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This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX® | Patients with idiopathic overactive bladder (OAB) treated with onabotulinumtoxinA (BOTOX®) injections into the bladder as standard of care in clinical practice. No intervention was administered in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Drug | OnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization | 12 Weeks | |
| Length of Time of Clean Intermittent Catheterization (CIC) Use | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Urinary Tract Infection (UTI) | 12 Weeks |
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Inclusion Criteria:
-Patients treated with BOTOX® for Overactive Bladder.
Exclusion Criteria:
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Patients prescribed BOTOX® for the treatment of idiopathic OAB in clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Davis | California | 95616 | United States | ||
| Capital Region Urology |
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| Irvine |
| California |
| 92612 |
| United States |
| The Charlotte-Mecklenburg Hospital Authority DBA Carolinas Healthcare System | Charlotte | North Carolina | 28203 | United States |
| Alliance Urology Specialists, PA | Greensboro | North Carolina | 27403 | United States |
| Forsyth Memorial Hospital Inc. dba Novant Health Urology Partners | Winston-Salem | North Carolina | 27103 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Virginia Women's Center Inc. | Richmond | Virginia | 23233 | United States |
| 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 |
|---|---|
| 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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