None listed
Conditions
Brief summary
Backgropund: Over 50% of all kidney stones are treated with extracorporeal shockwave lithotripsy (SWL). Kidney stones up to 2 cm in diameter are well recognized indication for SWL. The most efficacious scheme of conducting this procedure has not been standardized yet. To do so number of shockwaves per session, number of sessions, shockwave power and frequency, power ramping and use of compression belt should be defined and routinely applied. Apart from number of shockwaves per session and number of sessions other features have already been specified. Other important factors consist of type of lithotryptor and presence of unfavourable clinical characteristics like steep infundibular-pelvic angle and narrow and/or long infundibulum. Objectives: 1. To choose the most efficacious number of shockwaves 2. To compare different lithotryptors in terms of efficacy 3. To validate the SWL unfavourable clinical features (steep infundibular-pelvic angle, infundibular width, infundibular length)
Interventions
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.
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)
Sponsors
Piotr Bryniarski
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Single kidney stone 5- 20 mm diameter on X-ray, IVP or CT
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)
Outcome results
None listed