Download as pdf or txt
Download as pdf or txt
You are on page 1of 3

Continence 1 (2022) 100010

Contents lists available at ScienceDirect

Continence
journal homepage: www.elsevier.com/locate/cont

The fundamentals of quality assurance during urodynamics


A. Gammie a ,∗, M.J. Drake a , E. Finazzi Agro b
a
Bristol Urological Institute, Southmead Hospital, Bristol BS10 5NB, UK
b
Department of Surgical Sciences, University of Rome, Italy

ARTICLE INFO ABSTRACT


Keywords: Measurement of sufficient accuracy for diagnosis to be made reliably is vital for key diagnostic tests from which
Urodynamics treatment recommendations are derived. We describe the fundamental requirements for quality assurance in
Quality urodynamics, covering the key points for calibration, zeroing, resting pressures, live signals, transmission tests
Assurance
and annotation. These represent the features which must be demonstrated for all such tests.

1. Introduction and aims The desired level of quality in any diagnostic test is naturally to
present an accurate measurement, at a level of accuracy sufficient for
Many ICS standards and documents contain guidelines for maintain- diagnosis to be reliably made. The following sections list the indicators
ing and improving the quality of urodynamic testing [1–6]. The aim of reliability of measurement that are used in urodynamics, and those
of this document is to gather these into one summary paper, that can steps that are used to control for quality.
be used as a reference for urodynamic practitioners keen to promote
quality. The need to do so is not in question. Not only has the topic 3.1. Calibration
been central to ICS standards, but a recent study [7] has highlighted
the need to improve practice in urodynamics. This paper will assist in Every item of measurement equipment needs to be calibrated
providing a focus for essentials that must be delivered in order to meet against a known value in order to be sure that results the equipment
this need. gives are acceptably accurate. Keeping a log of checks made is recom-
mended, ideally occurring on a weekly or monthly basis. These checks
2. Methods will also be included in the annual maintenance inspection.

ICS standard documents [1–6] and papers searched using ‘quality’ (a) For pressure measurement, comparison can be made against the
and ‘urodynamic(s)’ in the title or keywords [7–16] were used as height of a column of water. A check is therefore easily carried
the basis for a summary of practical points to use in good quality out by raising a filled tube of water to a known height above the
assurance in urodynamic testing. Points of good practice that relate water-filled transducer, or for air-filled catheters submerging to
to actions during the test itself are summarised. Issues of post-test a known depth of water [3].
interpretation of urodynamic tests are not included, but care must be (b) Volume measurement can be checked against a known weight or
taken after the test that artefacts are recognised and accounted for, and volume of fluid. Recalibration is only necessary when the value
that results automatically generated by the urodynamic machine are shown is more than 3% inaccurate [3].
not unquestioningly accepted [1,2]. (c) Flow rate may be roughly checked with a defined flow rate
bottle, but the voided volume check above will in fact also check
3. Quality assurance in urodynamics the flow rate.

Quality Assurance is defined by the Oxford English Dictionary as 3.2. Zeroing


‘‘The maintenance of a desired level of quality in a service or product,
especially by means of attention to every stage of the process of delivery The standard reference pressure used as the zero level in urodynam-
or production’’. The action of maintaining that desired level is Quality ics is atmospheric pressure [1–5] (see point A in Fig. 1). This means that
Control. We check, and then control when necessary, in order to gain pressures recorded during the test are physiologically meaningful. Since
assurance of measurement quality. internal organ pressure is never actually zero, it is not meaningful to set

∗ Correspondence to: Bristol Urological Institute, 3rd Floor, L & R Building, Southmead Hospital, Bristol BS10 5NB, UK.
E-mail address: Andrew.gammie@bui.ac.uk (A. Gammie).

https://doi.org/10.1016/j.cont.2022.100010

2772-9737/© 2022 The Author(s). Published by Elsevier B.V. on behalf of International Continence Society. This is an open access article under the CC
BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
A. Gammie, M.J. Drake and E.F. Agro Continence 1 (2022) 100010

