PT  - JOURNAL ARTICLE
AU  - Chancellor, Michael B.
AU  - Patel, Vaishali
AU  - Leng, Wendy W.
AU  - Shenot, Patrick J.
AU  - Lam, Wayne
AU  - Globe, Denise R.
AU  - Loeb, Alex L.
AU  - Chapple, Christopher R.
TI  - OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity
AID  - 10.1212/WNL.0b013e3182a2ca4d
DP  - 2013 Aug 27
TA  - Neurology
PG  - 841--848
VI  - 81
IP  - 9
4099  - http://n.neurology.org/content/81/9/841.short
4100  - http://n.neurology.org/content/81/9/841.full
SO  - Neurology2013 Aug 27; 81
AB  - Objective: To evaluate the effects of onabotulinumtoxinA on patient-reported outcomes including health-related quality of life (HRQOL), treatment satisfaction, and treatment goal attainment in patients with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO).Methods: In this multicenter, double-blind, randomized, placebo-controlled, phase III, 52-week study (ClinicalTrials.gov NCT00311376), patients with UI due to NDO who were not adequately managed with anticholinergic therapy were treated with intradetrusor injections of onabotulinumtoxinA (200 or 300 U) or placebo (0.9% saline). HRQOL measures included the Incontinence Quality of Life (I-QOL) Questionnaire total score, and the 3 domain scores (avoidance and limiting behavior, psychosocial, and social embarrassment), the modified Overactive Bladder Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ), and Patient Global Assessment. Assessments were made at baseline, posttreatment week 6 (primary time point), week 12, and at 12-week intervals.Results: Patients (mean age of 46 years with 30.5 weekly UI episodes at baseline) were randomized to receive placebo (n = 149) or onabotulinumtoxinA (200 U [n = 135] or 300 U [n = 132]). At week 6, improvements from baseline in I-QOL Questionnaire total score were greater (p < 0.001) in both onabotulinumtoxinA-treated groups vs placebo. Responses to the OAB-PSTQ also demonstrated greater mean improvements from baseline (p < 0.001) in both onabotulinumtoxinA-treated groups vs placebo at week 6. Patients who received onabotulinumtoxinA also reported greater improvement in the Patient Global Assessment than those in the placebo group (p ≤ 0.001 vs placebo).Conclusions: Patients with UI due to NDO reported greater improvement in HRQOL and treatment satisfaction with onabotulinumtoxinA than with placebo consistently across several patient-reported outcome instruments.Classification of evidence: This study provides Class I evidence that onabotulinumtoxinA intradetrusor injections (200 or 300 U) can improve quality of life measures in patients with NDO not adequately managed with anticholinergic therapy.CIC=clean intermittent catheterization; HRQOL=health-related quality of life; I-QOL=Incontinence Quality of Life; MID=minimally important difference; MS=multiple sclerosis; NDO=neurogenic detrusor overactivity; OAB=Overactive bladder; OAB-PSTQ=Overactive Bladder Patient Satisfaction with Treatment Questionnaire; PGA=Patient Global Assessment; PRO=patient-reported outcome; QOL=Quality of life; SCI=spinal cord injury; UI=urinary incontinence