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).
Signed written informed consent
Female aged 18-80
Participant with known idiopathic Overactive Bladder condition based on medical records for at least 6 months prior to enrollment
Participant with at least 8 daily urinary output episodes on average during a 3-day voiding diary
Participant with Body Mass Index > 40 kg/m2
Participant with history of evidence of pelvic, urological or urogenital abnormality that in the determination of the investigator would interfere with study conduct
Participant with known or suspected overactive bladder caused by any neurological conditions (neuromuscular disorders such as Myasthenia Gravis, Amyotrophic Lateral Sclerosis (ALS), Eaton-Lambert Syndrome, Alzheimer's, Parkinson, Multiple Sclerosis (MS), stroke, etc.)
Participant with suspected retention or with Post Void Residue (PVR)> 150 ml, as measured during screening. Post void residual may be repeated one week after first assessment if the original value is greater than 150 ml
Vensica Therapeutics Ltd.
Lead sponsor
TFS Trial Form Support
Collaborator