OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder

Abstract

Introduction: A prespecified pooled analysis of two placebo-controlled, phase 3 trials evaluated whether the number of prior anticholinergics used or reason for their discontinuation affected the treatment response to onabotulinumtoxinA 100U in overactive bladder (OAB) patients with urinary incontinence (UI).

Methods: Patients with symptoms of OAB received intradetrusor injections of onabotulinumtoxinA 100U or placebo, sparing the trigone. Change from baseline at week 12 in UI episodes/day, proportion of patients reporting a positive response ('greatly improved' or 'improved') on the treatment benefit scale (TBS), micturition and urgency were evaluated by number of prior anticholinergics (1, 2 or ≥ 3) and reason for their discontinuation (insufficient efficacy or side effects). Adverse events (AE) were assessed.

Results: Patients had taken an average of 2.4 anticholinergics before study enrolment. OnabotulinumtoxinA reduced UI episodes/day from baseline vs. placebo, regardless of the number of prior anticholinergics (-2.82 vs. -1.52 for one prior anticholinergic; -2.58 vs. -0.58 for two prior anticholinergics; and -2.92 vs. -0.73 for three or more prior anticholinergics; all p < 0.001). The proportion of TBS responders was higher with onabotulinumtoxinA vs. placebo (69.0% vs. 37.2% for one prior anticholinergic; 58.8% vs. 24.8% for two prior anticholinergics and 56.4% vs. 22.5% for three or more prior anticholinergics; all p < 0.001). Similar results were observed regardless of the reason for discontinuation. OnabotulinumtoxinA reduced the episodes of urgency and frequency of micturition vs. placebo in all groups. AEs were well tolerated, with a comparable incidence in all groups.

Conclusion: In patients with symptoms of OAB who were inadequately managed by one or more anticholinergics, onabotulinumtoxinA 100U provided significant and similar treatment benefit and safety profile regardless of the number of prior anticholinergics used or reason for inadequate management of OAB. ClinicalTrials.gov: NCT00910845, NCT00910520.

© 2014 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.

Figures

Figure 1

(A) Change from baseline in daily average UI episodes at week 12 in the overall pooled population and subgroups, and (B) proportion of patients achieving ≥ 50% or 100% reduction from baseline in UI episodes at week 12 in the overall pooled population. Error bars are 95% ± CI. *p †p < 0.05 vs. placebo. ACH, anticholinergic; CI, confidence interval; onabotA, onabotulinumtoxinA; UI, urinary incontinence.

Figure 2

Proportion of patients with a positive response (their condition ‘greatly improved’ or ‘improved’) on the treatment benefit scale at week 12 in the overall pooled population and subgroups. Error bars are 95% ± CI. *p 

Figure 3

Change from baseline in daily average episodes of (A) urgency and (B) micturition at week 12 in the overall pooled population and subgroups. Error bars are 95% ± CI. *p †p < 0.05 vs. placebo. ACH, anticholinergic; CI, confidence interval; onabotA, onabotulinumtoxinA.

Figure 4

Duration of CIC in the pooled safety population. CIC was initiated when PVR ≥ 350 ml, or if PVR ≥ 200 ml and