Pedro 2008.

Methods	Study design: RCT. Study duration: January 2005 to June 2007. Follow‐up/Treatment duration: 4 weeks.
Participants	Country: USA. Setting: single centre. Patients from the ED with renal colic secondary to a distal ureteral stone. Number: treatment group: 34; control group: 35. Mean age ± SD, years: treatment group: 36.69 ± 13.06; control group: 42.03 ± 12.85. Sex, M/F: treatment group: 28/6; control group: 27/8. Exclusion criteria: stones > 8 mm on stone protocol CT; renal insufficiency (SCr > 1.8 mg/dL); a solitary kidney and UTI; concomitant use of alpha‐blocker; pregnancy; history of ureteral stricture; allergic reaction to study medication.
Interventions	Treatment group Alfuzosin: 1 pill daily after breakfast until the stone was passed; dose not stated. Control group Placebo: 1 pill daily after breakfast until the stone was passed.
Outcomes	Stone expulsion rate. Stone expulsion time. Use of analgesics. Pain scores. Side effects.
Funding sources	Sanofi‐Aventis Pharmaceuticals.
Declarations of interest	None stated.
Notes	Sample size calculated.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "... using a random number assignment. A computerized random number generator was used." Comment: This method of random sequence generation was considered to have low risk of bias.
Allocation concealment (selection bias)	Low risk	No quotes available. Comment: Allocation was concealed; therefore the allocation method was considered to have low risk of bias.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: “Investigators were blinded to the randomization scheme and patients and investigators were blinded to medication until termination of the study.” Comment: Double‐blinding was performed; therefore risk of performance bias was considered to be low.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No quotes available. No blinding of outcome assessments described. 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. 7 patients excluded: stone passage before first dose in 4. and withdrawal of consent in 3. Comment: small number 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.