Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Ureteric stones (kidney stone) are very common and painful; 2-3% of the general population (1.8 million in the UK) have suffered from this condition. Ureteric stones can pass in their own time and some patients only require initial treatment with pain killers and, if appropriate, anti-sickness medication and drugs which relax the muscle fibres of the ureter. In some cases the treatments described above do not work or patients are not suitable for such care and further routine intervention (stone removal) is required. This study is investigating two methods used to remove stones: •extracorporeal shockwave lithotripsy (ESWL), which is a shockwave treatment applied from the outside of the body, and ureteroscopic stone treatment, a telescopic procedure to remove the stone.

Who can participate?
Patients aged 16 or older who have a single ureteric stone in the ureter

What does the study involve?
Participants are randomly allocated to be treated with either ESWL or ureteroscopy. All participants are followed up for a period of six months. Participants complete questionnaires about their general health, pain and use of painkillers at the time they join the study, directly before their treatment and again one week after the procedure. At about 8 weeks and 6 months after joining the trial participants complete further questionnaires. In addition, following their ureteric stone treatment, participants return to an outpatient clinic at their recruiting hospital to check how they are getting on. If their symptoms are still not adequately controlled they may receive further treatment as necessary.

What are the possible benefits and risks of participating?
There may be no direct benefit to patients who take part, but they will be helping doctors to assess which treatment is best and safest.

Where is the study run from?
The study is co-ordinated by the Centre for Healthcare Randomised Trials (CHaRT) and is co-sponsored by the University of Aberdeen and NHS Grampian (UK)

When is the study starting and how long is it expected to run for?
March 2013 to February 2017

Who is funding the study?
NHS National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Health Technology Assessment programme (NETSCC HTA) (UK)

Who is the main contact?
Prof. S McClinton

Trial website

Contact information



Primary contact

Prof Sam McClinton


Contact details

Department of Urology
Ward 44
Aberdeen Royal Infirmary
AB25 2ZB
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

HTA 10/137/01, 3/087/12

Study information

Scientific title

A multicentre randomised controlled trial of extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones



Study hypothesis

The hypothesis being tested is that outcome in patients receiving extracorporeal shockwave lithotripsy (ESWL) as their first treatment option is not inferior to outcome in patients receiving direct ureteroscopic retrieval.

Ethics approval

NRES Committees –- North of Scotland, 15/02/2013, ref: 13/NS/0002

Study design

Multicentre randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Ureteric stone treatment


Participants will be randomly allocated to either ESWL or ureteroscopy.

Extracorporeal shockwave lithotripsy (ESWL) involves generation of a shock-wave, external to the body, focused on the stone, causing it to fragment with the fragments subsequently passing spontaneously. A variety of systems (differing means of generating shock-waves, different focusing mechanisms) are available. It is routinely performed in an outpatient setting with pain relief or sedation as required. Recruitment will occur only in established centres with fixed-site lithotripters. This will allow some standardisation of protocols on times to treatment and ESWL delivery. Up to two sessions of ESWL will be considered as one intervention as per standard practice.

Ureteroscopy is the use of small semi-rigid or flexible ureteroscopes, in conjunction with intracorporeal lithotripsy devices, such as the holmium laser, to directly visualise and fragment ureteric stones. Smaller stones, in the lower ureter, can often be removed intact using basketing devices. It is currently most often performed as a day-case procedure (but may require hospital admission depending on complexity) and usually requires general anaesthesia.

Intervention type



Not Applicable

Drug names

Primary outcome measure

The study has a primary clinical and a primary economic outcome reflecting the multidimensional nature of the possible effects the intervention may have.

Clinical: Clearance of ureteric stones operationally defined as “no further intervention required to facilitate stone clearance” up to 6 months from randomisation.

Economic: Incremental cost per quality adjusted life years (QALYs) gained at 6 months from randomisation. QALYs are based on the responses to the EQ-5D.

Secondary outcome measures

Patient-reported, measured at pre and 1 week post intervention, 8 weeks and 6 months post randomisation:
1. Severity of pain measured by the Numeric Rating scale (NRS)
2. Generic health profile measured by the SF-12 (8 weeks and 6 months only)
3. Health status measured by the EQ5D
4. Use of analgesia
5. Acceptability of received procedure (8 weeks and 6 months only)

Clinical: Further interventions received, complications up to 6 months post randomisation

Economic: NHS primary and secondary care use and costs up to 6 months, patient costs; incremental cost per surgical interventions averted.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Presence of stone confirmed by Computed Tomography Scan of the Kidneys, Ureters and Bladder (CTKUB)
2. Patients with a ureteric stone requiring removal
3. Adults ≥16 years of age
4. Single ureteric stone requiring treatment
5. Suitable for either ESWL or ureteroscopic treatment
6. Capable of giving written informed consent, which includes adherence with the requirements of the trial.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Pregnancy
2. Stones not confirmed by CTKUB
3. Bilateral ureteric stone(s)
4. Patients with abnormal urinary tract anatomy (such as a horseshoe kidney or ileal conduit)
5. Patients unable to understand or complete trial documentation

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
AB25 2ZB
United Kingdom

Sponsor information


University of Aberdeen (UK)

Sponsor details

Research and Innovation
University Office
King’s College
AB24 3FX
United Kingdom

Sponsor type




NHS Grampian

Sponsor details

Aberdeen Royal Infirmary
AB25 2ZN
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

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

Basic results (scientific)

Publication list

2017 evaluation of recruitment processes in:
2018 protocol in:

Publication citations

Additional files

Editorial Notes

24/05/2018: Publication reference added. 15/08/2017: Publication reference added.