systematische review ultrasound bladder scanner oct. 2016
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Systematic Review on effectiveness and cost effectiveness of ultrasound bladder scanner for
postvoidal measurement in reducing unnecessary catheterization and the risk of urinary tract
infection associated with catheterization
Attia, D 1, Hiligsmann, M.1, Hellinckx, H3, Wijnen, B.F.M1 , Evers, S.M.A.A.1, 2
1 Department of Health Services Research, CAPHRI School for Public Health and Primary Care,
Maastricht University, Maastricht, The Netherlands
2 Trimbos Institute, National Institute of Mental Health and Addiction, Utrecht, The Netherlands
3 Health Economics and Outomes Research (HEOR) beMedTech, Belgium
Dalia Attia
Student ID I6106301
1st academic supervisor: Silvia Evers
2nd academic supervisor: Mickaël Hiligsmann
Institutional supervisor at BeMedTech, Belgium: Hans Hellinckx
MSc Healthcare Policy, Innovation and Management
Faculty of Health, Medicine and Life science
Maastricht University
Year 2016
Journal: Clinical Nursing Journal
Article Words: 4965 without tables and appendixes
(Submissions should not exceed 8,000 words, excluding abstract, tables, figures, and reference
list.as per criteria for review articles on clinical nursing journal. And not less than 3000 words)
Abstract: 294
(Should not exceed 300 words)
40 pages
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ABSTRACT
Background: Ultrasound bladder technology has been adapted as a bladder assessment tool
of urine retention and to measure Postvoid residual urine volume instead of intermediate
catheterization. Due to the significance of bladder ultrasound in reducing undesirable
complications of catheterization, this review aims to examine (up-to-date) evidence on
effectiveness and cost-effectiveness of this new technology, alongside with the methodological
quality of all recent studies.
Method: Systematic search were limited to English-language studies in humans from the
year 1985 to June 2016. The Studies documenting incontinent hospitalised patients to evaluate
bladder urinary volume in different healthcare settings, and using ultrasound bladder scanner as
an alternative to catheterization, and avoiding urinary tract infections associated with
catheterisation Any relevant experimental designs were included, as well as any partial or full
Economic Evaluation. Each article was critically appraised for quality using special tools.
Result: the review yielded 29 relevant studies with methodological quality ranging from
moderate to high. In spite of different device models; users; patient positions; or healthcare
setting, results were consistent and can be generalized revealing accuracy of bladder volume
assessment by bladder scanners. Seven studies with sufficient sample size demonstrated a
reasonable reduction in UTI rate and avoidance of unnecessary catheterization. Three of them
evaluated the cost savings partially. Nevertheless; no complete economic evaluation were found to
document the device cost-effectiveness.
Conclusion: the review evolved by providing sufficient evidence on the device accuracy to
the evaluation of clinical benefits in diagnosing retention without the use of intermittent
catheterization thus decreasing the costs associated with catheterization and reducing the risk of
urinary tract infection.
Relevance to clinical practice: ultrasound bladder should commonly be used by nurses and
specialists in peri-operative units, neurology units, obstetrics-gynecology units, long-term care,
home care and rehabilitative units, to verify retention prior to catheterization.
Keywords: Urinary retention, urinary tract infection, UTI, Ultrasound bladder, CAUTI,
nosocomial infection, Cost-effectiveness
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Contents
SUMMARY ........................................................................................................................................ 1
1. INTRODUCTION ........................................................................................................................ 4
1.1 Background ............................................................................................................................ 4
1.2 New clinical guidelines and recommendations ....................................................................... 4
1.3 Aim of the study ..................................................................................................................... 5
2. METHOD ................................................................................................................................... 5
2.2 Literature Search .................................................................................................................... 6
2.3 Data Extraction....................................................................................................................... 6
2.4 Quality Assessment ................................................................................................................ 6
2.5 Evidence Synthesis ................................................................................................................. 6
3. RESULTS ................................................................................................................................... 7
3.1 Study Selection ..................................................................................................................... 7
3.2 Study characteristics ............................................................................................................. 7
3.3 Methodological quality ......................................................................................................... 17
3.4 Summary on Accuracy of Bladder Scanners Results .............................................................. 20
3.5 Summary on Health Outcomes of Bladder Ultrasound .......................................................... 26
4. DISCUSSION ............................................................................................................................ 31
5. CONCLUSION ............................................................................................................................. 32
6. RELEVANCE TO CLINICAL PRACTICE........................................................................................ 32
APPENDIX 1: List of abbreviations .......................................................................................... 33
APPENDIX 2: Search string, inclusion and exclusion criteria ................................................... 34
APPENDIX 3: EPH PP GLOBAL SCORING ................................................................................... 35
REFERENCES ........................................................................................................................... 36
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1. INTRODUCTION
1.1 Background
Urinary retention (UR) is not considered a life-threatening symptom, however, it constitutes
to a long-term burden on the individual and institutional expenditures as well as negative impact
on quality of life of patients (1). UR is the inability to empty the bladder voluntarily or tolerating it
being full, and can be diagnosed as acute UR or chronic UR. UR is more common in elderly men than
women and its incidence is more frequent in the postoperative period (1, 2).
To diagnose the UR, a quantitative measure for bladder management is used to measure
Postvoid residual urine volume (PVR) as recommended by the clinical practice guidelines prepared
by the agency for health care policy and research(3). A traditional technique like catheterization is
used to measure the amount of urine in the bladder immediately after urination PVR (1, 2). Many
studies have shown that UR has been associated with poor outcomes including urinary tract
infection, bladder overdistension, urethral trauma and higher hospital mortality rates, as direct
clinical complications.
One of the main side effects of catheterization is urinary tract infections (UTIs), also called
nosocomial infection, which further increase hospital length of stay. The estimated cost of treating
a UTI ranges from $500 to $1000 per patient while the risk of developing UTI increases 3% to 6%
each day a catheter remains indwelling (4). Furthermore, results indicated a possible $3.64 cost of
each catheter tray supply and $680 cost per each UTI (5). These estimations were also emphasized
by Meddings et al. who stated that catheter-related UTI is associated with an additional cost of $676
per admission (or $2836 if further complicated by bacteraemia), when an unnecessary urinary
catheter is forgotten (6).
Although catheterization is the most common diagnostic procedure in primary healthcare to
measure urine volume, yet it has many drawbacks like being painful and uncomfortable for the
patient leading to lower patient satisfaction. Another significant problem is the high incidence of
urinary tract infection due to the passage of bacteria through a catheter into urethra causing a kind
of infection called catheter-associated urinary tract infection (CAUTI) (2).
Moreover, routine catheterization can be even more challenging for cognitive impaired
patients or physically disabled patients after hip fracture or stroke, causing a higher burden on the
nursing staff at PHC and decreased quality of life of patients and their caregivers at home (1, 2).
As an alternative technology, Mevcha & Drake stated that portable ultrasound bladder (UB)
offers a portable, non-invasive, painless method which satisfies patient's comfort and dignity
(2010). Additionally, there is an indirect benefit by safely avoiding urinary infection or urethral
trauma caused by catheterization. Lastly, direct and indirect savings in nurses' time, tools for
catheterization, laundering, and medical imaging services are being recognized to counterbalance
the costs associated with implementing PBU (2, 7).
1.2 New clinical guidelines and recommendations
In general, urinary tract infection (UTI) has long been considered the most common
healthcare-associated infection (HAI), which can be mostly preventable. UTI accounts for 40% of all
hospital-acquired infection, 32% of them are linked to CAUTI which is a life-threatening infection
(3). Given its clinical significance, many published guidelines and protocols to prevent CAUTI,
advocate for the reduction of unnecessary catheterization and removal the catheter as soon as
possible. Some of them have mentioned the use of ultrasound bladder (UB), like “Bladder Bundle”
implemented by the Michigan Health and Hospital Association (MHA) Keystone Center for Patient
Safety & Quality, and “Urinary retention protocols” also called catheter restriction protocols,
recommend the integration of portable bladder ultrasound to verify retention prior to catheterization
(6).
