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

Ochoa‐Gomez 2011.

Methods
  • Study design: double‐blind RCT.

  • Study duration: June 2006 to December 2007.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Mexico.

  • Setting: single centre, ED.

  • Patients older than 18 years with distal reno‐ureteral stones between 5 and 10 mm.

  • Number: treatment group/study group A: 32; placebo group/study group B: 33.

  • Mean age ± SD, years: treatment group: 38.5 ± 11.3; placebo group: 38.2 ± 12.4.

  • Sex, M/F: treatment group: 15/17; placebo group: 21/12.

  • Exclusion criteria: hydronephrosis; acute or chronic renal insufficiency; multiple ureteral lithiasis; history of surgery or endourological procedures; large and impacted ureteral calculi; pregnancy; lactation; distal ureteral lithiasis in a single kidney; taking alpha‐ or beta‐blockers; nitrates of calcium antagonists; patients who worked as airline pilots.

Interventions Study group A/Treatment group
  • Tamsulosin 0.4 mg daily.

  • Standard regimen (not described).


Study group B/placebo group
  • Placebo drug.

  • Standard regimen (not described).


All participants were instructed to drink at least 2 L of water per day and to carry out normal activities.
Outcomes
  • Stone expulsion rate.

  • Stone expulsion time.

  • Stone size.

  • Drug adverse events.

Funding sources None stated.
Declarations of interest None stated.
Notes Follow‐up every 14 days with plain abdominal film and abdominal ultrasonogram.
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 have unclear risk of bias.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk No quotes available. Blinding of both participants and personnel.
Comment: Double‐blinding was performed; therefore risk of performance bias was considered to be low.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No quotes available. No blinding of outcome assessments described. No imaging at the end of follow‐up was done to evaluate stone clearance.
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: no participants 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 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.