Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234179134
Study information
Scientific title
Acronym
Study hypothesis
We are looking at the effect patient position has on the success of lithotripsy for stones located in the upper ureter. Upper ureteric stones may be treated with the patient lying on his/her back or front. We aim to determine whether one position is more effective at breaking the stone than the other.
As of 05/04/2012, the anticipated end date of trial has been updated from 01/08/2008 to 01/08/2007.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
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 the contact details below to request a patient information sheet
Condition
Urological and Genital Diseases: Calculus of ureter
Intervention
All patients presenting for lithotripsy to an upper ureteric stone will be approached immediately prior to treatment regarding inclusion. A full explanation of the treatment and study protocol will be given and the patients will be given the opportunity to ask questions and consult family members. Those in agreement to participate will be asked to sign a consent form. The position for treatment will be allocated immediately prior to treatment using sealed envelopes. All patients will receive a maximum of 3000 shockwaves at a maximum power of 100%. Following each treatment patients will be asked to complete a short patient satisfaction questionnaire, including a pain score.
Patients will be reviewed at the time of their second treatment two weeks later with a KUB x-ray (standard practice). The presence, site and size of any residual stone will be recorded. The second treatment will also be given in the same position as the first. Any patients requiring a second treatment will be reviewed in an outpatient clinic 2 weeks later to determine the
outcome, again using a KUB x-ray (standard practice).
Sample size - a sample of 182 patients (91 patients in each group) would enable the detection of a standardised difference in SWL success rates of 20% or greater when patients are treated prone versus supine. This estimate was based on a two-tailed, paired t-test, using 80% power and a 5% significance level.
Study End Point - the study will be discontinued once either the stone has been confirmed to have passed using x-ray KUB or persistent stone presence following two consecutive treatments.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Proximal ureteric stone passage rates at 2 weeks following first SWL treatment
2. Proximal ureteric stone passage rates at 2 weeks following second SWL treatment
Secondary outcome measures
1. Total time taken to perform treatment (time from first screening to discontinuation of shock wave delivery)
2. Power and number of shocks delivered per treatment
3. PCA (patient controlled analgesia) use
4. Complication rates and the number of ancillary procedures required in each group
Overall trial start date
19/04/2006
Overall trial end date
01/08/2007
Reason abandoned
"Participant recruitment issue"
Eligibility
Participant inclusion criteria
Any patient with a proximal ureteric stone (all stones located proximal to the sacroiliac joint) will be considered for inclusion.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
182 patients (91 patients in each group)
Participant exclusion criteria
1. Ureteric stent or nephrostomy in situ
2. Radiolucent stone
3. Any patient unable to lie supine or prone for any reason
4. < 16 years old
Recruitment start date
19/04/2006
Recruitment end date
01/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Urological Institute
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Bristol NHS Trust
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