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1.3 Aim of the study
The association between urinary catheterization and urinary tract infection is well
documented in the literature (1, 2, 5, 8). A recent meta-analysis was found to be conducted in
2010 by Palese et Al, who stated that overall evidence on using ultrasound bladder scanner
helping the reduction in risk of urinary tract infection associated with catheterization was
consistent, and concluded that UB significantly reduced the risk of CAUTI by 73%, however, lack of
assessing study quality was considered the main limitation for this study (1). Therefore, more
research for clinical and cost effective alternatives is still needed.
Previous research shows positive results regarding the effectiveness of UB and reducing
CAUTI. There is also an assumed potential of UB to be cost-effective for reducing undesirable
complications of catheterization and decreasing unnecessary catheterization. We decided to
conduct a systematic review which aims to examine (up-to-date) evidence concerning the
methodological quality of all recent studies and the effect of this quality on the interpretation of
effectiveness and cost-effectiveness results.
2. METHOD
2.1 Study PICO
Device and comparator
There are two methods for assessing PVR urine volume: sterile catheterization as a direct
method and bladder ultrasound as an indirect method.
A catheter is a soft, thin, flexible tube that is inserted through the urethra to drain urine
from the bladder. Post-void residual is the removal of urine remaining in the bladder after the
person has urinated through the placement of a catheter and functions to measure the extent of
PVR (one-time or intermittent catheterization) and to decrease the build-up of urine in the bladder
(indwelling catheterization). Catheterization, as mentioned earlier, is one main cause of bladder
infections, UI, and permanent damage to the urinary system, especially the bladder and kidneys (1,
2, 8).
Urinary bladder ultrasound products are an automated technology used as a diagnostic aid
by Healthcare professionals (primarily nurses), who administer the device to measure PVR volume
and prevent unnecessary catheterization (8).
Due to its non-invasive nature, the use of ultrasound technology may reduce the risk of
urethral trauma and urinary infection associated with catheterization. The BU is available in both
3-dimensional (3D) and 2-dimensional (2D) versions. There is also portable ultrasound machines
offer potential benefits over the stationary machines due to transferability and ease of use (9).
Population
The scanner is used, in adults and children with urinary problems, as follows:
• postoperative patients at risk of urinary retention (UR);
• patients with UTIs, urinary incontinence (UI), enlarged prostate, urethral stricture,
neurogenic bladder and other lower urinary tract dysfunctions; and
• Patients with conditions that interfere with voidings, such as spinal cord injuries,
stroke, and diabetes.
All age ranges were included in our review from newborn to geriatrics.
Outcome
To indicate effectiveness, in terms of accuracy, we reported on estimation mean difference
between control and intervention group (mL), and how significant the difference (P<0.05) was. We
also used % or number to rate the reduction in the incidence of UTI and avoidance of unnecessary
cauterization.
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For the economic evaluations of UB, either full or partial, we reported on cost-benefit or cost
savings (in monetary value) and incremental cost by (number of years) or Cost-effectiveness (in
terms of incremental cost-effectiveness ratio ICER).
2.2 Literature Search
The following electronic databases were searched: Medline and NHSEED to identify all
English language studies available in print or online between January 1985 and July 2016. We have
chosen the NHS Economic Evaluation Database (NHS EED) to identify as many studies on economic
evaluations in the literature as possible (available through www.york.ac.uk/inst/crd)
The search strategy included information on the problem/population, intervention,
comparison, outcome, type of treatment, type of study (PICOTT), as medical technology is
evaluated (Schardt, 2007). Based on the last existing published meta-analysis on UB, we generated
our search terms (1). Search terms, Inclusion and exclusion criteria for study selection are
enclosed in Appendix 2.
The articles were assessed for eligibility in 2 stage process by a single reviewer. Initially by
reviewing study titles and abstracts and additionally by critical reading for full text was applied to
exclude the articles that did not meet the selection criteria. More literature was also identified by
citation tracking using reference lists from retrieved papers, after removing duplicates.
One researcher undertook the initial literature search, scanning abstracts to identify eligible
studies. If it was unclear as to whether the study met the selection criteria, advice was sought from
a second researcher and a consensus opinion made.
2.3 Data Extraction
Key data were independently extracted from the identified papers using a structured form
(extraction matrix). Data extraction forms included the key components of general study
information (title, author, and country of study), study characteristics (population data,
intervention, and comparator) and outcome.
2.4 Quality Assessment
All articles were assessed for quality, by two researchers, using the Effective Public Health
Practice Project (EPHPP)(10). A global scoring was given of strong, moderate or weak, based on six
criteria: overall study design, whether or not there was selection bias, confounding, blinding, data
collection method and finally a number of withdrawals and dropouts.
This standardized tool was developed by EPHPP in order to provide high-quality systematic
reviews for evidence to support the practice. This tool has been evaluated for content and initial
construct validity and inter-rater reliability.
2.5 Evidence Synthesis
A meta-analysis was not possible due to the heterogeneity of the interventions, settings,
participants, and outcome measures. Instead, a rating system of levels of evidence to draw
conclusions on effectiveness, based on previously used best evidence syntheses was used.
Three levels of strength based on the basis of study design, methodological quality (EPHPP)
were defined: STRONG, MODERATE, WEAK. Conclusions were drawn on the basis of the consistency
of results of studies with the highest available level of quality.
As per EPHPP recommendation (Appendix 3), we rated overall STRONG if no weak ratings,
MODERATE if one weak rating, and WEAK if 2 or more weak ratings of the 6 criteria: Selection Bias,
Study Design, Confounder, Blinding, Data Collection, and Withdrawal.
GLOBAL RATING FOR THIS PAPER:
1 STRONG (no WEAK ratings)
2 MODERATE (one WEAK rating)
3 WEAK (two or more WEAK ratings)
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3. RESULTS
3.1 Study Selection
Figure 1 Prisma diagram for Medline and NHS EED search results
The search strategy in Medline and NSHEED using combinations of free search terms, as
mentioned above, yielded 37 articles, 2 were duplicate and excluded. Thirty-five articles were
scanned for their title and abstract and eventually 3 articles were excluded due to a non-relevant
outcome. After critically reading the full text and applying the selection criteria, 15 articles were
excluded due to different parameters, intervention, comparator, and reviews. The remaining 17
articles met the general inclusion criteria, while citation tracking led to the inclusion of 12 additional
potentially relevant articles.
Only one economic evaluation (5) and one HTA (8) were included while searching on NHS
EED.
The reason for excluding articles was due to one or more of the following reasons: 1) general
non-relevance, 2) different study type, not clinical trial or cost evaluation study, 3) different
comparator 4) different outcome measures or/and 5) insufficient data
3.2 Study characteristics
Population
There were no limitations on the number of population which ranged from 15 – 4119
participants. The study of (11) with 4119 participants was an outlier because the rest of the studies
range between 11 – 281 participants. Mean age and gender were clearly mentioned in all papers;
+ 12 potentially relevant articles from reference search
TOTAL of 29 ARTICLES
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however, ethnicity was missing in most of them. Heterogeneity is overarching settings, age, gender
and inclusion criteria, which might constitute a threat to the external validity of the results of this
review. (Table.1)
Intervention
In all the studies the intervention groups were scanned by BU to measure intermediate
catheterization. Heterogeneity emerges from the intervention adopted since different ultrasound
bladder scanner models were used, BVI 2000, BVI 2500, BVI 2500+, BVI 3000, BVI 5000. (Table.1)
Settings and duration
Settings vary from one paper to another among postoperative patients, pediatric,
neurogenic, geriatric, postpartum, urology patients and patients in rehabilitation centers for long-
term care of different indications. In addition, the frequency with which the bladder was evaluated
was not completely documented while the duration of studies ranges between 2-24 months.
