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

Berger 2015.

Methods
  • Study design: prospective double‐blind RCT.

  • Study duration: April 2007 and February 2009.

  • Follow‐up/Treatment duration: 7 days.

Participants
  • Country: USA.

  • Setting: single centre.

  • All ureteral stones.

  • Number: treatment group: 53; placebo group: 47.

  • Mean age: treatment group: 40.62; placebo group: 44.52.

  • Sex, M/F: treatment group: 26% male; placebo group: 30% male.

  • Exclusion criteria: younger than 18 years; stone larger than 1 cm; infected stones; obstructing stones in solitary kidneys; currently taking Levitra, nifedipine, or steroids; requiring immediate surgical intervention; pregnant; already taking tamsulosin before enrolment.

Interventions Treatment group
  • Tamsulosin 0.4 mg once daily and standard analgesia (Vicodin and ibuprofen).


Placebo group
  • Placebo drug and standard analgesia (Vicodin and ibuprofen).

Outcomes
  • Stone expulsion rate.

  • Pain score.

  • Drug side effects.

  • Mean analgesic consumption.

Funding sources None.
Declarations of interest None.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "using a convenience sample."
Comment: This method of random sequence generation was considered to have high 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 Low risk Quote: "double‐blinded, placebo‐controlled."
Comment: double‐blind; therefore low risk of bias.
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 High risk Quote: "Of the 127 patients enrolled during this study, 15 were lost to follow‐up, and 12 received surgical intervention before the 7‐day mark, leaving 100 patients for analysis."
Comment: Owing to a reasonable number of participants lost to follow‐up, risk of attrition bias was considered to be high.
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.