Contractility: Cuff Versus Urodynamics Testing In Males With Voiding Lower Urinary Tract Symptoms
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

 
Version 1.1 May 2018 
Page 1 of 14 
 
 
CONCUR 
 
Contractility: Cuff Versus Urodynamics Testing In 
Males With Voiding Lower Urinary Tract Symptoms 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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i List of Contents 
GENERAL INFORMATION 
Page No. 
TITLE PAGE 
 
1 
i LIST of CONTENTS 
2 
ii RESEARCH REFERENCE NUMBERS  
2 
iii KEY TRIAL CONTACTS 
 
3 
iv TRIAL SUMMARY 
 
4 
v FUNDING 
 
5 
SECTIONS 
1. BACKGROUND 
 
6 
2. AIMS AND OBJECTIVES 
8 
3. METHODS  
9 
4. SUBJECTS, SAMPLE SIZE AND STATISTICAL ANALYSIS 
12 
5. PROJECT TIMELINE 
13 
6. RESOURCES AND COST 
13 
7. REFERENCES 
14 
 
ii Research Reference Numbers 
IRAS number 
231323 
SPONSOR number 
8598 
PROSPERO ID 
CRD42018085737 
 
 

 
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iii Key Trial Contacts 
Chief Investigator 
Miss Helen Morton, Urology Research Fellow  
Department of Urology 
Freeman Hospital 
Freeman Road  
Newcastle upon Tyne 
NE7 7DN  
TEL: 0191 2139602 
Email: Helen.Morton@nuth.nhs.uk  
Sponsor 
Mr Aaron Jackson 
Newcastle Joint Research Office 
(Newcastle upon Tyne Hospitals NHS Foundation Trust) 
1st Floor Regent Point 
Regent Farm Road 
Gosforth 
Newcastle upon Tyne 
NE3 3HD 
TEL: 0191 282 5789 
Email: Aaron.Jackson@nuth.nhs.uk   
Funder(s) 
Mr Michael Drinnan 
Department of Medical Physics 
Newcastle upon Tyne Hospitals NHS Foundation Trust 
Royal Victoria Infirmary 
Queen Victoria Road 
Newcastle upon Tyne 
NE1 4LP 
TEL: 0191 213 7161 
Email: Michael.Drinnan@nuth.nhs.uk 
Key Protocol Contributors 
Radiation Lead: 
Mr Kevin Robson 
Radiation Physicist 
Department of Medical Physics 
Newcastle upon Tyne Hospitals NHS Foundation Trust 
TEL: 0191 213 8623 
Email: Kevin.Robson@nuth.nhs.uk  
Supervisors:  
Dr Alison Bray and Dr James Blake 
Department of Medical Physics 
Newcastle upon Tyne Hospitals NHS Foundation Trust 
Email: ABray3@nhs.net James.Blake@nuth.nhs.uk  
Mr Chris Harding 
Department of Urology 
Newcastle upon Tyne Hospitals NHS Foundation Trust 
TEL: 0191 244 8178 
Email: Chris.Harding@nuth.nhs.uk  
 

 
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iv Trial Summary 
Trial Title 
Contractility: Cuff Versus Urodynamics Testing In Males 
With Voiding Lower Urinary Tract Symptoms 
Short Title 
CONCUR 
Internal ref. no. 
8598 (Newcastle JRO reference number) 
Trial Design 
Pilot Observational Cohort Study 
Trial Participants 
Men aged 18 years old or over, who are referred for 
video urodynamics. They will have predominant voiding 
LUTS as assessed by IPSS at screening, and at least 2 
voided volumes on a frequency volume chart of 250 mL  
Planned Sample Size 
30 
Investigation Duration 
One visit, lasting roughly 90 minutes 
Interventions Performed 
Video cystometrogram, penile cuff test 
Follow up duration 
N/A 
Planned Trial Period 
15 months 
 
