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Trial registered on ANZCTR


Registration number
ACTRN12616000382471
Ethics application status
Approved
Date submitted
18/01/2016
Date registered
23/03/2016
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of various numbers of shock waves during shockwave lithotripsy for kidney stones: A multicenter, randomized, active controlled, clinical trial
Scientific title
Comparison of various numbers of shock waves during shockwave lithotripsy for kidney stones: A multicenter, randomized, active controlled, clinical trial
Secondary ID [1] 288230 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urolithiasis 297152 0
Condition category
Condition code
Renal and Urogenital 297375 297375 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Extracorporeal shockwave lithotripsy (SWL)- The lithotriptor attempts to break up the stone with minimal collateral damage by using an externally applied, focused, high-intensity acoustic pulse. . A fluoroscopic x-ray imaging system or an ultrasound imaging system is used to locate the stone and aim the treatment. The acoustic pulse is generated at the ellipsoidal focal point that is furthest from the patient and the stone positioned at the opposite focal point receives the focused shock wave.
The successive shock wave pressure pulses result in direct shearing forces, as well as cavitation bubbles surrounding the stone, which fragment the stones into smaller pieces that then can easily pass through the ureters.
Lithotriptors differ mainly in terms of shockwave generation source. There are piezoelectric, electromagnetic and electrohydraulic mechanisms. All patients will receive the same, preoperatively defined, treatment for their stones apart from the number of shockwaves which is the subject of our study. SWL scheme consist of:the following features:
.1. Power source: electromagnetic, piezoelectric
2. SWL performed by experienced operator (>50 SWL)
3. Power ramping (100 shockwaves with 10 kV and subsequent with 20 kV)
4. Shockwave frequency 1 Hz
5. Use of compression belt
6. Pain medication (diclofenac 100 mg tbl orally 20 minutes before SWL session)
7. Antibiotic prophylaxis in case of positive urine culture
8. One session
9. Low-viscosity ultrasound gel applied directly from the stock container
10. Imaging every 500 shockwaves for optimal targeting (both USG and X-ray)
11. Adjuvant drug therapy – 28 tablets of tamsulosin 0,4 mg - 28 tablets to be taken one per day starting the day of SWL

Patients will be randomly assigned to one of three groups (1000, 2000, 3000 shockwaves) to evaluate efficacy and safety of each number. The study will be conducted in 5 urologic centres (Bielsko-Biala, Chorzow, Katowice, Rybnik, Jaworzno) in Poland. Each centre will randomize 210 patients (3 groups x 70 patients)
For participants treatment will involve SWL as described above and follow -up which consists of computed tomography 3 months after treatment and answering the questionnaires
Lithotriptors:
Jaworzno: electromagnetic Dornier Lithotripter Compact Delta II - specification (http://www.dornier.com/Americas/linkservid/E44F3FE9-64E5-42B7-9755520CE9C4DB43/showMeta/0/)
Chorzow: electromagnetic - Storz Modulith SLX-MX - specification (http://www.medwow.com/med/extracorporeal-lithotripter/storz/modulith-slx-mx/113.model-spec)
Katowice - electromagnetic, Siemens Lithostar (http://www.healthcare.siemens.com/refurbished-systems-medical-imaging-and-therapy/urology-systems-ecoline/modularis-eco)
Rybnik - electromagnetic, Storz Modulith SLX-MX - specification (http://www.medwow.com/med/extracorporeal-lithotripter/storz/modulith-slx-mx/113.model-spec)
Bielsko-Biala - piezoelectric, Wolf Piezolith 3000 specification: (http://www.richard-wolf.com/broschueren/Shock_wave/ESWL_600_P3000_GB_XI08.pdf)
Intervention code [1] 293521 0
Treatment: Devices
Comparator / control treatment
There will be three paralell groups with 1:1:1 allocation. First group will receive 1000 shockwaves, second group 2000 shockwaves and the third one 3000 shockwaves. First group (1000) will be considered the control group..
Control group
Dose comparison

