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

Georgescu 2015.

Methods
  • Study design: randomised prospective trial.

  • Study duration: February 2013 and December 2013.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Romania.

  • Setting: single centre.

  • Patients 18 years or older with unilateral, non‐impacted, uncomplicated ureteral stones smaller than 1 cm.

  • Number: treatment group 1: 50; treatment group 2: 50; control group: 50.

  • Mean age ± SD, years: treatment group 1: 43.5 ± 13.31; treatment group 2: 44.26 ± 13.00; control group: 45.14 ± 11.58.

  • Sex, M/F: treatment group 1: 27/23; treatment group 2: 31/19; control group: 26/24.

  • Exclusion criteria: fever; UTI; high‐grade hydronephrosis; hypotension; acute or chronic renal failure; single kidney; urinary congenital anomalies; multiple or bilateral ureteral stones; history of open surgery or endoscopic procedures in the urinary tract; diabetes; peptic ulcer; concomitant treatment with alpha‐ or beta‐blockers, calcium antagonists, steroid, nitrates; pregnant or lactating women; patients requiring immediate stone removal.

Interventions Treatment group 1
  • Tamsulosin 0.4 mg daily.

  • Diclofenac sodium 50 mg/12 h.


Treatment group 2
  • Silodosin 8 mg daily.

  • Diclofenac sodium 50 mg/12 h.


Control group
  • Diclofenac sodium 50 mg/12 h.

Outcomes
  • Stone expulsion rate.

  • Stone expulsion time.

  • Mean number of pain episodes.

  • Rates of interventions/Hospital re‐admissions.

  • Drug adverse events.

Funding sources None stated.
Declarations of interest None stated.
Notes Follow‐up at 14 ± 2 days with urinalysis, KUB, and ultrasonography.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomization process was achieved by means of sealed envelopes equally nominating one of the three treatment alternative."
Comment: This method of random sequence generation was considered to be at low risk of bias.
Allocation concealment (selection bias) Low risk Quote: "Allocation concealment was performed using the SNOSE method (sequentially‐numbered, opaque, sealed envelopes)."
Comment: This method of allocation concealment was considered to be at low 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) 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.