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

Aldemir 2011.

Methods
  • Study design: RCT.

  • Study duration: March to July 2009.

  • Follow‐up: 10 days.

Participants
  • Country: Turkey.

  • Setting: single centre.

  • Patients with distal ureteral stones < 10 mm; > 17 years; diagnosed with KUB, US, and CT if necessary.

  • Number: treatment group 1: 31; treatment group 2: 30; control group: 29.

  • Mean age ± SD, years: treatment group 1: 42.4 ± 16.1; treatment group 2: 46.5 ± 16.5; control group: 43.5 ± 16.6.

  • Sex, M/F: treatment group 1: 22/9; treatment group 2: 17/13; control group: 19/10.

  • Exclusion criteria: presence of UTI; solitary kidney; severe hydroureteronephrosis; renal insufficiency; diabetes mellitus; multiple stones; bilateral stones; hypotension; pregnancy; previous spontaneous stone expulsion; previous distal ureteral surgery; history of intake of nifedipine, alpha‐adrenergic blockers, calcium antagonists, and steroids

Interventions Treatment group 1
  • Tamsulosin 0.4 mg once daily.


Treatment group 2
  • Rowatinex 100 mg once daily.


Control group
  • Diclofenac 100 mg once daily.


Participants in groups 1 and 2 received diclofenac when needed (100 mg once daily).
Outcomes
  • Mean stone expulsion time.

  • Stone expulsion rate.

  • Mean stone size.

  • Stone location.

  • Stone site.

  • Additional analgesic requirement.

  • Number of ureteral colics.

  • Upper urinary tract dilation.

  • Adverse events.

Funding sources None stated.
Declarations of interest None stated.
Notes Missing data on stone expulsion rate.
Follow‐up was 10 days, then again KUB, US, or CT.
All participants were suggested to drink at least 2 L of drinking water daily.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “Patients were randomized in 3 groups.”
Comment: Randomisation was 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 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: All participants completed the study; therefore risk of attrition bias was considered to be low.
Selective reporting (reporting bias) High risk No quotes available.
Comment: No predefined endpoints were mentioned; therefore risk 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 low.