AIMS: OnabotulinumtoxinA significantly reduces urinary incontinence (UI) and improves bladder management in patients with neurogenic detrusor overactivity (NDO). We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes (PROs) in patients with UI due to NDO in a double-blind, placebo-controlled study. METHODS:Patients with UI due to NDO (from multiple sclerosis or spinal cord injury) were randomized to intradetrusor placebo (n = 92) or onabotulinumtoxinA 200 U (n = 92) or 300 U (n = 91). PROs included Incontinence Quality of Life (I-QOL) Questionnaire to assess health-related quality of life (HRQoL), the 16-item modified Overactive Bladder-Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ) to assess treatment satisfaction, and Patient Global Assessment to assess treatment goal achievement. RESULTS:Mean improvement in I-QOL total score at weeks 6 and 12 was significantly greater with both onabotulinumtoxinA 200 U and 300 U versus placebo (Δ12.3 for 200 U and Δ14.9 for 300 U vs. placebo; P < 0.001), and was clinically meaningful. For those patients who completed the OAB-PSTQ, improvement in satisfaction at weeks 6 and 12 was significantly greater for onabotulinumtoxinA versus placebo (P < 0.001, all comparisons). At 6 weeks, greater proportions of onabotulinumtoxinA-treated patients than placebo reported being somewhat or very satisfied (200 U, 77.5% and 300 U, 67.8% vs. placebo, 39.5%), and significant progress toward or complete achievement of primary treatment goal (200 U, 62.9% and 300 U, 61.6% vs. placebo, 16.5%). CONCLUSIONS: NDO patients treated with onabotulinumtoxinA 200 or 300 U had significantly greater improvement in HRQoL and greater treatment satisfaction compared with placebo-treated patients, with no clinically relevant differences between onabotulinumtoxinA doses.
RCT Entities:
AIMS: OnabotulinumtoxinA significantly reduces urinary incontinence (UI) and improves bladder management in patients with neurogenic detrusor overactivity (NDO). We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes (PROs) in patients with UI due to NDO in a double-blind, placebo-controlled study. METHODS:Patients with UI due to NDO (from multiple sclerosis or spinal cord injury) were randomized to intradetrusor placebo (n = 92) or onabotulinumtoxinA 200 U (n = 92) or 300 U (n = 91). PROs included Incontinence Quality of Life (I-QOL) Questionnaire to assess health-related quality of life (HRQoL), the 16-item modified Overactive Bladder-Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ) to assess treatment satisfaction, and Patient Global Assessment to assess treatment goal achievement. RESULTS: Mean improvement in I-QOL total score at weeks 6 and 12 was significantly greater with both onabotulinumtoxinA 200 U and 300 U versus placebo (Δ12.3 for 200 U and Δ14.9 for 300 U vs. placebo; P < 0.001), and was clinically meaningful. For those patients who completed the OAB-PSTQ, improvement in satisfaction at weeks 6 and 12 was significantly greater for onabotulinumtoxinA versus placebo (P < 0.001, all comparisons). At 6 weeks, greater proportions of onabotulinumtoxinA-treated patients than placebo reported being somewhat or very satisfied (200 U, 77.5% and 300 U, 67.8% vs. placebo, 39.5%), and significant progress toward or complete achievement of primary treatment goal (200 U, 62.9% and 300 U, 61.6% vs. placebo, 16.5%). CONCLUSIONS: NDO patients treated with onabotulinumtoxinA 200 or 300 U had significantly greater improvement in HRQoL and greater treatment satisfaction compared with placebo-treated patients, with no clinically relevant differences between onabotulinumtoxinA doses.
Authors: Michael B Chancellor; Vaishali Patel; Wendy W Leng; Patrick J Shenot; Wayne Lam; Denise R Globe; Alex L Loeb; Christopher R Chapple Journal: Neurology Date: 2013-07-26 Impact factor: 9.910