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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: August 2011 to July 2012.
Participants Inclusion criteria: solitary radiopaque renal stones (10 to 20 mm).
Exclusion criteria: multiple stones, moderate or severe hydronephrosis, active infection, coagulopathy, stone size < 10 mm or > 20 mm, bilateral renal stones, radiolucent stones, anatomical abnormality in the ureter or ureteropelvic junction, cardiac pacemaker and uremia.
Diagnostic criteria: US, KUB and/or excretory urography.
Total number of participants randomly assigned: 60.
Group A (Slow SWL)
  • Number of participants randomly assigned: 30.

  • Age (mean): 5.35 ± 3.67.

  • Gender (M/F): 20/10.


Group B (Fast SWL)
  • Number of participants randomly assigned: 30.

  • Age (mean): 6.67 ± 2.94.

  • Gender (M/F): 18/12.

Interventions Group A (n = 30): SWL at 80 shock waves per minute.
Group B (n = 30): SWL at 120 shock waves per minute.
Co‐interventions: diclofenac paediatric suppository was prescribed as analgesia on discharge home.
Outcomes Stone clearance
  • How measured: measured as no residual fragment or only one clinically insignificant fragment <3mm (which was non‐symptomatic, non‐infectious and non‐obstructive) on KUB and US.

  • Time points measured: at 2 and 4 weeks after surgery.

  • Time points reported: at 2 and 4 weeks after surgery.

  • Subgroup: none.


Secondary procedures
  • How measured: not reported.

  • Time points measured: not reported.

  • Time points reported: not reported.

  • Subgroup: none.

Notes Funding Sources: not stated
Declaration of interests: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote from publication: 'Patients were recruited from the outpatient clinic and were prospectively randomised (envelope method) into 2 groups.'
Randomisation sequence generation not described.
Allocation concealment (selection bias) Unclear risk Envelope method used. Unclear whether envelopes were sequentially numbered and opaque.
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 All randomised participants were included in the analysis.
Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment Low risk All randomised participants were included in the analysis.
Incomplete outcome data (attrition bias) Secondary procedures Low risk All randomised participants were included in the analysis.
Incomplete outcome data (attrition bias) Hospital stay Unclear risk No information given.
Incomplete outcome data (attrition bias) Pain Unclear risk No information given.
Selective reporting (reporting bias) Unclear risk Prespeicified outcomes were fully described, but no published protocol available.
Other bias High risk Stone component and stone size were different between the groups.