Outcome
The clinical outcome of our primary interest was accuracy in quantifying bladder volumes,
measured by a mean difference (ml), correlation coefficient (r2), or bladder distension defined as a
bladder volume >500 ml (%). Further health outcomes on patients, nurses and hospitals are
measured by different indicators like reduction of unnecessary catheterization, reduction in UTI
and antibiotic use. Cost savings were also measured in terms cost expenditure of time and of
human and material resources. ICER was not found in any of the studies.
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TABLE 1: The characteristics of the study population, type, and duration of intervention and relevant outcome results
Arranged by descending date
# AUTHORS OBJECTIVES/
OUTCOME
STUDY
TYPE
COUNTR
Y
SETTINGS PARTICIPANTS INTERVENTION CLINICAL OUTCOME COST
EVALUATION
# INC SEX
N or %
of
female
s
AGE Device
model
Frequency
Follow-up
device
1 (12)
Is UBS a valid
technique for
measurement of
postpartum urinary
bladder volume?
Cohort
analytical
study
MALAYSI
A
Obstetrics
and
Gynecology
Dep.
190
Post-partum
women
All F 16-
47
Mean
26.9
BVI
3000
190:1 per
catheter
3 months
• 1ry: accuracy
measurement of BV in
postpartum women
• 2ry: correlation bet
body weight and
accuracy of
measurement
-
2 (13) Explore whether
close preoperative
ultrasound
monitoring starting
in the emergency
room (ER) could
prevent
postoperative
bladder distension
among acute
orthopedic patients
Randomiz
ed
control
trial
SWEDEN ER to an
orthopedic
ward for
acute
surgery
281 Inclusion
criteria were
admittance
via the ER to
an
orthopedic
ward for
acute surgery
171 F Above
16
BVI
3000
21 months
• 1ry: accuracy
measurement of BV in
postoperative
distention, defined as
a bladder volume
>500 ml.
• 2ry: UTI and hospital
length of stay.
-
3 (14) Compare the rates
of unnecessary
catheterization, UR
and UTI in post-
operative patients,
before and after
implementing a
bladder ultrasound
program in
neurosurgical units
Quasi-
experime
nt
TAIWAN Two
neurosurge
ry unit
/ National
University
Hospital
244
Age ‡18
Pts
hospitalized
in
neurosurgica
l units
119 F 63·3
± 14y
ears
in CG
55·6
± 18y
ears
in SG
BVI
5000
9 months • 1ry: bladder
distension, defined as
a bladder volume
>500 ml
• 2ry: Unnecessary
catheterizations
• 3ry: UTI in
postoperative pts
before and after
-
10 | P a g e
implementation of the
program
4 (15)
Monitoring urinary
bladder volume and
detecting
postoperative
urinary retention in
children with an
ultrasound scanner.
Quasi-
experime
nt
NORWAY Anesthesiol
ogy
Departmen
t /
University
Hospital
48
Children
0-15 years
- Mean
= 3y
BVI
3000
1 year
• Accuracy in children
above and below 3
years
-
5 (16) Detecting
postoperative
urinary retention
with an ultrasound
scanner
Quasi-
experime
nt
NORWAY postanesth
esia care
unit (PACU)
36 Pts
undergoing
spinal
anesthesia
19 F Mean
=50
(20-
86 )
BVI
2500+
1 year • Accuracy in post-
operative adults
-
6 (8) Economic model to
estimate cost
savings
Economic
model
Ontario
canada
complex
continuing
care (CCC)
facilities
50 Pts admitted
to CCC and
require
intermediate
catheterizati
on
1 year - • expected net
costs to a CCC
facility
• unnecessary
catheterization
and UTIs
avoided due to
adopting the
portable
bladder
7 (17)
Examine the impact
of using UB in
Reduction of urinary
tract infection and
antibiotic use after s
urgery
Quasi-
experime
nt
Geneva,
Switzerla
nd
Anesthesiol
ogy dep.
132
8
adult pts
scheduled
for
orthopedic or
abdominal su
rgery
Almos
t half
Mean
= 60
- 529 (phase
I), 499
(phase II),
and 300
pts during
the 2- year
follow-up
(phase III)
-
• the incidence
of UTI
• Adherence to
guidelines
during and after
the experiment
by 2 years
• Reduction of
unnecessary
catheterization
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• Reduction in
UTI and anti
biotic use
8 (18) Compare the impact
of volume-
dependent
intermittent
catheterization
(VDIC) and time-
dependent
intermittent
catheterization
(TDIC) on financial
burden and clinical
outcomes in
patients with spinal
cord lesions (SCL).
Cohort
analytical
study
Israel Spinal
Rehabilitati
on dep.
24 Pts with
Spinal cord
lesion (SCL)
4 F Mean
=
20.6
BVI
5000
12-30 days • The number
of
catheterizations
per pt per day,
• the time
required to
perform volume
measurements
and
catheterizations
, their total cost
9 (19) Evaluate differences
between
BladderScan and
catheterization in
terms of the
expenditure of time
and of human and
material resources
A
prospecti
ve study
TAIWAN rehabilitati
on hospital
71 pts
undergoing
inpt or outpt
rehabilitation
therapy
31 F - BVI
3000
5 months • expenditure
of time and of
human and
material
resources
1
0
(20) Compare the
accuracy of portable
and stationary
ultrasonography
equipment in
estimating residual
bladder volume.
A
prospecti
ve study
TAIWAN rehabilitati
on hospital
64 Pts’
diagnoses
included
spinal cord
injury (n =
23), stroke
(n = 32),
traumatic
27 F BVI
3000
192:3 per
catheter
(3
independe
nt
examiners)
• The mean errors and
mean percentage
error resulting from
use of the 2 types of
equipment were
recorded
12 | P a g e
brain injury
(n = 6) and
other
conditions (n
= 3)
6 month
1
1
(21) Measure the
Effectiveness of the
portable UBS in the
measurement of
residual urine
volume after total
mesorectal
extirpation: and the
cost-benefit analysis
as compared with
postoperative
catheterization:
RCT
dealing
with the
economic
benefit
JAPAN Surgery
dep.
30 Pts with
after total
mesorectal
extirpation
13
female
s
avera
ge 69
BVI
3000
One year • Accuracy
• Cost benefit
1
2
(22) Evaluate accuracy of
PVI in an acute care
neuroscience unit
Cohort
analytical
study
CANADA acute care
neuroscien
ce unit
30
acute care
neuroscience
population,
suspected to
be retaining
urine
17 F Mean
65 y
BVI
5000
2 months • accuracy,
• Effect on nursing
practice in an acute
care neuroscience unit.
-
1
3
(23)
Evaluated the
usefulness of a
bladder scanner in
reducing the
frequency of
catheterization in
women prior to
laparoscopy
Prospecti
ve clinical
Study
UK Obstetrics
and
Gynecology
dep.
40
Women,
Prepared for
gynecologica
l laparoscopy
All F BVI
2500
6 months • accuracy in
quantifying bladder
volumes
• Reduce
unnecessary
catheterization
1
4
(24) Urinary Retention in
Patients in a
Geriatric
Rehabilitation Unit:
Prevalence, Risk
Factors, and Validity
Prospecti
ve clinical
Study
CANADA Geriatric
dep.
