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

Itoh 2013.

Methods
  • Study design: prospective RCT.

  • Study duration: March 2010 to August 2010.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Japan.

  • Setting: single centre.

  • Symptomatic men with unilateral distal ureteral calculi smaller than 10 mm.

  • Number: control group: 56; treatment group: 56.

  • Mean age ± SD, years: control group: 55.8 ± 10.4; treatment group: 56.3 ± 11.7.

  • Sex, M/F: only male patients.

  • Exclusion criteria: UTI; severe hydronephrosis; diabetes; ulcers; hypotension; renal dysfunction; multiple stones or ureteral stricture.

Interventions Study group A/Control group
  • Diclofenac sodium suppository 50 mg.


Study group B/Treatment group
  • Silodosin 8 mg daily.

  • Diclofenac sodium suppository 50 mg.


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

  • Stone expulsion time.

  • Stone size.

  • Need for analgesics.

  • Drug adverse events.

Funding sources None stated.
Declarations of interest None.
Notes Diagnostics for follow‐up were not described.
Conference abstract in 2015.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomly divided into two groups by using a random number table envelope 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 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: 1 participant 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 High risk No quotes available. Stone size was significantly different between the 2 study groups. Furthermore, only men were included in the study.
Comment: Owing to potential selection bias, we considered judgement as having high risk of bias.