Skip to main content
. 2018 Apr 5;2018(4):CD008509. doi: 10.1002/14651858.CD008509.pub3

Kaneko 2010.

Methods
  • Study design: prospective randomised study.

  • Study duration: November 2005 to August 2006.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Japan.

  • Setting: single centre.

  • Males with symptomatic ureteral stones, 10 mm or smaller, diagnosed with X‐ray, US, and NCCT, when necessary.

  • Number: treatment group: 31; control group: 34.

  • Mean age ± SD, years: treatment group: 50 ± 8.8; control group: 45 ± 8.7.

  • Sex, M/F: all male.

  • Exclusion criteria: UTI; severe hydronephrosis; multiple stones; hypotension; ureteral stricture; current use of calcium antagonist or alpha‐adrenergic blockers.

Interventions Treatment group
  • Tamsulosin 0.2 mg once daily.


Control group
  • Watchful waiting.


50 mg diclofenac suppository on demand for all participants.
Outcomes
  • Stone expulsion rate.

  • Stone expulsion time.

  • Total diclofenac dosage.

Funding sources None stated.
Declarations of interest None stated.
Notes Follow‐up: maximum of 4 weeks, weekly or biweekly X‐ray and US.
Sample size was arbitrarily determined and was not based on statistical calculation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomly allocated into two treatment groups by using a random number table."
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: 6 participants were excluded from the study and were balanced between intervention groups; 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.