Supine versus Prone Extracorporeal Shockwave Lithotripsy for Proximal Ureteric Stones

ISRCTN	ISRCTN34344346
DOI	https://doi.org/10.1186/ISRCTN34344346
Protocol serial number	N0234179134
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	North Bristol NHS Trust

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 05/04/2012

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss K Davenport
Scientific

Bristol Urological Institute
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/08/2007
Reason abandoned (if study stopped)	"Participant recruitment issue"

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	182
Key inclusion criteria	Any patient with a proximal ureteric stone (all stones located proximal to the sacroiliac joint) will be considered for inclusion.
Key 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
Date of first enrolment	19/04/2006
Date of final enrolment	01/08/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Bristol Urological Institute

Bristol
BS10 5NB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes