Bhagat 2007.

Study characteristics
Methods	Study design: placebo controlled, double blind, prospective RCT Number of centers/setting: not reported Country: India Dates of the study: September 2004 to July 2005
Participants	Total number of participants randomized: 60 tamsulosin group: 30 placebo group: 30 Age (mean, years): tamsulosin group: 35.9 (SD 7.8) placebo group: 42.3 (SD 12.3) Sex (M/F): tamsulosin group: 22/7 placebo group: 24/5 Stone location: tamsulosin group: 14 renal calix/6 renal pelvis/5 upper ureteral/4 lower ureteral placebo group: 12 renal calix/9 renal pelvis/6 upper ureteral/2 lower ureteral Stone size: not reported Inclusion criteria: people who were to receive SWL for a single radiopaque renal 6–24 mm or ureteral 6–15 mm calculus Exclusion criteria: recent open or endoscopic surgical intervention, radiolucent calculus, past unsuccessful SWL, renal impairment (creatinine > 1.5 mg/dL), inadequate kidney function, recurrent calciuria, UTI, receiving calcium channel blockers or alpha1‐blockers (or both), congenital urinary anomalies, history of pyeloureteral surgery and children
Interventions	Treatment group: tamsulosin 0.4 mg/day until complete stone clearance or max 30 days standard care: once daily Proxyvon (dextropropoxyphene hydrochloride 65 mg and acetaminophen 400 mg) orally for analgesia as required; minimum 2.5 L fluids was advised; if severe pain (emergency room or hospital admission), injectable diclofenac or pethidine given Control group: placebo SWL: Lithotriptor: Dornier Compact S Lithotriptor with electromagnetic shock wave generator Power setting: 14–15 kV, interval: 70/min per session Number of shocks: 1500, number of sessions: 1
Outcomes	Primary: number stone clearance How measured: stone free or clinically insignificant asymptomatic residual fragments < 3 mm on excretory urography Time point measured: ≤ 4 weeks Secondary: median analgesic dose Subgroups: stone size
Funding sources	Not reported
Declarations of interest	Not reported
Notes	Language of publication: English Type of publication: full text Date of contact attempt with study authors: 7 July 2019 – general inquiry to Drs Devasia and Kekre Contact status: no reply to‐date
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Block randomization was performed with even distribution, using computer‐generated numbers." Comment: appropriate method of random sequence generation.
Allocation concealment (selection bias)	Unclear risk	Comment: allocation concealment not addressed.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "placebo‐controlled, randomized, double‐blind study": "the patients were randomized into either placebo or study group." Comment: participants likely blinded.
Blinding of outcome assessment (detection bias) Investigator assessed; not susceptible (auxiliary treatments)	Low risk	Comment: outcome judged not susceptible to detection bias.
Blinding of outcome assessment (detection bias) Investigator assessed; susceptible (stone clearance, time to stone clearance)	Unclear risk	Comment: blinding of outcome assessors not addressed.
Blinding of outcome assessment (detection bias) Investigator assessed; susceptible (major adverse events)	Unclear risk	Comment: blinding of outcome assessors not addressed.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "of the 60 patients randomized 58 completed the study, and one from each group discontinued medication and was excluded from analysis." Comment: low (< 10%) loss to follow‐up.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available.
Other bias (additional SWL sessions)	Unclear risk	Comment: unclear whether > 1 SWL session was administered.