Maitra 2012.

Methods	Study design: prospective placebo‐controlled RCT. Study duration: January 2006 to December 2010. Follow‐up/Treatment duration: 6 weeks.
Participants	Country: India. Setting: single centre. Adults aged 18 or older, stones smaller than 10 mm located in the distal ureter (in an area extending from the lower border of the S‐1 joint to the ureterovesicular junction). Number: treatment group 1/tamsulosin group: 50; treatment group 2/tamsulosin and nifedipine group: 50; placebo group: 50. Mean age ± SD, years: treatment group 1: 32.7, no SD; treatment group 2: 36.4, no SD; placebo group: 39.2, no SD. Sex, M/F: treatment group 1: 39/11; treatment group 2: 40/10; placebo group: 37/13. Exclusion criteria: desire to treat colic; gross back pressure changes; recurrent urinary tract infection; ischaemic heart disease; history of previous surgery in the distal ureter; acute renal failure.
Interventions	Treatment group 1/tamsulosin group Tamsulosin 0.4 mg daily. Treatment group 2/tamsulosin + nifedipine group Nifedipine 5 mg twice daily. Tamsulosin 0.4 mg daily. Placebo group Diclofenac and Buscopan ‐ not described in detail.
Outcomes	Stone expulsion rate. Time to stone passage. Number of colic episodes. Need for analgesics and anti‐spasmodic treatment.
Funding sources	None stated.
Declarations of interest	None.
Notes	Follow‐up weekly with KUB and US.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No quotes available. Comment: randomisation stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.
Allocation concealment (selection bias)	Unclear risk	No quotes available. Insufficient information to permit judgement. Comment: Owing to insufficient information, allocation concealment was considered to have unclear 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. Comment: no participants lost to follow‐up; therefore risk of attrition bias was considered to be low.
Selective reporting (reporting bias)	High risk	No quotes available. Occurrence of adverse effects was not predefined as outcome measurement. Time to stone expulsion was not measured with SDs. Number of colic episodes was not specified. Analgesic use was not described in detail (no SDs given). Comment: inconsistency in describing outcome measurements; therefore risk of bias was considered to be high.
Other bias	High risk	No quotes available. Comment: questionable whether this study was placebo‐controlled based on information provided in the Methods section; therefore risk of other sources of bias was considered to be unclear.