title: A randomised, prospective double-blind, propiverine-controlled trial of imidafenacin in patients with overactive bladder.
abstract: OBJECTIVE
  To assess the efficacy and safety of imidafenacin compared with propiverine for treatment of overactive bladder (OAB) in Korean patients.
  
  
  METHODS
  Patients with OAB symptoms were randomised to double-blind treatment with 0.1 mg of imidafenacin twice daily (group A) or propiverine 20 mg once daily (group B) for 12-week regimen, and assessed for efficacy and safety. The primary efficacy outcome was per cent change of weekly urgency urinary incontinence (UUI) episodes at week 12. The secondary efficacy outcomes were changes in the micturitions per day, urine volume voided per micturition, urgency episodes per day, complete disappearance of incontinence episodes and severity of urgency from baseline to week 12. Quality of life and safety profiles were also compared.
  
  
  RESULTS
  Of 162 patients randomised, 140 completed the study protocol. The per cent change of weekly UUI episodes at week 12 was -69.1% in group A and -70.4% in group B (both p < 0.0001). The lower limit of 95% one-sided confidence interval of the difference between the groups was above the non-inferiority margin (-19.42%). Other voiding parameters and quality of life significantly improved at week 12 in both the groups. The discontinuation rates caused by adverse events were low in both the groups. While dry mouth was the most common adverse event (group A: 28.4% vs. B: 30.4%, p = 0.783), the severity of dry mouth was significantly less in the group A than B (p = 0.042) There were no significant differences in other safety profiles.
  
  
  CONCLUSIONS
  After the 12-week treatment of imidafenacin 0.1 mg twice daily, all OAB symptoms and quality of life improved. Imidafenacin was not inferior to propiverine for the reduction of UUI episodes, and was better tolerated than propiverine in the safety profile. Our results indicate that imidafenacin is a safe and effective drug in Korean patients with OAB.
authors.affiliation: Department of Urology, Gangneung Asan Medical Center, University of Ulsan College of Medicine, Gangneung, Korea.
authors.forename: C
authors.initials: C
authors.lastname: Park
authors.forename: J
authors.initials: J
authors.lastname: Park
authors.forename: M-S
authors.initials: MS
authors.lastname: Choo
authors.forename: J C
authors.initials: JC
authors.lastname: Kim
authors.forename: J G
authors.initials: JG
authors.lastname: Lee
authors.forename: J Z
authors.initials: JZ
authors.lastname: Lee
authors.forename: K-S
authors.initials: KS
authors.lastname: Lee
authors.forename: D Y
authors.initials: DY
authors.lastname: Kim
authors.forename: S-J
authors.initials: SJ
authors.lastname: Lee
authors.forename: J T
authors.initials: JT
authors.lastname: Seo
mesh_terms: D001561:Benzilates / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D014549:Urinary Incontinence / Q000188:drug therapy; D014554:Urination / Q000187:drug effects; D064804:Urological Agents / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001561:Benzilates; D007093:Imidazoles; D018727:Muscarinic Antagonists; D064804:Urological Agents; C015586:propiverine; C120953:imidafenacin