167 Elderly pts
with:
Impaired
recognition,
immobility,
hip fracture,
111
(66%)
Mean
80 y
Range
57-
95 y
BVI
2500+
13 month
s
• accuracy in
quantifying bladder
volumes in elder pts
-
13 | P a g e
of Bladder Scan
Evaluation
stroke,
diabetes
1
5
(25)
Efficacy of a
portable 3-
dimensional
ultrasound scanning
device in
measurement for
residual urine
volume in
ambulatory women
with urinary
incontinence,
Cohort
analytical
study
USA Center for
Aging and
Geriatric
dep.
95
Ambulatory
women with
urinary
incontinence.
All F Mean
age
67 y
BVI
2500
- • accuracy,
• Correlation bet age,
weight, BMI, parity,
hysterectomy , and
accuracy of
measurement
• Sensitivity and
specificity
1
6
(5) Determine The
effectiveness of
implementing a
bladder ultrasound
program in
orthopedic surgery
units
A quasi-
experime
nt
Minnesot
a
USA
Large
tertiary
care
hospital -
three units
of
orthopaedi
c surgery
103
proposed
sampling of
orthopedic
pts
47% Mean
63 y
BVI
2500
- • Number of
catheterizations
avoided: avoiding
unnecessary
catheterization
• Urinary tract
infections
Rates and
Costs.
• cost analysis
of UBS
acquisition
pt/ provider
(nurses)
Satisfaction
1
7
(11) Evaluate the
effectiveness of
the ultrasound in
the
determination of
urinary
volume in post-
operative patients
A quasi-
experime
nt
NETHERL
ANDS
Anaesthesi
ology dep.
c=
192
0+
I=
219
6
All patients
undergoing
orthopedic
surgery in
the
mentioned
period
62% Mean
45 y
BVI
3000
9 months • Number of
catheterizations
avoided: avoiding
unnecessary
catheterization
• 2ry: Number
of urinary
infections in
postoperative
pts
1
8
(26)
Examine the
accuracy of BVI
Prospecti
ve clinical
Study
Ontario,
Canada
urodynamic
unit
78 women
undergoing
uroflowmetry
in our
ALL F Mean
56 ±
14
(SD).
BVI
2500
80:1 per
catheter
accuracy in quantifying
bladder
volumes
-
14 | P a g e
urodynamic
unit
1
9
(27) Examine the
accuracy of BVI
Prospecti
ve clinical
Study
Netherla
nds
Pre- and
post-
induction
of
anesthesia
50 scheduled to
undergo
surgeries
requiring
anesthesia
and
catheterizati
on
aged
18–88
years
BVI
2500
50:3 per
catheter
accuracy in quantifying
bladder
volumes
-
2
0
(28) Evaluate the clinical
utility of a new
portable ultrasound
device (PUD) in the
management of
intermittent catheter
programs in pts with
neuropathic bladder
a
randomiz
ed
control
trial
Vancouv
er,
Canada
Tertiary
care center
providing
inpt and
ambulatory
rehabilitati
on services
38 pts with
neurologic
disabilities as
a result of
SCI or other
spinal
disorder.
>= 18 y
8 F Mean
36.5 y
portabl
e
ultraso
und
device
(PUD
1 month • evaluate the
frequency of
catheterizations,
• frequency of
overdistention, and
• pt satisfaction with
use of a new portable
ultrasound device (PUD)
in the management of
intermittent catheter
programs
-
2
1
(29) Assess the accuracy,
reliability, and
clinical utility of UB
Comparat
ive
analysis
UNITED
STATES
urology
clinic
249 Pts with
urologic
conditions
90 F Mean
73 ±
10
(SD).
BVI
2500
556:3 per
catheter
243 BVI
2500
303 BVI
2500+
14 month
s
(2 indep
examiners)
- • Reduction in
UTI incidence
• Cost savings
versus purchase
cost
2
2
(30) bedside
assessments of
bladder volumes by
portable bladder
ultrasound in place
of intermittent
Cost
analysis
Maryland
US
orthopedic
and
genitourina
ry
department
805 pts who had
an
orthopedic or
genitourinary
procedure
684 F Mean
74
(22-
103
BVI
2500
12 month - • rates of UTI
reduction
• expenditures
and cost-
savings
attributable to
15 | P a g e
catheterization : to
reduce the incidence
of nosocomial
urinary tract
infections
portable
bladder
ultrasound
2
3
(31)
Comparing
catheterization with
ultrasound scanning
Prospecti
ve clinical
Study
Maryland
US
Urology
/gynecolog
y clinic
72 women
presenting
for
urogynecolo
gical
evaluation
All F - BVI
2500
72:1 per
catheter
• accuracy in
quantifying bladder
volumes
2
4
(32) Investigate the
accuracy of a
portable ultrasound
scanner as an
alternative method
of measurement
Prospecti
ve clinical
Study
SINGAPO
RE
of Geriatric
dep.
46 Inpt at
geriatric dep,
Or outpt
attending
continence
clinic
34 F 40-
95 Y
BVI-
2500
180:20 per
catheter
2 months
• accuracy in
quantifying bladder
volumes
2
5
(33) Effectiveness of
bladder scan in
geriatric
rehabilitation
Prospecti
ve clinical
study
COLUMBI
A
acute
rehabilitati
on unit and
geriatric
unit
16 Geriatric pts - over
65
years
of age
BVI
2000
3 month - • Reduction in
unnecessary
catheterization
• Reduction in
UTI incidence
2
6
(34) Accuracy of portable
ultrasound scanning
in the measurement
of residual urine
volume
Prospecti
ve clinical
study
AUSTRAL
IA
Urology
dep.
100
Urology pts 49 F Mean
58 y
BVI
2500+
100:1 per
catheter
• accuracy in
quantifying bladder
volumes
-
2
7
(35) Accuracy of Bladder
volume estimation
in the elderly using
a portable
ultrasound-based
measurement device
Prospecti
ve clinical
study
CANADA Geriatric
and
urology
clinic
44 Pt attending
Geriatric
continence
clinic or
urology
clinic.
27 F Mean
= 76
BVI
2000
73:2 per
catheter
(2 diff
examiners)
• Accuracy,
• ease of use of
portable ultrasound
device in a geriatric
outpt population
-
16 | P a g e
2
8
(36) Accuracy of Bladder
volume
determination using
a dedicated,
portable ultrasound
scanner.
Prospecti
ve clinical
study
Seattle
US
urology
clinic and
spinal cord
injury unit
112 spinal cord
injury pts
- - BVI
2000
656:4 per
catheter
10-months
• accuracy in
quantifying bladder
volumes
-
2
9
(37) Evaluate Residual
urine volumes in pts
with spinal cord
injury
Prospecti
ve clinical
study
Seattle
US
Inpt
rehab/spin
al cord
15 Spinal cord
injured (SCI)
pts
4 F - BVI
2000
224:4 per
catheter
• accuracy in
quantifying bladder
volumes
-
N: number of patients, F: female, dep: department, SG: study group, CG: control group
17 | P a g e
3.3 Methodological quality
Since the nurses and practitioners had to be trained on the device and patients had to be
consented on the usage of the device, therefore the blinding section was not applicable in most of
the studies, except of few who did blind the results of 2 examiners from each other. In this regards,
we have concluded an overall rating with and without including blinding. Likewise, the dropouts and
withdrawals were not likely in most of the papers due to the successive examination of both
intervention and control in a short time period and mostly on the same patients.
Based on overall rating without blinding, 13 studies were MODERATE, 11 were STRONG, and
4 were WEAK. One study was not rated since it was an economic model (8)
TABLE 2: Description of key methodological properties and quality of eligible studies (based on
EPHPP)
Arranged by descending date
# Authors
Select
ion
Bias
2. Study
Design
3.
