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

Autorino 2005.

Methods
  • Study design: single‐centre RCT.

  • Study duration: unclear.

  • Follow‐up/treatment: maximum 2‐week treatment.

Participants
  • Country: Italy.

  • Setting: single centre.

  • Patients with symptomatic ≤ 10 mm distal ureteral stones, diagnosed with NCCT.

  • Number: treatment group: 50; control group: 46.

  • Mean age ± SD, years: treatment group: 46.3 ± 10.9; control group: 44.5 ± 11.3.

  • Sex, M/F: treatment group: 36/14; control group: 26/20.

  • Exclusion criteria: UTI; severe hydronephrosis; diabetes; ulcer disease; hypotension or hypertension treated with alpha‐blockers or calcium antagonists; pregnancy; multiple stones; history of spontaneous stone expulsion; ureteral stricture.

Interventions Treatment group
  • Tamsulosin 0.4 mg once daily.

  • Standard therapy

    • Diclofenac 100 mg daily.


Control group
  • Standard therapy

    • Diclofenac 100 mg daily.

  • Aescin (an anti‐oedema extract of the horse chestnut tree) 80 mg daily.

Outcomes
  • Stone expulsion rate.

  • Expulsion time.

  • Need for analgesics.

  • Need for hospitalisation.

  • Drug side effects.

Funding sources None stated.
Declarations of interest None stated.
Notes Aescin = standard therapy at this centre.
Included participants from the study by Autorino et al 2005.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Randomization, not blinded, was performed using a stratified permuted randomization algorithm.”
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 were included in the analysis; 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.