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

Lojanapiwat 2008.

Methods
  • Study design: RCT.

  • Study duration: 10 January to 9 July 2006.

  • Follow‐up/Treatment duration: 28 days.

Participants
  • Country: Thailand.

  • Setting: multi‐centre.

  • Patients with distal ureteral stone 4‐10 mm, measured by KUB.

  • Number: treatment group 1: 25; treatment group 2: 25; control group: 25.

  • Mean age ± SD, years: treatment group 1: 48.00 ± 15.74; treatment group 2: 46.71 ± 12.20; control group: 46.52 ± 13.63.

  • Sex, M/F: treatment group 1: 15/10; treatment group 2: 20/5; control group: 20/5.

  • Exclusion criteria: UTI; severe hydronephrosis; history of ureteric surgery.

Interventions Treatment group 1
  • Tamsulosin 0.2 mg once daily for a maximum of 28 days.

  • Standard therapy.


Treatment group 2
  • Tamsulosin 0.4 mg once daily for a maximum of 28 days.

  • Standard therapy.


Control group
  • Standard therapy

    • Diclofenac 50 mg twice daily for 10 days.


If participants developed renal colic during treatment, they were given an IM injection of 75 mg diclofenac in the emergency department.
Outcomes
  • Stone expulsion rate.

  • Stone expulsion time.

  • Number of diclofenac injections.

  • Side effects.

Funding sources Astellas Pharma (Thailand).
Declarations of interest None.
Notes Sample size calculated.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Block randomized in three groups by the assistant nurse."
Comment: This method of random sequence generation was considered to have unclear risk of bias.
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 High risk No quote available.
Comment: no blinding; therefore risk of performance bias was considered to be high.
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) Low risk No quotes available. Expected outcomes were reported according to objectives.
Comment: Risk of reporting bias was therefore 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 to be low.