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

Abdel‐Meguid 2010.

Methods
  • Study design: parallel RCT.

  • Study duration: June 2008 to December 2009.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Saudi Arabia.

  • Setting: single centre.

  • Adults > 18 years of either sex; single, unilateral, newly diagnosed condition; 4‐10 mm in transverse diameter; distal ureteral stones; normal kidney function.

  • Number: treatment group 75; control group 75.

  • Median age (range, years): treatment group 34 (20‐67); control group 36 (19‐72).

  • Sex, M/F: treatment group: 50/25; control group: 53/22.

  • Exclusion criteria: history of ipsilateral ureteral endoscopic or surgical manipulations or ESWL; patients with symptomatic UTI; those pregnant or lactating; patients already receiving alpha‐blockers, beta‐blockers, calcium channel antagonists, or corticosteroids; serious medical conditions; refused randomisation; lost to follow‐up during the study period.

Interventions Treatment group
  • Tamsulosin 0.4 mg once daily.

  • Hydration, analgesia (diclofenac 100 mg) as needed.


Control group
  • Placebo.

  • Hydration, analgesia (diclofenac 100 mg) as needed.

Outcomes
  • Stone passage rate.

  • Stone passage time.

  • Weekly stone passage rate.

  • Episodes of renal colic.

  • Need for analgesia.

  • Drug adverse events.

Funding sources None stated.
Declarations of interest None stated.
Notes Baseline assessment included non‐contrast spiral CT and furthermore weekly follow‐ups with KUB and US. NCCT was repeated at end of study to confirm stone status.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were allocated randomly in 1:1 ratio into either group."
Comment: This method of random sequence generation was considered to have low risk of bias.
Allocation concealment (selection bias) Low risk Quote: "Using sealed envelopes."
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: "Both treating physicians and patients were blinded to randomization."
Comment: double‐blind and therefore low risk of bias.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No blinding of outcome assessments described.
Comment: No description was available; therefore this method of outcome assessment was considered to have unclear risk of bias.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "17 patients were excluded due to not accepting randomization (6) and loss to follow‐up during study period (4 in group A and 7 in group B)."
Comment: Owing to relatively high numbers of exclusions and losses to follow‐up, incomplete outcome data were stated and risk of bias was 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. The 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 to be low.