title: Long-term efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: an interim analysis.
abstract: OBJECTIVE
  To evaluate the long-term efficacy and safety of repeat onabotulinumtoxinA injections in patients inadequately managed by anticholinergics for urinary incontinence (UI) due to neurogenic detrusor overactivity.
  
  
  METHODS
  Patients who completed either of 2 preceding phase III studies were offered entry into an extension study and received repeat onabotulinumtoxinA 200 U or 300 U. The data were integrated across the phase III and ongoing extension studies. The present interim analysis included all patients who received ≥ 1 onabotulinumtoxinA treatment. The data were analyzed by treatment cycle (cycles 1-5). The primary assessment was the change from baseline in UI episodes/wk at 6 weeks after each treatment. Additional assessments included ≥ 50% and 100% reductions in UI episodes, volume/void, Incontinence Quality of Life responses, and adverse events.
  
  
  RESULTS
  A total of 387, 336, 241, 113, and 46 patients received 1, 2, 3, 4, and 5 onabotulinumtoxinA treatments, respectively. The UI episodes/wk were consistently reduced compared with baseline after repeated onabotulinumtoxinA treatment (-22.7, -23.3, -23.1, -25.3, and -31.9 for the 200-U onabotulinumtoxinA group in cycles 1-5). The proportion of patients reporting ≥ 50% and 100% ("dry") reductions from baseline in UI episodes at week 6 ranged from 73%-94% and 36%-55%, respectively. Increases in the mean volume/void (mean increase >130 mL) and improvements in quality of life were also observed after repeat treatment. The most common adverse events were urinary tract infections and urinary retention, with no change in the adverse event profile over time.
  
  
  CONCLUSIONS
  The results of our study have shown that repeated onabotulinumtoxinA treatments provide sustained reductions in UI episodes and increases in the volume/void and quality of life in patients with neurogenic detrusor overactivity and UI who were inadequately managed by anticholinergics, with no new safety signals.
authors.affiliation: Department of Urology, Carolinas Rehabilitation, 1100 Blythe Boulevard, Charlotte, NC 28203, USA. Michael.Kennelly@carolinashealthcare.org
authors.forename: Michael
authors.initials: M
authors.lastname: Kennelly
authors.forename: Roger
authors.initials: R
authors.lastname: Dmochowski
authors.forename: Karen
authors.initials: K
authors.lastname: Ethans
authors.forename: Gilles
authors.initials: G
authors.lastname: Karsenty
authors.forename: Heiner
authors.initials: H
authors.lastname: Schulte-Baukloh
authors.forename: Brenda
authors.initials: B
authors.lastname: Jenkins
authors.forename: Catherine
authors.initials: C
authors.lastname: Thompson
authors.forename: Daniel
authors.initials: D
authors.lastname: Li
authors.forename: Cornelia
authors.initials: C
authors.lastname: Haag-Molkenteller
mesh_terms: D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D001750:Urinary Bladder, Neurogenic / Q000150:complications*; D053201:Urinary Bladder, Overactive / Q000150:complications*; D014549:Urinary Incontinence / Q000188:drug therapy* / Q000209:etiology*
chemical_list: D019274:Botulinum Toxins, Type A