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This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX® | Patients who receive botulinum toxin Type A (BOTOX®) treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) | at up to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with urinary incontinence (due to NDO, eg, as a result of SCI or MS, or due to OAB) who have an inadequate response to or are intolerant of an anticholinergic medication
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| Name | Affiliation | Role |
|---|---|---|
| Ahunna Ukah | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NU Hospitals | Padmanabha Nagar | Banglore | 560070 | India | ||
| Bodyline Hospitals |
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| Label | URL |
|---|---|
| More Information | View source |
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|
| Ahmedabad |
| Gujarat |
| 380007 |
| India |
| Fortis Hospitals | Bengaluru | Karnataka | 560076 | India |
| Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute | Mumbai | Maharashtra | 400053 | India |
| AMAI Charitable Trust's ACE Hospital and Research Centre | Pune | Maharashtra | 411004 | India |
| Inamdar Multispeciality Hospital | Pune | Maharashtra | 411040 | India |
| Dr. Ram Manohar Lohia Hospital | New Delhi | National Capital Territory of Delhi | 110001 | India |
| Indian Spinal Injuries Centre | New Delhi | National Capital Territory of Delhi | 110070 | India |
| Fortis Escorts Heart Institute | Okhla Road | New Delhi | 110025 | India |
| Christian Medical College & Hospital | Ludhiana | Punjab | 141008 | India |
| Christian Medical College and Hospital | Vellore | Tamil Nadu | 632004 | India |
| Global Hospital | Hyderabad | Telangana | 500004 | India |
| 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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