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

Ibrahim 2013.

Methods
  • Study design: prospective RCT.

  • Study duration: July 2012 and December 2012.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Iraq.

  • Setting: single centre.

  • Symptomatic ureteric stone < 10 mm in diameter.

  • Number: treatment group 1/study group II: 40; treatment group 2/study group III: 40; control group/study group I: 32.

  • Mean age ± SD, years: study group I: 36.71 ± 11.64; study group II: 38.17 ± 14.54; study group III: 36.5 ± 11.54.

  • Sex, M/F: study group I: 25/7; study group II: 32/8; study group III: 34/6.

  • Exclusion criteria: acute infection; a solitary kidney; elevated levels in renal functional tests at presentation; severe hydronephrosis; bilateral ureteric stones; pregnancy or lactation; current use of alpha‐blockers, calcium channel blockers, or steroids; age < 18 years; any allergic reaction to study medication.

Interventions Control group/Study group I
  • Diclofenac potassium orally 50 mg and/or diclofenac sodium as an IM injection of 75 mg on demand.


Treatment group 1/Study group II
  • Tamsulosin: 0.4 mg daily.

  • Diclofenac potassium orally 50 mg and/or diclofenac sodium as an IM injection of 75 mg on demand.


Treatment group 2/Study group III
  • Alfuzosin 10 mg daily.

  • Diclofenac potassium orally 50 mg and/or diclofenac sodium as an IM injection of 75 mg on demand.

Outcomes
  • Stone passage rate.

  • Stone expulsion time.

  • Drug adverse events.

Funding sources None.
Declarations of interest None.
Notes Follow‐up weekly for 4 weeks; every visit focussed history, physical examination, and urinary US.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients were randomised systematically at a ratio of 1:1."
Comment: randomisation stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.
Allocation concealment (selection bias) Unclear risk No quotes available. Insufficient information to permit judgement.
Comment: Owing to insufficient information, allocation concealment was considered to be at unclear risk of bias.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No quotes available. No blinding described.
Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.
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 High risk No quotes available.
Comment: Numbers of participants lost to follow‐up in the different study groups were not equally distributed; therefore risk of attrition bias was considered to be high.
Selective reporting (reporting bias) Unclear risk No quotes available.
Comment: Owing to insufficient information to permit judgement, risk of reporting bias was considered to be unclear.
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.