title: Distal Ureteric Stones and Tamsulosin: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial.
abstract: OBJECTIVE
  We assess the efficacy and safety of tamsulosin compared with placebo as medical expulsive therapy in patients with distal ureteric stones less than or equal to 10 mm in diameter.
  
  
  METHODS
  This was a randomized, double-blind, placebo-controlled, multicenter trial of adult participants with calculus on computed tomography (CT). Patients were allocated to 0.4 mg of tamsulosin or placebo daily for 28 days. The primary outcomes were stone expulsion on CT at 28 days and time to stone expulsion.
  
  
  RESULTS
  There were 403 patients randomized, 81.4% were men, and the median age was 46 years. The median stone size was 4.0 mm in the tamsulosin group and 3.7 mm in the placebo group. Of 316 patients who received CT at 28 days, stone passage occurred in 140 of 161 (87.0%) in the tamsulosin group and 127 of 155 (81.9%) with placebo, a difference of 5.0% (95% confidence interval -3.0% to 13.0%). In a prespecified subgroup analysis of large stones (5 to 10 mm), 30 of 36 (83.3%) tamsulosin participants had stone passage compared with 25 of 41 (61.0%) with placebo, a difference of 22.4% (95% confidence interval 3.1% to 41.6%) and number needed to treat of 4.5. There was no difference in urologic interventions, time to self-reported stone passage, pain, or analgesia requirements. Adverse events were generally mild and did not differ between groups.
  
  
  CONCLUSIONS
  We found no benefit overall of 0.4 mg of tamsulosin daily for patients with distal ureteric calculi less than or equal to 10 mm in terms of spontaneous passage, time to stone passage, pain, or analgesia requirements. In the subgroup with large stones (5 to 10 mm), tamsulosin did increase passage and should be considered.
authors.affiliation: Department of Emergency Medicine, The Townsville Hospital, Townsville, Queensland, Australia; School of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: Jeremy.Furyk@health.qld.gov.au.
authors.forename: Jeremy S
authors.initials: JS
authors.lastname: Furyk
authors.affiliation: School of Medicine, University of Queensland, Brisbane, Queensland, Australia; Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Kevin
authors.initials: K
authors.lastname: Chu
authors.affiliation: Department of Emergency Medicine, The Townsville Hospital, Townsville, Queensland, Australia.
authors.forename: Colin
authors.initials: C
authors.lastname: Banks
authors.affiliation: Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Jaimi
authors.initials: J
authors.lastname: Greenslade
authors.affiliation: Gold Coast Health Service District (Gold Coast University Hospital and Robina Hospital, Griffith University, Bond University), Gold Coast, Queensland, Australia.
authors.forename: Gerben
authors.initials: G
authors.lastname: Keijzers
authors.affiliation: School of Medicine, University of Queensland, Brisbane, Queensland, Australia; Department of Emergency Medicine, Nambour General Hospital, Nambour, Queensland, Australia.
authors.forename: Ogilvie
authors.initials: O
authors.lastname: Thom
authors.affiliation: Gold Coast Health Service District (Gold Coast University Hospital and Robina Hospital, Griffith University, Bond University), Gold Coast, Queensland, Australia.
authors.forename: Tom
authors.initials: T
authors.lastname: Torpie
authors.affiliation: Department of Emergency Medicine, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
authors.forename: Carl
authors.initials: C
authors.lastname: Dux
authors.affiliation: Department of Surgery, The Townsville Hospital, Townsville, Queensland, Australia; School of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.
authors.forename: Rajan
authors.initials: R
authors.lastname: Narula
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014514:Ureteral Calculi / Q000000981:diagnostic imaging / Q000188:drug therapy*; D064804:Urological Agents / Q000627:therapeutic use*
chemical_list: D013449:Sulfonamides; D064804:Urological Agents; D000077409:Tamsulosin