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Trial registered on ANZCTR


Registration number
ACTRN12623000799651
Ethics application status
Approved
Date submitted
10/07/2023
Date registered
26/07/2023
Date last updated
30/08/2023
Date data sharing statement initially provided
26/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of pressure on fluid irrigation on pain during flexible cystoscopy
Scientific title
The role of pressure on fluid irrigation on pain during flexible cystoscopy in men - a randomised, double-blinded controlled trial
Secondary ID [1] 310091 0
None
Universal Trial Number (UTN)
U1111-1294-9444
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain during cystoscopy 330643 0
Condition category
Condition code
Surgery 327466 327466 0 0
Surgical techniques
Renal and Urogenital 327525 327525 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Routine flexible cystoscopies will be performed in Westmead Public Hospital’s Endoscopy unit. All participants will be in the supine position and receive 10mL of Instillagel (lidocaine 2% gel) immediately prior to their flexible cystoscopy insertion. Intraurethral lidocaine gel will remain within the participant’s urethra for 1 minute prior to insertion of the cystoscope to allow for standardisation.

There will be two intervention arms, that of pressure-bag irrigation and bag-squeeze irrigation. All other equipment will be standardised, including heights of irrigation bags (60cm above the participant’s bladder), the amount and dwell time of Lignocaine impregnated lubricant (10mL, 1 minute) and type of flexible cystoscope (16fr Olympus) will be standardised. These different pressure levels will be used for the duration of the cystoscopy which is estimated to take less than 5 minutes. Procedures will be done by Urology Registrar or Consultant.

The intervention arm 1 will be fluid irrigation utilising a standardised pressure bag set at 350mmHg based on flow measurements to achieve same pressure as manual bag squeeze.

Intervention arm 2 will be fluid irrigation using ‘bag-squeeze’ method. This occurs by a staff member squeezing the fluid bag during the cystoscopy to increase the fluid rate.
Intervention code [1] 326490 0
Treatment: Surgery
Intervention code [2] 326491 0
Treatment: Devices
Comparator / control treatment
The control arm will be fluid irrigation under gravity which will be administered continuously throughout the cystoscopy until the bladder is adequately filled to allow inspection. This usually takes less than 5 minutes.

All other equipment will be standardised, including heights of irrigation bags (60cm above the participant’s bladder), the amount and dwell time of Lignocaine impregnated lubricant (10mL, 1 minute) and type of flexible cystoscope (16fr Olympus) will be standardised.

Procedures will be done by Urology Registrar or Consultant.
Control group
Active

Outcomes
Primary outcome [1] 335332 0
Pain assessed using visual analogue scale
Timepoint [1] 335332 0
Visual analogue pain scale will be conducted at end of procedure
Secondary outcome [1] 423985 0
Pain intensity assessed using PROMIS Pain intensity 1a scale (scale from 0-10).
Timepoint [1] 423985 0
Patient Reported Outcome Measurement Information Tool (PROMIS) scores. Score assessed at day 7 post-procedure. This tool has been previously validated
Secondary outcome [2] 423986 0
Complications - urinary tract infection, haematuria, urinary retention
- Assessed by reviewed patient's medical records
- Survey will be sent to patients 30 days after procedure to allow for self-reporting
Timepoint [2] 423986 0
30 day post procedure
Secondary outcome [3] 424241 0
Pain interfering in patient's daily activities will be assessed by PROMIS Pain Inference 6a Scale (6 questions relating to the impact of pain upon their daily activities in the last 7 days) on a scale from 1-5
Timepoint [3] 424241 0
Patient Reported Outcome Measurement Information Tool (PROMIS) scores. These tools have been previously validated.. Score assessed at day 7 post-procedure. This tool has been previously validated
Secondary outcome [4] 424242 0
Anxiety from procedure will be assessed by PROMIS Anxiety 4a Scale (4 questions relating to emotional distress in the last 7 days)
Timepoint [4] 424242 0
Patient Reported Outcome Measurement Information Tool (PROMIS) scores. These tools have been previously validated. Score assessed at day 7 post-procedure. This tool has been previously validated.

