Treatment of refractory idiopathic overactive bladder with incobotulinumtoxinA and vibe delivery system (XAVIER): pilot study

BACKGROUND: Intradetrusor botulinum neurotoxin type A (BoNT/A) with onabotulinumtoxinA (onabotA), is an established treatment for overactive bladder (OAB). This study aims to evaluate the safety, usability, and initial efficacy of ViXe - a combination of incobotulinumtoxinA with the needle-free, ultrasound-assisted intravesical Vibe delivery system - in women with OAB. METHODS: Parallel, exploratory, multicenter, randomized, double-masked, placebo- and sham-controlled. Women (18-80 years) with idiopathic OAB were randomized 1:1 to ViXe or placebo. Primary endpoints: 12-week safety and patient satisfaction. Secondary endpoints: initial efficacy measured by bladder diaries and validated questionnaires. RESULTS: Eighty-two screened, 48 were randomized (ViXe 25; placebo 23); 47 completed. Safety: Treatment-emergent adverse events occurred in 44.0% ViXe vs. 39.1% placebo patients; fewer events were reported in the ViXe group (13 vs. 17); all mild-moderate; no serious events. Treatment-related adverse events were fewer with ViXe (8.0%) than with placebo (21.7%). Patient experience favored ViXe on several comfort domains; willingness to continue was higher (73.7% vs. 28.6%). Urinary incontinence decreased by 58% compared to 35% at week 6 and 59% compared to 45% at week 12 (ViXe vs. placebo); Overactive bladder questionnaires showed improvement in both groups, but it was not statistically significant. Satisfaction favored ViXe, with 63.16% patients satisfied, versus 57.14% dissatisfied in the placebo group. CONCLUSIONS: ViXe is safe and well-tolerated, with only mild to moderate AEs. The needle-free, office-amenable workflow and handling advantages of incobotulinumtoxinA support feasibility and patient acceptability. These data collectively justify a larger, adequately powered Phase 2b/3 trial to determine clinical efficacy and assess durability.