Confo
under
s
4.
Blinding
5.
Data
Collec
tion
Metho
ds
6.
Withdra
wals
And
Dropou
ts
Overall
Overall
Without
Blinding
1 (12)
M
PROSPECTIVE
CLINICAL
STUDY
S NA S NK WEAK MODERAT
E
2 (13) S RCT S NA S S MODERA
TE STRONG
3 (14) M QUASI M NA S NK WEAK MODERAT
E
4 (15) M QUASI S NA S NK WEAK MODERAT
E
5 (16) M QUASI S NA S NK WEAK MODERAT
E
6 (8) *
7 (17) M QUASI S NA S NK WEAK MODERAT
E
8 (18) S
COHORT
ANALYTICAL
STUDY
S NA S NK MODERA
TE STRONG
9 (19) M
PROSPECTIVE
CLINICAL
STUDY
S NA S NK WEAK MODERAT
E
1
0 (20) M
PROSPECTIVE
CLINICAL
STUDY
S S S NK MODERA
TE
MODERAT
E
1
1 (21) S RCT S NA S S
MODERA
TE STRONG
18 | P a g e
1
2
(22)
M
COHORT
ANALYTICAL
STUDY
S NA W S MODERA
TE STRONG
1
3
(Moselhi and
Morgan
2001)
M
PROSPECTIVE
CLINICAL
STUDY
S NA M S WEAK MODERAT
E
1
4 (24) M
PROSPECTIVE
CLINICAL
STUDY
S NA M NK WEAK MODERAT
E
1
5
(25)
M
COHORT
ANALYTICAL
STUDY
S NA S S MODERA
TE STRONG
1
6 (5) M QUASI S NA S S
MODERA
TE STRONG
1
7 (11) M QUASI S NA S NK
MODERA
TE
MODERAT
E
1
8 (26) M
PROSPECTIVE
CLINICAL
STUDY
S NA S NK MODERA
TE
MODERAT
E
1
9 (27) M
PROSPECTIVE
CLINICAL S NA S NK
MODERA
TE
MODERAT
E
2
0 (28) S RCT S NA S M
MODERA
TE STRONG
2
1 (29) M
PROSPECTIVE
CLINICAL
STUDY
S S S NK STRONG STRONG
2
2 (30) M
PROSPECTIVE
CLINICAL M W M NK WEAK WEAK
2
3 (31) M
PROSPECTIVE
CLINICAL
STUDY
W NA S NK WEAK WEAK
2
4 (32) M
PROSPECTIVE
CLINICAL
STUDY
S S S NK MODERA
TE STRONG
2
5 (33) M
PROSPECTIVE
CLINICAL
STUDY
S NA S NK WEAK MODERAT
E
2
6 (35) M
PROSPECTIVE
CLINICAL
STUDY
W NA S NK WEAK WEAK
2
7 (34) M
PROSPECTIVE
CLINICAL
STUDY
S NA M NK WEAK WEAK
2
8 (36) M
PROSPECTIVE
CLINICAL
STUDY
S S S NK MODERA
TE STRONG
19 | P a g e
2
9 (37) M
PROSPECTIVE
CLINICAL S S S NK
MODERA
TE STRONG
S: strong, M: moderate, W: weak, NK: not known, NA: not applicable
*economic model
20 | P a g e
3.4 Summary on Accuracy of Bladder Scanners Results
Accuracy in terms of mean difference, correlation, sensitivity, and specificity (Table 3)
There was a controversy between studies in terms of overestimation and underestimation of
device BVR compared to actual catheterization BVR. However, all BVI models have shown high validity
compared to intermediate cauterized volume, measured by significant correlation ranging from r2=
0.78 - 0.94, which was high. Device accuracy, sensitivity, and specificity were also measured in some
studies, showing promising results 94%, 97% and 91% respectively. (Table 3, 4)
Nineteen studies reported that BU had acceptable levels of clinical effectiveness (reliability) in
terms of volume mean difference between BU measured volume and catheterized volume. Some
papers reported overestimation of PVR and others reported under- estimation, with overall
acceptable mean error range from -81 to +105 ml (22, 24). The difference also between the two
methods was not affected by parity, age, body mass index (BMI), and uterine size (12).
In Marks et al, BVI underestimated bladder volume in women more than in men but
generally accurate 94% and was correlated closely (r2 = 0.90, P < .001) (29).
For low volumes of PVR, BU is highly sensitive and moderately specific, like in Goode et al
study (r2 = 0.60, P < .001) showing high specificity and moderate sensitivity of 96.5% and 66.7%
in detecting PVR ≥100 ml (25). While high PVR volumes, it was moderately sensitive and highly
specific (26). Reported sensitivities ranged from 0.67 to 0.97, and reported specificities ranged
from 0.63 to 0.97.
Generally, the accuracy of BU is reasonable and acceptable in patients with urologic
conditions, which might be altered by gender and volume of PVR. Accuracy is proved to be lower in
women and in PVR higher than 150 ml.
Repeated consecutive measurements do not significantly improve the correlation of a BU
reading with catheterization reading, however, simple training increase inter-rater reliability.
Another study showed Portable BU was less accurate that stationary BU, however, more
convenient with acceptable clinical use. The mean absolute errors were 34.4 mL (69.5%, P < .05)
and 21.9 mL (16.6%, P < .05) for portable and stationary BU. Portable and stationary ultrasounds
had sensitivities of 80% and 87%, respectively, and specificities of 90% and 100%, respectively (20).
Different BVI devices were tested in different settings, for their reliability, and different
results were concluded, as follows:
Pediatrics
One study in Norway on children confirmed that BVI 3000 reliability was good in children
above the age of 3 years and underestimated in younger children (15).
Patients with Neurogenic Conditions
Another study on patients admitted in urology clinic and spinal cord injury unit in Seattle
indicated that the BVI 2000 is an accurate alternative to catheterization for determining BVI residual
volume (36).
Patients with Urologic Conditions
Studies conducted on patients with urological conditions, were two of them showed an
overestimation of BVI residual volume (25, 34) and another two showed underestimation (29) (26).
However, all of them showed high correlation with actual volume and overall accuracy which
assumes that BVI was an accurate and reliable device for bladder volume measurement in adult
urology outpatients.
21 | P a g e
Peri - postoperative and acute care patients
Six studies in Peri-operative populations found BU reasonably acceptable, although there are
controversial results. one study of Moselhi et al found that the devices overestimated catheter
derived bladder volumes by 39 ml (23). while another 3 studies found the opposite—that the
devices underestimated catheter bladder volume by 105mL, 21 ml and 7% (16, 22, 27).
All Study investigators concluded that BU can be used peri-operatively to establish bladder
volume, taking into account mean error (under- estimation or overestimation) of the bladder
volume, owing to the good agreement between BU and catheter estimates of PVR.
Rehabilitation settings: Geriatrics and spinal cord injuries
Two studies examined the reliability of BVR measurement by BU comparing it with the
urethral catheterization in incontinent patients with spinal cord injuries (SCI) in rehabilitation
settings, which showed an acceptable overestimation of PVR (19, 20, 37).
Another three studies examined the reliability of BVR measurement by BU in incontinent
geriatric populations in rehabilitation settings, which showed an acceptable overestimation (32, 35)
and underestimation (24) compared to true bladder volume.
In conclusion , despite the controversy results (overestimation and underestimation) and
lower reliability for volumes greater than 200 ml, 5 studies estimate the ultrasonic device efficient
enough to recommend its Geriatric Use.
Post-Partum Care & Gynecology Dep
Two studies concluded that BVR measurement showed underestimation which was not
significant and results were highly correlated with true residual volume obtained by catheterization
in immediate postpartum period. The difference also between the two methods was not affected by
parity, age, body mass index (BMI), and uterine size (12).
