Basiri 2010

Methods	Study design: parallel‐group randomised controlled trial. Setting: multi‐centred (6 centres)/Iran. Dates when study was conducted: February 2007 to October 2009.
Participants	Inclusion criteria: distal ureteral calculi. Exclusion criteria: poorly controlled coagulation disorders, active urinary tract infection, urinary tract anomalies, non‐functioning kidney and hypertension. Diagnostic criteria: not reported. Total number of participants randomly assigned: 100. Group A (SWL) Number of participants randomly assigned: 50. Age (mean): 5.5 +/‐4.7. Gender (M/F): 29/21. Group B (TUL) Number of participants randomly assigned: 50. Age (mean): 6.5+/‐3.9. Gender (M/F): 27/23.
Interventions	Group A (n = 50): SWL using an under table Compact Delta II lithotriptor (Dornier MedTech, Kennesaw, Georgia) under ultrasound (66%) or fluoroscopic (34%) guidance, impulse rate 1,250‐2,400 (mean 1,530) and power 11‐13 kV Group B (n = 50): transureteral lithotripsy (TUL) with holmium laser (5) or pneumatic lithotriptor (45). 6 Fr (48 patients) or 8.5 Fr (2 patients) semirigid ureteroscope passed to facilitate this. Co‐interventions: none.
Outcomes	Stone clearance How measured: US KUB. (If stone free excretory urography at 3 months). Time points measured: 2 weeks and 3 months. Time points reported: at discharge, at 2 weeks and 3 months. Subgroup: none. Complications How measured: during the surgical procedure direct visualisation, USS KUB. Time points measured: at the time of surgery, at 2 weeks and 3 months. Time points reported: not reported. Subgroup: none. Secondary procedures How measured: US KUB. (If stone free excretory urography at 3 months). Time points measured: 2 weeks and 3 months. Time points reported: not reported. Subgroup: none. Hospital stay How measured: measured the time of anaesthesia and post operative hospital stay. Time points measured: during the surgery and from surgery to discharge. 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)	Low risk	Quote from publication: 'Patients were included in the study based on the randomised numerical schedule'.
Allocation concealment (selection bias)	Unclear risk	Quote from publication: 'A total of 100 children with distal ureteral calculi were consecutively assigned by Peto randomisation'. Not enough information on whether this was an open schedule.
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: "Follow up was completed in all patients"
Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment	Low risk	Quote from publication: "Follow up was completed in all patients"
Incomplete outcome data (attrition bias) Secondary procedures	Low risk	Quote from publication: "Follow up was completed in all patients"
Incomplete outcome data (attrition bias) Hospital stay	Low risk	Quote from publication: "Follow up was completed in all patients"
Incomplete outcome data (attrition bias) Pain	Unclear risk	No information given.
Selective reporting (reporting bias)	High risk	No published protocol available. All of the outcomes were not prespecified but described in the result of article.
Other bias	Low risk	Not detected.