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

Itoh 2011.

Methods
  • Study design: prospective RCT.

  • Study duration: NS.

  • Follow‐up/Treatment duration: 8 weeks.

Participants
  • Country: Japan.

  • Setting: single centre.

  • Symptomatic unilateral ureteral calculi smaller than 10 mm.

  • Number: control group: 92; treatment group: 89.

  • Mean age, years: NS.

  • Sex, M/F: NS.

  • Exclusion criteria: NS.

Interventions Control group
  • Pain medication (drug type and dosage not described).


Treatment group
  • Silodosin 8 mg daily.


All participants were instructed to drink 2 L of water daily.
Outcomes
  • Stone expulsion rate.

  • Stone expulsion time.

  • Need for analgesics (not described in Results section).

  • Drug adverse events (not described in Materials and Methods section).

Funding sources None stated.
Declarations of interest None stated.
Notes Conference abstract.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No quotes available.
Comment: randomisation stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.
Allocation concealment (selection bias) Unclear risk No quotes available. Insufficient information to permit judgement.
Comment: Owing to insufficient information, allocation concealment was considered to be at 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 Unclear risk No quotes available.
Comment: Loss to follow‐up was not described; therefore risk of attrition bias was considered to be unclear.
Selective reporting (reporting bias) High risk No quotes available. Need for analgesics was one of the outcome parameters but was not described in Results section. Adverse events were described in Results section but were not stated as one of the outcome parameters.
Comment: Owing to inconsistency in describing outcome parameters, risk of reporting bias was considered to be high.
Other bias Unclear risk No quotes available.
Comment: Owing to insufficient information to permit judgement, risk of other sources of bias was considered to be unclear.