First In Human (FIH) clinical study for the evaluation of an ultrasound based botulinum toxin - A delivery system in subjects with Idiopathic Overactive Bladder (OAB)

Abstract

Over active bladder (OAB) is defined by increased urinary incontinence, daily micturition, nocturia and urinary urgency. Present available treatments include, among others, oral medications and intravesical Botulinum Toxin A injections. Oral medications are associated with poor compliance, and Botulinum Toxin A injections are time consuming, invasive and are not financially rewarding for the urologists. Vensica Medical is developing an ultrasound based BonT/A delivery system that enables a simple, minimally invasive, and fast delivery of Botulinum Toxin A to the urinary bladder for the treatment of OAB. Vensica has completed the ultrasound based BonT/A delivery system First In Human study - Safety and Initial Performance of the ultrasound-based, needle-free BonT/A delivery system in Subjects with Idiopathic Overactive Bladder. The clinical study was a single center, prospective, open label study on 10 female OAB subjects that initiated on December 7th 2018 and completed on May 23rd. 2019 with full results. The results of study show no serious adverse events (device related or not) as well as improvement in several efficacy endpoints. The conclusion from the study is that the ultrasound based BonT/A delivery system is safe, easily operated by the physicians and accepted by the subjects. Further clinical studies should be conducted to further establish the efficacy of the system.