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

被引:19
作者
Ginsberg, David A. [1 ]
Drake, Marcus J. [3 ,4 ]
Kaufmann, Albert [5 ]
Radomski, Sidney [6 ]
Gousse, Angelo E. [7 ]
Chermansky, Christopher J. [8 ]
Magyar, Andrew [9 ]
Nicandro, Jean Paul [2 ]
Nitti, Victor W. [10 ]
机构
[1] Univ Southern Calif, Los Angeles, CA 90033 USA
[2] Allergan Plc, Irvine, CA USA
[3] Univ Bristol, Bristol, Avon, England
[4] Bristol Urol Inst, Bristol, Avon, England
[5] Kliniken Maria Hilf GmbH, Monchengladbach, Germany
[6] Univ Toronto, Toronto, ON, Canada
[7] Bladder Hlth & Reconstruct Urol Inst, Miami, FL USA
[8] Univ Pittsburgh, Med Ctr, Pittsburgh, PA USA
[9] Allergan Plc, Bridgewater, NJ USA
[10] NYU, New York, NY USA
关键词
urinary bladder; overactive; urinary incontinence; onabotulinumtoxinA; botulinum toxins; quality of life; URINARY-INCONTINENCE; DOUBLE-BLIND; 3-ADRENOCEPTOR AGONIST; POOLED ANALYSIS; UNITED-STATES; SYMPTOMS; WOMEN; IMPACT; QUESTIONNAIRE; MIRABEGRON;
D O I
10.1016/j.juro.2017.05.068
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:898 / 905
页数:8
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