RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder

Key Inclusion Criteria

• 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 at least 5 Urinary Incontinence episodes during a 3-day voiding diary and at least 1 per day
• 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 medication consumption until the 12-week follow-up visit
• Participants on tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) drugs should be on stable dose for at least 3 months prior to enrollment and agree to remain on stable medication consumption until the 12-week follow-up visit

Key Exclusion Criteria

• 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
• Participant is pregnant or breastfeeding
• Participant with current or known recurrent urinary tract infection (3 or more infections in the last 6 months), or presence of urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone
• Participant who has received botulinum toxin injections for any condition within the past 9 months
• Participant who has received neurostimulation for the treatment of Overactive Bladder in the last 6 months.
• Participant on any active biofeedback, pelvic muscle rehabilitation, or pelvic floor physical therapy within the past 4 weeks (Self-performed Kegels exercises are allowed)
• Participant with more than minimal level of suspected stress incontinence or mixed incontinence with stress component likely to confound study outcome, based on a 3-day voiding diary or medical history, or when stress incontinence score in the Medical, Epidemiologic, and Social Aspects (MESA) incontinence questionnaire is higher than the urgency incontinence score
• Participant with current or planned treatment with drugs that interfere with neuromuscular transmission (e.g., aminoglycoside, polypeptide antibiotics, lincomycin antibiotics, or aminoquinolines as well as tubocurarine-type muscle relaxants)