Condition category
Urological and Genital Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss K Davenport

ORCID ID

Contact details

Bristol Urological Institute
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes