title: Durable improvements in urinary incontinence and positive treatment response in patients with idiopathic overactive bladder syndrome following long-term onabotulinumtoxinA treatment: Final results of 3.5-year study.
abstract: OBJECTIVE
  Here we present the final results from an extension study assessing long-term onabotulinumtoxinA treatment (3.5 years) in patients with idiopathic overactive bladder.
  
  
  METHODS
  Patients who completed either of 2 Phase III trials were eligible to enter a 3-year extension study in which they received multiple onabotulinumtoxinA (100 U) treatments. Data were analyzed for the overall population of patients who received 100 U in any treatment cycle (n=829) and within discrete subgroups of patients who received exactly 1 (n=105), 2 (n=118), 3 (n=117), 4 (n=83), 5 (n=46), or 6 (n=33) treatments of the 100 U dose throughout the study (n=502).
  
  
  RESULTS
  Of the 829 patients enrolled, 51.7 % completed the study. Discontinuations due to AEs/lack of efficacy were low (5.1/5.7 %); other reasons were not treatment-related. Mean reductions from baseline in urinary incontinence (UI) episodes/day (week 12; co-primary endpoint) were consistent among discrete subgroups who received 1 (-3.1), 2 (-2.9, -3.2), 3 (-4.1 to -4.5), 4 (-3.4 to -3.8), 5 (-3.0 to -3.6), or 6 (-3.1 to -4.1) treatments. A consistently high proportion of patients reported improvement/great improvement on the Treatment Benefit Scale (week 12; co-primary endpoint) in the discrete subgroups across all treatments (70.0-93.5 %). Median time to request retreatment was ≤6 months for 34.2 %, >6-≤12 months for 37.2 %, and >12 months for 28.5 % of patients. Most common AE was UTI, with no changes in safety profile over time.
  
  
  CONCLUSIONS
  Long-term onabotulinumtoxinA treatment resulted in consistent reductions in UI and high proportions of patients reporting improvement after each treatment, with no new safety findings.
authors.affiliation: Hôpital universitaire Pitié-Salpétrière, UPMC, Paris 6, Paris, France. Electronic address: emmanuel.chartier-kastler@aphp.fr.
authors.forename: E
authors.initials: E
authors.lastname: Chartier-Kastler
authors.affiliation: New York university, school of medicine, New-york, NY, United States.
authors.forename: V
authors.initials: V
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authors.affiliation: Rowan university, school of osteopathic medicine, Stratford, NJ, United States.
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authors.lastname: Chapple
authors.affiliation: Allergan holdings ltd, Marlow, United Kingdom.
authors.forename: J
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authors.affiliation: University of Toronto, Toronto, Canada.
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