A randomised clinical trial to evaluate the effect of reducing the shock wave frequency during shock wave lithotripsy for renal calculi

ISRCTN ISRCTN08124462
DOI https://doi.org/10.1186/ISRCTN08124462
Secondary identifying numbers N0234166115
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
28/07/2008
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 Kim Davenport
Scientific

North Bristol NHS Trust
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrological and Genital Diseases: Renal calculi
InterventionConsecutive patients with renal calculi attending for lithotripsy will be randomised to receive treatment at either 60 or 120 shock waves per minute. The shock wave lithotripsy treatment will be given using the current protocols, with patient care being altered in no other way. Patients will be reviewed after 3 months with a KUB X-ray, and retreated to a maximum of three treatments if there are remaining fragments greater than 4mm.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2002
Completion date01/08/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants100
Key inclusion criteria100 adults
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/03/2002
Date of final enrolment01/08/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North Bristol NHS Trust (UK) NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2006 Yes No