Surgical Interventions for Renal Stones
Research type
Research Study
Full title
The clinical and cost effectiveness of surgical interventions for stones in the lower kidney: The PUrE RCT- Percutaneous Nephrolithotomy (PNL), Flexible Ureterorenoscopy (FURS) and Extracorporeal Lithotripsy (ESWL) for lower pole Kidney stones.
IRAS ID
188563
Contact name
Samuel McClinton
Contact email
Sponsor organisation
Grampian Health Board
ISRCTN Number
ISRCTN98970319
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Summary of Research
Renal tract stone disease is very common and mainly affects adults of working age and the incidence has been increasing. Approximately 50% of renal stones will cause symptoms and up to 26 % will require an active intervention. Currently the NHS has three treatment options for lower pole kidney stones, extracorporeal shock wave lithotripsy (ESWL), percutaneous nephrolithotomy (PNL) and flexible ureterorenoscopy with laser lithotripsy (FURS). Current evidence indicates that these treatment options differ in efficacy, invasiveness, anaesthetic requirement, treatment setting, number of procedures and type and rate of complications.A cochrane review highlighted that there is limited robust evidence to inform the relative effectiveness and cost-effectiveness of ESWL, FURS and PNL in the treatment of lower pole kidney stones. This multi centre RCT (2 RCT in 1)(with internal feasibility) will determine for lower pole stones does flexible ureterorenoscopy with laser lithotripsy result in a better quality of life (EQ-5D) then ESWL or PNL (chosen according to stone size).
Summary of Results
What was the reason for PUrE?
About 10% of people will suffer from kidney stones in their lifetime. Approximately 50% of those people will experience symptoms, typically kidney pain, and about 25% of patients with stones will require active treatment. Active treatment breaks up the stones into small fragments. Active treatments in the NHS include shockwave therapy (called ESWL or extracorporeal shockwave lithotripsy), telescopic surgery (FURS, flexible ureterorenoscopy) and keyhole surgery (PCNL, Percutaneous Nephrolithotomy). Stones commonly develop in the lower part (pole) of the kidney.
Previous studies suggested that for lower pole stones:
• and stones that are 10 mm and smaller in size, telescopic surgery is more likely to remove the stone with a single treatment.
• and for stones, that are larger than 10 mm up to 25 mm, keyhole surgery is more likely to remove the stone with a single treatment.
Previous studies did not measure the impact of these treatments on health and quality-of-life for patients.What did PUrE do?
We compared the effect on health and the economic impact of different care pathways of treatment for people with kidney stones in the lower part of their kidney.PUrE was two studies that were randomised controlled trials (RCT)s;
1 PUrE RCT 1 For people with smaller stones:
We compared telescopic surgery (flexible ureterorenoscopy. FURS) with shockwave therapy (extracorporeal lithotripsy, ESWL).2 PUrE RCT 2 For people with larger stones:
We compared telescopic surgery (flexible ureterorenoscopy. FURS) with keyhole surgery (percutaneous nephrolithotomy (PCNL).Patients were asked to take part by NHS doctors and nurses, from NHS hospitals and clinics in 49 towns and cities across the UK.
A computer program (random allocation) decided which treatment each person received with in each of the two RCTS. The participants, and the doctors caring for them, proceeded with the agreed treatment.
We asked participants to fill out health questionnaires every week after treatment for 12 weeks and at 12 months after joining the study.
We collected information from hospitals about what stone treatments and appointments participants had for the 12 months after they joined the study.
We assessed the cost of all the treatments participants had for their stones compared to their health gained (cost-effectiveness) over the 12 months after they joined the study.
What did PUrE find?
We found that for shockwave therapy and keyhole surgery improvement in participant health status was similar to telescopic surgery. Telescopic surgery was less cost-effective for the NHS in both studies.What does this mean?
These studies show that, based on health status and cost, shockwave therapy for smaller stones and keyhole surgery for larger stones are the first choice for active treatment in the NHS.REC name
North of Scotland Research Ethics Committee 1
REC reference
15/NS/0113
Date of REC Opinion
10 Nov 2015
REC opinion
Further Information Favourable Opinion