There is a paucity of data comparing the efficacy of onabotulinumtoxinA (onabotA) treatment between patients treated with one oral overactive bladder medication to those treated with more than one. This real-world study examines urinary incontinence episodes and treatment benefit of onabotA in patients who are refractory to one or more oral medications.

A prospective, observational study (NCT02161159) enrolled adult patients with overactive bladder with symptoms that were inadequately managed by oral medications. Patients were naïve to botulinum toxin for overactive bladder; efficacy and safety analyses were conducted on those that received >1 dose of onabotA. Adverse events and adverse drug reactions were recorded for up to 12 months after treatment with onabotA. We analyzed urinary incontinence episodes at baseline for all patients taking oral medications (-3 adrenergic receptor agonist [-3] and/or an anticholinergic) for overactive bladder. Only patients taking oral medications before, but not after onabotA and who had >1 diary entry at the indicated timepoint were included in analyses of urinary incontinence episodes after onabotA. Urinary incontinence was evaluated at 1 and 12 weeks after treatment with onabotA, and treatment benefit was evaluated using treatment benefit scores 12 weeks after treatment with onabotA.

Baseline urinary incontinence episodes were similar in patients treated with one versus more than one oral medication; reductions in urinary incontinence at week 12 post-onabotA did not differ based on the number of prior oral medications (Fig. 1). Urinary incontinence was significantly reduced (*P = <.001) in as little as 1 week after onabotA for all prior oral treatment groups (-3, -3.3*, n = 16; anticholinergic, -1.8*, n = 53; -3 + anticholinergic, -2.2*, n = 28; >1 anticholinergic, - 1.7*, n = 52). Of the 233 patients who reported treatment benefit scores at week 12, 88% were improved or greatly improved after onabotA. In the safety population (N = 504), 57 adverse events were reported in 38 patients (7.5%); 9 were serious. Urinary retention, as determined by the treating physician, was reported in 5 patients (1.0%); 1 was severe. Symptomatic urinary tract infection was reported in 2 patients (0.4%).

Treatment with onabotA led to significant reductions in urinary incontinence episodes. Prior to onabotA treatment, there was no significant difference in the number of urinary incontinence episodes per day in patients who had been on more than one oral overactive bladder medication as compared to only one oral overactive bladder medication.

Given these results, clinicians may want to consider onabotA treatment earlier as opposed to cycling through oral medications.