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. 2018 Jun 2;2018(6):CD010784. doi: 10.1002/14651858.CD010784.pub2
Methods Study design: parallel‐group randomised controlled trial.
Setting: multicentre (number not stated)/Turkey.
Dates when study was conducted: not specified.
Participants Inclusion criteria: single radio‐opaque lower ureteral stone.
Exclusion criteria: ureteral and/or bladder surgery, anatomic urinary system abnormality, vesicouretral reflux, neurogenic/non‐urogenic voiding dysfunction, bilateral or non‐opaque renal stones, severe hydronephrosis, colic pain attacks, and the use of diuretic and/or calcium channel blockers.
Diagnostic criteria: KUB and US or NCCT.
Total number of participants randomly assigned: 50 (45 completed the study).
Group A (doxazosin)
  • Number of participants randomly assigned: 24.

  • Age (mean): 7.2 +/‐ 3.5.

  • Gender (M/F): 14/10.


Group B (ibuprofen only)
  • Number of participants randomly assigned: 21.

  • Age (mean): 7.2 +/‐ 3.5.

  • Gender (M/F): 10/11.

Interventions Group A (n = 24): 0.03 mg/kg/d doxazosin once daily before bed plus the above dose of ibuprofen.
Group B (n = 21): ibuprofen 20 mg/kg/d divided into 2 equal doses. No placebo.
Co‐interventions: none.
Outcomes Stone clearance
  • How measured: stone passage was assessed using KUB radiography and ultrasonography and non contrast‐enhanced spiral computed tomography.

  • Time points measured: weekly for 3 weeks.

  • Time points reported: as 'during the 3 week follow up period'.

  • Subgroup: none.

Notes Funding Sources: authors declare no relevant financial interests.
Declaration of interests: not stated.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was performed using the permuted block method in MedCalc, version 11.5.1, program for the 50 participants.
Allocation concealment (selection bias) Unclear risk Concealment not detailed.
Blinding of participants and personnel (performance bias) All outcomes High risk Quote from publication: 'absence of placebo and therefore absence of blinding were additional limitations'.
Described as a limitation by authors.
Blinding of outcome assessment (detection bias) Subjective outcomes High risk Quote from publication: 'absence of placebo and therefore absence of blinding were additional limitations'.
Described as a limitation by authors.
Blinding of outcome assessment (detection bias) Objective outcomes Low risk Objective outcomes are not likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) Stone free rate High risk 1/25 (4.0%) and 4/25 (16.0%) participants in doxazosin and ibuprofen group were not included in the analysis, respectively. Adherence of participants are not balanced across intervention groups.
Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment Unclear risk Participants with adverse events were excluded in analysis.
Incomplete outcome data (attrition bias) Secondary procedures Unclear risk No information given.
Incomplete outcome data (attrition bias) Hospital stay Unclear risk No information given.
Incomplete outcome data (attrition bias) Pain High risk 1/25 (4.0%) and 4/25 (16.0%) participants in doxazosin and ibuprofen group were not included in the analysis, respectively. Adherence of participants are not balanced across intervention groups.
Selective reporting (reporting bias) High risk Patients with adverse events were excluded in analysis and no published protocol available.
Other bias Low risk Not detected.