title: Urodynamic results and clinical outcomes with intradetrusor injections of onabotulinumtoxinA in a randomized, placebo-controlled dose-finding study in idiopathic overactive bladder.
abstract: OBJECTIVE
  We assessed the effects of onabotulinumtoxinA (BOTOX®) on clinical and urodynamic variables in patients with idiopathic overactive bladder (OAB) and urinary urgency incontinence (UUI) with or without detrusor overactivity (DO), inadequately managed with anticholinergics.
  
  
  METHODS
  Three hundred thirteen patients with OAB were randomized to double-blind intradetrusor injection with placebo (n = 44) or 1 of 5 onabotulinumtoxinA doses (50-300 U; n = 269). Primary efficacy variable was change from baseline in UUI episodes/week at week 12. Urodynamic assessments at baseline and weeks 12 and 36 included maximum cystometric capacity (MCC) and volume at first involuntary detrusor contraction (IDC).
  
  
  RESULTS
  76.0% of patients had baseline DO. Changes from baseline in MCC and volume at first IDC with onabotulinumtoxinA ≥100 U were superior to placebo at week 12, generally decreasing by week 36. Significant dose-dependent increases in MCC were observed for all onabotulinumtoxinA doses at week 12, and for 150, 200, and 300 U at week 36. Data suggested a dose-response relationship. At week 12 on diary, 15.9% of placebo and 29.8-57.1% of onabotulinumtoxinA 50-300 U recipients, respectively, did not demonstrate UUI. OnabotulinumtoxinA doses >150 U were more commonly associated with post-void residual urine volumes >200 ml.
  
  
  CONCLUSIONS
  Improvements in urodynamic parameters and clinical outcomes generally trended together following onabotulinumtoxinA treatment. This therapy improved key urodynamic parameters in patients with idiopathic OAB and UUI, with no differences in outcomes between those with and those without baseline DO. Therefore, successful idiopathic OAB treatment with onabotulinumtoxinA does not appear to be related to pretreatment finding of DO.
authors.affiliation: Department of Urology, Medical University of South Carolina, Charleston, South Carolina 29403, USA. rovnere@musc.edu
authors.forename: Eric
authors.initials: E
authors.lastname: Rovner
authors.forename: Michael
authors.initials: M
authors.lastname: Kennelly
authors.forename: Heinrich
authors.initials: H
authors.lastname: Schulte-Baukloh
authors.forename: Jihao
authors.initials: J
authors.lastname: Zhou
authors.forename: Cornelia
authors.initials: C
authors.lastname: Haag-Molkenteller
authors.forename: Prokar
authors.initials: P
authors.lastname: Dasgupta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000188:drug therapy*; D014549:Urinary Incontinence / Q000150:complications / Q000188:drug therapy*; D014563:Urodynamics / Q000187:drug effects
chemical_list: D019274:Botulinum Toxins, Type A