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. 2018 Apr 5;2018(4):CD008509. doi: 10.1002/14651858.CD008509.pub3

Al Ansari 2010.

Methods
  • Study design: double‐blinded RCT.

  • Study duration: May 2007 to May 2009.

  • Follow‐up: 4 weeks.

Participants
  • Country: Qatar.

  • Setting: single centre.

  • Patients with distal ureteral stones of 10 mm or smaller, evaluated by KUB, US, and NCCT before treatment.

  • Number: treatment group: 50; control group: 50.

  • Mean age ± SD, years: treatment group: 37.18 ± 9.38; control group: 36.13 ± 9.32.

  • Sex, M/F: treatment group: 32/18; control group: 29/21.

  • Exclusion criteria: age < 18 years; non‐radiopaque stones; multiple stones; severe hydronephrosis; pregnancy; hypotension; peptic ulcer; history of endoscopic or open ureteral surgery; use of calcium channel blocker.

Interventions Treatment group
  • Tamsulosin 0.4 mg once daily.


Control
  • Placebo.

Outcomes
  • Stone expulsion rate.

  • Time for stone passage.

  • Number of pain episodes.

  • Need for diclofenac injection.

  • Total diclofenac dosage.

  • Blood pressure.

  • Possible side effects.

Funding sources None stated.
Declarations of interest None stated.
Notes Sample size calculated.
Weekly follow‐up with KUB, US, and urine analysis.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomized between study and placebo medications using a computer‐generated random number assignment, adjusted at a ratio of 1:1." Comment: This method of random sequence generation was considered to have low risk of bias.
Allocation concealment (selection bias) Low risk Quote: "Randomization data were kept strictly confidential, in sealed envelops, accessible only to the pharmacist at the end of the study."
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: "The investigators and patients were masked to the type of the treatment throughout the study."
Comment: double‐blind; therefore low risk of bias.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: “The investigators and patients were masked to the type of the treatment throughout the study.”
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 Unclear risk Quote: “Four patients in the placebo group were lost to follow‐up.”
Comment: Four participants in the placebo group were lost to follow‐up and were excluded from analysis. It is unclear whether this had a clinically relevant impact on the intervention effect estimate; therefore risk of attrition bias was considered to be unclear.
Selective reporting (reporting bias) Low risk No quotes available. Expected outcomes were reported according to objectives.
Comment: Risk of reporting bias therefore was 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 low.