Objectives 
Outcome Measures 
Primary 
 
To modify procedural steps of 
the penile cuff test  
To identify behaviour of the 
urethra during penile cuff 
inflation  
To test the basic assumption 
of the penile cuff test that the 
bladder neck remains open 
during flow interruption 
Reduction in variance 
between pcuff.int and pves.isv 
compared to previous data 
Qualitative description of 
urethral behaviour and 
bladder neck opening 
during the penile cuff test 
Secondary 
 
To compare non-invasive 
measurements from the 
penile cuff test against 
invasive indices of contractility 
To compare 2 different 
symptom scores for men with 
voiding LUTS 
To assess accuracy and inter-
observer variability of 
ultrasound residual 
measurement against a known 
volume.  
Comparison of pcuff.int with 
other indices including BCI 
and Watt’s Factor 
 
Correlation calculation to 
compare IPSS and ICIQ-
MLUTS 
Accuracy: catheterised PVR 
= gold standard  
Inter-observer agreement: 
paired t-test 
 
 

 
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v Funding and Support in Kind 
FUNDER(S) 
(Names and contact details of ALL 
organisations providing funding and/or 
support in kind for this trial) 
FINANCIAL AND NON FINANCIAL SUPPORT 
GIVEN 
Newcastle upon Tyne Hospitals NHS 
Foundation Trust 
Contact: Mr Michael Drinnan 
Department of Medical Physics 
Royal Victoria Infirmary 
Queen Victoria Road 
Newcastle upon Tyne 
NE1 4LP 
TEL: 0191 213 7161 
Email: Michael.Drinnan@nuth.nhs.uk 
100% provision of funding for project and MD 
studies from Trust Royalty Account 
Mediplus Ltd 
Contact: Mr James Urie 
Sales and Marketing Director 
Unit 7 The Gateway Centre 
Coronation Road 
Cressex Business Park 
High Wycombe 
HP12 3SU 
TEL: 01494 551200 
Email: James.Urie@mediplus.co.uk 
Funding awarded of 2 boxes of penile cuffs 
 
 

 
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1. Background  
Lower urinary tract symptoms (LUTS) are common in men, with population based studies 
estimating the prevalence of LUTS to be more than a quarter of men over the age of 60 
years (1-2). They can relate to a number of different conditions of the bladder, prostate and 
urethra. In particular, LUT symptoms including poor urinary flow, prolonged voiding and 
incomplete emptying could indicate either underactive bladder syndrome (UAB) or benign 
prostatic enlargement (BPE). There may be a substantial overlap in the symptoms 
experienced by men who may be suffering from one or both of these clinical syndromes. To 
aid treatment decision making, further investigations such as a bladder pressure study 
(urodynamics) can help to differentiate an exact cause. This may be the urodynamic 
diagnoses of detrusor underactivity (DU) and bladder outflow obstruction (BOO), 
respectively. Detrusor underactivity is currently defined by The International Continence 
Society (ICS) as ‘a contraction of reduced strength and/or duration, resulting in prolonged 
bladder emptying and/or a failure to achieve complete bladder emptying within a normal 
time span’(3). In addition, an alternative definition for UAB has been proposed by Chris 
Chapple et al(4) as; ‘a symptom complex suggestive of detrusor underactivity and is usually 
characterised by prolonged urination time with or without a sensation of incomplete 
bladder emptying, usually with hesitancy, reduced sensation on filling, and a slow urinary 
stream.’ These descriptive definitions are contrasted by the ICS definition of bladder outlet 
obstruction, which is characterised by ‘increased detrusor pressure and reduced urine flow 
rate.’ This reflects a diagnosis reached during urodynamic investigation, which has 
established indices/grading systems to quantify severity. The current working definitions for 
UAB/DU do not quantify the parameters they use. Recognising UAB/DU as the reason for a 
patient’s LUTS is a well-documented problem (4-5), and confusion due to the wide variety in 
terminology compounds this.  
 
