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

Balci 2014.

Methods
  • Study design: RCT.

  • Study duration: January 2010 and February 2011.

  • Follow‐up/Treatment duration: 28 days.

Participants
  • Country: Turkey.

  • Setting: single centre.

  • Stones in the lower one‐third of the ureter.

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

  • Mean age ± SD, years: 36.8 ± 11.3 overall.

  • Sex, M/F: not mentioned.

  • Exclusion criteria: proximal or intramural part of ureteral stone; active urinary tract infection; ureterohydronephrosis; acute renal failure; fever; multiple ureteral stones; history of surgery or endoscopic procedure of urolithiasis; chronic renal failure; diabetes mellitus; peptic ulcer; concomitant treatment with alpha‐blocker and beta‐blocker, calcium antagonists, or nitrates; pregnancy; lactation; patient desire for immediate stone removal.

Interventions Treatment group 1
  • Tamsulosin 0.4 mg once daily.


Treatment group 2
  • Nifedipine 30 mg once daily.


Control group
  • Diclofenac sodium 50 mg.


All participants were encouraged to maintain water intake of 2‐2.5 L/d.
Outcomes
  • Stone expulsion rate.

  • HU of stones.

  • Expulsion time.

  • Rate of pain relief therapy.

  • Mean analgesic consumption.

  • Drug side effects.

Funding sources None.
Declarations of interest None.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Randomization was performed using the Power Analysis & Sample Size Software (PASS_ ) for Windows (NCSS Inc., Kaysville, UT). According to the software, the patients were randomly assigned to one of the following three groups.”
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: All participants completed the study; therefore risk of attrition bias was considered to be low.
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.