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. 2018 Apr 5;2018(4):CD008509. doi: 10.1002/14651858.CD008509.pub3

Pickard 2015.

Methods
  • Study design: DB RCT.

  • Study duration: 11 January 2011 and 20 December 2013.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: UK.

  • Setting: multi‐centre.

  • Adults aged 18‐65 years with 1 stone measuring 10 mm or less (at largest dimension) in ureter identified on CT KUB.

  • Number: treatment group 1/tamsulosin group: 378; treatment group 2/nifedipine group: 379; placebo group: 379.

  • Mean age ± SD, years: treatment group 1: 43.1 ± 11.5; treatment group 2: 42.3 ± 11.0; placebo group: 42.8 ± 12.3.

  • Sex, M/F: treatment group: 315/68; treatment group 2: 317/66; placebo group: 299/85.

  • Exclusion criteria: known or suspected pregnancy (confirmed by a pregnancy test); women who were breastfeeding; asymptomatic incidentally found ureteric stone; stone not previously confirmed by CT KUB; stone with any single dimension > 10 mm; kidney stone without the presence of ureteric stone; multiple (i.e. ≥ 2) stones within ureter; bilateral ureteric stones; stone in a ureter draining a solitary kidney (anatomically or functionally); abnormal renal tract anatomy; presence of urinary sepsis; chronic kidney disease stage 4 or 5; currently taking an alpha‐blocker; currently taking a calcium channel blocker; currently taking PDE5 inhibitors; contraindication or allergy to tamsulosin or nifedipine; inability to understand or complete trial documentation.

Interventions Treatment group 1/tamsulosin group
  • Tamsulosin 0.4 mg daily until the stone was passed, need for intervention was agreed, or 4 weeks had passed since randomisation.


Treatment group 2/nifedipine group
  • Nifedipine 30 mg daily until the stone was passed, need for intervention was agreed, or 4 weeks had passed since randomisation.


Control group
  • Placebo: 1 pill daily until the stone was passed, need for intervention was agreed, or 4 weeks had passed since randomisation.


Standard pain medication ‐ not described in detail.
Outcomes Primary outcome measurements
  • Stone expulsion rate.

  • Reduction in incremental cost per QALY gained at 12 weeks.


Secondary outcome measurements
  • Pain scores.

  • Time to stone passage.

  • Participant‐reported discontinuation of trial medications.

  • NHS primary and secondary care use and costs up to 3 months.

Funding sources UK National Institute for Health Research Health Technology Assessment Programme.
Declarations of interest Trial author JN is a member of the HTA commissioning board and the NIHR HTA and Efficacy and Mechanism Evaluation editorial board. All other trial authors declare no competing interests.
Notes Sample size calculation.
Follow‐up at 4 and 12 weeks with questionnaires, case report forms during clinical visits, or telephone contact.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "... by a remote randomisation system."
Comment: This method of random sequence generation was considered to have low risk of bias.
Allocation concealment (selection bias) Low risk Quote: "... supplied by an independent Source."
Comment: This method of allocation concealment was considered to have low risk of bias.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Participants, clinicians, and trial personnel remained unaware of the allocated group."
Comment: Double‐blinding was performed; therefore risk of performance bias was considered to be low.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk No quotes available.
Comment: Personnel responsible for outcome assessments were blinded; therefore risk of detection bias was considered to be low.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No quotes available.
Comment: Small number of participants lost to follow‐up equally balanced between treatment groups; therefore risk of attrition bias was considered to be low.
Selective reporting (reporting bias) Low risk No quotes available. Expected outcomes were reported according to objectives.
Comment: Risk of reporting bias was therefore considered to be low.
Other bias Unclear risk No quotes available.
Comment: Time to stone passage was evaluated in only a small portion of the study group (potential selection bias); therefore risk of other bias was considered to be unclear.