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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
210
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
Urology Nevada
Reno, Nevada, United States
RECRUITINGMean daily urinary incontinence
Change from baseline in mean daily Urinary Incontinence (UI) episodes at 12-weeks post treatment according to a 3-day diary
Time frame: 12 weeks
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