Fig. 1. An example urodynamic trace showing the first minute of a test, with all appropriate markers and quality indicators in place. At point A, the transducers were open to
atmosphere and ‘Zero All’ was selected. Point B shows a good cough test displaying equal pressure rises on both pves (blue line) and pabd (red line). At point C, normal range
resting pressures are displayed (approximately 10 cmH2 O in the illustrated case). At this point, the patient was supine (this was documented by the dotted line leading to ‘‘Su’’
at the top of the screen; ideally, such markers should be readily understood, rather than just two letters). At point D, the patient couch was being lowered, to enable the patient
to stand At point E they were in the process of standing up; this was associated with a lot of ‘‘noise’’ in the pressure lines due to change of position, and holding the lines to
avoid them getting pulled out. The transducer level was set to the level of the symphysis pubis at point F. A marker at point G when the patient is standing still shows that the
resting pressures are higher than when supine, but are in the normal range for the upright position (approximately 35 cmH2 O in the illustrated case). At point H, the pressure
lines are fully set up ready to start the test. A further cough test here would be helpful to verify that no transmission errors had been introduced during movement. Except when
recording atmospheric pressure (between A and X), this trace shows a ‘‘live signal’’ characteristic of a patient who is moving and breathing, which a gives further reassurance that
true physiological pressures are being measured. The initial spike at point X is due to an artefact on turning the transducer dome tap.

zero while recording patient pressures. Additionally, zeroing to patient Table 1


A summary of quality control actions for a urodynamic test. If the issue is a poor
pressure may inadvertently be done during a transient pressure rise,
response to a cough or the lack of a live signal, then the operator can start at the top
resulting in anomalous negative pressure readings afterwards. Once of the left-hand column and work down. If the issue is with abnormal resting pressures,
zeroed to atmosphere, the resting pressures can then be used to assess the operator uses the right-hand column.
signal quality (see item 3.3 below). Care must also be taken to ensure Cough test/ live signal problem? Resting pressure problem?
the volume reading is zero when the jug is empty. Flush line Zero to atmosphere
Close leak Check level with reference height
Check taps Flush line
3.3. Resting pressure values Fill 50 mL Check line for leak or block
Move catheter Move catheter
Change catheter Change catheter
Many decades of experience in urodynamics have led to known nor-
mal values for pressure within the large majority of patients [1,11,13].
These are, for both intravesical (pves ) and abdominal (pabd ) pressures
(using atmospheric pressure as zero): 3.4. Presence of a ‘live’ signal

• Patient supine: 5 – 20 cmH2 O When a patient breathes, talks or moves there are small changes in
• Patient seated: 15–40 cmH2 O pressure generated within the abdomen (see Fig. 1). These changes will
• Patient standing: 30–50 cmH2 O be picked up by the pressure lines and displayed as small perturbations
in the signal — the pves and pabd traces should not be completely flat,
Neither pves nor pabd should be zero at the start of filling (see though the pdet trace may be flat if the perturbations completely cancel
points C and G in Fig. 1). Detrusor pressure, pdet , however, should be each other out. If this ‘live signal’ is lost, it indicates that pressure
approximately zero if the bladder is at rest, since pves and pabd should transmission from the patient to the transducer is not occurring. Trans-
be equal, or very nearly so. The accepted range for pdet at the start of mission must be checked and restored (see 3.5 below) before the test
a test is between −5 and +5 cmH2 O [2,5,16]. is continued.
If these values are not seen at the start of a study or after a change During the voiding phase, it occasionally happens that this live
in position, then the zeroing to atmosphere and the height of the signal is lost on the pves line. This is normally attributed to the catheter
transducers should be checked first. If the problem persists, then water- pressing against, or even being folded within, the bladder wall. If
the live signal is lost after the point of maximum flow (Qmax ), then
filled lines should be flushed and connectors checked for leaks. Failing
the values of pressure at Qmax can generally be presumed as reliable,
that, the catheters can be moved or replaced. Table 1 (right-hand
though some indication of doubt should be mentioned in the report.
column) summarises these steps in sequence.
If, however, the live signal is lost before Qmax is achieved, and reliable
During the study, baseline resting pressures should not decrease. If pressure signals at that point are necessary to answer the urodynamic
a steady decline in pressure is seen on a trace, then that catheter line question, the test may have to be repeated. The same conditions apply
should be flushed through with water (if water-filled) and checked for if the pves catheter has been voided before Qmax is achieved.
leaks. If air-filled catheters are used, then the decline may be due to Some ‘live’ noise on the pressure lines may be not due to the patient,
a change in the catheter position. Note that if an air balloon needs to but are caused by other mechanical factors. Examples of these are
be refilled, it must be fully emptied first. A large and abrupt decline in knocks on the tubing, which generate spikes on the affected line, or
pressure in any system is indicative of the catheter falling out, and it vibrations from the pump, which are regular phasic pressure changes
will need to be replaced before continuing the study. in the filling line while fluid is being pumped into the bladder. Such

