Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001087943
Ethics application status
Approved
Date submitted
16/08/2011
Date registered
19/10/2011
Date last updated
19/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomised study to determine the effectiveness of bladder pre-filling prior to removal of an indwelling catheter in men who have recently undergone transurethral resection of the prostate.
Scientific title
A prospective randomised study to determine the effectiveness of bladder pre-filling prior to removal of an indwelling catheter in men who have recently undergone transurethral resection of the prostate.
Secondary ID [1] 262843 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TOV study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients undergoing transurethral resection of prostate due to lower urinary tract problems or bladder outlet problems 270566 0
Condition category
Condition code
Renal and Urogenital 270735 270735 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After medical officer indicates need for removal of IDC in patients randomly assigned to intervention group - bladder is pre-filled with up to 250mls of normal saline via a gravity feed drip with the IDC clamped for 10 minutes before removal of IDC
Intervention code [1] 269567 0
Treatment: Other
Comparator / control treatment
standard IDC removal i.e. When medical officer deems appropriate, balloon is passively deflated and IDC removed
Control group
Active

Outcomes
Primary outcome [1] 269434 0
Time to pass trial of void
Timepoint [1] 269434 0
Time taken to pass the trial of void after removal of catheter
Secondary outcome [1] 287640 0
Time to discharge
Timepoint [1] 287640 0
Time taken to discharge patient after successful trial of void

Eligibility
Key inclusion criteria
All patients undergoing TURP who are cognitively able to understand and consent to study
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitively unable to understand and consent
Patients unable to read and understand English in order to comply with protocol

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)
Consecutive patients idendified from OT lists, Consent obtained. in preadmission Clinic or on ward post TURP when given a subject ID number. Random assignment using sealed envelope system employed which are kept locked in Nurse Unit Manager's office until time for IDC removal
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
100 patients numbers randomly generated using computer randomisation sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269665 0
Hospital
Name [1] 269665 0
Royal Brisbane & Womens Hospital
Country [1] 269665 0
Australia
Primary sponsor type
Individual
Name
Helen HEIM
Address
Clinical Nurse
7BS Urology
7th Floor NHB
Butterfield St
HERSTON QLD 4029
Country
Australia
Secondary sponsor category [1] 266702 0
Individual
Name [1] 266702 0
Joan Webster
Address [1] 266702 0
Nursing Director Research
Centre for Clinical Nursing Bld 34
Butterfield St
HERSTON QLD 4029
Country [1] 266702 0
Australia
Secondary sponsor category [2] 268757 0
Individual
Name [2] 268757 0
Charles de Ruiter
Address [2] 268757 0
Nurse Unit Manager
7BS Urology
7th Floor, NHB
RBWH
Butterfield St
HERSTON QLD 4029
Country [2] 268757 0
Australia
Secondary sponsor category [3] 268958 0
Individual
Name [3] 268958 0
Nigel Dunglison
Address [3] 268958 0
Director of Urology
RBWH
Butterfeild St
HERSTON QLD 4029
Country [3] 268958 0
Australia
Other collaborator category [1] 252202 0
Individual
Name [1] 252202 0
Dr Nigel Dunglison
Address [1] 252202 0
Director of Urology
Dept of urology
8th Floor NHB
RBWH
Butterfield St
HERSTON QLD 4029
Country [1] 252202 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269615 0
RBWH Human Research Ethics Committee (HREC)
Ethics committee address [1] 269615 0
Level 7 Block 7
Butterfield St
HERSTON QLD 4029
Ethics committee country [1] 269615 0
Australia
Date submitted for ethics approval [1] 269615 0
Approval date [1] 269615 0
23/11/2010
Ethics approval number [1] 269615 0
HREC/10/QRBW/324

Summary
Brief summary
To determine if pre-filling of bladder prior to IDC removal allows men to regain bladder control faster and thereby allowing earlier discharge
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33024 0
Address 33024 0
Country 33024 0
Phone 33024 0
Fax 33024 0
Email 33024 0
Contact person for public queries
Name 16271 0
Helen HEIM
Address 16271 0
Clinical Nurse
7BS Urology
7th Floor NHB
Butterfield St
HERSTON QLD 4029
Country 16271 0
Australia
Phone 16271 0
61 7 3636 8789
Fax 16271 0
61 7 3636 3485
Email 16271 0
helen_heim@health.qld.gov.au
Contact person for scientific queries
Name 7199 0
Joan Webster
Address 7199 0
Nursing Director Research
Centre for Clinical Nursing
Building 34
Butterfield St
HERSTON QLD 4029
Country 7199 0
Australia
Phone 7199 0
61 7 3636 8590
Fax 7199 0
Email 7199 0
joan_webster@health.qld.gov.au

No information has been provided regarding IPD availability


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.