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Trial registered on ANZCTR
Registration number
ACTRN12621001528842
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
10/11/2021
Date last updated
10/11/2021
Date data sharing statement initially provided
10/11/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Patient preference and safety of self-removal of ureteric stents
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Scientific title
Efficacy and safety of ureteric stents in patients who have recently undergone ureteroscopy for stone disease
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Secondary ID [1]
303402
0
None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urolithiasis
320690
0
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Nephrolithiasis
323996
0
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Ureteroscopy
323997
0
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Condition category
Condition code
Surgery
318535
318535
0
0
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Surgical techniques
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Renal and Urogenital
321502
321502
0
0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Self-removal of ureteric stents via string extraction by patients
The process of ureteric stent removal involves patients being given both written (public), verbal (private) and video information (private) - which has been designed specifically for this study. Participants will be provided with a link to view the video after their appointment. The video duration is approximately 2 minutes.
The instructions for ureteric stent removal by patient are as follows:
1. Wash your hands
2. Stand up to remove
3. To remove the stent, the visible string is held firmly and a steady, continuous pulling action should be applied until the entire stent comes out. The stent is flexible and should uncurl and come out easily.
4. Check the stent has been completely removed - blue plastic tube approximately 20cm long
5. Expect some mild discomfort in your back and urethra on removal. A small amount of blood in the urine is normal after removal but should settle.
If there are any concerns regarding the stent removal, please contact the Urology Registrar at Royal North Shore Hospital.
This information above is provided on a written handout which also has the time and date of stent removal for patients. I.e Remove on Monday the 18th October at 0900am
Patients will remove the stent in their own home. Other methods of removal include by a nurse in an outpatient clinic/surgeons' rooms or via a flexible cystoscopy performed either in hospital theatre or in the outpatient clinic
Patients are self-selecting method of removal.
Patients will submit a questionnaire and be called by the Primary Investigator 1 week following stent removal.
Stents are being left generally for 3-5 days post procedure
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Intervention code [1]
319707
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Treatment: Other
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Intervention code [2]
321977
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Treatment: Devices
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Comparator / control treatment
Patients who have their ureteric stent removed either through a subsequent flexible cystoscopy under local anaesthesia or by a health professional (doctor or nurse) via string extraction in a hospital clinic
Patients will elect which method they would like their ureteric stent removed. If there is no preference patient's will be allocated to the self-removal group.
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Control group
Active
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Outcomes
Primary outcome [1]
326489
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Successful removal of ureteric stent
Assessed by patient via survey and through follow-up with Principal Investigator
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Assessment method [1]
326489
0
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Timepoint [1]
326489
0
7-14 days post-operatively
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Secondary outcome [1]
391674
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Hospital Readmission
By speaking directly with patient during follow up and via accessing medical records as appropriate
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Assessment method [1]
391674
0
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Timepoint [1]
391674
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2 weeks post-operatively
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Secondary outcome [2]
391675
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Urinary Tract Infection
Confirmed by patient and with Urine MSU result
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Assessment method [2]
391675
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Timepoint [2]
391675
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2 weeks post-operatively
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Eligibility
Key inclusion criteria
Inclusion Criteria
• Patients undergoing elective ureteropyeloscopy and laser lithotripsy of renal or ureteric calculi who will have double J ureteric stents placed
• Patients aged between 20-70
• Patients who are independent in their activities of daily living (ADLs)
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Minimum age
20
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
• Patients who had ureteric stents placed for non-calculous disease – i.e. cancer, renal disease, ureteric stricture
• Patients <20 and >70 years of age
• Patients who are semi-dependent or completely dependent in their ADLs (i.e. nursing home residents)
• Patients who have physical difficulties which limit their ability in removing stents
• Patients who have had stents left for > 2 weeks prior to removal, which increases the risk of encrustation and therefore potential difficulty in removing the stent.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Statistical analysis will be performed using the SPSS software.
Mean and standard deviations will be used to characterise the demographic variables. Assuming the data is parametric, the Chi-squared test will be used to compare binomial outcomes within the independent samples. When comparing continuous variables, the student’s t-test will be used. A p-value of <0.05 will be considered statistically significant. Analysis will be overseen by a statistician
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
15/10/2021
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Date of last participant enrolment
Anticipated
31/01/2023
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Actual
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Date of last data collection
Anticipated
17/02/2023
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Actual
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Sample size
Target
180
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Accrual to date
3
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
18665
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Gosford Hospital - Gosford
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Recruitment hospital [2]
18666
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [3]
18667
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Wyong Public Hospital - Hamlyn Terrace
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Recruitment hospital [4]
18668
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The Northern Beaches Hospital - Frenchs Forest
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Recruitment hospital [5]
20782
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North Shore Private Hospital - St Leonards
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Recruitment postcode(s) [1]
33103
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2250 - Gosford
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Recruitment postcode(s) [2]
33104
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2065 - St Leonards
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Recruitment postcode(s) [3]
33105
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2259 - Hamlyn Terrace
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Recruitment postcode(s) [4]
33106
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2086 - Frenchs Forest
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Funding & Sponsors
Funding source category [1]
307818
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Hospital
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Name [1]
307818
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Royal North Shore Hospital
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Address [1]
307818
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Reserve Road
St Leonards
Sydney
NSW 2065
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Country [1]
307818
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Australia
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Primary sponsor type
Hospital
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Name
Royal North Shore Hospital
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Address
Reserve Road
St Leonards
Sydney
NSW 2065
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Country
Australia
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Secondary sponsor category [1]
308524
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None
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Name [1]
308524
0
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Address [1]
308524
0
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Country [1]
308524
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
307824
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North Sydney HREC
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Ethics committee address [1]
307824
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Research Office, Level 13 Kolling Building 10 Westbourne St St Leonards NSW 2065
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Ethics committee country [1]
307824
0
Australia
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Date submitted for ethics approval [1]
307824
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08/02/2021
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Approval date [1]
307824
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04/05/2021
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Ethics approval number [1]
307824
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Summary
Brief summary
Following treatment of urinary tract stones, ureteric stents are typically left in for one to two weeks post-operatively. Removal of these stents can be performed in multiple ways - either by the patient themselves, by a nurse or via a subsequent procedure. This study investigates these methods of ureteric stent removal to see which is better tolerated by patients. We hypothesise that self-removal of ureteric stents will be preferable. This is because of convenience, reducing risk of potential exposure to COVID-19 and reducing hospital costs.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
108630
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Dr Cameron James Parkin
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Address
108630
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Royal North Shore Hospital
Department of Urology
Reserve Road
St. Leonards
Sydney
NSW 2065
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Country
108630
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Australia
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Phone
108630
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+61 437060192
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Fax
108630
0
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Email
108630
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[email protected]
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Contact person for public queries
Name
108631
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Cameron James Parkin
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Address
108631
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Royal North Shore Hospital
Department of Urology
Reserve Road
St. Leonards
Sydney
NSW 2065
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Country
108631
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Australia
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Phone
108631
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+61 2 9926 7111
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Fax
108631
0
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Email
108631
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[email protected]
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Contact person for scientific queries
Name
108632
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Cameron James Parkin
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Address
108632
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Royal North Shore Hospital
Department of Urology
Reserve Road
St. Leonards
Sydney
NSW 2065
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Country
108632
0
Australia
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Phone
108632
0
+61 2 9926 7111
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Fax
108632
0
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Email
108632
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
IPC will not be available
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
13626
Ethical approval
See attached
381393-(Uploaded-18-10-2021-15-48-38)-Study-related document.pdf
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.
Download to PDF