Vincendeau 2010.

Methods	Study design: prospective RCT. Study duration: 1 February 2002 to 8 December 2006. Follow‐up/Treatment duration: 6 weeks.
Participants	Country: France. Setting: multi‐centre. Patients > 18 years hospitalised in emergency wards for acute renal colic and having a radio‐opaque distal ureteral stone between 2 and 7 mm. Number: treatment group: 66; control group: 63. Mean age ± SD, years: treatment group: 38.9 ± 13.4; control group: 39.0 ± 11.4. Sex, M/F: treatment group: 43/18; control group: 52/9. Exclusion criteria: pregnant or breastfeeding women; receiving alpha‐/beta‐blockers; transient hypotension; liver impairment; requiring surgical procedure because of infection or continuation of pain after medical treatment; spontaneous passage before randomisation.
Interventions	Treatment group Tamsulosin 0.4 mg daily for 42 days or until stone expulsion. Control group Matching placebo for 42 days or until stone expulsion. Both groups received ketoprofen 50 mg, 3 capsules daily, and phloroglucinol 80 mg, 6 tablets daily, for 5 days. All participants were told to drink at least 2 L water daily and to filter urine.
Outcomes	Time to stone expulsion. Rate of stone expulsion. Number of pain relapses. Dosage of pain medication. Adverse events.
Funding sources	Financed by the French Ministry of Health and Yamanouchi Pharmaceutical Co Ltd.
Declarations of interest	Dr. Vincendeau is an investigator for Astellas Pharma Inc, AstraZeneca, Beckman‐Coulter/Hybritech Inc, and Pfizer Incorporated.
Notes	Follow‐up of 42 days. Evaluation with X‐ray and US on days 1, 14, 28, and 42. Telephone contact on days 21 and 35.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was centrally performed, concealed, and stratified by center in blocks of 4 according to a computer generated random number table." Comment: This method of random sequence generation was considered to have low risk of bias.
Allocation concealment (selection bias)	Low risk	Quote: "... sequentially numbered boxes containing the whole treatment for each patient following the order of the randomization list." 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: "All patients, health medical and nursing staffs, and pharmacists remained masked throughout the study period." 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: missing outcome data balanced in numbers across both groups, with similar reasons for missing data across 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.