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Clinical Trial
. 2017 Oct;198(4):897-904.
doi: 10.1016/j.juro.2017.05.068. Epub 2017 May 20.

Long-Term Treatment with OnabotulinumtoxinA Results in Consistent, Durable Improvements in Health Related Quality of Life in Patients with Overactive Bladder

David A Ginsberg  1 , Marcus J Drake  2 , Albert Kaufmann  3 , Sidney Radomski  4 , Angelo E Gousse  5 , Christopher J Chermansky  6 , Andrew Magyar  7 , Jean Paul Nicandro  8 , Victor W Nitti  9 ; 191622-096 Investigators
Affiliations
Clinical Trial

Long-Term Treatment with OnabotulinumtoxinA Results in Consistent, Durable Improvements in Health Related Quality of Life in Patients with Overactive Bladder

David A Ginsberg et al. J Urol. 2017 Oct.

Abstract

Purpose: We present the long-term effects of repeat onabotulinumtoxinA 100 U treatment on health related quality of life in patients with overactive bladder and urinary incontinence who had an inadequate response to and/or were intolerant of an anticholinergic.

Materials and methods: Patients who completed either of 2, 24-week phase III trials could enter a 3-year extension study and request multiple onabotulinumtoxinA 100 U treatments as needed. Results of the I-QOL (Incontinence-Quality of Life) and KHQ (King's Health Questionnaire) are reported for up to 6 treatments. Consistency of the response to repeat onabotulinumtoxinA treatments was evaluated by classifying patients by the I-QOL response to the first treatment and analyzing responses to treatments 2 to 6.

Results: After onabotulinumtoxinA treatments 1 to 6, improvements in I-QOL scores were consistently 2 to 3 times the minimally important difference, and improvements in KHQ role limitations and social limitations domain scores were 5 to 6 and 3 to 4 times the minimally important difference, respectively. Most patients achieved or exceeded the minimally important difference for I-QOL and KHQ domain scores. Furthermore, 72.9% of patients who achieved or exceeded the minimally important difference for I-QOL after treatment 1 did so for all subsequent treatments. Of patients with a poor response after treatment 1, 38.3% achieved improvements greater than the minimally important difference for all subsequent treatments.

Conclusions: In patients with overactive bladder and incontinence consistent and clinically meaningful improvements in health related quality of life were observed with repeat onabotulinumtoxinA 100 U treatments. A positive response after treatment 1 tended to predict similar responses to subsequent treatments, whereas a lack of response to treatment 1 did not preclude positive response(s) to later treatments.

Keywords: botulinum toxins; onabotulinumtoxinA; overactive; quality of life; urinary bladder; urinary incontinence.

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