Effect of voltage escalation and shock wave rate during stone treatment
| ISRCTN | ISRCTN95762080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95762080 |
| Secondary identifying numbers | 089/10 |
- Submission date
- 17/06/2010
- Registration date
- 06/07/2010
- Last edited
- 30/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Beat Roth
Scientific
Scientific
Urology Department (Urologische Universitätsklinik)
Inselspital
Bern
3010
Switzerland
Study information
| Study design | Single-centre prospective randomised controlled single-blind interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet [in German] |
| 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 |
| Study objectives | 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(s) | Bern Ethics Committee (Ethikkommission Bern), May 2010, ref: 089/10 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2010 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 640 |
| Key inclusion criteria | 1. Patients with renal or ureteral stones scheduled for shock wave lithotripsy 2. Patients > 20 years of age 3. Informed consent |
| Key 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) |
| Date of first enrolment | 01/07/2010 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Inselspital
Bern
3010
Switzerland
3010
Switzerland
Sponsor information
Inselspital, University Hospital Berne (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
c/o Beat Roth
Urology Department (Urologische Universitätsklinik)
Bern
3010
Switzerland
"ROR" |
https://ror.org/01q9sj412 |
|---|
Funders
Funder type
Hospital/treatment centre
Inselspital, University Hospital Berne (Switzerland) - Urology Department (Urologische Universitätsklinik)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2016 | Yes | No |
