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

Lee 2014.

Methods
  • Study design: prospective open‐label RCT.

  • Study duration: July 2010 to August 2012.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Korea.

  • Setting: 2 university hospitals.

  • Patients 18 years or older with renal colic and a single, unilateral, radiopaque, proximal ureteral calculus smaller than 7 mm.

  • Number: treatment group: 54; control group: 54.

  • Mean age ± SD, years: treatment group: 43.6 ± 12.4; control group: 47.9 ± 11.4.

  • Sex, M/F: treatment group: 33/54; control group: 35/54.

  • Exclusion criteria: ureteral calculi > 6 mm; multiple ureteral calculi; febrile urinary tract infection; single kidney; non‐functioning kidney; pregnancy; azotaemia; ureteral stricture; severe hydronephrosis; current treatment with medications that could affect stone passage, such as alpha‐blockers, calcium channel blockers, steroids, or nitrates; desire for immediate stone removal because of colic.

Interventions Study group A/Control group
  • Ultracet ER (pain medication).


Study group B/Treatment group
  • Tamsulosin 0.2 mg once daily.

  • Ultracet ER (pain medication).


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

  • Time to stone passage.

  • Post‐trial EuroQOL score.

  • Oral analgesic requirements.

  • Drug adverse events.

Funding sources None.
Declarations of interest None.
Notes Sample size calculation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A predefined randomization sequence was created by a computer random number generator using a block size of 4."
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 High risk Quote: "This prospective, randomized, open‐label, multicenter trial."
Comment: Open‐label trial is considered to have high 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 No quotes available.
Comment: significant number of participants lost to follow‐up. Loss to follow‐up was not balanced between intervention groups; therefore 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.