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ISRCTN
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ISRCTN95762080
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ClinicalTrials.gov identifier
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Public title
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Effect of voltage escalation and shock wave rate during stone treatment
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Scientific title
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Randomised, single blinded trial to compare immediate versus delayed voltage escalation and the effect of different shock wave rates during shock wave lithotripsy of single kidney or ureteral stones
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Acronym
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N/A
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Serial number at source
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089/10
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Study hypothesis
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In animal models delayed voltage escalation during shock wave lithotripsy of renal stones has been shown to be more effective, with a concurrent lower rate of renal damage (subcapsular or perirenal hematomas). These animal studies suggest that low-energy shock waves might provide a beneficial effect by priming the stones for fragmentation by the following higher energy waves. Therefore, a delayed voltage increase might be more effective for the stone fragmentation with concurrent lower energy dose and lower kidney damage.
For ureteral stones, energy adaptation did not show any beneficial effect. But as in kidney stones, a lower shock wave rate might have a beneficial impact. We therefore postulate, that shock wave frequency of 60 shocks per minute has a better outcome in ureteral stone patients than a shock wave rate of 90 shocks per minute and for renal calculi, a voltage escalation shock wave lithotripsy has a better outcome than a immediate voltage escalation.
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Ethics approval
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The Bern Ethics Committee (Ethikkommission Bern) approved in May 2010 (ref: 089/10)
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Study design
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Single centre prospective randomised controlled single blind interventional study
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Urinary stone treatment with shock wave lithotripsy
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Participants - inclusion criteria
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1. Patients with renal or ureteral stones scheduled for shock wave lithotripsy
2. Patients > 20y of age
3. Informed consent
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Participants - exclusion criteria
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1. Pregnancy
2. < 20y of age
3. Anticoagulation or aspirin medication
4. Urinary tract infection
5. Stones > 2cm (indication for Percutaneous Nephrolithotomy [PCNL] or Ureteroscopic stone treatment)
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Anticipated start date
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01/07/2010
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Anticipated end date
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31/12/2011
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet [in German]
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Target number of participants
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640
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Interventions
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Shock wave lithotripsy of ureteral and renal calculi. Duration of treatment is about 1h and there is only one single treatment per patient.
The follow up is done by ultrasound, blood samples, x-rays and urinary examination 1 day and three months after the intervention.
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Primary outcome measure(s)
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Stone disintegration / stone clearance after 3 months
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Secondary outcome measure(s)
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1. Secondary treatments or interventions for the same stone
2. Perirenal / subcapsular hematomas
3. Complications according to the Dindo-Clavien system
4. Microalbumin and Beta-2 microglobulin measurement as a marker of renal damage (proximal tubulus / glomerular)
Outcomes will be measured at 1 day and 3 months after the intervention.
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Sources of funding
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Inselspital, University Hospital Berne (Switzerland) - Urology Department (Urologische Universitätsklinik)
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Trial website
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Publications
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Contact name
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Dr
Beat
Roth
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Address
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Urology Department (Urologische Universitätsklinik)
Inselspital
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City/town
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Bern
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Zip/Postcode
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3010
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Country
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Switzerland
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Sponsor
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Inselspital, University Hospital Berne (Switzerland)
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Address
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c/o Beat Roth
Urology Department (Urologische Universitätsklinik)
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City/town
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Bern
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Zip/Postcode
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3010
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Country
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Switzerland
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Date applied
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17/06/2010
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Last edited
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06/07/2010
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Date ISRCTN assigned
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06/07/2010
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