Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001718437p
Ethics application status
Not yet submitted
Date submitted
6/12/2016
Date registered
14/12/2016
Date last updated
13/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the effect of alpha-blocker versus observation on stone passage following shockwave lithotripsy treatment for renal or ureteric stones.
Scientific title
Comparing the effect of alpha-blocker versus observation on stone expulsion rate post-shockwave lithotripsy treatment for renal or ureteric stones.
Secondary ID [1] 290532 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CASEY Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urolithiasis 300953 0
Condition category
Condition code
Renal and Urogenital 300751 300751 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tamsulosin 0.4mg oral tablet daily for up to a maximum of 28 days commencing immediately following shockwave lithotripsy.
Instruction is given for patient to take the full 28 tablets. Compliance is monitored using a patient reported questionnaire to document the number of tablets actually taken.
There is no minimum treatment duration mandated.
Intervention code [1] 296383 0
Treatment: Drugs
Comparator / control treatment
Patient will not be given tamsulosin following shockwave lithotripsy
Control group
Active

Outcomes
Primary outcome [1] 300171 0
Stone passage rate assessed using a low-dose computed tomography kidney, ureter and bladder at 6 weeks following shockwave lithotripsy
Timepoint [1] 300171 0
6 weeks following shockwave lithotripsy
Secondary outcome [1] 329236 0
Pain associated with stone passage using a visual analogue scale at day 7 and 6 weeks following shockwave lithotripsy.
Timepoint [1] 329236 0
7 days following shockwave lithotripsy, and 6 weeks following shockwave lithotripsy
Secondary outcome [2] 329237 0
Analgesic requirement for the first 7 days following shockwave lithotripsy using a patient questionnaire.
The questionnaire is specifically designed for this study and asks patient to report the number of tablets of simple analgesia used and the number of tablets of opioid analgesia used.
Timepoint [2] 329237 0
7 days following shockwave lithotripsy
Secondary outcome [3] 330059 0
Economic burden associated with stone episode calculated by number of days off work
Timepoint [3] 330059 0
6 weeks following shockwave lithotripsy

Eligibility
Key inclusion criteria
1) Patients presented for and completed shockwave lithotripsy treatment for renal or ureteric stones.
2) Patient must be eligible for fluoroscopic guided shockwave lithotripsy with no contraindications
3) Adults between 18 and 80 years of age (inclusive)
4) Presence of stone confirmed by computed tomography of the kidney, ureter and bladder
5) Capable of giving written informed consent, which includes compliance with the requirements of the trial
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Women who are breastfeeding
2) Patients currently taking an a-blocker
3) Patients currently taking PDE5 inhibitors
4) Contraindication or allergy to tamsulosin
5) Patient who are unable to understand or complete trial documentation

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)
Randomisation and allocation will be done through hospital pharmacy experienced in clinical trials using numbered concealed containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation generated by computer software.
Masking / blinding
Open (masking not 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
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
From experience at our institution, the expected stone clearance rate following ESWL without treatment is 70%. A recent meta-analysis (Chan et al. 2015) reports a risk ratio of 1.2 favouring treatment. Thus, assuming an absolute risk difference of 14%, a power of 80% and alpha of 5% we calculate a sample size of 141 in each arm. Given an expected loss to follow up of 10%, we intend to accrue 157 patients in each arm.

For the primary outcome, we will report the absolute risk difference with confidence interval and will test signifcance of the difference with the chi-square test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2017
Actual
Date of last participant enrolment
Anticipated
4/02/2019
Actual
Date of last data collection
Anticipated
29/03/2019
Actual
Sample size
Target
314
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14794 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 295157 0
Self funded/Unfunded
Name [1] 295157 0
No funding source
Country [1] 295157 0
Primary sponsor type
Hospital
Name
Department of Urology, Case Hospital, Monash Health
Address
Department of Urology, Casey Hospital, 62-70 Kangan Drive, Berwick VIC 3806
Country
Australia
Secondary sponsor category [1] 293980 0
None
Name [1] 293980 0
Address [1] 293980 0
Country [1] 293980 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296461 0
Monash Health
Ethics committee address [1] 296461 0
246 Clayton Road, Clayton, Victoria 3168
Ethics committee country [1] 296461 0
Australia
Date submitted for ethics approval [1] 296461 0
03/03/2017
Approval date [1] 296461 0
Ethics approval number [1] 296461 0

Summary
Brief summary
Extracorporeal shockwave lithotripsy (SWL) is a non-invasive method of treating kidney and ureteric stones <2cm in size. SWL uses high frequency sound waves to break stones into small fragments, to allow it to pass through the urinary tract. Tamsulosin is a selective alpha-1-adrenoceptor antagonist that may lead to ureteral relaxation, reduce pain associated with stone passage and enhance the passage of stone fragments. It has been reportedly used for this purpose for more than a decade. A recent scientific study (meta-analysis by Chen and co-authors) combining the result of multiple randomised controlled trials looking at the effect of tamsulosin in assisting stone passage has been published in 2015. The study of 2093 patients found tamsulosin to be effective in improving the passage of stones and reducing the pain associated with stone passage following SWL. When looking only at the subgroup of 442 patients with stone size of 4-10mm, the study did not find tamsulosin to be useful in assisting stone passage. This is consistent with a recent study by Pickard in The Lancet journal, which found tamsulosin to be not useful in assisting stone passage or reducing pain in patients with stones in the ureter. In Australian practice, SWL are generally used for stones less than 1cm in size. Therefore, at the moment there are still conflicting data on the usefulness of tamsulosin in the cohort of stone patients we treat in Australia with SWL. We aim to answer this question in our randomised trial. The meta-analysis by Chen in 2015 also recommended further study looking into the ability of tamsulosin to reduce repeated SWL and the economic benefits of tamsulosin in this setting. Therefore, we also aim to answer the question of whether tamsulosin use after SWL leads to any economic benefit, which can come from the reduced cost of medical service delivery, and reduced economic burden on the society.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70434 0
Dr Henry Han-I Yao
Address 70434 0
Department of Urology, Casey Hospital, 62-70 Kangan Drive, Berwick VIC 3806
Country 70434 0
Australia
Phone 70434 0
+61387681490
Fax 70434 0
Email 70434 0
henryhiyao@gmail.com
Contact person for public queries
Name 70435 0
Dr Henry Han-I Yao
Address 70435 0
Department of Urology, Casey Hospital, 62-70 Kangan Drive, Berwick VIC 3806
Country 70435 0
Australia
Phone 70435 0
+61387681490
Fax 70435 0
Email 70435 0
henryhiyao@gmail.com
Contact person for scientific queries
Name 70436 0
Dr Henry Han-I Yao
Address 70436 0
Department of Urology, Casey Hospital, 62-70 Kangan Drive, Berwick VIC 3806
Country 70436 0
Australia
Phone 70436 0
+61387681490
Fax 70436 0
Email 70436 0
henryhiyao@gmail.com

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