Victor W Nitti1, David Ginsberg2, Karl-Dietrich Sievert3, David Sussman4, Sidney Radomski5, Peter Sand6, Dirk De Ridder7, Brenda Jenkins8, Andrew Magyar9, Christopher Chapple10. 1. Department of Urology, New York University, New York, New York. Electronic address: Victor.Nitti@nyumc.org. 2. Department of Urology, University of Southern California, Los Angeles, California. 3. Department of Urology and Andrology, Paracelsus Medical University, Salzburg, Austria. 4. Department of Surgery, Rowan University School of Osteopathic Medicine, Stratford, New Jersey. 5. Division of Urology, University of Toronto, Toronto, Ontario, Canada. 6. NorthShore University HealthSystem, University of Chicago, Skokie, Illinois. 7. University Hospitals KU Leuven, Leuven, Belgium. 8. Allergan plc, Irvine, California. 9. Allergan plc, Bridgewater, New Jersey. 10. Department of Urology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Sheffield, United Kingdom.
Abstract
PURPOSE: 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. MATERIALS AND METHODS: Patients who completed either of 2, 24-week phase 3 trials could enter a 3-year extension and continue treatment withonabotulinumtoxinA 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.
RCT Entities:
PURPOSE: 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. MATERIALS AND 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: Ethan M Balk; Gaelen P Adam; Katherine Corsi; Amanda Mogul; Thomas A Trikalinos; Peter C Jeppson Journal: J Gen Intern Med Date: 2019-05-06 Impact factor: 5.128
Authors: Cindy L Amundsen; Yuko M Komesu; Christopher Chermansky; W Thomas Gregory; Deborah L Myers; Emily F Honeycutt; Sandip P Vasavada; John N Nguyen; Tracey S Wilson; Heidi S Harvie; Dennis Wallace Journal: Eur Urol Date: 2018-02-24 Impact factor: 20.096
Authors: Whitney K Hendrickson; Cindy L Amundsen; David D Rahn; Isuzu Meyer; Megan S Bradley; Ariana L Smith; Deborah L Myers; J Eric Jelovsek; Emily S Lukacz Journal: Female Pelvic Med Reconstr Surg Date: 2021-03-01 Impact factor: 1.913
Authors: Kurt McCammon; Angelo Gousse; Alfred Kohan; David Glazier; Jennifer Gruenenfelder; Zhanying Bai; Anand Patel; Douglass Hale Journal: Female Pelvic Med Reconstr Surg Date: 2021-07-01 Impact factor: 1.913