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.
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.
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.
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.
Minerva urology and nephrology. 2026 May 20 [Epub ahead of print]
Omri Schwarztuch Gildor, Avner Geva, Avi Eftel, Frederico Branco, Luis Xambre, Roger R Dmochowski, Michael Vainrib, XAVIER Study Group
Department of Urology, Meir Medical Center affiliated to the Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel - ., Vensica Medical LTD, New-York, NY, USA., Hospital da Prelada, Porto, Portugal., Department of Urology, Vila Nova de Gaia Hospital Center, Vila Nova de Gaia, Portugal., Department of Urology, Vanderbilt University, Nashville, TN, USA., Department of Urology, Meir Medical Center affiliated to the Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.