Condition category
Urological and Genital Diseases
Date applied
02/07/2018
Date assigned
06/07/2018
Last edited
06/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
A number of men will experience bothersome urinary symptoms, which become more common as they age. A number of conditions can cause these symptoms, and general practitioners may refer men to their local hospital for further assessment and treatment. Symptoms can include poor flow of urine, the need to pass urine more frequently, or the sensation that the bladder is not completely emptying. This can be due to an enlargement of the prostate gland. However, these symptoms may also be caused when the bladder muscle is unable to contract (squeeze) as well as it previously has to empty the bladder. This is known as an underactive bladder. It is important to distinguish between the two conditions as a cause for these symptoms, to prevent side effects from unnecessary medications or operations. Currently, men undergo a bladder pressure test (urodynamics). This involves a catheter inserted into the bladder, through which it is filled with fluid and the pressure measured. A second small tube is inserted into the rectum to measure the pressure in the abdomen. A second technique for measuring bladder pressures is the use of a small inflatable cuff which is placed around the penis (penile cuff test). The bladder pressure can then be assessed by inflating the cuff and interrupting the flow of urine. The bladder can be filled naturally before the test, which means a catheter tube will not be required. This study is designed to find out ways to make the penile cuff test more accurate, and compare this to results obtained from a bladder pressure test performed at the same time.

Who can participate?
Men aged over 18 undergoing video-urodynamics (bladder pressure test)

What does the study involve?
Participants complete a bladder diary for 3 days at home and bring it to their appointment. They complete a symptom score and then undergo a urine flow test and an ultrasound assessment of post-void residual urine. Bladder and rectal catheters are then inserted for the standard bladder pressure test with x-ray screening. The patient's bladder is then refilled, a penile cuff is applied and a second void is performed (no x-ray screening) with the penile cuff test active. The patient's bladder is filled a third time and the line is removed from the bladder. A further void with the penile cuff test active is performed with x-ray screening of the bladder and urethra.

What are the possible benefits and risks of participating?
There are no direct benefits to participants. The results of this study will hopefully help improve the investigation of men with similar problems in the future. There are no serious risks involved in participating in this study. The risks of standard bladder pressure tests involve a small chance of blood in the urine temporarily following the test, or developing a urine infection. 2% of men find the penile cuff test uncomfortable, or may see blood in the urine following the test. The majority of men tolerate the test well. The standard bladder pressure test involves the use of x-rays to take images of the bladder and urethra. For this study x-rays are also taken during the second penile cuff test to examine the effect the cuff has on the urethra as it inflates. These procedures use ionising radiation to form images of your body and provide other clinical information. Ionising radiation can cause cell damage that may, after many years or decades turn cancerous. We are all at risk of developing cancer during our lifetime. The normal risk is that this will happen to about 50% of people at some point in their life. The cumulative radiation exposure from these tests is considered small and is not likely to adversely affect the participants. The standard bladder pressure test would increase this risk by a very small amount (0.003%). Taking part in this study will only increase the risk slightly – the same as if the standard test was done twice.

Where is the study run from?
Freeman Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2017 to January 2020

Who is funding the study?
Mediplus Limited

Who is the main contact?
Helen Morton
Helen.Morton@nuth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Helen Morton

ORCID ID

Contact details

Department of Urology
Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom
+44 (0)191 2139602
Helen.Morton@nuth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

38747

Study information

Scientific title

Contractility: cuff versus urodynamics testing in males with voiding lower urinary tract symptoms

Acronym

CONCUR

Study hypothesis

A number of men will experience bothersome urinary symptoms, which become more common as they age. A number of conditions can cause these symptoms, and general practitioners may refer men to their local hospital for further assessment and treatment. Symptoms can include poor flow of urine, the need to pass urine more frequently, or the sensation that the bladder is not completely emptying. This can be due to an enlargement of the prostate gland. These symptoms can also be caused when the bladder muscle is not able to contract (squeeze) as well as it previously has to empty the bladder. This is known as underactive bladder (UAB).
It is important to distinguish between the two conditions as a cause for these symptoms, to prevent side effects from unnecessary medications or operations. Currently, men would need to undergo a bladder pressure test (urodynamics). This involves inserting a catheter via the penis into the bladder, through which the bladder is filled with fluid and pressure is measured. A separate second small tube is inserted into the rectum to measure the pressure in the abdomen. The pressure changes are observed as the bladder is filled, and then urine is passed around the catheter.
A second technique for measuring bladder pressure is the use of a small inflatable cuff which is placed around the penis (penile cuff test). The bladder pressure can then be determined by inflating the cuff and interrupting the flow of urine. The bladder can be filled naturally before the test, which means a bladder catheter tube is not required. This study is designed to find out ways we can make the penile cuff test even more accurate, and compare this to results obtained from the bladder pressure test, and will take x-ray pictures of the urinary tract during the test.

