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This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX® 100U | Experimental | Botulinum Toxin Type A 100U into the detrusor muscle on Day 1 in patients with Overactive Bladder |
|
| BOTOX® 200U | Experimental | Botulinum Toxin Type A 200U into the detrusor muscle on Day 1 in patients with Neurogenic Detrusor Overactivity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Biological | Botulinum Toxin Type A into detrusor muscle on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score | Baseline, Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Contact | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Busan | Korea | 49241 | South Korea | ||
| The Catholic University of Korea Bucheion St. Mary Hospital |
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| Gyeonggi-do |
| Korea |
| 14647 |
| South Korea |
| Seoul National University Hospital | Seoul | Korea | 03080 | South Korea |
| Asan Medical Center | Seoul | Korea | 05505 | South Korea |
| Samsung Medical Center | Seoul | Korea | 06351 | South Korea |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| 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 |
| D001745 | Urinary Bladder Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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