De Domenicis 2005

Methods	Study design: parallel‐group randomised controlled trial. Setting: single centre/Italy. Dates when study was conducted: July 2002 to July 2003.
Participants	Inclusion criteria: radio‐opaque calculi in the distal ureter treated with SWL or ULT as primary therapy. Exclusion criteria: not reported. Diagnostic criteria: US and IVU. Total number of participants randomly assigned: 31. Group A (SWL) Number of participants randomly assigned: 13. Age (mean): 7.2. Gender (M/F): 14/9. Group B (ULT) Number of participants randomly assigned: 17. Age (mean): 7.2. Gender (M/F): 5/12.
Interventions	Group A (n = 14): SWL was administered using a second‐generation lithotripter. EDAP sonolith 4000+ lithotripter while prone, ˜2500 shock waves (1900‐3500) were delivered, usually at 450 kJ (330‐694). Group B (n = 17): A 7.5 F ureteroscope with a 5 F operative channel; Storz, Germany) combined with a ballistic lithotripter (LithoclastR) (1.9 F tapered semi‐flexible probe ) or holmium‐YAG laser (400 um fibres) was used for ULT. Retrograde endoscopy with or without basket extraction of the fragments. Co‐interventions: ureteric open‐ended catheter left in place for 24‐72 hours. Double‐pigtail ureteric stent for 1 week if ureteric dilatation was used.
Outcomes	Stone clearance How measured: US KUB and X‐ray. Time points measured: 3‐4 weeks after treatment. Time points reported: not reported. Subgroup: none. Complications How measured: not reported. Time points measured: not reported. Time points reported: not reported. Subgroup: none. Secondary procedures How measured: US KUB and X‐ray. Time points measured: 3‐4 weeks after treatment. 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: 'The patients were assigned to SWL or ULT using a randomised computer system...'
Allocation concealment (selection bias)	Low risk	Quote from publication: '...patients were given a number and sealed treatment envelopes with printed numbers used for the allocation...'
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	Low risk	All randomised participants were included in the analysis.
Incomplete outcome data (attrition bias) Pain	Unclear risk	No information given.
Selective reporting (reporting bias)	High risk	No published protocol available. Complication rate not specified as set in the objectives but authors quote 'no major complications in any procedure'. Operation time and length of hospital stay were not prespecified.
Other bias	Low risk	Not detected.