title: Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study.
abstract: OBJECTIVE
  These are the final results of the prospective, multicenter, long-term (3.5-year) study of the efficacy/safety of onabotulinumtoxinA for overactive bladder syndrome.
  
  
  METHODS
  Patients who completed either of 2, 24-week phase 3 trials could enter a 3-year extension and continue treatment with onabotulinumtoxinA 100 U as needed to control overactive bladder symptoms. Data were analyzed by the treatment(s) received (up to 6) and in discrete subgroups that received 1, 2, 3, 4, 5 or 6 treatments (to evaluate the consistency of the response after repeat treatments in the same patient groups). Assessments included the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients who reported improvement/great improvement in urinary symptoms on the TBS (Treatment Benefit Scale) at week 12 as co-primary end points. Other end points were the change from baseline in I-QOL (Incontinence Quality of Life), the number of urgency and micturition episodes per day; duration of effect; the number of adverse events; and the initiation of intermittent catheterization.
  
  
  RESULTS
  Consistent mean reductions in urinary incontinence were observed following continued onabotulinumtoxinA treatment, ranging from -3.1 to -3.8 in the overall population and -2.9 to -4.5 in the discrete subgroups. Durable improvements were seen in overactive bladder symptoms and quality of life. A high proportion of patients rated their condition as improved/greatly improved. The median duration of effect was 7.6 months. The most common adverse event was urinary tract infection. The rate of de novo catheterization after the first treatment was 4.0% and it ranged from 0.6% to 1.7% after subsequent treatments.
  
  
  CONCLUSIONS
  Long-term onabotulinumtoxinA treatment consistently decreased overactive bladder symptoms and improved quality of life with no new safety signals.
authors.affiliation: Department of Urology, New York University, New York, New York. Electronic address: Victor.Nitti@nyumc.org.
authors.forename: Victor W
authors.initials: VW
authors.lastname: Nitti
authors.affiliation: Department of Urology, University of Southern California, Los Angeles, California.
authors.forename: David
authors.initials: D
authors.lastname: Ginsberg
authors.affiliation: Department of Urology and Andrology, Paracelsus Medical University, Salzburg, Austria.
authors.forename: Karl-Dietrich
authors.initials: KD
authors.lastname: Sievert
authors.affiliation: Department of Surgery, Rowan University School of Osteopathic Medicine, Stratford, New Jersey.
authors.forename: David
authors.initials: D
authors.lastname: Sussman
authors.affiliation: Division of Urology, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Sidney
authors.initials: S
authors.lastname: Radomski
authors.affiliation: NorthShore University HealthSystem, University of Chicago, Skokie, Illinois.
authors.forename: Peter
authors.initials: P
authors.lastname: Sand
authors.affiliation: University Hospitals KU Leuven, Leuven, Belgium.
authors.forename: Dirk
authors.initials: D
authors.lastname: De Ridder
authors.affiliation: Allergan plc, Irvine, California.
authors.forename: Brenda
authors.initials: B
authors.lastname: Jenkins
authors.affiliation: Allergan plc, Bridgewater, New Jersey.
authors.forename: Andrew
authors.initials: A
authors.lastname: Magyar
authors.affiliation: Department of Urology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Sheffield, United Kingdom.
authors.forename: Christopher
authors.initials: C
authors.lastname: Chapple
mesh_terms: D065087:Acetylcholine Release Inhibitors / Q000008:administration & dosage; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D014563:Urodynamics / Q000502:physiology*
chemical_list: D065087:Acetylcholine Release Inhibitors; D019274:Botulinum Toxins, Type A
keywords: onabotulinumtoxinA; quality of life; urinary bladder, overactive; urinary incontinence; urinary tract infections