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This First In Human study is aimed to evaluate the safety and initial efficacy of the Vibe delivery system in delivering Botox (TM) to the bladder wall in patients diagnosed with overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Subjects treated with Botox (TM) with the Vibe investigational delivery system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibe Delivery system | Device | delivery of Botox (TM) to the bladder wall using an ultrasound technology with the Vibe delivery system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events Reporting | Incidence of device related SAEs | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events Reporting | Incidence of device related SAEs within | 12 weeks |
| Incontinence | Change from Baseline in the mean number of Episodes of Urinary Incontinence/24h, as assessed by urinary diary |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response | Percentage of subjects who have a Positive Treatment Response on the Treatment Benefit Scale (TBS) | 12 weeks |
| Change in Quality of Life Total Score | Change from baseline in Overactive Bladder Quality of life (OAB-q) total score. The OAB-q questionnaire is a validated, multi-sectional questionnaire that assesses the patient's coping with overactive bladder symptoms. The questionnaire is commonly used in clinical research and clinical setting for this indication, and consists of the following 6 scores:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ‪Maya Shick‬ | Consultant | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jablonec Nad Nisou Medical Center | Jablonec nad Nisou | Czechia | ||||
| Braga Medical Center |
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| 12 weeks |
| Micturition | Change from Baseline in frequency of Micturition Episodes/24h, as assessed by urinary diary | 12 weeks |
| Nocturia | Change from Baseline in Daily Average Number of Nocturia Episodes, as assessed by urinary diary | 12 weeks |
| Urgency | Change from baseline in Urinary urgency, as assessed by urinary diary | 12 weeks |
| 12 weeks |
| Braga |
| Portugal |
| 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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