Eligibility
Key inclusion criteria
Male
18 years or older
No previous complications during flexible cystoscopies
No anticipated additional procedure is to be required during cystoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic pelvic pain
Bladder pain syndrome or interstitial cystitis
Chronic pain syndrome
History of meatal stenosis, urethral stricture or bladder neck contracture
Use of analgesia within 24 hours of cystoscopy
Presence of indwelling urethral catheter within 24 hours of cystoscopy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment via opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
We conducted a power calculation using mQuery Advisor to assess the pain score difference between the control group and intervention arms, and then also between the two intervention arms. Two sided t-tests were used with a standard deviation of 2 on VAS was based on clinical significance and the calculated standard deviation presented from Berajoui et all.

We intend to utilise descriptive statistics to summarise participant characteristics in each group, namely Fisher’s exact test to assess for categorical differences between the intervention arms and the independent t-test for continuous characteristics. If there is variation between the three arms then then we will perform propensity score matching to allow for this heterogeneity.
We will assess for normality of VAS and PROMIS scores and further testing will be done accordingly (ie.Mann-Whitney U test). We will also stratify for prior flexible cystoscopy

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/08/2023
Actual
28/08/2023
Date of last participant enrolment
Anticipated
26/12/2023
Actual
Date of last data collection
Anticipated
20/02/2024
Actual
Sample size
Target
190
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25095 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 40765 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 314253 0
Hospital
Name [1] 314253 0
Westmead Hospital
Country [1] 314253 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 316190 0
None
Name [1] 316190 0
Address [1] 316190 0
Country [1] 316190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313373 0
Western Sydney Local Health District Human Ethics Research Committee
Ethics committee address [1] 313373 0
Westmead Hospital,
Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Ethics committee country [1] 313373 0
Australia
Date submitted for ethics approval [1] 313373 0
20/04/2023
Approval date [1] 313373 0
11/07/2023
Ethics approval number [1] 313373 0
2023/ETH00609

Summary
Brief summary
This research project is testing the effectiveness of using pressurised fluid during flexible cystoscopy insertion in reducing pain.
We know that the most significant pain is experienced during camera insertion. There is some evidence that a ‘bag squeeze’, which temporarily generates an increase in fluid pressure that can reduce a participant’s pain, it is unclear how much pressure during the ‘squeeze’ is ideal and it is not easily reproducible. Hence, we also will use pressurised fluid bags with a standardised pressure level to make this more reproducible for participants.

Whilst fluid-pressure bags are commonly utilised other areas of Urology such as ureteroscopy, it would represent an experimental intervention for pain-reduction in Flexible Cystoscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127918 0
Dr Ankur Dhar
Address 127918 0
Westmead Hospital
Corner Hawkesbury Road and Darcy Road
Westmead NSW 2145
Country 127918 0
Australia
Phone 127918 0
+61 2 88906693
Fax 127918 0
Email 127918 0
Ankur.Dhar@health.nsw.gov.au
Contact person for public queries
Name 127919 0
Dr Ankur Dhar
Address 127919 0
Westmead Hospital
Corner Hawkesbury Road and Darcy Road
Westmead NSW 2145
Country 127919 0
Australia
Phone 127919 0
+61 2 88906693
Fax 127919 0
Email 127919 0
Ankur.Dhar@health.nsw.gov.au
Contact person for scientific queries
Name 127920 0
Dr Ankur Dhar
Address 127920 0
Westmead Hospital
Corner Hawkesbury Road and Darcy Road
Westmead NSW 2145
Country 127920 0
Australia
Phone 127920 0
+61 2 88906693
Fax 127920 0
Email 127920 0
Ankur.Dhar@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data set underlying published results will be available after completion of trial.
When will data be available (start and end dates)?
Start - immediately following publication
End - no set date, minimum 7 years post-publication
Available to whom?
Relevant researchers who have a metholodologically sound proposal can apply to review data set. This requests will be reviewed by investigators.
Available for what types of analyses?
for meta-analysis
How or where can data be obtained?
Submit request with relevant information to investigator (Ankur.Dhar@health.nsw.gov.au)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.