Ferre 2009.

Methods	Study design: RCT. Study duration: August 2006 to November 2007. Follow‐up/Treatment duration: 14 days.
Participants	Country: USA. Setting: ED/single centre. Patients > 18 years, CT‐confirmed single distal ureteral stone. Number: treatment group: 39; control group: 41. Mean age ± SD, years: treatment group: 47 ± 14; control group: 45 ± 12. Sex, M/F: treatment group: 32/6; control group: 24/15. Exclusion criteria: allergy or sensitivity to study drug (tamsulosin hydrochloride); sulfa/sulfonamide allergy; lithiasis of ureteral intramural tract; AKI or CKD; fever; presence of multiple ureteral stones; peptic ulcer disease; liver failure; pregnancy; breastfeeding; history of urinary surgery; history of endoscopic treatment; concomitant treatment with any of the following pharmaceuticals: ‐lytic drugs, calcium channel antagonists, nitrates, and vardenafil hydrochloride; inability to use study pain scale; inability to read, write, and speak English.
Interventions	Treatment group Tamsulosin 0.4 mg daily for 10 days. Standard analgesic therapy. Control group Standard analgesic therapy Ibuprofen: 800 mg orally, 3 times daily. Oxycodone: 5 to 10 mg orally, every 4 to 6 hours as needed for pain.
Outcomes	Spontaneous passage rate. Stone expulsion time. Number of episodes of colicky pain. Number of return visits to the ED or unscheduled primary care visits. Amount of opioid analgesic used. Number of days of missed work or inability to perform usual functions. Adverse events. Self‐reported pain scores.
Funding sources	This study was funded by an academic grant from the Maine Medical Center Mentored Research Committee.
Declarations of interest	None stated.
Notes	Follow‐up with all participants at 2, 5, and 14 days post discharge from the ED. Sample size calculated.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “Randomization was accomplished by using a table of random numbers.” Comment: This method of random sequence generation was considered to be at low risk of bias.
Allocation concealment (selection bias)	Low risk	Quote: “The information on group assignment was contained in a sealed envelope within each study packet, and the envelopes were clearly labelled “do not open until informed consent is obtained.” Comment: This method of allocation concealment was considered to be at low 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. 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. Participants lost to follow‐up (4), discontinued intervention (2), excluded because the stone was located in the proximal ureter (1). Comment: Losses to follow‐up were balanced across treatment groups; 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.