Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
089/10
Study information
Scientific title
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
Acronym
Study hypothesis
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.
Ethics approval
Bern Ethics Committee (Ethikkommission Bern), May 2010, ref: 089/10
Study design
Single-centre prospective randomised controlled single-blind interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet [in German]
Condition
Urinary stone treatment with shock wave lithotripsy
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Stone disintegration/stone clearance after 3 months
Secondary outcome measures
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.
Overall trial start date
01/07/2010
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with renal or ureteral stones scheduled for shock wave lithotripsy
2. Patients > 20 years of age
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
640
Participant exclusion criteria
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)
Recruitment start date
01/07/2010
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Switzerland
Trial participating centre
Inselspital
Bern
3010
Switzerland
Funders
Funder type
Hospital/treatment centre
Funder name
Inselspital, University Hospital Berne (Switzerland) - Urology Department (Urologische Universitätsklinik)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26119561