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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: single centre/Egypt.
Dates when study was conducted: April 2007 to July 2010.
Participants Inclusion criteria: radiopaque distal ureteric calculi < 12 mm.
Exclusion criteria: anatomical abnormalities, non‐radio‐opaque stones, voiding dysfunction, urinary tract infection, severe hydronephrosis, or history of endoscopic or open ureteral surgery were excluded.
Diagnostic criteria: US urinary tract, KUB and renal function. NCCT in selected cases.
Total number of participants randomly assigned: 61.
Group A (tamsulosin)
  • Number of participants randomly assigned: 32.

  • Age (mean): 7.3 ± 4.2.

  • Gender (M/F): 18/15.


Group B (placebo)
  • Number of participants randomly assigned: 28.

  • Age (mean): 7.1 ± 3.2.

  • Gender (M/F): 18/10.

Interventions Group A (n = 33): tamsulosin 0.4 mg for children > 4 years and 0.2 mg for younger children at bedtime.
Group B (n = 28): placebo.
Co‐interventions: standard analgesia ibuprofen.
Outcomes Stone clearance
  • How measured: parents were asked to filter the urine to detect fragments of stone expulsion, KUB or NCCT to confirm passage of stone.

  • Time points measured: 4 weeks.

  • Time points reported: not reported.

  • Subgroup: none.

Notes Funding Sources: none.
Declaration of interests: no conflict of interest.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote from publication: "Children were randomly divided into two groups".
Not specified.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Not described.
Blinding of outcome assessment (detection bias) Subjective outcomes Unclear risk Not described.
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 Low risk Quote from publication: "All patients completed the study".
Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment Low risk Quote from publication: "All patients completed the study".
Incomplete outcome data (attrition bias) Secondary procedures Low risk Quote from publication: "All patients completed the study".
Incomplete outcome data (attrition bias) Hospital stay Low risk Quote from publication: "All patients completed the study".
Incomplete outcome data (attrition bias) Pain Unclear risk No information given.
Selective reporting (reporting bias) Unclear risk Secondary procedures was not specified and no published protocol available.
Other bias Low risk Not detected.