Observational Study of Botulinum Toxin Type A in Patients With Urinary Incontinence Associated With Overactive Bladder
BOREAL
1 other identifier
observational
474
1 country
50
Brief Summary
This 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2016
Shorter than P25 for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedOctober 24, 2016
October 1, 2016
6 months
February 1, 2016
October 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Target Patients Prescribed Botox® in Clinical Practice
Day 1
Secondary Outcomes (16)
Treatments Previously Prescribed
Day 1
Number of Sites Injected
Day 1
Total Dose of Botox® Used
Day 1
Types of Anaesthesia and Antibiotic Prophylaxis Used
Day 1
Cytobacteriological Examination of the Urine
Day 1
- +11 more secondary outcomes
Study Arms (1)
Botox®
Patients prescribed botulinum toxin Type A (Botox®) injection for the treatment of urinary incontinence associated with neurogenic detrusor overactivity or overactive bladder as per standard of care in clinical practice.
Interventions
Botulinum toxin Type A (Botox®) injection as prescribed as standard of care in clinical practice.
Eligibility Criteria
Adult patients treated with Botox® for urinary incontinence associated with NDO or IOAB in clinical practice.
You may qualify if:
- Patients who receive a Botox® injection for urinary incontinence.
You may not qualify if:
- Patients not residing in France.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (50)
Site D'Aix En Provence
Aix-en-Provence, 13616, France
CL Toulouse Lautrec
Albi, 81000, France
CHU Angers
Angers, 49033, France
CH Angouleme
Angoulême, 16959, France
CH Avranches Granville
Avranches, 50300, France
CH Bagnols Sur Ceze
Bagnols-sur-Cèze, 30200, France
CH Belfort
Belfort, 90016, France
CHU Besancon
Besançon, 25030, France
CL Saint Augustin
Bordeaux, 33000, France
CHU Bordeaux
Bordeaux, 33076, France
CH de Cahors
Cahors, 46000, France
CH Châlons-en-Champagne
Châlons-en-Champagne, 51000, France
CHU Clermont Ferrand
Clermont-Ferrand, 63003, France
CH Colmar
Colmar, 68024, France
CHU Mondor (APHP)
Créteil, 94010, France
CH Hopale Ctre Calot/Helio
Cucq, 62780, France
CHU Dijon
Dijon, 21079, France
CHI E.Durkheim Plateau de La Justice
Épinal, 88021, France
CH Raymond Poincare (APHP)
Garches, 92380, France
CH Renee Sabran Hyeres (HCL)
Giens-Hyeres, 83406, France
GH de la Rochelle Ré-Aunis
La Rochelle, 17000, France
CH Bicêtre (APHP)
Le Kremlin-Bicêtre, 94270, France
CH Le Mans
Le Mans, 72037, France
CHU Limoges
Limoges, 87042, France
CL Mutualiste Porte de L'Orient
Lorient, 56100, France
CH de la Conception (APHM)
Marseille, 13005, France
CH Mont de Marsan
Mont-de-Marsan, 40000, France
CL Beau Soleil
Montpellier, 34070, France
CHU Montpellier
Montpellier, 34090, France
CH Mulhouse
Mulhouse, 68100, France
CHU Nimes
Nîmes, 30029, France
GH Saint Joseph
Paris, 75014, France
CH Tenon (APHP)
Paris, 75020, France
CH Lyon Sud (HCL)
Pierre-Bénite, 69495, France
CH de Pontoise
Pointoise Cedex, 95301, France
USLD de Lusignan
Poitiers, 86021, France
CH Annecy
Pringy, 74374, France
SIH Privas La Voulte
Privas, 07007, France
Polyclinique Les Bleuets
Reims, 51100, France
CHU de Rennes
Rennes, 35033, France
CHU de Rouen
Rouen, 76031, France
CL de L'Alliance Saint Cyr/Loire
Saint Cyr/Loire, 37540, France
CH Saint-Avold
Saint-Avold, 57500, France
CL Mutualiste Chirurgicale
Saint-Etienne, 42100, France
CH de Saintonge (Saintes)
Saintes, 17108, France
Hôpital Civil / Nouvel Hôpital Civil
Strasbourg, 67000, France
CH Foch
Suresnes, 92150, France
Clinique de l'Ormeau Pyrénées
Tarbes, 65000, France
CHU Toulouse
Toulouse, 31059, France
CHU Tours
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2016
First Posted
February 3, 2016
Study Start
February 1, 2016
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
October 24, 2016
Record last verified: 2016-10