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This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms have not been adequately managed by oral anticholinergic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients With Urinary Incontinence Due to iOAB | Patients with urinary incontinence due to iOAB treated with BOTOX® in accordance with physician standard practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | botulinum toxin Type A administered in accordance with physician standard practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS) | Baseline, Week 12 | |
| Change From Baseline in Number of Urinary Incontinence Episodes | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Re-Injection of BOTOX® | 12 Months | |
| Number of Nocturia Episodes | 12 Months | |
| Usage of Incontinence Support Products |
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Inclusion Criteria:
Exclusion Criteria:
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Patients With Urinary Incontinence Due to iOAB
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Brix | Bad Mergentheim | 97980 | Germany | |||
| Urologie Turmschtraße |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37260130 | Derived | Farrelly E, Hamid R, Lorenzo-Gomez MF, Schulte-Baukloh H, Yu J, Patel A, Nelson M. One treatment with onabotulinumtoxinA relieves symptoms of overactive bladder in patients refractory to one or more oral medications. Neurourol Urodyn. 2023 Aug;42(6):1203-1213. doi: 10.1002/nau.25221. Epub 2023 Jun 1. | |
| 33955921 | Derived |
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|
| 12 Months |
| Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence | Baseline, 12 Months |
| Berlin |
| 10551 |
| Germany |
| Uwe-Carsten | Berlin | 12099 | Germany |
| Albrecht Kastein | Berlin | 12247 | Germany |
| ATURO | Berlin | 14197 | Germany |
| MVZ Burgdorf | Burgdorf, Hanover | 31303 | Germany |
| Ev.-Luth. Diakonissenanstalt Dresden | Dresden | 01099 | Germany |
| Stefan Carl | Emmendingen | 79312 | Germany |
| Zentrum für Urologie FFM | Frankfurt | 60439 | Germany |
| Georg-August-Universität Göttingen | Göttingen | 37075 | Germany |
| Universitätsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Urologikum Hamburg | Hamburg | 22081 | Germany |
| Urologische Praxis Volksdorf | Hamburg | 22359 | Germany |
| Claudia Olszak-Warnat | Herne | 44649 | Germany |
| Westpfalz-Klinikum Kaiserslautern | Kaiserslautern | 67655 | Germany |
| Urologie Zentrum Kiel | Kiel | 24103 | Germany |
| Joachim Weiß | Lampertheim | 68623 | Germany |
| Uro- Vital-Zentrum, GP Hellmeier, Krause et al | Landshut | 84028 | Germany |
| Tom Kempe | Leipzig | 04109 | Germany |
| Institut Dr. Schulze | Markkleeberg | 04416 | Germany |
| Elke Stagge | Mülheim | 45468 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Urologen am Stadtpark | Nuremberg | 90409 | Germany |
| Urologicum Osnabrück | Osnabrück | 49076 | Germany |
| Simone Maier | Reutlingen | 72764 | Germany |
| Andres Melchior | Salzatal OT Schiepzig | 06198 | Germany |
| Andreas Reinhard Wicht | Sangerhausen | 06526 | Germany |
| Franz Hirschle | Singen | 78224 | Germany |
| Wolfgang Theurer | Stuttgart | 70174 | Germany |
| Benjamin Fischer | Tuttlingen | 78532 | Germany |
| Dietmar Jung | Tuttlingen | 78532 | Germany |
| Kontinenzzentrum Südwest | Villingen-Schwenningen | 78052 | Germany |
| Hospital Universitario Burgos | Burgos | 09006 | Spain |
| Hospital de Cabueñes | Gijón | 33394 | Spain |
| Hospital Virgen de la Victoria | Málaga | 29010 | Spain |
| Complejo Hospitalario Universitario Ourense | Ourense | 32005 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Universitario Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hospital de Valme | Seville | 41014 | Spain |
| Urologimottagningen, Hallands Sjukhus Halmstad | Halmstad | 30185 | Sweden |
| Urologiska kliniken, Södersjukhuset AB | Stockholm | 11883 | Sweden |
| Karolinska Hospital | Stockholm | 17177 | Sweden |
| Karolinska Hospital | Stockholm | 18288 | Sweden |
| Kvinnokliniken, Danderyds Sjukhus AB | Stockholm | 18288 | Sweden |
| Kirurgkliniken, Västervik Sjukhus | Västervik/Kalmar | 59381 | Sweden |
| Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Edgbaston | Birmingham | B15 2TH | United Kingdom |
| Southern General Hospital | Glasgow, Lanarkshire | G51 4TF | United Kingdom |
| Leeds Teaching Hospitals NHS Trust, St. James's University Hospital | Leeds, West Yorkshire | LS9 7TF | United Kingdom |
| University College London Hospitals NHS foundation Trust | London | NW1 2BU | United Kingdom |
| Imperial College Healthcare NHS Trust, The Bays, St Mary's Hospital | London | W2 1NY | United Kingdom |
| St Helens & Knowsley Teaching Hospitals NHS Trust, Whiston Hospital | Prescot, Merseyside | L35 5DR | United Kingdom |
| Salisbury NHS Foundation Trust, Salisbury District Hospital | Salisbury, Wiltshire | SP2 8BJ | United Kingdom |
| Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available. |
| 33955918 | Derived | Short orals. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S21-S77. doi: 10.1097/SPV.0000000000000934. No abstract available. |
| 32719964 | Derived | Hamid R, Lorenzo-Gomez MF, Schulte-Baukloh H, Boroujerdi A, Patel A, Farrelly E. OnabotulinumtoxinA is a well tolerated and effective treatment for refractory overactive bladder in real-world practice. Int Urogynecol J. 2021 Jan;32(1):65-74. doi: 10.1007/s00192-020-04423-0. Epub 2020 Jul 27. |
| 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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