Clinical trial NCT02673047: Observational Study of Botulinum Toxin Type A in Patients With Urinary Incontinence Associated With Overactive Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder, Overactive
Urinary Bladder, Neurogenic
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-02-03
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients treated with Botox® for urinary incontinence associated with NDO or IOAB in clinical practice.

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.


Eligibility criteria: Inclusion Criteria:

-Patients who receive a Botox® injection for urinary incontinence.

Exclusion Criteria:

-Patients not residing in France.

Primary outcomes:
measure: Target Patients Prescribed Botox® in Clinical Practice
timeFrame: Day 1
Secondary outcomes:
measure: Treatments Previously Prescribed
timeFrame: Day 1
measure: Number of Sites Injected
timeFrame: Day 1
measure: Total Dose of Botox® Used
timeFrame: Day 1
measure: Types of Anaesthesia and Antibiotic Prophylaxis Used
timeFrame: Day 1
measure: Cytobacteriological Examination of the Urine
timeFrame: Day 1
measure: Total Number of Botox® Cycles in Non-naive Patients (previously received Botox®)
timeFrame: Day 1
measure: Length of Botox® Treatment in Non-naive Patients
timeFrame: Day 1
measure: Time Since Last Botox® Injection in Non-naive Patients
timeFrame: Day 1
measure: Characteristics of Injector Sites (Locations)
timeFrame: Day 1
measure: Characteristics of Injector Physicians
timeFrame: Day 1
measure: Characteristics of Patients
timeFrame: Day 1
measure: Number of Patients by Pathology History
timeFrame: Day 1
measure: Number of Patients by Medical and Surgical History
timeFrame: Day 1
measure: Reduction of Number of Daily Urinary Incontinence Episodes in Non-naive Patients
timeFrame: Day 1
measure: Percentage of Continent Patients in Non-naive Patients
timeFrame: Day 1
measure: Number of Adverse Events during the Visit
timeFrame: Day 1
Other outcomes:
Locations:
city: AIX en Provence
country: France
facility: Site D'Aix En Provence
city: Albi
country: France
facility: CL Toulouse Lautrec
city: Angers Cedex 01
country: France
facility: CHU Angers
city: Angouleme Cedex 9
country: France
facility: CH Angouleme
city: Avranches
country: France
facility: CH Avranches Granville
city: Bagnols-Sur-Ceze
country: France
facility: CH Bagnols Sur Ceze
city: Belfort Cedex
country: France
facility: CH Belfort
city: Besancon Cedex
country: France
facility: CHU Besancon
city: Bordeaux Cedex
country: France
facility: CHU Bordeaux
city: Bordeaux
country: France
facility: CL Saint Augustin
city: Cahors
country: France
facility: CH de Cahors
city: Chalons-En-Champagne
country: France
facility: CH Châlons-en-Champagne
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Colmar Cedex
country: France
facility: CH Colmar
city: Creteil
country: France
facility: CHU Mondor (APHP)
city: Cucq
country: France
facility: CH Hopale Ctre Calot/Helio
city: Dijon Cedex
country: France
facility: CHU Dijon
city: Epinal Cedex
country: France
facility: CHI E.Durkheim Plateau de La Justice
city: Garches
country: France
facility: CH Raymond Poincare (APHP)
city: Giens-Hyeres
country: France
facility: CH Renee Sabran Hyeres (HCL)
city: La Rochelle
country: France
facility: GH de la Rochelle Ré-Aunis
city: Le Kremlin-Bicetre
country: France
facility: CH Bicêtre (APHP)
city: Le Mans Cedex 9
country: France
facility: CH Le Mans
city: Limoges Cedex
country: France
facility: CHU Limoges
city: Lorient
country: France
facility: CL Mutualiste Porte de L'Orient
city: Marseille
country: France
facility: CH de la Conception (APHM)
city: Mont de Marsan
country: France
facility: CH Mont de Marsan
city: Montpellier
country: France
facility: CL Beau Soleil
city: Montpellier
country: France
facility: CHU Montpellier
city: Mulhouse
country: France
facility: CH Mulhouse
city: Nimes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: GH Saint Joseph
city: Paris
country: France
facility: CH Tenon (APHP)
city: Pierre-Benite Cedex
country: France
facility: CH Lyon Sud (HCL)
city: Pointoise Cedex
country: France
facility: CH de Pontoise
city: Poitiers Cedex
country: France
facility: USLD de Lusignan
city: Pringy Cedex
country: France
facility: CH Annecy
city: Privas
country: France
facility: SIH Privas La Voulte
city: Reims
country: France
facility: Polyclinique Les Bleuets
city: Rennes Cedex
country: France
facility: CHU de Rennes
city: Rouen Cedex
country: France
facility: CHU de Rouen
city: Saint Cyr/Loire
country: France
facility: CL de L'Alliance Saint Cyr/Loire
city: Saint-Avold
country: France
facility: CH Saint-Avold
city: Saint-Etienne
country: France
facility: CL Mutualiste Chirurgicale
city: Saintes Cedex
country: France
facility: CH de Saintonge (Saintes)
city: Strasbourg
country: France
facility: Hôpital Civil / Nouvel Hôpital Civil
city: Suresnes
country: France
facility: CH Foch
city: Tarbes
country: France
facility: Clinique de l'Ormeau Pyrénées
city: Toulouse Cedex 9
country: France
facility: CHU Toulouse
city: Tours Cedex 09
country: France
facility: CHU Tours
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: