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

Kupeli 2004.

Methods
  • Study design: RCT.

  • Study duration: February 2003 and March 2004.

  • Follow‐up/Treatment duration: 15 days.

Participants
  • Country: Turkey.

  • Setting: single centre.

  • Patients who had lower ureteral stones within the distal 5 cm of the ureter, assessed by KUB, intravenous pyelography, CT, and US when necessary.

  • Number: treatment group: 15; control group: 15.

  • Mean age, years (range): treatment group: 41.9 (23–63); control group: 43.74 (21–65).

  • Sex, M/F: 56/22 (total study).

  • Exclusion criteria: signs and symptoms of UTI; pregnancy; severely impacted stones; multiple stones; non‐opaque stones; severe hydronephrosis; hepatic dysfunction; non‐functioning kidney; treatment with calcium antagonists; morbid obesity.

Interventions Treatment group (group 2)
  • Conventional treatment.

  • Tamsulosin 0.4 mg daily orally for 15 days.


Control group (group 1)
  • Conventional treatment

    • Oral hydration.

    • Diclofenac sodium 100 mg daily orally for 15 days.


Four‐arm study, of which groups 3 and 4 underwent SWL.
Outcomes
  • Stone expulsion rate.

  • Side effects.

Funding sources None stated.
Declarations of interest None stated.
Notes Follow‐up only at the 15th day (last day of study) with plain abdominal X‐ray and helical CT.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed using the coin method."
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 Low risk Quote: "Patient follow‐up examinations were performed by two of us who were unaware of the treatment received."
Comment: Investigators evaluating follow‐up examinations were blinded; therefore risk of detection bias was considered to be low.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No quotes available.
Comment: No participants were lost to follow‐up; therefore risk of attrition bias was considered to be low.
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.