As with any muscle, it is the ability of the individual cells to contract that governs its 
function. In the case of the lower urinary tract, this means that detrusor smooth muscle 
contractility will affect how the bladder as a whole organ performs. Currently, bladder 
contractility is assessed in clinical practice by urodynamics – standard pressure-flow studies 
(PFS). This requires insertion of fine catheters into the bladder via the urethra, and into the 
rectum to measure and account for changes in abdominal pressure. The patient’s bladder is 
then filled until the patient expresses a desire to pass urine. They will then be asked to void, 
whilst measuring abdominal and bladder pressure. The detrusor pressure is derived by 
subtracting the abdominal pressure from the simultaneously measured vesical pressure. 
Performing PFS is  time-consuming, and the invasive nature of the procedure can cause 
patient discomfort, as well as leading to potential morbidity.(6-7) A significant concern is the 
risk of introducing infection, which can lead to urinary infection despite the use of an aseptic 
technique (8). Once performed, various parameters including aspects of detrusor pressure 
and urine flow can then be used to calculate one or more of a number of indices of bladder 
muscle contractility, such as the bladder contractility index (BCI) or more complex Watts 
Factor (WF), or used in nomograms like Schafer’s LIN-PURR nomogram (9). Isovolumetric 
bladder pressure – i.e. the pressure the bladder can achieve without flow of urine, is felt to 
reflect bladder contractility. This can be assessed in a short period at the beginning of a 
contraction during invasive PFS. To reduce the need for invasive investigations and improve 
the patient experience, various non-invasive methods of measuring isovolumetric bladder 

 
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pressure (and flow), have been proposed (10). These include the condom catheter method 
(11), as well as the penile cuff test which was developed in our unit. 
 
The penile cuff test involves the application of a small inflatable cuff similar to a blood 
pressure cuff around the penile shaft. The patient is asked to void, and once voiding has 
commenced the machine automatically inflates at a linear rate of 10 cmH2O per second. 
The cuff automatically deflates 2 seconds after interruption of flow or immediately if the 
safety limit of 200 cmH2O is reached.  Inflation-deflation cycles will continue until the void 
has finished. The technique relies on the principles that i) the pressure from the cuff is 
transmitted to the urethral lumen, ii) the bladder contraction is maintained during the 
period of flow interruption so that flow will recommence once the cuff pressure is released, 
and iii) the pressure in the penile urethra is the same as the bladder pressure (plus height 
difference in transducers due to hydrostatic pressure) – this requires the urethra proximal 
to the cuff to remain open during flow interruption to allow continuity of the urinary tract to 
transmit pressure between the bladder and urethra.  
Previous investigation (12) of cuff interruption pressure (pcuff.int) as an estimate of 
isovolumetric pressure found that there is generally an overestimate of invasively measured 
isovolumetric bladder pressure (pves.isv) by pcuff.int. A mean difference of 16.4 cmH2O was 
observed, although this was reduced once the difference in transducer reference height 
(mean 10 cmH2O) was taken into account. There was however, a large variability in the 
measurements with a standard deviation of 27.5 cmH2O, which was not accounted for by 
abdominal straining. Two different cuff widths were used (3.8 cm (51%) or 4.8 cm (49%)) 
and the mean difference and standard deviation were significantly better in men tested with 
the larger width cuff. Test-retest reliability was found to be better in the subgroup of 
patients who had voided more than 150 mL on both occasions. Further investigation into 
these potentially modifiable factors of voided volume and cuff size is necessary to provide 
information that we can use to improve the accuracy of the penile cuff test.  
Furthermore, preliminary work has suggested further modifiable factors which will form the 
basis of the investigations in the project. The analysis found:    
 
 A reduction in the error between pcuff.int and pves.isv during inflations occurring later in 
the void:  
In some patients this could be due to voluntary inhibition during initial inflations, 
which we will aim to minimise within patient coaching and introduction to the penile 
cuff. 
 Behaviour of the urethra during cuff inflation: 
Urethrography (x-ray screening of the urethra obtained when the bladder is filled 
with radio-opaque contrast) performed on one test subject during the initial 
development of the cuff test showed distension of the urethra occurred quickly after 
the beginning of cuff inflation till a steady state was seen. It did however seem to 
demonstrate kinking of the urethra during cuff inflation, which may be another 
source of error in the transmission of pressure between the cuff and the urethra, or 
maintaining continuity of the proximal urethra with the bladder. 
 

