Sur 2015.

Methods	Study design: DB placebo‐controlled RCT. Study duration: July 2010 and July 2012. Follow‐up/Treatment duration: 4 weeks.
Participants	Country: USA. Setting: multi‐centre. Patients ≥ 18 years with a unilateral calculus ≥ 4 mm and ≤ 10 mm at any location of the ureter visible within 7 days of study enrolment on kidney/ureter/bladder radiograph (KUB) and/or non‐contrast helical computed tomography (CT). Number: treatment group: 122; placebo group: 124. Mean age ± SD, years: treatment group: 47 ± 13; placebo group: 47 ± 15. Sex, M/F: treatment group: 72/43; placebo group: 80/37. Exclusion criteria: multiple ureteral calculi; a solitary kidney; refractory renal colic (renal colic or nausea/emesis that could not be well controlled with outpatient medications); a non‐opaque calculus; severe hydronephrosis.
Interventions	Treatment group Silodosin 8 mg daily. Placebo group Placebo drug. All participants received pain medication (oxycodone 5 mg). Other medication that would not confound study results was permitted and documented.
Outcomes	Primary outcome variables Stone expulsion rate. Secondary outcome variables Stone expulsion time. Need for ED visits or hospital admissions. Adverse events of medication. Need for surgical intervention. Need for outpatient narcotic use for pain relief. Incidence and severity of pain.
Funding sources	Actavis Inc. supported the study.
Declarations of interest	None stated.
Notes	Power calculation, intention‐to‐treat‐analysis.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "... using a randomization schedule prepared by a nonstudy statistician." Comment: This method of random sequence generation was considered to have low risk of bias.
Allocation concealment (selection bias)	Low risk	Quote: "Each kit had a unique sequential number." Comment: This method of allocation concealment was considered to have low risk of bias.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The investigator, patient, and study team were blinded to treatment assignment throughout 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	Low risk	No quotes available. Comment: Personnel responsible for outcome assessments were blinded; therefore risk of detection bias was considered to be low.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No quotes available. Comment: Numbers of participants lost to follow‐up in the different study groups were equally distributed; 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.