2
A. Gammie, M.J. Drake and E.F. Agro Continence 1 (2022) 100010

signals should be minimised if they occur, by keeping the tubes apart, of equipment and setting zero to atmosphere. During the test, qual-
taping them out of the way and avoiding touching the lines if possible. ity is assured by checking resting pressure levels are within normal
ranges, ensuring live signal is maintained and carrying out regular pres-
3.5. Regular transmission tests sure transmission checks. Following these simple practices will ensure
patient diagnoses are made on the basis of good quality measurements.
At the start of the test before filling begins, and at regular intervals
throughout the test, it is necessary to carry out quality assurance checks Declaration of competing interest
of pressure transmission on both pves and pabd (see point B in Fig. 1).
If an air bubble is trapped in the line, or if the catheter end becomes The authors declare that they have no known competing finan-
blocked in some way, the pressure readings will not be accurate, and cial interests or personal relationships that could have appeared to
diagnosis may be compromised. Good transmission of pressure can be influence the work reported in this paper.
checked by applying an equal change in pressure to both lines, and
checking that the displayed changes are indeed equal as expected. References
These test pressures can be generated by asking the patient to do a
cough or a Valsalva manoeuvre. [1] W. Schafer, P. Abrams, L. Liao, A. Mattiasson, F. Pesce, A. Spangberg, A.M. Ster-
The recommended interval between transmission checks is 1 min, ling, N.R. Zinner, P.van. Kerrebroeck, Good urodynamic practices: uroflowmetry,
filling cystometry, and pressure-flow studies, Neurourol. Urodyn. 21 (2002)
or after every 50 mL of fluid infused [1]. Checks should also be done
261–274, http://dx.doi.org/10.1002/nau.10066.
before and after the pressure flow study. If checks are difficult for the [2] P. Rosier, W. Schaefer, G. Lose, H. Goldman, M. Guralnick, S. Eustice, T.
patient, then a greater interval combined with regular inspection for Dickinson, H. Hashim, International Continence Society good urodynamic prac-
live signal between checks may be necessary. The suggested limit for tices and terms 2016: urodynamics, uroflowmetry, cystometry, and pressure-flow
good transmission to be assured is that the smaller pressure response study, Neurourol. Urodyn. 36 (2017) 1243–1260, http://dx.doi.org/10.1002/nau.
be at least 70% of the larger pressure response [16]. 23124.
[3] A. Gammie, B. Clarkson, C. Constantinou, M. Damaser, M. Drinnan, G. Geleijnse,
If the smaller signal is less than 70% of the larger, remedial action
D. Griffiths, P. Rosier, W. Schäfer, R. Van Mastrigt, International Continence
can be taken by flushing a water-filled line to remove the bubble, and
Society guidelines on urodynamic equipment performance, Neurourol. Urodyn.
checking for any leaks in the line’s connections. Occasionally, it is 33 (2014) 370–379, http://dx.doi.org/10.1002/nau.22546.
difficult to obtain a good response from an empty bladder, and thus [4] E.v.W. van Doorn, K. Anders, V. Khullar, S. Kulseng-Hanssen, F. Pesce, A.
it is sometimes helpful to fill the bladder with 50 mL and recheck the Robertson, D. Rosario, W. Schäfer, Standardisation of ambulatory urodynamic
response. Failing that, the catheters can be moved or replaced. Table 1 monitoring: Report of the Standardisation Sub-Committee of the International
(left-hand column) summarises these steps in sequence. Continence Society for Ambulatory Urodynamic Studies, Neurourol. Urodyn. 19
(2) (2000) 113–125, https://pubmed.ncbi.nlm.nih.gov/10679828/.
[5] M.J. Drake, S.K. Doumouchtsis, H. Hashim, A. Gammie, Fundamentals of uro-
3.6. Annotation and reporting of traces dynamic practice, based on International Continence Society good urodynamic
practices recommendations, Neurourol. Urodyn. 37 (2018) S50–S60, http://dx.
A good quality trace will also include annotations explaining events doi.org/10.1002/nau.23773.
that only those present during the test can verify, e.g. patient sensation, [6] A. Gammie, M.J. Drake, The fundamentals of uroflowmetry practice, based on