 
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There is a need for further investigation within this field, given the diversity which exists in 
the definitions of UAB and DU. There are multiple measurements available to assess 
contractility, but with scant guidance and evidence on threshold values, and no consensus 
on which is best. This is coupled with the invasive nature of the procedure used to acquire 
and calculate these measurements. The concepts of the underactive bladder syndrome, 
detrusor underactivity and bladder contractility are felt to overlap in term of symptoms, 
function and aetiology respectively (4). They are however often used interchangeably within 
the literature. We need to explore the relationships between the definitions and 
measurements, as symptoms in themselves are too non-specific for diagnosis and overlap 
with other conditions of the lower urinary tract. The penile cuff test has the potential to be 
widely used due to its non-invasive nature, but we need to refine the investigation to 
increase the repeatability associated with the test, and define the parameters which would 
be most useful. 
2. Aims and Objectives  
There are a number of confounding issues that affect the ability of pcuff.int to reflect an 
accurate measurement of intravesical pressure. We intend to refine the procedural steps of 
the cuff test to improve the measurement and reduce variability with pves.isv, therefore 
giving a more reproducible test. By improving the penile cuff test, we can then go on to 
assess how our non-invasive measurements correlate with urodynamically derived indices 
of contractility, and we will use data from this pilot to help construct our future 
methodology. Our current hypotheses are that; 1) accuracy of pcuff.int can be improved by 
modification of penile cuff test factors, 2) the number of valid inflations obtained per 
patient will increase with the modifications, and 3) that our non-invasive measure of 
contractility will correlate with pre-existing invasive indices.  
 
Our research protocol also gives us the opportunity to explore correlation between 
commonly used symptom scores, and accuracy in the assessment of ultrasound residual 
urine volume measurement. 
 
Our primary objectives are therefore: 
 To modify procedural steps of the penile cuff test that may reduce the previously 
observed variability and perform a pilot study to assess a reduction in variance 
 To identify behaviour of the urethra during penile cuff inflation, by performing x-ray 
screening during the penile cuff test, and assess whether this is another source of 
inaccuracy  
 To test the basic assumption of the penile cuff test that the bladder neck remains 
open during flow interruption 
 
Secondary objectives of the study include the following: 
 To compare non-invasive measurements from the penile cuff test against invasive 
indices of contractility 
 To compare 2 different symptom scores for men with voiding LUTS 
 To assess accuracy and inter-observer variability of ultrasound residual 
measurement against a known volume.  
 

 
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3. Methods  
Any eligible man referred for video-urodynamic investigation at the Freeman Hospital, 
Newcastle upon Tyne, will be invited to take part in the study.  
 
Patient Screening 
 
The following steps will be taken by the research team to ensure a patient is eligible for 
participation in this study: 
 Confirm the patient’s age and gender (using the investigation referral form) 
 Ensure the patient has completed a frequency volume chart (FVC), and review the 
information contained 
 Ensure the patient has completed an IPSS (International Prostate Symptom Score) 
questionnaire prior to attending for their appointment 
 Confirm co-morbidities and past medical history with the patient and their electronic 
records to identify any conditions which would contra-indicate the study as per the 
exclusion criteria 
 Assessment of capacity to give informed consent  
 
The following criteria have been devised with regards to patient participant in the study: 
  
 Inclusion Criteria  
o Male aged 18 years old or over 
o Referred for video urodynamics within our department  
o Predominant voiding LUTS as assessed by IPSS at screening. [The total IPSS score 
is out of 35, with up to 15 points for storage symptoms and 20 for voiding 
symptoms. If voiding symptoms as a percentage of total score is higher than 
storage symptoms they will be included in the study].  
o Capacity to understand study procedures and give informed consent  
o At least 2 voided volumes on FVC of 250 mL 
 
 Exclusion Criteria  
o Female patients  
o Inability to void  
o Long term catheterisation  
o Predominant storage LUTS on IPSS at screening  
o Fewer than 2 voids on FVC > 250 mL 
o Known pre-existing neurological cause for symptoms  
o Active urinary tract infection (UTI)