Ethics approval

Tyne & Wear South Research Ethics Committee, 25/06/2018, ref: 18/NE/0213

Study design

Non-randomised; Both; Design type: Diagnosis, Imaging, Other, Validation of investigation /therapeutic procedures

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

See additional files

Condition

Specialty: Renal Disorders, Primary sub-specialty: Urology; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of the genitourinary system

Intervention

Men over the age of 18 years old referred for video-urodynamics (bladder pressure test) are the target population of the study. Any patient meeting the eligibility criteria will be contacted over the telephone by the direct care team, and the study will be introduced. An IPSS patient symptom score will be performed to confirm eligibility. If the patient indicates that they would consider taking part in the study they will be scheduled for a urodynamics appointment in the urodynamics research session and an information leaflet sent out. As is standard care, the patient is also sent a frequency volume chart to complete for 3 days at home, and bring to their urodynamics appointment. When the patient attends for their appointment they will be met by a member of the research team. They will have the opportunity to ask questions, and the researcher will go through the process of informed consent. If the patient does not consent to participate their standard test only will be performed.

Patients who provide valid informed consent will complete a second symptom score (IPSS-MLUTS), and then undergo study investigation as follows:
1. Urine flow test and assessment of post void residual of urine. This is assessed by ultrasound examination by two members of the research team.
2. Insertion of bladder and rectal catheters for the standard bladder pressure test. The bladder catheter will be aspirated to ensure the bladder is empty at the start of the procedure.
3. Standard video-urodynamics will be performed (fill-void cycle) with x-ray screening.
4. The patient's bladder will be refilled, a penile cuff applied and a second void performed (no xray screening) with the penile cuff test active.
5. The patient's bladder will be filled a third time and the line from the bladder removed. A further void with the penile cuff test active will be performed with x-ray screening of the bladder and urethra.

Penile cuff tests will be evaluated by accepted quality control criteria to determine successful test. This sample size for this study is 30 patients with successful penile cuff tests.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Variance measured by calculating the mean difference and SD between cuff interruption pressure (pcuff.int) and intravesical pressure (pves.isv) at the single timepoint of this study. Reduction in variance will be measured by comparing this result to previous data using an F test
2. Urethral behaviour and bladder neck opening during x-ray screening of penile cuff test, reported by qualitative description

Secondary outcome measures

1. Comparison of non-invasive vs invasive indices of contractility will measure correlation between pcuff.int from the cuff test against BCI and Watt’s factor from CMG performed at the single timepoint of this study
2. Correlation of PROMs using IPSS and ICIQ-MLUTS measured at baseline
3. Accuracy of ultrasound post-void residual measurement measured by catheterised residual volume (mL) during 1st catheterisation at the single timepoint of this study

Overall trial start date

01/03/2017

Overall trial end date

05/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male participant aged 18 years old or over
2. Referred for investigation of urinary symptoms by video-urodynamics in our unit
3. Predominant voiding urinary symptoms (assessed by international prostate symptom score - IPSS - at screening. Included if score from voiding symptoms is a greater percentage of total score than storage symptoms)
4. At least two voids on their frequency volume chart of greater than or equal to 250 mL
5. Patient has capacity to understand the study procedures and give informed consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

1. All female patients
2. Any male patient less than 18 years of age
3. Inability to void
4. Long-term catheterisation
5. Predominant storage urinary symptoms on IPSS score
6. Fewer than 2 voids on frequency volume chart greater than or equal to 250 mL
7. Known pre-existing neurological cause for symptoms
8. Active UTI

Recruitment start date

01/08/2018

Recruitment end date

28/02/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

c/o Aaron Jackson
Newcastle Joint Research Office
Newcastle upon Tyne
NE7 7DN
United Kingdom
+44 (0)191 2825789
Aaron.jackson@nuth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Mediplus Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Publication of results as part of MD thesis
2. Dissemination of results by presentation at the International Continence Society (ICS) annual scientific meeting – Summer 2020
3. Planned publication in in a high-impact peer reviewed journal

IPD sharing statement
The datasets generated and analysed during the current study will be available upon request from Helen Morton (helen.morton@nuth.nhs.uk). This would be for medical professionals with an interest in non-invasive urodynamics requiring data for meta-analysis, or in response to queries/requests generated from publication of results in scientific journals/presented at conferences. This will be from the overall end point of the study (05/01/2020) and will be anonymised raw data only. This will be shared in a password protected file sent via an encrypted email service. Consent has been taken from patients following provision of a patient information sheet and data transparency information sheet.

Intention to publish date

24/09/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/07/2018: Uploaded protocol Version 1.1, 15 May 2018 (not peer reviewed).