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

IntroductionA 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).MethodsPatients 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.ResultsPatients 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.ConclusionIn 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.

Efficacy and tolerance of botulinum toxin injections after sacral nerve stimulation failure for idiopathic overactive bladder

“…Zargham et al 20 failed to identify an association between bladder trabeculation and efficacy of BoNT‐A. Besides, onabotulinumtoxinA success was not determined by the prior number of antimuscarinic medication 21 …”

Treatment Failure of Botulinum Toxin A in Patients with Idiopathic Overactive Bladder: Why Do Patients Discontinue Treatment?

“…Possible disadvantages are: risk of urinary retention requiring CISC, urinary tract infections, and the need for repeated injections after usually 6 -12 months. The approval of BoNT-A for idiopathic OAB was based on the 2 phase 3 randomized controlled trials, which demonstrated that BoNT-A 100U significantly improved OAB symptoms and QOL vs. placebo (3,4). Recently, Nitti et al showed (in a prospective extension of a phase 3 trial) that the efficacy and safety of BoNT-A are durable after a follow-up of 3.5 years (5).…”

Patient factors associated with onabotulinum toxin A treatment outcome in women with detrusor overactivity

“…Makovey et al reported that following 150–200 units of onaBoNTA success rates were lower in patients reporting lack of efficacy of antimuscarinic drugs (34 of 57, 68%), compared to those who stopped because of side effects (24 of 28, 86%) . In contrast, a pooled analysis of two trials of 100 units onaBoNTA showed no difference in treatment effect irrespective of the number of antimuscarinic preparations tried, or whether oral medication was stopped due to side effects or lack of efficacy . It may be a possibility that some patients have a more resistant disease state, but whether this is a motor or sensory phenomenon is unclear.…”