The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000517178
Ethics application status
Approved
Date submitted
9/03/2019
Date registered
1/04/2019
Date last updated
1/04/2019
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Water irrigation following resection of bladder tumour
Scientific title
WATIP: Water Irrigation following transurethral resection of bladder tumour - a pilot study of feasibility and safety
Secondary ID [1] 297682 0
None
Universal Trial Number (UTN)
Trial acronym
WATIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 311960 0
Condition category
Condition code
Cancer 310538 310538 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Irrigation of the bladder using water irrigation during (by the surgeon in the operating theatre) and after (by nursing staff on the ward) bladder tumour resection. Duration of water irrigation will be for at least 3 hours, and can continue for longer at the discretion of the treating clinician
Intervention code [1] 313914 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319400 0
Feasibility, assessed as at least 90% of eligible participants being able to receive the study intervention
Timepoint [1] 319400 0
Immediate - within 24 hours of resection
Secondary outcome [1] 368024 0
Safety - assessed by the rate of adverse events of CTCAE grade 3 or higher
Timepoint [1] 368024 0
24 to 48 hours following bladder tumour resection
Secondary outcome [2] 368025 0
Recurrence-free survival
Timepoint [2] 368025 0
3 and 12 months following bladder tumour resection

Eligibility
Key inclusion criteria
1. Age 18 or older
2. Capacity to provide informed consent
3. Suspected bladder cancer on flexible cystoscopy or imaging
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. At risk of water toxicity:
a. History of hyponatraemia (serum sodium below normal limits, usually 135 mmol/L)
b. Chronic renal impairment (eGFR < 30)
c. Congestive cardiac failure (Ejection Fraction < 25%)
2. Suspected or confirmed pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13350 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 13351 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 25949 0
3128 - Box Hill
Recruitment postcode(s) [2] 25950 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 302207 0
Charities/Societies/Foundations
Name [1] 302207 0
ANZUP trials group
Address [1] 302207 0
Lifehouse, Level 6, 119-143 Missenden Road,

Camperdown NSW 2050
Country [1] 302207 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 2
5 Arnold Street
Box Hill
Victoria 3128
Country
Australia
Secondary sponsor category [1] 302057 0
None
Name [1] 302057 0
Address [1] 302057 0
Country [1] 302057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302886 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 302886 0
Level 2, 5 Arnold Street
Box Hill
Victoria 3128
Ethics committee country [1] 302886 0
Australia
Date submitted for ethics approval [1] 302886 0
Approval date [1] 302886 0
21/02/2019
Ethics approval number [1] 302886 0
E12-2018

Summary
Brief summary
The purpose of this study is to determine if continuous irrigation of the bladder using sterile water for at least 3 hours is feasible and safe in bladder tumour resection.

Who is it for?
You may be eligible for this study if you are an adult who is suspected of having bladder cancer.

Study details
Standard surgery for bladder tumours involves irrigation of the bladder during and after the surgery using sterile saline (salt water). If you participate in this study, you will have sterile water used for this irrigation during and for at least 3 hours after surgery instead.

If irrigation using water is found to be feasible and safe, it can then be assessed further to see if it can prevent the bladder cancer. from coming back. This could have a major impact on treating bladder cancer
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91738 0
Prof Shomik Sengupta
Address 91738 0
Eastern Health Clinical School, Monash University
Level 2, 5 Arnold Street
Box Hill
Victoria 3128
Country 91738 0
Australia
Phone 91738 0
+61 03 9094 9546
Fax 91738 0
Email 91738 0
shomik.sengupta@monash.edu
Contact person for public queries
Name 91739 0
Prof Shomik Sengupta
Address 91739 0
Eastern Health Clinical School, Monash University
Level 2, 5 Arnold Street
Box Hill
Victoria 3128
Country 91739 0
Australia
Phone 91739 0
+61 03 9094 9546
Fax 91739 0
Email 91739 0
shomik.sengupta@monash.edu
Contact person for scientific queries
Name 91740 0
Prof Shomik Sengupta
Address 91740 0
Eastern Health Clinical School, Monash University
Level 2, 5 Arnold Street
Box Hill
Victoria 3128
Country 91740 0
Australia
Phone 91740 0
+61 03 9094 9546
Fax 91740 0
Email 91740 0
shomik.sengupta@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
equirement to sign data access agreement,
What supporting documents are/will be available?
Study protocol
Informed consent form
Summary results
No Results