Journal
EUROPEAN UROLOGY
Volume 52, Issue 3, Pages 850-859Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.eururo.2007.04.026
Keywords
botulinum toxin type a; I-QOL; neurogenic urinary; incontinence; quality of life; validity
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Objective: To evaluate the impact of botulinum toxin type A (BoNTA) on health-related quality of life in patients with neurogenic urinary incontinence (UI) using the incontinence Quality of Life questionnaire (I-QOL). Methods: Randomized, double-blind, multicenter, placebo-controlled study involving eight centers across Belgium, France, and Switzerland. Patients (n = 59) with UI due to neurogenic detrusor overactivity (spinal cord injury, n = 53; multiple sclerosis, n = 6) who were inadequately managed on oral anticholinergics received a single dose of BoNTA (200 U or 300 U, Botox ((R))) or placebo. I-QOL scores at screening and after treatment at weeks 2, 6, 12, 18, and 24 were recorded. Results: Median total and subscale I-QOL scores increased significantly from screening with BoNTA 300 U compared with placebo at all time points (p < 0.05) and with BoNTA 200 U compared with placebo at all time points for total score and the Avoidance Limiting Behavior subscale (p < 0.05), and at weeks 2, 6, 12, and 18 (p < 0.05), but not 24 for the Psychosocial Impact and Social Embarrassment subscales. Approximately twice as many BoNTA recipients as placebo recipients achieved at least a minimal important difference in total I-QOL score at 2, 6, 12, and 24 wk. Conclusions: BoNTA significantly improves UI-associated health-related quality of life in patients with neurogenic Ul. (D 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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