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

Eryildirim 2015.

Methods
  • Study design: RCT.

  • Study duration: January 2014 and January 2015.

  • Follow‐up/Treatment duration: maximum 4 weeks.

Participants
  • Country: Turkey.

  • Setting: single centre.

  • Patients with ureteral stones 5‐10 mm.

  • Number: treatment group: 60; control group: 60.

  • Mean age ± SD, years: control group: 37.23 ± 1.56; tamsulosin group: 37.07 ± 2.26.

  • Sex, M/F: 84/36.

  • Exclusion criteria: multiple stones; previous stone‐related procedures; obstruction; stent placement; congenital anomalies; active UTI; pregnancy; renal insufficiency; urgent stone removal and/or auxiliary procedures for intractable pain; obstruction; infection and other related complications during follow‐up period.

Interventions Control group
  • Diclofenac sodium 75 mg on demand.


Tamsulosin group
  • Tamsulosin 0.4 mg.

  • Diclofenac sodium 75 mg on demand.

Outcomes
  • Stone passage rate.

  • Analgesics required.

  • Need for stone removal procedures.

  • Number of renal colics.

  • Number of ED visits.

  • HRQOL.

  • VAS scores during pain.

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: “simple randomization method by generating a random digit (0–60 in each group) has been used within each group.”
Comment: This method of random sequence generation was considered to be at low risk of bias.
Allocation concealment (selection bias) Unclear risk No quotes available. Insufficient information to permit judgement.
Comment: Owing to insufficient information, risk of allocation concealment was considered to be unclear.
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 Unclear risk No quotes available.
Comment: Losses to follow‐up were not clearly described; therefore risk of attrition bias was considered to be unclear.
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.