Condition category
Urological and Genital Diseases
Date applied
17/06/2010
Date assigned
06/07/2010
Last edited
30/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Beat Roth

ORCID ID

Contact details

Urology Department (Urologische Universitätsklinik)
Inselspital
Bern
3010
Switzerland

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 measures

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

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

Sponsor information

Organisation

Inselspital, University Hospital Berne (Switzerland)

Sponsor details

c/o Beat Roth
Urology Department (Urologische Universitätsklinik)
Bern
3010
Switzerland

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26119561

Publication citations

Additional files

Editorial Notes