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Low Incidence of Clean Intermittent Catheterization with OnabotulinumtoxinA in Diverse Age Groups of Overactive Bladder Patients and Substantial Improvements in Urinary Symptoms and Quality of Life
Victor Nitti, MD1, Sidney Radomski, MD2, Eric Rovner, MD3, Marcus Drake, MD4, Karel Everaert, MD5, Christopher Chapple, MD6, David Ginsberg, MD7, Tamer Aboushwareb, MD8, Cheng-Tao Chang, PhD9, Roger Dmochowski, MD10.
1New York University Langone Medical Center, New York, NY, USA, 2University of Toronto, Toronto, ON, Canada, 3Medical University of South Carolina, Charleston, SC, USA, 4Bristol Urological Institute, Bristol, United Kingdom, 5Ghent University Hospital, Ghent, Belgium, 6The Royal Hallamshire Hospital, Sheffield Teaching Hospitals, NHS Foundation Trust, Sheffield, United Kingdom, 7USC Institute of Urology, Los Angeles, CA, USA, 8Allergan plc, Irvine, CA, USA, 9Allergan plc, Bridgewater, NJ, USA, 10Vanderbilt University Medical Center, Nashville, TN, USA.

BACKGROUND: We evaluated the risk of clean intermittent catheterization (CIC) and assessed the efficacy and quality of life (QOL) outcomes after onabotulinumtoxinA treatment in different age groups of overactive bladder (OAB) patients.
METHODS: Pooled data from onabotulinumtoxinA-treated patients in three randomized, controlled trials (N=1177) were analyzed (post-hoc) by age: <40, 40-49, 50-59, 60-69 and ≥70 years. Assessments at week 12 post-treatment included CIC incidence and duration, mean and percent change from baseline in urinary incontinence (UI) episodes/day, proportions of patients with ≥50% UI reduction, positive response (urinary symptoms ‘improved’/‘greatly improved’) on the treatment benefit scale, change from baseline in Kings Health Questionnaire (KHQ) domains and adverse events (AEs).
RESULTS: The <40 group had the lowest CIC rate (1.1%) after onabotulinumtoxinA treatment, which increased slightly with age (3.2%, 5.3%, 5.3%, 7.2% in 40-49, 50-59, 60-69, and ≥70 groups). Mean CIC duration was 3 and 44 days in the <40 and 40-49 groups and 78-88 days in the other groups. All groups showed substantial reductions in UI episodes/day (-2.4, -2.6,-3.1, -3.6, -2.9) and percent change in UI (range: -46.8% to -64.4%). High proportions of patients achieved ≥50%UI reduction (range: 58.2%-71.1%) and positive treatment response (range: 66.2%-73.8%). Improvements in KHQ domain scores were ~3-6 times the minimally important difference. Urinary tract infection was the most common AE in all groups. CONCLUSIONS: CIC risk in onabotulinumtoxinA-treated OAB patients was low in all groups and increased slightly with age. All groups showed substantial UI reductions, QOL improvements and treatment benefit. OnabotulinumtoxinA was well-tolerated.


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