Porpiglia 2006.

Methods	Study design: prospective RCT. Study duration: January 2004 to September 2005. Follow‐up/Treatment duration: 10 days.
Participants	Country: Italy. Setting: single centre. Patients with symptomatic distal ureteral stones > 4 mm, recruited from ED, diagnosed with KUB/US or CT if necessary. Number: treatment group 1: 33; treatment group 2: 24; treatment group 3: 33; control group: 24. Mean age ± SD, years: treatment group 1: 47.8 ± 1.3; treatment group 2: 45.3 ± 2.2; treatment group 3: 48.2 ± 0.6; control group: 45.2 ± 0.88. Sex, M/F: treatment group 1: 17/16; treatment group 2: 20/4; treatment group 3: 23/10; control group: 12/12. Exclusion criteria: fever; high‐grade hydronephrosis; diabetes; gastric ulcer; pregnancy; hypotension; history of spontaneous stone expulsion; declared hypersensitivity to tamsulosin or corticosteroids; previous ureteral surgery.
Interventions	Treatment group 1 Tamsulosin 0.4 mg daily. Treatment group 2 Deflazacort: 30 mg daily. Treatment group 3 Tamsulosin 0.4 mg daily. Deflazacort: 30 mg daily. Control group Analgesics on demand. All participants received first treatment with 500 mL saline and analgesic (diclofenac or tramadol). All participants were allowed to use symptomatic therapy with IM injections of diclofenac (on demand) and were instructed to drink a minimum of 2 L of water daily.
Outcomes	Stone expulsion rate. Analgesic consumption. Safety. Number of ureteroscopies.
Funding sources	None stated.
Declarations of interest	None stated.
Notes	Treatment on an "intention‐to‐treat" basis. Sample size calculated.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No quotes available. Comment: randomisation stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.
Allocation concealment (selection bias)	Unclear risk	No quotes available. Insufficient information to permit judgement. Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No quotes available. No blinding described. Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No quotes available. No blinding of outcome assessments described. Not all participants received CT scan at the end of the trial period. Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No quotes available. Comment: small number (3) of participants lost to follow‐up; therefore risk of attrition bias was considered to be low.
Selective reporting (reporting bias)	Low risk	No quotes available. Expected outcomes were reported according to objectives. Comment: Risk of reporting bias was therefore considered to be low.
Other bias	Low risk	No quotes available. Study appears to be free of other sources of bias. Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.