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

Rahim 2012.

Methods
  • Study design: RCT.

  • Study duration: 24 November 2008 to 24 May 2009.

  • Follow‐up/Treatment duration: 28 days.

Participants
  • Country: Pakistan.

  • Setting: single centre.

  • Patients with 4‐7 mm distal ureteral stones.

  • Number: treatment group: 45; control group: 45.

  • Mean age ± SD, years: treatment group: 32.40 ± 10.28; control group: 32.84 ± 12.13.

  • Sex, M/F: treatment group: 32/13; control group: 31/14.

  • Exclusion criteria: UTI; severe hydronephrosis; pregnancy; ulcer disease; hypotension; patients taking calcium channel blockers; serum creatinine more than 2 mg/dL; multiple ureteral stones; bilateral distal ureteral stones; solitary kidney; ureteral stricture; patients desiring immediate stone retrieval.

Interventions Treatment group
  • Tamsulosin 0.4 mg once daily.

  • Diclofenac sodium 50 mg tablets twice daily.


Control group
  • Diclofenac sodium 50 mg tablets twice daily.


Follow‐up weekly with US.
Outcomes
  • Stone expulsion: yes/no.

  • Stone expulsion time.

  • Stone size.

  • Analgesic consumption (not mentioned in Results section).

Funding sources None stated.
Declarations of interest None stated.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "using random number table."
Comment: This method of random sequence generation was considered to have low 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 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 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) High risk No quotes available.
Comment: Total dosage of diclofenac used was not described in Results section, although it was mentioned as an outcome measurement in the Methods section. Owing to this inconsistency in describing outcome measurements, this type of reporting bias was considered to be high.
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.