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Chartier-Kastler E, Nitti V, De Ridder D, et al. 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. Prog Urol. 2015;25(13):739doi: 10.1016/j.purol.2015.08.047.
Chartier-Kastler, E., Nitti, V., De Ridder, D., Sussman, D., Sand, P., Sievert, K., Chapple, C., Charmaine, J., Magyar, A., & Radomski, S. (2015). 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. Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie, 25(13), 739. https://doi.org/10.1016/j.purol.2015.08.047
Chartier-Kastler, E, et al. "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." Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie vol. 25,13 (2015): 739. doi: https://doi.org/10.1016/j.purol.2015.08.047
Chartier-Kastler E, Nitti V, De Ridder D, Sussman D, Sand P, Sievert K, Chapple C, Charmaine J, Magyar A, Radomski S. 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. Prog Urol. 2015 Nov;25(13):739. doi: 10.1016/j.purol.2015.08.047. PMID: 26544243.
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Prog Urol. 2015 Nov;25(13):739. doi: 10.1016/j.purol.2015.08.047.

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.

Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie

E Chartier-Kastler, V Nitti, D De Ridder, D Sussman, P Sand, K Sievert, C Chapple, J Charmaine, A Magyar, S Radomski

Affiliations

  1. Hôpital universitaire Pitié-Salpétrière, UPMC, Paris 6, Paris, France. Electronic address: [email protected].
  2. New York university, school of medicine, New-york, NY, United States.
  3. University hospitals KU Leuven, Leuven, Belgium.
  4. Rowan university, school of osteopathic medicine, Stratford, NJ, United States.
  5. Evanston continence center, Evanston, IL, United States.
  6. Paracelsus medical university, Salzburg, Austria.
  7. Royal Hallamshire hospital, Sheffield, United Kingdom.
  8. Allergan holdings ltd, Marlow, United Kingdom.
  9. Allergan, Inc, Bridgewater, NJ, United States.
  10. University of Toronto, Toronto, Canada.

PMID: 26544243 DOI: 10.1016/j.purol.2015.08.047

Abstract

OBJECTIVES: 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.

CONCLUSION: 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.

Copyright © 2015. Published by Elsevier Masson SAS.

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