners reduced the incidence of urinary tract infections for patients with acute ischemic stroke.31
In addition to the clinical evidence, decision-makers may wish to consider whether local health care providers’ or caregivers’ knowledge of ultrasound, the related cost for the device and potential training, or other practical issues impact the application of bladder scanners. The local prevalence of urinary incontinence, people’s values and preferences on daytime urine loss, and local absorbent costs may also affect the application of the available evidence.
The current report identified some research gaps in the body of evidence regarding using bladder scanners for personal care homes. Providing robust evidence on the impact of bladder scanners for the management of acute urinary retention and on other outcomes, like catheterization and emergency department transfers, will require future studies with enough statistical power and using robust designs.
randomized controlled trial
standard deviation
mini-mental state examination score
quality of life
ultrasound-assisted prompted
conventional prompted voiding
Geriatric Depression Scale
36-Item Short Form Survey
Short Form 12 item (version 2) Health Survey
EuroQoL-5D
Activities of Daily Living
Selection of Included Studies.
Note that this appendix has not been copy-edited.
Characteristics of Included Primary Clinical Studies.
Note that this appendix has not been copy-edited.
Strengths and Limitations of Clinical Studies Using the Downs and Black Checklist.
Note that this appendix has not been copy-edited.
Summary of Findings by Outcome — Daytime Urine Loss.
Summary of Findings by Outcome — Absorbent Cost.
Summary of Findings by Outcome — Patients’ QoL Measured by EQ-5D.
Summary of Findings by Outcome — Patients’ Mental State Measured by MMSE.
Summary of Findings by Outcome — Patients’ Depression Level Measured by GDS.
Summary of Findings by Outcome — Patients’ Physical Function Measured by Barthel Index.
Summary of Findings by Outcome — Patients’ Level of Motivation or ADL Measured by Vitality Index.
Summary of Findings by Outcome — Caregivers’ QOL.
Summary of Findings by Outcome — Change in Caregivers’ Care Burden Measured by VAS.
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