title: Silodosin to facilitate passage of ureteral stones: a multi-institutional, randomized, double-blinded, placebo-controlled trial.
abstract: BACKGROUND
  Using a selective α-blocker for medical expulsive therapy (MET) is a cost-effective treatment approach widely used for ureteral stones.
  
  
  OBJECTIVE
  To evaluate the efficacy of silodosin, a selective α-1a receptor antagonist, in this setting.
  
  
  METHODS
  This was a multicenter, phase 2 study conducted in adult patients with a unilateral ureteral calculus of 4-10mm. Of 239 patients in the safety population, six discontinued due to adverse events.
  
  
  METHODS
  Patients were randomized 1:1 to receive silodosin 8 mg or placebo for up to 4 wk.
  
  
  METHODS
  The primary outcome was spontaneous stone passage, analyzed using logistic regression. Secondary outcomes included time to stone passage, emergency room (ER) visits, hospital admissions, analgesic use, and incidence and severity of pain.
  
  
  CONCLUSIONS
  No significant differences between the silodosin and placebo groups were observed for passage rate of all stones (52% vs 44%, respectively; p=0.2). However, silodosin achieved a significantly greater rate of distal ureter stone passage than placebo (p=0.01). Significant differences were not observed for ER visits, hospital admission, or use of analgesics. The number of patients in the intent-to-treat population was slightly below the calculated sample size (232 vs 240) and sample sizes were not calculated for subgroup analyses.
  
  
  CONCLUSIONS
  This is among the first prospective, randomized, multi-institutional trials to examine the efficacy of a selective α-1a antagonist as MET in patients with ureteral calculi and did not demonstrate a benefit to the entire ureter. However, silodosin was found to be well tolerated and beneficial in facilitating the passage of distal ureteral stones, warranting additional future studies on distal stone elimination.
  
  
  RESULTS
  In this report, we looked at the efficacy of silodosin for the treatment of ureteral stones. We found that silodosin increased passage of distal ureteral stones.
authors.affiliation: University of California, San Diego, San Diego, CA, USA. Electronic address: rlsur@ucsd.edu.
authors.forename: Roger L
authors.initials: RL
authors.lastname: Sur
authors.affiliation: Carolina Urologic Research Center, Myrtle Beach, SC, USA.
authors.forename: Neal
authors.initials: N
authors.lastname: Shore
authors.affiliation: Naval Medical Center, San Diego, CA, USA.
authors.forename: James
authors.initials: J
authors.lastname: L'Esperance
authors.affiliation: The Ohio State University Wexner Medical Center, Columbus, OH, USA.
authors.forename: Bodo
authors.initials: B
authors.lastname: Knudsen
authors.affiliation: Columbia University College of Physicians and Surgeons, New York, NY, USA.
authors.forename: Mantu
authors.initials: M
authors.lastname: Gupta
authors.affiliation: Watson Laboratories, Salt Lake City, UT, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Olsen
authors.affiliation: New York University School of Medicine, New York, NY, USA.
authors.forename: Ojas
authors.initials: O
authors.lastname: Shah
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004632:Emergency Medical Services / Q000706:statistics & numerical data; D005260:Female; D006739:Hospital Administration / Q000706:statistics & numerical data; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D016896:Treatment Outcome; D014513:Ureter / Q000187:drug effects*; D014514:Ureteral Calculi / Q000150:complications / Q000188:drug therapy*
chemical_list: D000317:Adrenergic alpha-Antagonists; D000700:Analgesics; D007211:Indoles; C095285:silodosin
keywords: Adrenergic α-blockers; Medical expulsion therapy; Nephrolithiasis; Silodosin; Ureteral calculi; Urolithiasis