Stefano Salvatore,1 Marcus Drake,2 Karel Everaert,3 Eric Rovner,4 Roger Dmochowski,5 David Ginsberg,6 Sidney Radomski,7 Tamer Aboushwareb,8 Cheng-Tao Chang,9 Christopher Chapple,10 Victor Nitti11
1Department of Urogynaecology, San Raffaele Hospital, Milan, Italy; 2Department of Urology, Bristol Urological Institute, Bristol, UK; 3Department of Urology, Ghent University Hospital, Ghent, Belgium; 4Department of Urology, Medical University of South Carolina, Charleston, SC, USA; 5Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA; 6Department of Urology, USC Institute of Urology, Los Angeles, CA, USA; 7Department of Urology, University of Toronto, Toronto, ON, Canada; 8Department of Urology, Allergan plc, Irvine, CA, USA; 9Department of Statistics, Allergan plc, Bridgewater, NJ, USA; 10Department of Urology, The Royal Hallamshire Hospital, Sheffield Teaching Hospitals, NHS Foundation Trust, Sheffield, UK; 11Department of Uro-Gynecology and Urology, New York University Langone Medical Center, New York, NY, USA
Objective: To determine clean intermittent catheterization (CIC) risk and onabotulinumtoxinA treatment response in
diverse age groups of OAB patients.
Materials/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. Week 12 assessments post-treatment included CIC incidence and duration, %change from baseline in urinary incontinence (UI) episodes/day, proportions of patients with ≥50%UI reduction, positive response (urinary symptoms ‘improved’/’greatly improved’) on treatment benefit scale, change from baseline in Kings Health Questionnaire (KHQ) domains, and 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 days in the <40 group and 44-88 days in all other groups. All groups showed substantial %UI reduction (-46.8% to -64.4%). High proportions of patients achieved ≥50%UI reduction and treatment benefit. Improvements in KHQ domains were ~3-6x the minimally important difference. Urinary tract infection was the most common AE.
Conclusions: CIC risk in onabotulinumtoxinA-treated OAB patients was low in all groups, increasing slightly with age. All groups showed substantial UI reductions, QOL improvements and treatment benefit. OnabotulinumtoxinA was well-tolerated.