Vensica Therapeutics Ltd.
This Phase 2b study is a prospective, multicenter, double blind, randomized, placebo and sham controlled trial to assess the safety, efficacy and dose response of NT 201 delivered by the Vibe System in participants with idiopathic overactive bladder (OAB).
Key Inclusion Criteria: 1. Signed written informed consent 2. Female aged 18-80 3. Participant with known idiopathic Overactive Bladder condition based on medical records for at least 6 months prior to enrollment 4. Participant with at least 8 daily urinary output episodes on average during a 3-day voiding diary 5. Participant with at least 5 Urinary Incontinence episodes during a 3-day voiding diary and at least 1 per day 6. Participants on antimuscarinics and/or beta-3 adrenergic agonists drugs should be on a stable dose for at least 1 month prior to screening and agree to remain on stable…
Combination of NT 201 200U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure
Combination of NT 201 300U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure
Placebo identical in package and appearance to NT 201 together with all steps of Vibe System preparation and insertion to the bladder, but without the actual activation of the ultrasound energy
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