IncobotulinumtoxinA Versus OnabotulinumtoxinA for Treatment of Overactive Bladder Syndrome: A Randomized Single-blinded Non-inferiority Trial.

OBJECTIVE

To compare the efficacy of incobotulinumtoxinA to onabotulinumtoxinA for the treatment of idiopathic overactive bladder syndrome.

METHODS

This study is a single-blinded, randomized, non-inferiority trial. Participants received intradetrusor injections of either 100 units of incobotulinumtoxinA or 100 units of onabotulinumtoxinA. The primary outcome was measured as a change in the mean number of urgency urinary incontinence episodes from baseline to 2-6 weeks post-procedure.

RESULTS

Data from 59 participants were analyzed (29 incobotulinumtoxinA, 30 onabotulinumtoxinA). Most participants were between 40 and 59 years of age and postmenopausal. There were significantly more postmenopausal participants in the onabotulinumtoxinA group (51.72% incobotulinumtoxinA, 80% onabotulinumtoxinA, P<.05). Comparing incobotulinumtoxinA to onabotulinumtoxinA, the difference in mean reduction of urgency urinary incontinence episodes from baseline to 2-6 weeks post-treatment was 0.41 (90% confidence interval -0.88 to 1.71), meeting the predetermined non-inferiority margin of -1. The mean daytime voids decreased by 0.97 ± 2.54 from baseline of 7.28 ± 2.77 in the incobotulinumtoxinA group, and by 2.97 ± 4.74 from baseline of 9.57 ± 5.61 in the onabotulinumtoxinA group (P<.05). The Patient Global Impression of Improvement scores were significantly different between the 2 groups (2.57 ± 1.34 IncobotulinumtoxinA, 1.93 ± 0.83 OnabotulinumtoxinA [P<.05]). However, the number of participants answering "very much better" and "much better" was similar between the groups (64% IncobotulinumtoxinA, 71% OnabotulinumtoxinA). There was no statistically significant difference in other secondary outcomes or with adverse events between the 2 groups.

CONCLUSION

Intradetrusor incobotulinumtoxinA was found to be non-inferior to onabotulinumtoxinA in the treatment of idiopathic overactive bladder syndrome and offers a more pure, cost-effective, and logistically convenient alternative.