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 (200U or 300U, Botox) or placebo. I-QOL scores at screening and after treatment at weeks 2, 6, 12, 18, and 24 were recorded. RESULTS:Median total and subscaleI-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. CONCLUSIONS: BoNTA significantly improves UI-associated health-related quality of life in patients with neurogenic UI. European Association of Urology.
RCT Entities:
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 (200U or 300U, Botox) 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 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. CONCLUSIONS: BoNTA significantly improves UI-associated health-related quality of life in patients with neurogenic UI. European Association of Urology.