title: Randomized, double-blind placebo controlled trial of the once daily antimuscarinic agent solifenacin succinate in patients with overactive bladder.
abstract: OBJECTIVE
  In this phase 3 trial we assessed the efficacy of solifenacin 5 mg and 10 mg daily in patients with symptoms related to overactive bladder. In addition, we assessed the safety and acceptability of solifenacin.
  
  
  METHODS
  The study was a multicenter, multinational, randomized, double-blind, placebo controlled trial. Patients were randomized to 12-week once daily treatment with solifenacin 5 mg, solifenacin 10 mg or placebo. The primary efficacy variable was changed from baseline to study end point in mean number of micturitions per 24 hours. Secondary efficacy variables included changes from baseline in mean number of urgency, nocturia and incontinence episodes per 24 hours, and mean volume voided per micturition.
  
  
  RESULTS
  Compared with changes obtained with placebo (-1.59), micturitions per 24 hours were statistically significantly decreased with solifenacin 5 mg (-2.37, p = 0.0018) and solifenacin 10 mg (-2.81, p = 0.0001). A statistically significant decrease was observed in the number of incontinence episodes with both solifenacin doses (5 mg, p = 0.002 and 10 mg, p = 0.016). This effect was also seen for episodes of urge incontinence (5 mg, p = 0.014 and 10 mg, p = 0.042). Of patients reporting incontinence at baseline, fully 50% achieved continence after treatment with solifenacin. Episodes of nocturia were statistically significantly decreased in patients treated with solifenacin 10 mg (-0.71, -38.5%) versus placebo (-0.52, -16.4%, p = 0.036). Episodes of urgency were statistically significantly reduced with solifenacin 5 mg (-2.84, -51%, p = 0.003) and solifenacin 10 mg (-2.90, -52%, p = 0.002). Mean volume voided per micturition was statistically significantly increased with both solifenacin doses (p = 0.0001). Treatment with solifenacin was well tolerated. Dry mouth, mostly mild in severity, was reported in 7.7% of patients receiving solifenacin 5 mg and 23% receiving solifenacin 10 mg (vs 2.3% with placebo).
  
  
  CONCLUSIONS
  In this study treatment with solifenacin 5 mg and 10 mg once daily significantly improved all the major symptoms of overactive bladder including frequency, urgency and incontinence. Solifenacin 10 mg also decreased the frequency of nocturia. Solifenacin therapy was associated with a favorable tolerability profile and a low incidence of dry mouth, especially at the 5 mg starting dose.
authors.affiliation: King's College Hospital, Denmark Hill, London, United Kingdom. lcardozo@compuserve.com
authors.forename: L
authors.initials: L
authors.lastname: Cardozo
authors.forename: M
authors.initials: M
authors.lastname: Lisec
authors.forename: R
authors.initials: R
authors.lastname: Millard
authors.forename: O
authors.initials: O
authors.lastname: van Vierssen Trip
authors.forename: I
authors.initials: I
authors.lastname: Kuzmin
authors.forename: T E
authors.initials: TE
authors.lastname: Drogendijk
authors.forename: M
authors.initials: M
authors.lastname: Huang
authors.forename: A M
authors.initials: AM
authors.lastname: Ridder
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D011812:Quinuclidines / Q000008:administration & dosage*; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000008:administration & dosage*; D001745:Urinary Bladder Diseases / Q000150:complications / Q000188:drug therapy*; D014549:Urinary Incontinence / Q000188:drug therapy* / Q000209:etiology
chemical_list: D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate