Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NT 201 200U and Vibe System · 1 trial · 1 indication
Change from baseline in mean daily Urinary Incontinence (UI) episodes at 12-weeks post treatment according to a 3-day diary
| Arm | Type | Description |
|---|---|---|
| Active arm: NT 201 200U and Vibe System | ACTIVE_COMPARATOR | - |
| Active arm: NT 201 300U and Vibe System | ACTIVE_COMPARATOR | - |
| Control arm: Placebo (drug-free solution) and sham (i.e., insertion of the Vibe Catheter with no act | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NT 201 200U and Vibe System | COMBINATION_PRODUCT | Combination of NT 201 200U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure |
| NT 201 300U and Vibe System | COMBINATION_PRODUCT | Combination of NT 201 300U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure |
| Placebo and sham | COMBINATION_PRODUCT | 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 |
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...