Urinary Bladder, Overactive Clinical Trial
— BOREALThis study will describe the prescription conditions of botulinum toxin Type A (Botox®) injection for the treatment of urinary incontinence due to neurogenic detrusor overactivity (NDO) or idiopathic overactive bladder (IOAB) as per standard of care in clinical practice in France.
| Status | Completed |
| Enrollment | 474 |
| Est. completion date | August 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: -Patients who receive a Botox® injection for urinary incontinence. Exclusion Criteria: -Patients not residing in France. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Site D'Aix En Provence | AIX en Provence | |
| France | CL Toulouse Lautrec | Albi | |
| France | CHU Angers | Angers Cedex 01 | |
| France | CH Angouleme | Angouleme Cedex 9 | |
| France | CH Avranches Granville | Avranches | |
| France | CH Bagnols Sur Ceze | Bagnols-Sur-Ceze | |
| France | CH Belfort | Belfort Cedex | |
| France | CHU Besancon | Besancon Cedex | |
| France | CL Saint Augustin | Bordeaux | |
| France | CHU Bordeaux | Bordeaux Cedex | |
| France | CH de Cahors | Cahors | |
| France | CH Châlons-en-Champagne | Chalons-En-Champagne | |
| France | CHU Clermont Ferrand | Clermont-Ferrand | |
| France | CH Colmar | Colmar Cedex | |
| France | CHU Mondor (APHP) | Creteil | |
| France | CH Hopale Ctre Calot/Helio | Cucq | |
| France | CHU Dijon | Dijon Cedex | |
| France | CHI E.Durkheim Plateau de La Justice | Epinal Cedex | |
| France | CH Raymond Poincare (APHP) | Garches | |
| France | CH Renee Sabran Hyeres (HCL) | Giens-Hyeres | |
| France | GH de la Rochelle Ré-Aunis | La Rochelle | |
| France | CH Bicêtre (APHP) | Le Kremlin-Bicetre | |
| France | CH Le Mans | Le Mans Cedex 9 | |
| France | CHU Limoges | Limoges Cedex | |
| France | CL Mutualiste Porte de L'Orient | Lorient | |
| France | CH de la Conception (APHM) | Marseille | |
| France | CH Mont de Marsan | Mont de Marsan | |
| France | CHU Montpellier | Montpellier | |
| France | CL Beau Soleil | Montpellier | |
| France | CH Mulhouse | Mulhouse | |
| France | CHU Nimes | Nimes | |
| France | CH Tenon (APHP) | Paris | |
| France | GH Saint Joseph | Paris | |
| France | CH Lyon Sud (HCL) | Pierre-Benite Cedex | |
| France | CH de Pontoise | Pointoise Cedex | |
| France | USLD de Lusignan | Poitiers Cedex | |
| France | CH Annecy | Pringy Cedex | |
| France | SIH Privas La Voulte | Privas | |
| France | Polyclinique Les Bleuets | Reims | |
| France | CHU de Rennes | Rennes Cedex | |
| France | CHU de Rouen | Rouen Cedex | |
| France | CL de L'Alliance Saint Cyr/Loire | Saint Cyr/Loire | |
| France | CH Saint-Avold | Saint-Avold | |
| France | CL Mutualiste Chirurgicale | Saint-Etienne | |
| France | CH de Saintonge (Saintes) | Saintes Cedex | |
| France | Hôpital Civil / Nouvel Hôpital Civil | Strasbourg | |
| France | CH Foch | Suresnes | |
| France | Clinique de l'Ormeau Pyrénées | Tarbes | |
| France | CHU Toulouse | Toulouse Cedex 9 | |
| France | CHU Tours | Tours Cedex 09 |
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Target Patients Prescribed Botox® in Clinical Practice | Day 1 | No | |
| Secondary | Treatments Previously Prescribed | Day 1 | No | |
| Secondary | Number of Sites Injected | Day 1 | No | |
| Secondary | Total Dose of Botox® Used | Day 1 | No | |
| Secondary | Types of Anaesthesia and Antibiotic Prophylaxis Used | Day 1 | No | |
| Secondary | Cytobacteriological Examination of the Urine | Day 1 | No | |
| Secondary | Total Number of Botox® Cycles in Non-naive Patients (previously received Botox®) | Day 1 | No | |
| Secondary | Length of Botox® Treatment in Non-naive Patients | Day 1 | No | |
| Secondary | Time Since Last Botox® Injection in Non-naive Patients | Day 1 | No | |
| Secondary | Characteristics of Injector Sites (Locations) | Day 1 | No | |
| Secondary | Characteristics of Injector Physicians | Day 1 | No | |
| Secondary | Characteristics of Patients | Day 1 | No | |
| Secondary | Number of Patients by Pathology History | Day 1 | No | |
| Secondary | Number of Patients by Medical and Surgical History | Day 1 | No | |
| Secondary | Reduction of Number of Daily Urinary Incontinence Episodes in Non-naive Patients | Day 1 | No | |
| Secondary | Percentage of Continent Patients in Non-naive Patients | Day 1 | No | |
| Secondary | Number of Adverse Events during the Visit | Day 1 | No |
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