INTRODUCTION AND HYPOTHESIS: Clinically meaningful overactive bladder syndrome (OAB) symptom relief is associated with patient satisfaction. This study evaluated the effects of onabotulinumtoxinA on patient satisfaction and goal attainment. METHODS: In a 36-week, multicenter, double-blind study, 313 participants with idiopathic OAB and urinary urgency incontinence inadequately managed with anticholinergics were randomized to placebo or one of five onabotulinumtoxinA doses. Assessment included a modified OAB-Patient Satisfaction with Treatment Questionnaire (PSTQ) and four Patient Global Assessment questions assessed changes in symptoms, quality of life, activity limitations, and emotions. RESULTS: Mean changes from baseline in OAB-PSTQ scores for the main module (Q2-Q13) at week 12 were greater for each onabotulinumtoxinA group (range, -31.5% to -48.9%) versus placebo (-17.6%). Greater proportions of patients in onabotulinumtoxinA groups attained their primary goal (range, 34.5% to 65.3%) versus placebo (23.7%). CONCLUSIONS:Patients with OAB are more likely to be satisfied and/or achieve their primary treatment goal with onabotulinumtoxinA treatment than with placebo, consistent with symptom improvements.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: Clinically meaningful overactive bladder syndrome (OAB) symptom relief is associated with patient satisfaction. This study evaluated the effects of onabotulinumtoxinA on patient satisfaction and goal attainment. METHODS: In a 36-week, multicenter, double-blind study, 313 participants with idiopathic OAB and urinary urgency incontinence inadequately managed with anticholinergics were randomized to placebo or one of five onabotulinumtoxinA doses. Assessment included a modified OAB-Patient Satisfaction with Treatment Questionnaire (PSTQ) and four Patient Global Assessment questions assessed changes in symptoms, quality of life, activity limitations, and emotions. RESULTS: Mean changes from baseline in OAB-PSTQ scores for the main module (Q2-Q13) at week 12 were greater for each onabotulinumtoxinA group (range, -31.5% to -48.9%) versus placebo (-17.6%). Greater proportions of patients in onabotulinumtoxinA groups attained their primary goal (range, 34.5% to 65.3%) versus placebo (23.7%). CONCLUSIONS:Patients with OAB are more likely to be satisfied and/or achieve their primary treatment goal with onabotulinumtoxinA treatment than with placebo, consistent with symptom improvements.
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