Outcomes
Primary outcome [1] 296927 0
Stone free rate (presence of a stone more than 2 mm) on contrast enhanced computed tomography (yes/no)
Timepoint [1] 296927 0
3 months after treatment
Primary outcome [2] 297262 0
If residual stone present– diameter of residual stone (mm) - contrast enhanced computed tomography
Timepoint [2] 297262 0
3 months after treatment
Secondary outcome [1] 319721 0
Visual analogue pain score - questionnaire
Timepoint [1] 319721 0
just after SWL session
Secondary outcome [2] 320507 0
Oral analgesic requirements during 1 month after treatment (yes/no) - by telephone interview with participant
Timepoint [2] 320507 0
up to one month after SWL
Secondary outcome [3] 320508 0
Additional procedures after SWL (nephrostomy, URSL) (yes/no) - by telephone interview with participant
Timepoint [3] 320508 0
up to one month after SWL
Secondary outcome [4] 320509 0
Clavien complications scale (I, II, IIIa, IIIb, IVa, IVb, V) - Post-operative complications, as defined on Clavien complications scale
Timepoint [4] 320509 0
Up to one month after SWL
Secondary outcome [5] 320510 0
Infundibular-pelvic angle (<70 degrees/>70 degrees)-contrast enhanced computed tomography
Timepoint [5] 320510 0
3 month after SWL
Secondary outcome [6] 320511 0
Infundibular length (<1cm/>1 cm)-contrast enhanced computed tomography
Timepoint [6] 320511 0
3 months after SWL
Secondary outcome [7] 320512 0
Infundibular width (<5mm/>5mm)-contrast enhanced computer tomography
Timepoint [7] 320512 0
3 months after SWL
Secondary outcome [8] 320513 0
Urine culture (positive/negative)
Timepoint [8] 320513 0
3 months after SWL
Secondary outcome [9] 320514 0
Blood pressure (mmHg) - by sphygmomanometer
Timepoint [9] 320514 0
3 months after SWL
Secondary outcome [10] 320519 0
Haematoma (yes/no) - contrast enhanced computer tomography
Timepoint [10] 320519 0
3 months after swl
Secondary outcome [11] 320520 0
Creatinine concentration (mmol/l) - by serum assay
Timepoint [11] 320520 0
3 months after SWL
Secondary outcome [12] 320521 0
FIPS questionnaire (1-6 points) - Patient satisfaction, assessed by FIPS.
Timepoint [12] 320521 0
3 months after SWL
Secondary outcome [13] 320531 0
efficacy according to type of lithotripter (electromagnetic, piezoelectric) - contrast enhanced computed tomography
Timepoint [13] 320531 0
3 months after SWL
Secondary outcome [14] 320532 0
efficacy according to urologic centre - contrast enhanced computed tomography
Timepoint [14] 320532 0
3 months after SWL
Secondary outcome [15] 320533 0
efficacy according to age of patients - contrast enhanced computed tomography
Timepoint [15] 320533 0
3 months after SWL
Secondary outcome [16] 320534 0
efficacy according to sex of patients - contrast enhanced computed tomography
Timepoint [16] 320534 0
3 months after SWL
Secondary outcome [17] 320535 0
efficacy according to BMI of patients - contrast enhanced computed tomography
Timepoint [17] 320535 0
3 months after SWL

Eligibility
Key inclusion criteria
1. Single kidney stone 5- 20 mm diameter on X-ray, IVP or CT
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. More than one stone in affected kidney
2. Hemorrhagic disease
3. Morbid obesity (BMI >35)
4. Patients taking painkillers continuously
5. Ureteral stone
6. Age under 18
7. Inserted ureteral catheter
8. Solitary kidney
9. Fever
10. Acute urinary tract infection
11. Abdominal aortic aneurysm
12. Creatinine concentration > 150 umol/l
13. Distal ureteral obstruction
14. Pregnancy
15. Contrast allergy
16. Enhanced computer tomography conducted in the past 12 months
17. History of previous failed SWL
18. Known shockwave-resistant stones (calcium oxalate monohydrate, brushite, cystine)

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)
opaque envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
logistic regression. Number needed to evaluate for logistic regression in given with formula
n > 10 (k+1), where n is a number of patients and k is the number of assessed variables. as k equals 19 so n > 200, per centre at minimum.
With the assistance of gpower program [1] sample size may be estimated including the following information:
1. two tailed test
2. odds ratio 1,71
3. alpha error prob. 0,05
4. power 90%
5. R^2 other X 0,5
6. X distribution - binomial
7 X parm u 0,33

which gives 906 patients as total sample size. We will accept attrition of 16% which gives 1050 patients who should be enrolled in the study.

1. Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191.

Faul, F., Erdfelder, E., Buchner, A., & Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 1149-1160.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
25/04/2016
Actual
1/09/2016
Date of last participant enrolment
Anticipated
27/04/2018
Actual
1/09/2016
Date of last data collection
Anticipated
1/09/2016
Actual
1/09/2016
Sample size
Target
1
Accrual to date
Final
1
Recruitment outside Australia
Country [1] 7491 0
Poland
State/province [1] 7491 0
Silesia

Funding & Sponsors
Funding source category [1] 292833 0
Self funded/Unfunded
Name [1] 292833 0
unfunded
Country [1] 292833 0
Primary sponsor type
Individual
Name
Piotr Bryniarski
Address
Department of Urology in Zabrze, Medical University of Silesia, 41-800 Zabrze, 3 Maja Street 13-15
Country
Poland
Secondary sponsor category [1] 291573 0
None
Name [1] 291573 0
Address [1] 291573 0
Country [1] 291573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294093 0
Ethics Committee of Medical University of Silesia
Ethics committee address [1] 294093 0
Ethics committee country [1] 294093 0
Poland
Date submitted for ethics approval [1] 294093 0
Approval date [1] 294093 0
17/11/2015
Ethics approval number [1] 294093 0
KNW/0022/KB1/32/II/15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62438 0
Dr Piotr Bryniarski
Address 62438 0
Department of Urology, Medical University of Silesia, 3 Maja Street 13-15, Zabrze 41-800
Country 62438 0
Poland
Phone 62438 0
+48605611963
Fax 62438 0
Email 62438 0
[email protected]
Contact person for public queries
Name 62439 0
Piotr Bryniarski
Address 62439 0
Department of Urology, Medical University of Silesia, 3 Maja Street 13-15, Zabrze 41-800
Country 62439 0
Poland
Phone 62439 0
+48605611963
Fax 62439 0
Email 62439 0
[email protected]
Contact person for scientific queries
Name 62440 0
Piotr Bryniarski
Address 62440 0
Department of Urology, Medical University of Silesia, 3 Maja Street 13-15, Zabrze 41-800
Country 62440 0
Poland
Phone 62440 0
605611963
Fax 62440 0
Email 62440 0
[email protected]

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

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