Schurch Brigitte, Denys Pierre, Kozma Chris M, Reese Pat Ray, Slaton Terra, Barron Richard L
Spinal Cord Injury Center, University Hospital Balgrist, Zurich, Switzerland.
Eur Urol. 2007 Sep;52(3):850-8. doi: 10.1016/j.eururo.2007.04.026. Epub 2007 Apr 19.
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).
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 (200U or 300U, Botox) or placebo. I-QOL scores at screening and after treatment at weeks 2, 6, 12, 18, and 24 were recorded.
Median total and subscale I-QOL scores increased significantly from screening with BoNTA 300U compared with placebo at all time points (p<0.05) and with BoNTA 200U 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.
BoNTA significantly improves UI-associated health-related quality of life in patients with neurogenic UI.
使用尿失禁生活质量问卷（I-QOL）评估A型肉毒杆菌毒素（BoNTA）对神经源性尿失禁（UI）患者健康相关生活质量的影响。
在比利时、法国和瑞士的八个中心进行的随机、双盲、多中心、安慰剂对照研究。因神经源性逼尿肌过度活动导致尿失禁的患者（n = 59，脊髓损伤患者53例，多发性硬化患者6例），口服抗胆碱能药物治疗效果不佳，接受单剂量BoNTA（200U或300U，保妥适）或安慰剂治疗。记录筛查时以及治疗后第2、6、12、18和24周的I-QOL评分。
与安慰剂相比，300U BoNTA治疗组在所有时间点的I-QOL总分及各子量表评分中位数均显著升高（p<0.05）；与安慰剂相比，200U BoNTA治疗组在总分及避免限制行为子量表的所有时间点评分中位数均显著升高（p<0.05），在第2、6、12和18周时（p<0.05），但在心理社会影响和社交尴尬子量表第24周时无显著升高。在第2、6、12和24周时，达到I-QOL总分至少最小重要差异的BoNTA治疗组患者数量约为安慰剂组的两倍。
BoNTA可显著改善神经源性尿失禁患者与尿失禁相关的健康相关生活质量。