The accuracy of measurement is affected by body weight and the increasing amount of BVR.
However, the result of this study only apply to postcesarean section women, and therefore, could
not be generalized to all patients (12, 31).
22 | P a g e
TABLE 3 summary of accuracy for estimating bladder volume with the bladder scanner
Arranged by patients population
Study Conditions Population
M/F
Mean age
context
Correlation
coefficient (r)
Mean volume
difference
True/ultrasound
(ml)
Bladder distension
(%)
Contol:study gp
Accuracy rate sensitivity
specificity
conclusion
1 (15) PEDIATRIC
CARE
N=48
Children
0-15 yrs
Urinary retention
4 ml (SD = 25 )
children above the
age of 3 years
and -18 ml (SD =
19 ml) in younger
Reliability was good for
children above the age of 3
years. The volume was
underestimated in younger
children
2 (36) NEUROGENIC
PTS
N: 11
NC
spinal cord injury
r = 0.79,
P < .05
significant correlation
coefficient indicated that the
BVI is an accurate
alternative to catheterization
for determining bladder
volumes
3 (25) UROLOGY PTS N: 95 F
67 years
Urinary
incontinence in
ambulatory women
17 mL
P < .0001;
95% (CI) 8–25 mL
Sensitivity of
66.7% and a
specificity of
96.5% in
detecting PVR >
or = 100 ml.
Overestimation by 17 ml,
but highly correlated with
the actual residual volume.
4 (26) UROLOGY PTS N: 78 F
56+-14 y
urology unit
most accurate
(60.6%) when the
readings were
below 50 ml and
least accurate
(10%) when
readings were
higher than 150
ml
Underestimate and
correlated poorly with the
actual residual volume.
5 (29) UROLOGY PTS
(OLDER)
Group 1: 182
92/90
60.6 years
Group 2: 57
urology unit
r = 0.90
P < .001
overall accuracy of
94%
sensitivity of 97%,
a specificity of
91%
underestimated by 10 cc in
men and 20 cc in women,
yet closely correlated with
the actual residual volume,
23 | P a g e
with high sensitivity and
specificity
6 (34) UROLOGY PTS Group 1: 50
28/22 (59.5 years)
Group 2: 50
23/27 (58.1 years)
urology unit
(studies
urodynamic)
41 ml. (95% CI 26
to 55 ml.).
24 ml. (95% CI 17
to 31 ml.)
0.86 (R2 = 0.73)
0.97 (R2 = 0.94)
Overestimation with Low
mean difference but highly
correlated
7 (13) PERI & POST-
OPERATIVE &
ACUTE CARE
PTS
N:281
110:171
Above 16
Orthopedic pts
The bladder
distention > 500
ml: 27.1% vs
17.0%;
Respectively
Postoperative bladder
distension was significantly
higher in the control group.
8 (14) PERI & POST-
OPERATIVE &
ACUTE CARE
PTS
244
125:119
63·3 ± 14years in
the control group,
55·6 ± 18years in
the study group
r= 0·86,
0·87
nurses ,
researchers
respectively
The bladder
distention > 500
ml: 13·4% and
20·3%,
respectively
These measurements
demonstrated high
consistency and accuracy
bet 2 examiners
9 (16) PERI & POST-
OPERATIVE &
ACUTE CARE
PTS
N:36
19/17
50 Yr
postanesthesia care
unit (PACU)
-21.5mL Underestimated 21.5 ml
(95% CI: 147 - 104mL0
But acceptable
1
0
(23) PERI & POST-
OPERATIVE &
ACUTE CARE
PTS
N:40 F
Before laparoscopy
+ 39ml Overestimated + 39 ml
(95%CI )
But acceptable
1
1
(22) PERI & POST-
OPERATIVE &
ACUTE CARE
PTS
N:30
neuroscience unit
mean error of -
105 mL
slightly underestimated the
catheterized volumes, but
were highly correlated with
catheterized volumes
24 | P a g e
1
2
Brouwer el
al
PERI & POST-
OPERATIVE &
ACUTE CARE
PTS
N=50
18-80 y
Before anesthesia
r2 = 0.94 in
awake
patients (P <
.01) and
r2 = 0.95 in
Anesthetized
patients (P <
.01).
Underestimate
7% across the total
volume range of
17 mL to 970 mL
Underestimation of PVR, on
average by 7%
Underestimation of PVR was
greater in females than in
males (P < .02).
Correlation was good in
awake and anesthetized pts
1
3
(38) REHABITATION
: GERIATRIC
AND LONG
TERM CARE
N: 64
37/27
NC
spinal cord injury,
stroke, traumatic
brain injury and
other conditions
34.4 mL
(69.5%, P < .05)
for portable
bladder
ultrasound
21.9 mL
(16.6%, P < .05)
for the stationary
ultrasound
Portable/stationar
y sensitivities :
80%and 87%, resp,
Specificities:
90% and 100%,
resp
portable ultrasounds is less
accurate than stationary
ultrasounds, particularly
with small bladder volumes.
However, portable
ultrasonography is more
convenient to use and has
an acceptable accuracy for
clinical use.
1
4
(24) REHABITATION
: GERIATRIC
AND LONG
TERM CARE
N: 167
57/110
80 ± 7.62 years
Rehabilitation Unit
Geriatric
r: 0.87 Error
average - 80,6ml
(P = 0.001)
Volume ≤150ml
underestimated true bladder
volume by an average of
80.6 mL but highly
correlated
1
5
(32) REHABITATION
: GERIATRIC
AND LONG
TERM CARE
N: 46
12/34
79 ± 8.2 years
Geriatric Medical
Unit
r: 0.78 and
0.76
The mean
absolute error of
the scanner was
52 mL.
For volumes below
200 mL and 100
mL, this was 36
mL and 24 mL
respectively
86 to 89%
according to the
cutoff point
Overestimation proportional
to the residual volume but
highly correlated
1
6
(35) REHABITATION
: GERIATRIC
AND LONG
TERM CARE
N:36
geriatric outpt
population
correlation
coefficients
were highly
significant
Acceptable overestimation
25 | P a g e
1
7
(37) REHABITATION
: GERIATRIC
AND LONG
TERM CARE
N=15
Spinal cord injured
(SCI) pts
r2 = 0.80. average error was
18% for
catheterized
volumes within
the range 50-
700ml
Highly correlated results
1
8
(12) POST-PARTUM
CARE &
GYNECOLOGY
DEP.
N:190 F
16 - 47 yrs
No sig diff UBS is comparable with
urethral catheterization.
However, accuracy is
affected by body weight and
increasing amount of BV.
1
9
(31) POST-PARTUM
CARE &
GYNECOLOGY
DEP.
N=72
gynecology clinic
r = 0.924;
P < 0.001
17 ml Underestimation by 17 ml
but not significant,
measures highly correlated
with the PVR obtained by
catheterization
N: number of patients, NK: not known, r: correlation coefficient of pearson, r2: correlation, CI: confidence interval
26 | P a g e
3.5 Summary on Health Outcomes of Bladder Ultrasound
Reduction in Unnecessary Catheterization and Urinary Tract Infections (Table 4)
Thirteen studies included health-related outcomes, which was divided into many indicators:
reduction of unnecessary catheterization, reduction in UTI (CAUTI) and antibiotic use. Results for an
avoidance of unnecessary catheterization ranged from 14% to 80% in Lee et al. and Fred et al.
respectively. Also, reduction in UTI was as high as 72% in Slappendal et al. and as low as 9% in
Frederickson et al. antibiotic use reduction was measured in a study of Stephan et al to be 13 %.
