Symptomatic ureteric stone passage enabled by drugs (SUSPEND)

• Research type

  Research Study

• Full title

  Use of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: a multicentre placebo controlled randomised trial of a calcium channel blocker(nifedipine)and an alpha blocker(tamsulosin) - The SUSPEND trial

• IRAS ID

  45748

• Contact name

  Sam McClinton

• Sponsor organisation

  University of Aberdeen

• Eudract number

  2010-019469-26

• ISRCTN Number

  ISCTRN69423282

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Kidney stone disease is a common health problem affecting about 1.6 million adults in the UK. In some patients the stone will fall out of the kidney and become lodged in the tube (ureter) between the kidney and bladder. The majority of sufferers experience a sudden episode of prolonged abdominal pain, usually sufficiently severe to need emergency admission to hospital. Given the pain experienced passing a ureteric stone and the high cost of having to remove them, any simple treatment that hastens or increases the chance of spontaneous stone passage would be welcomed by both patients and the NHS.Stones are expelled by rhythmic tightening (contraction) and opening (relaxation) of the ureter milking the stone downwards and out of the body. Stones may get stuck because the ureter downstream of the stone fails to relax to allow it through; suggesting that relaxant drugs may hasten stone passage. Recently two different relaxant drugs have undergone early testing for this purpose; tamsulosin (an alpha blocker) and nifedipine (a calcium channel blocker). These drugs are widely used for other health problems with a good safety profile and can be taken as once daily capsules. Preliminary results are encouraging with both drugs seeming to increase the chance of passing the stone by 50% and speed the process up by 4 days. The study we are planning will involve giving one of three alternative treatments - tamsulosin, nifedipine or dummy tablet (placebo), to 1200 people diagnosed with ureteric stones who agree to take part. The main things we will measure are whether the stone passed on its own or needed active intervention, and how much pain was experienced by each participant.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  10/S0501/31

• Date of REC Opinion

  15 Jun 2010

• REC opinion

  Favourable Opinion