 
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Patient Pathway  
 
1. Urodynamic referral forms will be screened upon receipt in the department. Patients 
meeting initial criteria (male, >18 years old) will be contacted by the researcher. The 
study will be introduced and if he wishes to participate: 
 IPSS will be performed over the telephone  
 The study will be explained in detail 
 The patient will be given the opportunity to ask questions  
 A patient information leaflet will be sent out via post, as well as a 
frequency volume chart and an appointment for the investigation  
 
2. The patient will attend the department on the day of investigation. They will be met 
by the researcher, who will confirm if the patient wishes to participate in the study. 
The FVC will be assessed at this point to ensure eligibility for the cuff test. If the 
patient is not eligible or no longer wishes to participate in the study, they will only 
undergo the test requested by their clinician. If they do wish to take part, the 
researcher will take written informed consent from the patient. A more detailed 
symptoms questionnaire (ICIQ-MLUTS) will then be performed. 
 
3. Prior to the start of the investigation, the cuff will be shown to the patient, and the 
researcher will describe the steps of the procedure and need to avoid voluntary 
inhibition or straining. The cuff will be placed on the patient’s fingers and inflated to 
demonstrate the test. Opportunity will be given at this point for the patient to ask 
any further questions about the procedure 
 
4. The patient will undergo investigation with video-urodynamics and penile cuff test 
consistent with ICS Good Practice standards. In total there will be 3 fill-void cycles – 
1. PFS, 2. Simultaneous PFS and cuff test and 3. Non-invasive penile cuff test. These 
are detailed in the following steps. Radiological screening will be performed for the 
1st and 3rd cycles.  
 
5. The PFS will be performed as per the standard clinical pathway in our department. 
This includes the following steps: 
 The patient will be asked to perform a free flow (if able) into a 
standard load cell flowmeter. If the patient is unable to perform a free 
flow they will move on to ultrasound volume assessment and then 
catheterisation at this stage. 
 If a free flow is achieved by the patient then an ultrasound 
examination for residual urine volume will be performed by two 
members of the research team, and values recorded. 
 Installation of local anaesthetic gel into the urethra. 
 Urethral catheterisation using 8Fr double lumen cystometry catheter 
(Digitimer Ltd, Welwyn Garden City, United Kingdom). 
 Residual urine will be aspirated via the filling line using a 50 mL luer 
lock syringe to confirm bladder is empty at the start of the test, and 
recorded against the volume measured by the ultrasound.  

 
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 Insertion of 4Fr vented manometer line into the rectum (Digitimer 
Ltd, Welwyn Garden City, United Kingdom). 
 The fluid filled lines will be connected to external pressure 
transducers (MX960P1, Smith Medical, Czech Republic) at the level of 
the pubic symphysis and zeroed to atmospheric pressure. 
 The bladder will be filled at a rate of 50 mL per minute with room 
temperature 0.9% normal saline, or Urograffin® 150 if x-ray screening 
to be performed. The rate may be reduced if the patient does not 
tolerate the standard filling rate (i.e. if it is inducing detrusor 
overactivity or sensory urgency) 
 Filling will continue until the patient expresses a strong desire to void, 
and total instilled volume noted. 
 The patient will then be asked to void, and voided volume (mL) and 
duration of void (seconds) recorded. 
 Throughout the test, intravesical pressure (pves), abdominal pressure 
(pabd), subtracted detrusor pressure (pdet) and flow rate will be 
recorded continuously. 
 
6. If the patient was not able to reach a cystometric capacity of at least 200 mL, or if 
there is severe detrusor overactivity then they will not proceed with the next steps 
of the study. Our estimated attrition rate would be around 25% (we currently 
observe around 1/3 patients unable to achieve this, but anticipate the more 
stringent selection criteria for this study to reduce the value).  
 
7. The researcher will verbally re-confirm that the patient wishes to proceed with the 
penile cuff test, and agreement to the use of x-ray screening.  
 