confirmation of leakage, labelling of artefacts, patient position and so international continence society good urodynamic practices recommendations,
Neurourol. Urodyn. 37 (2018) S44–S49, http://dx.doi.org/10.1002/nau.23777.
on. These markers will ensure that interpretation can be made with
[7] M. Aiello, J. Jelski, A. Lewis, J. Worthington, C. McDonald, P. Abrams, A.
knowledge of the true clinical situation (see points A, C and G in Fig. 1).
Gammie, C. Harding, S. Biers, H. Hashim, J.A. Lane, M.J. Drake, Quality control
The final report of the urodynamic test should, for the same reason, of uroflowmetry and urodynamic data from two large multicenter studies of male
include comments on the quality of the urodynamic measurements and lower urinary tract symptoms, Neurourol. Urodyn. 39 (4) (2020) 1170–1177,
of the representative nature of the observations made. These points are http://dx.doi.org/10.1002/nau.24337.
particularly important for those centres where the person conducting [8] A. Gammie, T.M. Kessler, Half the message is just mess: judging the value
the test is not the person writing the report. of urodynamics based on partial or poor-quality results, BJU Int. 126, 4–5,
http://dx.doi.org/10.1111/bju.15063.
[9] F.L. Zeller, J.M. García-Garzón, A. García-Gonzalez, Good urodynamic practices
3.7. Uroflowmetry in a non-specialized center: quality control analysis, Arch. Esp. Urol. 67 (7)
(2014) 615–620, https://pubmed.ncbi.nlm.nih.gov/25241834/.
Quality control during uroflowmetry is largely preventative in na- [10] L.S. MacLachlan, E.S. Rovner, Good urodynamic practice: keys to performing
ture, advising the patient on how to do the test to give the best chance a quality UDS study, Urol. Clin. North Am. 41 (3) (2014) 363–373, vii, http:
of a reliable and meaningful result. The patient should be asked to //dx.doi.org/10.1016/j.ucl.2014.04.005.
[11] L. Liao, W. Schaefer, Quantitative quality control during urodynamic studies
arrive with a comfortably full bladder, and to urinate only when they
with TVRs for cystometry in men with lower urinary tract symptoms suggestive
would normally, in order that the test may be truly representative of
of benign prostatic hyperplasia, Int. Urol. Nephrol. 46 (7) (2014) 1301–1308,
normal function. The patient should be instructed to allow the urine http://dx.doi.org/10.1007/s11255-014-0668-3.
stream to flow steadily into the collection funnel and not move it [12] L. Liao, W. Schaefer, Qualitative quality control during urodynamic studies
around. Male patients should be cautioned not to squeeze and release with TSPs for cystometry in men with lower urinary tract symptoms suggestive
the urethra, as this causes anomalous fluctuations in the flow rate. All of benign prostatic hyperplasia, Int. Urol. Nephrol. 46 (6) (2014) 1073–1079,
patients should be asked if possible not to strain, so that lower urinary http://dx.doi.org/10.1007/s11255-013-0633-6.
[13] S. McCooty, P. Latthe, Quality control in urodynamics, Nurs. Stand. 27 (43)
tract function can be clearly tested. Care should be taken not to knock
(2013) 35–38, http://dx.doi.org/10.7748/ns2013.06.27.43.35.e7166.
the flowmeter, as this will cause artefactual spikes on the flow trace. [14] S. Hogan, A. Gammie, P. Abrams, Urodynamic features and artefacts, Neurourol.
It is also important that staff give the patient prompt access to the Urodyn. 31 (7) (2012) 1104–1117, http://dx.doi.org/10.1002/nau.22209.
flowmeter, and ensure suitable privacy for the patient while voiding. [15] A. Renganathan, R. Cartwright, L. Cardozo, D. Robinson, S. Srikrishna, Qual-
ity control in urodynamics: Analysis of an international multi-center study,
4. Conclusions Neurourol. Urodyn. 28 (5) (2009) 380–384, http://dx.doi.org/10.1002/nau.
20679.
[16] J.G. Sullivan, L. Swithinbank, P. Abrams, Defining achievable standards in
To gain assurance of quality in urodynamics, good practice must be
urodynamics - a prospective study of initial resting pressures, Neurourol. Urodyn.
followed and quality control employed. The key factors in setting up 31 (2012) 535–540, http://dx.doi.org/10.1002/nau.21229.
equipment for good quality urodynamic tests are regular calibration

You might also like