Supine versus Prone Extracorporeal Shockwave Lithotripsy for Proximal Ureteric Stones
| ISRCTN | ISRCTN34344346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34344346 |
| Secondary identifying numbers | N0234179134 |
- 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
Scientific
Bristol Urological Institute
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| 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 the contact details below to request a patient 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 | 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 study start date | 19/04/2006 |
| 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 number of participants | 182 patients (91 patients in each group) |
| 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
- England
- United Kingdom
Study participating centre
Bristol Urological Institute
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
North Bristol NHS Trust
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 |