8. The bladder will be re-filled to the same total volume as the first PFS (taking into 
account residual fluid volume from the first fill-void cycle). A simultaneous PFS and 
penile cuff test will then be performed, including the following extra steps:  
 The appropriately sized penile cuff (Mediplus Ltd) will be positioned 
around the penis, and the distance between the mid-point of the 
penile cuff and the upper border of the pubic symphysis recorded. 
 Both the urethral and rectal pressure lines will remain in situ. 
 The patient will be asked to void, and the cuff will automatically 
inflate (at a rate of 10 cmH2O per 1 second) once flow is detected.  
 The cuff will continue to inflate until flow is interrupted, or until the 
safety limit of 200 cmH2O is reached.  
 The cuff will then automatically deflate, allowing flow to resume, and 
further inflation-deflation cycles are performed until completion of 
the void. 
 
9. A final fill will then be performed, the urethral catheter will be removed, and a 
standard penile cuff test (as described in step 7 above) will be performed, with x-ray 
screening of the bladder and urethra during the periods of cuff inflation. This will be 
operated by an appropriately qualified radiographer. 
 

 
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10. Results of the standard PFS will be reported following usual departmental 
procedure, and returned to the responsible clinician for the patient for further 
management. Results from the penile cuff test will not affect standard care for the 
patient. 
4. Subjects, sample size and statistical analysis 
Subjects 
Any eligible man referred for video-urodynamic investigation at the Freeman Hospital, 
Newcastle upon Tyne, will be invited to take part in the study. Men will continue to be 
recruited until 30 eligible men undergo a successful penile cuff test defined as one or more 
valid inflations which were not excluded by previously defined quality control criteria for the 
test; no recovery of flow after cuff deflation, erratic flow trace resulting in ambiguity of 
pcuff.int and continued flow above the inflation safety limit of 200 cm H2O. 
 
Sample size 
We are performing a pilot study to see if changes made to the cuff test procedure offer 
improvement in the observed error between pcuff.int and pves.isv before proceeding with 
further work to compare cuff derived values to other indices of contractility. The general 
accepted sample size required for a pilot study to determine mean and standard deviation, 
and help perform power calculations for future studies is 20-30 degrees of freedom(13), so 
we have chosen the upper limit of this range for number of patients to ensure we have 
enough values to provide reliable estimates of means and standard deviations.  
 
Valid Test Criteria 
Cuff tests will go on to further analysis if the fill volume is > 250 mL, and if the test was 
performed with the standard size 4.8cm cuff. 
Quality control standards were established during the development of the penile cuff test 
(14), to allow observers to decide if an inflation is valid and suitable for further analysis. 
Inflation cycles will be excluded from analysis if any of the conditions were met: 
 There was no recovery of flow after cuff deflation (in practice this also usually 
includes the final inflation of a void) 
 There was an erratic flow trace – giving ambiguity about the cuff pressure at flow 
interruption 
 Flow was not interrupted before the safety limit of 200 cmH2O. 
 
Statistical analysis 
Our primary analysis will involve a comparison of the pressure required to interrupt urine 
flow (pcuff.int) and simultaneously measured isovolumetric bladder pressure (pves.isv). Our 
hypothesis is that modifications to the procedural steps of the penile cuff test will improve 
the accuracy of pcuff.int. Mean and standard deviation between pcuff.int and pves.isv will be 
calculated, and compared with results from our analysis of past work using an F test to see if 
the variances within the two populations are different.  
 
Analysis of the secondary outcomes will be as follows. The symptoms scores from the IPSS 
and ICIQ-MLUTS patient questionnaires will be compared. The frequency of symptoms will 
be reported, and correlation between the corresponding variables in the two scores 

 
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assessed, as well as statistical difference. We will also compare pcuff.int with other indices of 
contractility derived from the simultaneous PFS including BCI and Watt’s Factor, using a 
measure of difference such as a T test or ANOVA, as well as examining the correlation 
between the various indices. Analysis of the ultrasound residual measurements will assess 
accuracy and inter-observer agreement. The catheterised post void residual volume will be 
used as the gold standard and mean ultrasound values and difference recorded. Inter-
observer agreement will be assessed using a paired t-test. 
 
