| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN34344346 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0234179134 |
| Public title | Supine versus Prone Extracorporeal Shockwave Lithotripsy for Proximal Ureteric Stones |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Urological and Genital Diseases: Calculus of ureter |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Any patient with a proximal ureteric stone (all stones located proximal to the sacroiliac joint) will be considered for inclusion. |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 19/04/2006 |
| Anticipated end date | 01/08/2008 |
| Status of trial | Ongoing |
| Target number of participants | 182 patients (91 patients in each group) |
| Interventions | 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. |
| 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 |
| 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 |
| Sources of funding | North Bristol NHS Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Miss K Davenport |
| Contact details | Bristol Urological Institute
Southmead Hospital
Bristol
United Kingdom
BS10 5NB |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN34344346 |
| Date last extracted from ISRCTN register | 17/04/2008 |
