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| Name | Class |
|---|---|
| TFS Trial Form Support | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean daily urinary incontinence | Change from baseline in mean daily Urinary Incontinence (UI) episodes at 12-weeks post treatment according to a 3-day diary | 12 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tami Abudi | Contact | 972525989833 | tami@vensica.com |
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| 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 |
|
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
| C005703 | salicylhydroxamic acid |
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