5. Project Timeline  
With knowledge of recruitment to previous similar studies performed in the department we 
propose a 15 month programme as follows: 
 
Months 1-2 Study set up  
Months 2-14 Recruitment 
Months 14-15 Data analysis 
 
The end point for this project will be September 2019 
6. Resources and Cost  
Equipment  
 
The following equipment may be used for the pressure-flow study, covered by the 
department within the tariff for the patient’s investigation as requested by the referring 
clinician: 
 Disposables: 
o Catheter pack 
o STERETS® Unisept 0.05% w/v cutaneous solution (Medlock Medical Ltd., 
Oldham, UK) 
o Instillagel local anaesthetic jelly 11mL (FARCO-PHARMA GmbH, Cologne, 
Germany) 
o 50 mL luer lock syringe 
o Digitimer Ltd. Urodynamics pack – includes the 8Fr urethral double lumen 
catheter and the 4Fr rectal manometry line 
o Pressure transducer pack (Smith Medical) 
o Optilube Lubricating jelly 5g (Optimum Medical Solutions, Leeds, UK) 
o Sterile gloves 
o Contrast medium - Urograffin® 150 for infusion - 36.5g I per 250mL (Bayer 
Plc, Berkshire, UK) 
o 0.9% sodium chloride 500 mL bag (Fresenius Kabi Ltd., Cheshire, UK) 
 
The following equipment is required for the penile cuff test (additional to standard) 
 Pressure cuffs (Provided by Mediplus Ltd – distributors of cuffs and commercially 
available cuff machine) 
 Cuff machine (exisiting hospital equipment) 
 

 
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7. References 
1 Boyle P et al. The prevalence of lower urinary tract symptoms in men and women in four 
centres. The UrEpik study. BJUI 2003; 92: 409-14 
2 Smith DP et al. Relationship between Lifestyle and Health Factors and Severe Lower 
Urinary Tract Symptoms (LUTS) in 106,435 Middle-Aged and Older Australian Men: 
Population Based Study. PLOS One 2014; 9(10): 1-10 
3 ICS terminology 2002 
4 Chapple CR et al. The Underactive bladder: a New Clinical Concept? Eur Urol 2015; (68): 
351-353 
5 Smith PP, Birder LA, Abrams P, Wein AJ and Chapple CR. Detrusor Underactivity and the 
Underactive Bladder: Symptoms, Function, Cause—What DO We Mean? ICI-RS Think Tank 
2014. Neurourology and Urodynamics 2016; 35:312–317  
6 Klingler HC et al. Morbidity of the evaluation of the lower urinary tract with transurethral 
multichannel pressure-flow studies. J Urol 1998; 159:191-194 
7 Porru D et al. Evaluation of morbidity of multi-channel pressure-flow studies. Neurourol 
Urodyn 1999; 18(6): 647-652 
8 Onur R, Ozden M, Orhan I, Khalkan A, Semercioz A. Incidence of bacteraemia after 
urodynamic study. J Hosp Infect 2004; 57(3): 241-244 
9 van Mastrigt R and Pel JJ. Towards a noninvasive diagnosis of infravesical obstruction. BJUI 
1999; 84: 195-203 
10 Griffiths DJ. Detrusor Contractility: Order Out of Chaos. Scand J Urol Nephrol Suppl 2004; 
215: 93–100 
11 Huang Foen Chung JWNC, Spigt MG, Knottnerus JA and van Mastrigt R. Comparative 
analysis of the reproducibility and applicability of the condom catheter method for 
noninvasive urodynamics in two Dutch centers. Urol Int 2008;81:139-148 
12 McIntosh SL et al. Noninvasive assessment of bladder contractility in men. J Urol 
2004;172:1394-1398 
13 Lenth RV. Russ Lenth’s power and sample size page [Webpage]. Accessed 07/04/2017, 
from https://homepage.divms.uiowa.edu/~rlenth/Power/index.html 
14 Drinnan MJ et al. Inter-observer agreement in the estimation of bladder pressure using a 
penile cuff. Neurourol Urodyn 2002;22:296-300