Spot Study: 24-hour vs random spot urine stone biochemistry tests

• Research type

  Research Study

• Full title

  A prospective, feasibility study to compare spot urine samples versus conventional 24-hour urine collections for the assessment of urine based risk factors in patients with kidney stones

• IRAS ID

  250918

• Contact name

  Shalom Srirangam

• Contact email

  Shalom.Srirangam@elht.nhs.uk

• Sponsor organisation

  East Lancashire Hospitals NHS Trust

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  Kidney stone disease is a common problem in the UK (lifetime risk > 12% in males; >6% in females). Additionally, >50% of sufferers will have another one in the future. Assessment of high risk patients requires analysis of urine collection for 48 hours (2 x timed 24-hour samples).

  Contemporary evidence and our experience, demonstrates poor compliance when patients are asked to submit a 48-hour urine specimen. Often, the collection is inaccurate and many patients simply do not provide the sample due to the inconvenience. Thus, patient management is significantly hampered. An alternative option is to use a small volume, random ‘spot’ urine sample to perform the same analyses. However, previous attempts to evaluate ‘spot’ versus 2 x 24-hour samples have been inconclusive.

  The aim is to determine whether ‘spot’ samples collected at specific times are comparable to the conventional 48-hour urine sample. The 18-month study involves a 2-armed observational study to compare two groups of patients:
  • Group 1: patients with proven stones
  • Group 2 (control): patients without stones

  Patients will be recruited from those attending the department of Urology as well as Trust staff. In both groups participants will undergo standard blood tests and will be asked to collect urine for a 48-hour period. During the 48-hour urine collection period, a small ‘spot’ urine sample will be taken at defined periods. Both the ‘spot’ urine sample and the entire 48-hour urine specimen will undergo the same analyses.

  The study will measure the difference in the stone-forming risk factors between ‘spot’ and conventional 48-hour urine samples. It will also assess the performance of ‘spot’ urine versus 48-hour urine and identify differences in risk factors in those with and without stones. If ‘spot’ urine analysis is viable, accurate and meaningful, then this will significantly improve patient inconvenience and compliance, while reducing NHS laboratory costs.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  19/NE/0190

• Date of REC Opinion

  5 Jun 2019

• REC opinion

  Favourable Opinion