Elgalaly 2017

Methods	Study design: parallel‐group randomised controlled trial. Setting: single centre/Egypt. Dates when study was conducted: September 2014 to October 2015.
Participants	Inclusion criteria: age < 18 years, single unilateral radiopaque DUS, and largest stone diameter of 10 mm. Exclusion criteria: multiple, bilateral or recurrent stones, radiolucent stone, largest stone diameter > 10 mm, UTI or urosepsis, anomalies of the ureter or the kidney, previous urinary tract endoscopy or surgery, marked hydronephrosis, and abnormal renal function. Diagnostic criteria: history, physical examination, laboratory investigations including urine analysis and serum creatinine, radiological assessment with plain abdominal KUB radiograph and abdomino‐pelvic ultrasonography. Total number of participants randomly assigned: 40. Group A (silodosin) Number of participants randomly assigned: 20. Age (mean): 8.4 (3.1). Gender (M/F): 12/8. Group B (placebo) Number of participants randomly assigned: 20. Age (mean): 7.7 (2.3). Gender (M/F): 15/5.
Interventions	Group A (n = 20): silodosin 4 mg at bedtime. Group B (n = 20): placebo. Co‐interventions: none.
Outcomes	Stone clearance How measured: children were advised to urinate in a potty under parent or guardian observation to ensure the exact time of stone passage by visual confirmation of the stone and subsequently confirmed radiologically. Time points measured: 2‐ or 4‐weeks. Time points reported: not reported. Subgroup: none.
Notes	Funding Sources: none. Declaration of interests: none.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "Treatment was assigned on a randomised basis using the closed envelope randomisation method into two equal groups...".
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote from publication: "This single‐blinded study". It is unclear who was blinded.
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Quote from publication: "This single‐blinded study". It is unclear who was blinded.
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Objective outcomes are not likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) Stone free rate	Low risk	2/20 (10.0%) and 1/20 (5.0%) participants in silodosin and placebo group were not included in the analysis, respectively.
Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment	Low risk	2/20 (10.0%) and 1/20 (5.0%) participants in silodosin and placebo group were not included in the analysis, respectively.
Incomplete outcome data (attrition bias) Secondary procedures	Unclear risk	No information given.
Incomplete outcome data (attrition bias) Hospital stay	Unclear risk	No information given.
Incomplete outcome data (attrition bias) Pain	Low risk	2/20 (10.0%) and 1/20 (5.0%) participants in silodosin and placebo group were not included in the analysis, respectively.
Selective reporting (reporting bias)	Unclear risk	Prespecified outcomes were fully described, but no published protocol available.
Other bias	Low risk	Not detected.