MedPath

Observational Study of Botulinum Toxin Type A in Patients With Urinary Incontinence Associated With Overactive Bladder

Completed
Conditions
Urinary Bladder, Overactive
Urinary Bladder, Neurogenic
Interventions
Biological: botulinum toxin Type A
Registration Number
NCT02673047
Lead Sponsor
Allergan
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
474
Inclusion Criteria

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

Exclusion Criteria

-Patients not residing in France.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Botox®botulinum toxin Type APatients 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.
Primary Outcome Measures
NameTimeMethod
Target Patients Prescribed Botox® in Clinical PracticeDay 1
Secondary Outcome Measures
NameTimeMethod
Number of Adverse Events during the VisitDay 1
Total Number of Botox® Cycles in Non-naive Patients (previously received Botox®)Day 1
Length of Botox® Treatment in Non-naive PatientsDay 1
Time Since Last Botox® Injection in Non-naive PatientsDay 1
Characteristics of Injector Sites (Locations)Day 1
Treatments Previously PrescribedDay 1
Number of Sites InjectedDay 1
Total Dose of Botox® UsedDay 1
Types of Anaesthesia and Antibiotic Prophylaxis UsedDay 1
Cytobacteriological Examination of the UrineDay 1
Characteristics of Injector PhysiciansDay 1
Characteristics of PatientsDay 1
Number of Patients by Pathology HistoryDay 1
Number of Patients by Medical and Surgical HistoryDay 1
Reduction of Number of Daily Urinary Incontinence Episodes in Non-naive PatientsDay 1
Percentage of Continent Patients in Non-naive PatientsDay 1

Trial Locations

Locations (50)

CH Bagnols Sur Ceze

🇫🇷

Bagnols-Sur-Ceze, France

CL Toulouse Lautrec

🇫🇷

Albi, France

CH Angouleme

🇫🇷

Angouleme Cedex 9, France

CH Avranches Granville

🇫🇷

Avranches, France

CHU Besancon

🇫🇷

Besancon Cedex, France

CHU Mondor (APHP)

🇫🇷

Creteil, France

CHU Clermont Ferrand

🇫🇷

Clermont-Ferrand, France

CH Colmar

🇫🇷

Colmar Cedex, France

CHU Dijon

🇫🇷

Dijon Cedex, France

CH Raymond Poincare (APHP)

🇫🇷

Garches, France

CHI E.Durkheim Plateau de La Justice

🇫🇷

Epinal Cedex, France

GH de la Rochelle Ré-Aunis

🇫🇷

La Rochelle, France

CH de la Conception (APHM)

🇫🇷

Marseille, France

CH Mont de Marsan

🇫🇷

Mont de Marsan, France

CH Mulhouse

🇫🇷

Mulhouse, France

CHU Montpellier

🇫🇷

Montpellier, France

CL Beau Soleil

🇫🇷

Montpellier, France

CH Lyon Sud (HCL)

🇫🇷

Pierre-Benite Cedex, France

CH Tenon (APHP)

🇫🇷

Paris, France

CH de Pontoise

🇫🇷

Pointoise Cedex, France

SIH Privas La Voulte

🇫🇷

Privas, France

USLD de Lusignan

🇫🇷

Poitiers Cedex, France

CH Annecy

🇫🇷

Pringy Cedex, France

Polyclinique Les Bleuets

🇫🇷

Reims, France

CHU de Rennes

🇫🇷

Rennes Cedex, France

CHU de Rouen

🇫🇷

Rouen Cedex, France

CH Saint-Avold

🇫🇷

Saint-Avold, France

CH de Saintonge (Saintes)

🇫🇷

Saintes Cedex, France

Clinique de l'Ormeau Pyrénées

🇫🇷

Tarbes, France

CHU Toulouse

🇫🇷

Toulouse Cedex 9, France

Hôpital Civil / Nouvel Hôpital Civil

🇫🇷

Strasbourg, France

CH Foch

🇫🇷

Suresnes, France

CHU Tours

🇫🇷

Tours Cedex 09, France

CL Saint Augustin

🇫🇷

Bordeaux, France

CH Hopale Ctre Calot/Helio

🇫🇷

Cucq, France

CHU Limoges

🇫🇷

Limoges Cedex, France

CL Mutualiste Porte de L'Orient

🇫🇷

Lorient, France

Site D'Aix En Provence

🇫🇷

AIX en Provence, France

CHU Angers

🇫🇷

Angers Cedex 01, France

CH Bicêtre (APHP)

🇫🇷

Le Kremlin-Bicetre, France

CH Châlons-en-Champagne

🇫🇷

Chalons-En-Champagne, France

CH Belfort

🇫🇷

Belfort Cedex, France

CHU Bordeaux

🇫🇷

Bordeaux Cedex, France

CH de Cahors

🇫🇷

Cahors, France

CH Le Mans

🇫🇷

Le Mans Cedex 9, France

CH Renee Sabran Hyeres (HCL)

🇫🇷

Giens-Hyeres, France

GH Saint Joseph

🇫🇷

Paris, France

CHU Nimes

🇫🇷

Nimes, France

CL de L'Alliance Saint Cyr/Loire

🇫🇷

Saint Cyr/Loire, France

CL Mutualiste Chirurgicale

🇫🇷

Saint-Etienne, France

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