To present the long-term effects of repeat onabotulinumtoxinA 100U treatment on health-related quality of life in overactive bladder patients with urinary incontinence who had an inadequate response to/were intolerant of an anticholinergic.
Patients completing either of two 24-week, phase III trials could enter a 3-year extension study and request multiple onabotulinumtoxinA 100U treatments as needed. Results for the I-QOL (Incontinence-Quality of Life) and KHQ (King's Health Questionnaire) are reported for upto 6 treatments. Consistency of response with repeated onabotulinumtoxinA treatments was evaluated by classifying patients by I-QOL response to the first treatment and analyzing responses for treatments 2-6.
After onabotulinumtoxinA treatments 1-6, improvements in I-QOL scores were consistently 2-3 times the minimally important difference, and improvements in KHQ Role Limitations and Social Limitations domain scores were 5-6 and 3-4 times the minimally important difference. Most patients achieved/exceeded the minimally important difference for I-QOL and KHQ domain scores. Furthermore, 72.9% of patients who achieved/exceeded the minimally important difference for I-QOL after treatment 1 did so in all subsequent treatments. Over one-third (38.3%) of patients with a poor response after treatment 1 achieved improvements greater than the minimally important difference in all subsequent treatments.
In overactive bladder patients with incontinence, consistent and clinically meaningful improvements in health-related quality of life were observed with repeated onabotulinumtoxinA 100U treatments. A positive response after treatment 1 tended to predict similar responses to subsequent treatments, whereas lack of response to treatment 1 did not preclude positive response(s) to later treatments.
The Journal of urology. 2017 May 20 [Epub ahead of print]
David A Ginsberg, Marcus J Drake, Albert Kaufmann, Sidney Radomski, Angelo Gousse, Christopher J Chermansky, Andrew Magyar, Jean Paul Nicandro, Victor W Nitti, 191622-096 investigators
University of Southern California, Los Angeles, California. Electronic address: ., University of Bristol and Bristol Urological Institute, Bristol, United Kingdom., Kliniken Maria Hilf GmbH, Mönchengladbach, Germany., University of Toronto, Toronto, Canada., Bladder Health and Reconstructive Urology Institute, Miami, Florida., University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania., Allergan, plc, Bridgewater, New Jersey., Irvine, California., New York University, New York, New York.