In a very high study sample of Stephan et al, a comprehensive reduction in antibiotic treatment
from 17.9 to 15.6% (P<.005) significantly due to a reduction of UTI from 10.4 to 3.9 % (P<.001) (17).
Patient’s and nurses satisfaction with the device was also measured in some papers like
Fredrickson et al. showing high satisfaction rate of 93% and 97%, respectively (5).
Different settings with different durations had different reduction rates, as mentioned below:
Pre - postoperative and acute care patients
Seven studies concluded that there was a potential relationship between the implementation of
portable bladder ultrasound with reductions in catheterizations and subsequent UTI. They also
recommended this device to be a quick and effective technique for reducing the frequency of
preoperative catheterization. (11, 14, 17, 21-23, 30)
Geriatric Medicine Patients and Long-Term Care Facility Patients
Authors of 3 studies stated that PVI reduced hospital costs by decreasing the numbers of
catheterizations, UTIs, and nursing time involved. (5, 19, 33). The result revealed more time required
for catheterization (3 to 8 times) than for the BU, which further emphasize that BVI is a time-saving
method and in terms of medical human resources costs as well (19). The author also reported on
patients and nurses satisfaction to be 93% and 97%, respectively (5).
Spinal And Neurogenic Bladder Problems
Economic impact of BU in patients with spinal cord lesions (SCL), disclosed a significant
reduction in number of catheterizations per patient per day, time required to perform volume
measurements and catheterizations, and their total cost, by approximately 44, 49, and 46%
respectively by using BU (18) . While Anton et al. showed a significant reduction (P = .026) in the mean
frequency of the catheterization in the intervention group (2.99) compared to the control group (4.19)
(28).
Cost savings and economic models (Table 4)
One study estimated a cost reduction of $680 for every UTI prevented by using the bladder
ultrasound, demonstrating that the cost of the BVI ($8300) would be retrieved after 200 bladder
scans. However, limitations to this study were the lack of formal economic analysis in the study and
cost analysis was based on author opinion and the study methodological quality was graded week.
(30).
Another result indicated a possible $3.64 cost savings of each catheter tray supply and $680
cost savings per each UTI reduction. These were further computed per reduction rates and an
estimation of 3 years of ultrasound machine use would be needed to recover the acquisition cost of
BVI 2500 (5).
In Ontario 2006, an economic model revealed that about 169 catheterizations and 1 UTI were
avoided daily in a typical Complex Continuous Care facility. With the adoption of BU, total annual cost
to a CCC facility (including catheter costs, nurse time, and UTI treatment costs but excluding device
costs) was valued to be $35,770 and $247,835 (without the adoption of this technology). The
difference in cost savings between the 2 methods would be $212,065 cost savings over 1 year(8)
.
27 | P a g e
TABLE 4 summaries of published results for UTI reduction and avoiding unnecessary catheterization with the bladder scanner
Study Conditions No of subjects Catheter
avoided, %
UTI reduction, % Time
required, %
Satisfaction
rate of
patients and
nurses
Cost saved conclusion
1 (14) POST-
OPERATIVE &
ACUTE CARE
PTS
N:244
63 years
neurosurgical
units in Taiwan
9 months
35.3% reduced
to 7%
After 3
months
(dec by 80%)
3.47% reduced
to 2.87%
after 3 months
, to 1.39%
after 6 months
(dec by 60%)
75.7% of
patients were
willing and
satisfied with
BVI as an
alternative
2 (17) POST-
OPERATIVE &
ACUTE CARE
PTS
N: 1328
60 years
Anesthesia
unit in
Switzerland
2 follow-up
years
10.4 to 3.9 %
(P<.001)
(Dec by 62.5%)
Antibiotic treatment
decreased from
17.9 to 15.6%
(P<.005)
3 (23) PRE-
OPERATIVE &
ACUTE CARE
PTS
N:40
women prior
to laparoscopy
UK
6 months
65% avoided
4 (22) POST-
OPERATIVE &
ACUTE CARE
PTS
N: 30
65 years
Acute care/
Neuroscience
unit
Canada
2 months
32% avoided
28 | P a g e
5 (21) POST-
OPERATIVE &
ACUTE CARE
PTS
N:30
69 years
Surgery
department
Japan
12 months
38% avoided 17.4 catheters
saved for each pt.
6 (30) POST-
OPERATIVE &
ACUTE CARE
PTS
N: 805
74 years
Orthopedic
surgery units
urological or
gynecological
12 months
Reduced to
22 %
Dec by 50% The cost of each UTI
incidence was
estimated at $680
(US) , means
1 portable bladder
device needed to be
used 200 times in
order to recover the
purchase cost (list
price purchased at
$8,300[US]
7 (11) POST-
OPERATIVE &
ACUTE CARE
PTS
Before, N:
1920
45.7 years
After, N: 2196
45.2 years
Orthopedic
surgery units,
NL
9 months
31% reduced
to 16%,
(15% avoided)
Number
decreased from
18 to 5.
(Dec by 72%)
Number of
catheters used
decreased from 602
to 349
statistically
Significant (P <
.05) reduction
in the need for
urinary
catheterizations
and the
likelihood of
UTIs.
8 (19) REHABITATION
: GERIATRIC
AND LONG
TERM CARE
N: 71
Rehabilitation
hosp.
Taiwan
time required
for
catheterizatio
n was 3 to 8
29 | P a g e
5 months times higher
than
BladderScan.
9 (5) REHABITATION
: GERIATRIC
AND LONG
TERM CARE
N: 50
intervention
N:53 control
General
Surgery (uro,
gynecology
and colon)
61 ± 17 years
(Orthopaedics)
63 ± 15 years
USA
1.96 reduced
to 1.68
(14 %
avoided)
13% to 4%
(Dec by 9%)
93% of pts
and 97% of
nurses
additional cost of
$676 per admission
$2886 cost savings
over 1 year
3 years of
ultrasound machine
use would be
needed to recover
the acquisition cost
1
0
(33) REHABITATION
: GERIATRIC
AND LONG
TERM CARE
N: 16
83 years
Rehabilitation
Unit, Geriatric
(orthopedics,
stroke)
3 months
47% avoided 50% reduced to
12 %
(Dec by 38%)
1
1
(8) REHABITATION
: GERIATRIC
AND LONG
TERM CARE
N=50
complex
continuing
care (CCC)
facilities
economic
model
total annual cost
was estimated at
$35,770 with the
adoption of the
bladder scanner
technology.
Without the
adoption of the
technology, the
cost to a typical
CCC facility was
estimated at
$247,835.
30 | P a g e
$212,065 cost
savings over 1
year
1
2
(18) SPINAL AND
NEUROGENIC
BLADDER
PROBLEMS
N=13
SCL pts
44% avoided Number
decreased from
3 to 0
49% lower in
IG
46% lower in IG
1
3
(28) SPINAL AND
NEUROGENIC
BLADDER
PROBLEMS
N: 38
bladders
neurogenic
after
cord injury
Rehabilitation
Unit
Mean
frequency of
catheterizatio
n decreased
from (4.19) to
(2.99)
29% avoided
31 | P a g e
4. DISCUSSION
Device accuracy
Most of the studies with strong and moderate methodology quality would recommend the
use of bladder ultrasound device as an alternative to catheterization in identifying the intermediate
PVR volume. Despite lower reliability for volumes greater than 200 ml, however, many studies
estimated that the device is accurate and efficient enough to be recommended for clinical use. Yet,
attention should be given to certain conditions including obesity, the presence of abdominal masses
and pregnancy, should be ensured; as such conditions may change the accuracy of the detection of
urinary residue by BU.
