title: Tamsulosin hydrochloride vs placebo for management of distal ureteral stones: a multicentric, randomized, double-blind trial.
abstract: BACKGROUND
  α-Blockers induce selective relaxation of ureteral smooth muscle with subsequent inhibition of ureteral spasms and dilatation of the ureteral lumen. The aim of the study was to evaluate the efficacy and safety of the α-blocker tamsulosin hydrochloride in patients with ureteral colic owing to a distal ureteral stone.
  
  
  METHODS
  This was a multicenter, placebo-controlled, randomized, double-blind study. Patients with emergency admission for ureteral colic with a 2- to 7-mm-diameter radio-opaque distal ureteral stone were included in the study. They received tamsulosin (0.4 mg/d) or matching placebo until stone expulsion or day 42, whichever came first. The main end point was time to stone expulsion between inclusion and day 42. Sequential statistical analysis was performed using the triangular test.
  
  
  RESULTS
  A total of 129 patients with acute renal colic were recruited from emergency wards between February 1, 2002, and December 8, 2006, in 6 French hospitals. Of these 129 randomized patients (placebo, 63; tamsulosin, 66), 7 were excluded from analyses: 5 for major deviations from inclusion criteria, 1 for stone expulsion before the first treatment administration, and 1 for consent withdrawal. At inclusion, mean (SD) stone diameters were 3.2 (1.2) and 2.9 (1.0) mm in the placebo and tamsulosin groups, respectively (P = .23). Expulsion delay distributions during 42 days did not show any difference (P = .30). The numbers of patients who spontaneously expelled their stone within 42 days were 43 of 61 (70.5%) and 47 of 61 (77.0%) in the placebo and tamsulosin groups, respectively (P = .41). Corresponding delays were 10.1 (10.0) and 9.6 (9.8) days (P = .82). Other secondary end points and tolerance were not different between groups.
  
  
  CONCLUSIONS
  Although well tolerated, a daily administration of 0.4 mg of tamsulosin did not accelerate the expulsion of distal ureteral stones in patients with ureteral colic.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00151567.
authors.affiliation: Department of Urology, University Hospital, Rennes 1 University, Rennes, France.
authors.forename: Sébastien
authors.initials: S
authors.lastname: Vincendeau
authors.forename: Eric
authors.initials: E
authors.lastname: Bellissant
authors.forename: Alain
authors.initials: A
authors.lastname: Houlgatte
authors.forename: Bertrand
authors.initials: B
authors.lastname: Doré
authors.forename: Franck
authors.initials: F
authors.lastname: Bruyère
authors.forename: Alain
authors.initials: A
authors.lastname: Renault
authors.forename: Catherine
authors.initials: C
authors.lastname: Mouchel
authors.forename: Karim
authors.initials: K
authors.lastname: Bensalah
authors.forename: François
authors.initials: F
authors.lastname: Guillé
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012737:Sex Factors; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D000077409:Tamsulosin; D013997:Time Factors; D017211:Treatment Failure; D014514:Ureteral Calculi / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D013449:Sulfonamides; D000077409:Tamsulosin