El‐Gamal 2012.

Methods	Study design: prospective DB RCT. Study duration: October 2006 to October 2010. Follow‐up/Treatment duration: 4 weeks.
Participants	Country: Egypt. Setting: single centre. Patients with distal third ureteral stones. Number: treatment group: 48; placebo group: 46. Mean age ± SD, years: group 1: 36.2 ± 6; group 2: 35.3 ± 5.7. Sex, M/F: NS. Exclusion criteria: UTI; ureteral strictures; renal impairment; solitary functioning kidney; pregnancy; lactation; sensitivity to alpha‐blockers.
Interventions	Group 1: placebo group. Group 2: tamsulosin group. Group 3: Uralyt group. Group 4: Uralyt and tamsulosin group. All participants were advised to increase fluid intake to more than 2 L per day and to receive IM injection of 75 mg of diclofenac sodium.
Outcomes	Mean stone size. Analgesic needs. Stone passage rate.
Funding sources	None stated.
Declarations of interest	None stated.
Notes	Non‐enhanced spiral CT was done at the end of study period for all participants.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “Patients were prospectively randomized through a computer generated randomization process into four equal groups.” Comment: This method of random sequence generation was considered to have low risk of bias.
Allocation concealment (selection bias)	Low risk	Quote: “The investigators and the patients were blinded to the treatment given, until the end of the study.” Comment: Randomisation method was described and would not allow investigator/participant to know or influence the intervention group before eligible participant entered into the study. Therefore 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 investigators and the patients were blinded to the treatment given, until the end of the study.” Comment: double‐blind; therefore low risk of bias.
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	Quote: “5 cases were lost to follow‐up (2 in the control group and one in each of the other three groups).” Comment: Owing to the small number of participants lost to follow‐up, risk of attrition bias was considered to be low.
Selective reporting (reporting bias)	High risk	No quotes available. Comment: Primary outcomes were not prespecified; therefore risk of reporting bias was considered to be high.
Other bias	Low risk	No quotes available. Comment: Owing to insufficient information to permit judgement, risk of other sources of bias was considered to be unclear.