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

Sen 2017.

Methods
  • Study design: prospective RCT.

  • Study duration: December 2013 to July 2015.

  • Follow‐up/Treatment duration: 3 weeks.

Participants
  • Country: Turkey.

  • Setting: single centre.

  • Patients with distal ureteral stones that were radio‐opaque and ≤ 10 mm.

  • Number: treatment group 1: 25; treatment group 2: 22; control group: 19.

  • Mean age ± SD, years: treatment group 1: 30 ± 7.6; treatment group 2: 37.9 ± 11.5; control group: 33 ± 11.3.

  • Sex, M/F: treatment group 1: 18/7; treatment group 2: 17/5; control group: 11/8.

  • Exclusion criteria: hypersensitivity to agents used; advanced hydronephrosis; persistent pain despite proper and adequate analgesic use; urinary tract infection; low blood pressure.

Interventions Treatment group 1
  • Doxazosin 4 mg once daily.


Treatment group 2
  • Doxazosin 8 mg once daily.


Control group
  • All participants received diclofenac 100 mg orally and daily hydration.

Outcomes
  • Stone expulsion rate.

  • Stone expulsion time.

  • Number of pain episodes.

  • Quantity of analgesics.

Funding sources None stated.
Declarations of interest None.
Notes Weekly follow‐up urine analysis and radiological assessment.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed with the MedCalc statistical software."
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) Unclear risk No quotes available.
Comment: Stone clearance rate and stone clearance time were not predefined explicitly in the Methods section. Owing to this inconsistency in describing outcome measurements, this type 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.