Although the studies used different BVI models, where some revealed overestimation and
others underestimation of urine volume measurements, however; their validity was supported by
high correlation between different examiners and high correlations with using intermittent
catheterization. Results can be generalized revealing accurately of bladder volume assessment by
bladder scanners, in spite of different models, users, patient positions; diagnosis, or healthcare
setting.
Patient health Outcomes – Medical, Clinical
Seven studies with sufficient sample size demonstrated reduction rate in unnecessary
catheterizations and UTIs up to 80%; 72%, respectively. The systematic use of the device will also
reduce patient discomfort, and also help to preserve patient dignity, based on satisfaction surveys
among nurses and patients.
Economic Impact
No complete economic evaluations were found to document the intervention's cost-
effectiveness. Three studies calculated the cost savings in private hospital settings, pertaining to
saved nursing time for facility staff through avoided catheterizations, and costs of treatment and
days of hospitalization associated with CAUTI. Additional training packages, batteries, and
maintenance should also be considered.
Two authors estimated a 3.64 cost of each catheter tray supply and $680 cost per each UTI
reduction, demonstrating that the cost of the BVI 2500 ($8300) would be retrieved after 200
bladder scans (30). In case of Fredrickson who conducted a partial economic evaluation, showing
14% and 9 % reduction in unnecessary catheterization and UTI, an estimation of 3 years of
ultrasound machine use would be needed to recover the acquisition cost of BVI 2500 (5).
A third HTA study in Ontario 2006 revealed that about 169 catheterizations and 1 UTI were
avoided daily in a typical Complex Continuous Care facility. The difference in cost savings between
the 2 methods would be$212,065 over 1 year for 50 patients (including catheter costs, nurse time,
and UTI treatment costs but excluding device costs) (8)
Several thousand of populations would benefit from this technology. However, it needs to be
quantified per each country or even smaller healthcare settings incontinence prevalence and
incidence.
Limitations
Several limitations apply this study. There were very few RCTs, although randomization may
have been appropriate in examining health outcomes, such as reductions in catheterizations and
UTI rates. Likewise, attrition rate and dropout rate was not clearly mentioned in most of the papers,
which negatively affected its methodological quality. Moreover, very few studies used blinding
techniques to investigators to prevent examiner bias. Blinding was not applicable in most of the
studies due to nature of the intervention which needed previous training to nurses and signed
32 | P a g e
consent from patients. The quality assessment tool used EPHPP was quite sharp which might have
decreased the overall quality of most studies.
Since the detection of urinary residue in the bladder is dependent on the examiners,
therefore; the methods and length of training should have been mentioned clearly, in order to
reduce the risk and threat of any internal validity of the results due to untrained nurses.
In most of the studies, samples were by convenience and tended to be too small to produce
sufficient power to identify differences between groups or over time which threaten the external
validity. Another threat of publication bias is due to our English language limitation to the extracted
papers, which might have been neglected important articles of an added value to our SR.
Studies also used different designs and population to assess effectiveness and reported on a
variety of different outcome measures and heterogeneity of studies, making it difficult to compute
all significant results together, and further develop a meta-analysis.
Complete economic evaluations on the device were missing, with only a few partial economic
evaluations on cost savings were conducted on a small scale, hospital level and not healthcare level.
Implications for research
Most of the literature available on BU technology addresses the accuracy of the equipment,
while little research on the clinical outcomes or benefits to the intervention. Larger sample sizes
should be also considered to document the impact of BU use on UTI rate and costs. Full economic
evaluations are needed and HTAs have to report on ICER rather than being just a review. More
satisfaction surveys on nurses and patients are needed to produce more evidence while including
also adverse effects of the device which was not tackled before in any paper.
5. CONCLUSION
Research has highly progressed from providing evidence accuracy to evaluation of the
clinical benefits of the bladder ultrasound scanner. In spite of the limitations of these studies, there
is some consistency in findings of accuracy, benefits, and satisfaction.
Based on existing evidence, the benefits of using bladder scan outweigh the risks using
intermittent catheterization. Since the intervention turned out to be more effective than the current
clinical routine already implemented, decision makers can choose to allocate resources differently.
However; there is a limited evidence of intervention's cost-effectiveness which is measured by its
impact on clinical outcomes, complications, cost, and patient/provider satisfaction.
6. RELEVANCE TO CLINICAL PRACTICE
Hospitals and nurses should follow Urinary retention protocols which are a type of catheter
restriction protocols that often incorporate the use of a portable bladder ultrasound to verify
retention prior to catheterization (6). BU are often purchased through operating budgets of
individual institutions and departments but sometimes under-used or misused due to lack of
efficient training for examiner (nurses and specialists), which limits its utility (7, 8). In practice, UB
should be commonly used by nurses and specialists in postoperative units, mainly obstetric-
gynecology units, complex continuing care, general practice, long-term care, home care and
rehabilitative units. This will limit unnecessary catheterization and reduce patient discomfort, costs
and days of hospitalization linked with urinary tract infection caused by catheterization.
33 | P a g e
APPENDIX 1: List of abbreviations
BVI Bladder volume instrument
BU Bladder ultrasound
CAUTI Catheter-associated urinary tract infection
CADTH Canadian Agency for Drugs and Technologies in Health
CBA Cost-benefit analysis
CEA Cost-effectiveness analysis
CHEC Consensus Health Economic Criteria
CUA Cost-utility analysis
CCA Cost-consequences analysis
CMA Cost-minimization analysis
DALY Disability-adjusted life years
EBM Evidence-based medicine
GRADE Group Reading Assessment and Diagnostic Evaluation
HAI healthcare-associated infection
NICE National Institute for Clinical Excellence
PICO People, Intervention, Comparator, Outcome
PRISMA Preferred Reporting Items for Systematic Reviews and Meta-
QALY Quality adjusted life years
SR Systematic review
UBS Ultrasound Bladder Scan
UR Urinary retention
UTIs Urinary tract infection
34 | P a g e
APPENDIX 2: Search string, inclusion, and exclusion criteria
MEDLINE: (Bladder-Scan[Text] OR Bladder Scan[Text] OR Bladder Scanner [Text] OR Bladder
Ultrasound[Text] OR Bladder Scanning[Text] OR Portable Ultrasound Device[Text]) AND Urinary Tract
Infection [MeSH] . The search was limited to humans and English (limit: ‘Humans ‘and ‘English’).
NHS EED: Bladderscan [any field] OR bladder scanner [any field] OR Bladder Ultrasound [any field]
INCLUSION CRITERIA
Based on PICOTT and the author´s own perception and interest, inclusion criteria were
created, as follows:
• Study design and methods that were described clearly: Any clinical trial (RCT, Quasi, or any
prospective clinical study), and any Economic evaluation (cost effective study, HTA, BIA. Etc. )
were used;
• Relevant population: target population was people hospitalized for treatment with a need to
evaluate bladder urinary volume;
• Relevant comparator: ultrasound bladder scan were compared with catheterization as normal
care;
• Relevant outcome: The paper included at least one of the following outcomes:
o Accuracy in measuring urine volume (mean difference, OR)
o Reduction in incidence of UTI (% or number)
o cost-benefit (in monetary value) or Cost-effectiveness in terms of incremental cost-
effectiveness ratio (ICER)
• Studies from (01-1-1985 till July 2016) were included, with no age restriction.
• English-language articles
EXCLUSION CRITERIA
A study was excluded if:
• Duplicate publications
• Nonsystematic reviews, letters, and editorials
• Non-English-language articles
• Animal and in-vitro studies
• Case reports
• the paper has a different study design, different study population, different comparators,
• The paper did not report any of the above-mentioned outcomes,
• Insufficient data (sample characteristics and dimensions unspecified)
35 | P a g e
APPENDIX 3: EPH PP GLOBAL SCORING
36 | P a g e
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