OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity

Abstract

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.

Figure 1. Effects of onabotulinumtoxinA on I-QOL Questionnaire score (intention-to-treat population)

(A) Change from baseline in I-QOL Questionnaire total score at weeks 6 and 12. (B) Percentage of patients with increase from baseline in I-QOL Questionnaire total score ≥11 points at weeks 6 and 12. *p < 0.001 vs placebo. I-QOL = Incontinence Quality of Life; MID = minimally important difference; OnabotA = onabotulinumtoxinA.

Figure 2. Effects of onabotulinumtoxinA on modified OAB-PSTQ score at weeks 6 and 12 (intention-to-treat population)

(A) Change from baseline in OAB-PSTQ total score (questions 2–13). (B) Percentage of patients reporting satisfaction with treatment (somewhat satisfied or very satisfied, modified OAB-PSTQ question 1). (C) Percentage of patients with self-report of no side effects (modified OAB-PSTQ question 14). (D) Percentage of patients reporting achievement of primary treatment goal (significant progress or complete achievement, modified OAB-PSTQ question 15). (E) Percentage of patients reporting having met or exceeded treatment expectations (modified OAB-PSTQ question 16). Percentages are based on the numbers of patients who answered at each time point. *p < 0.001 vs placebo. OAB-PSTQ = Overactive Bladder Patient Satisfaction with Treatment Questionnaire; OnabotA = onabotulinumtoxinA.

Figure 3. Effects of onabotulinumtoxinA on Patient Global Assessment in the intention-to-treat population

Percentage of patients reporting deterioration (worse), no change (NC), or improvement (Impr) in (A) overall symptoms; (B) quality of life; (C) activity limitations; and (D) overall emotion. Percentages are based on the numbers of patients who answered at each time point. *p < 0.001 vs placebo. OnabotA = onabotulinumtoxinA.