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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive; Urinary Bladder, Neurogenic
• Intervention / Treatment: Biological: botulinum toxin Type A

• Study Type: Observational
• Enrollment (Actual): 474

Contacts and Locations

Study Locations

• France
  • AIX en Provence, France, 13616
    • Site D'Aix En Provence
  • Albi, France, 81000
    • CL Toulouse Lautrec
  • Angers Cedex 01, France, 49033
    • CHU Angers
  • Angouleme Cedex 9, France, 16959
    • CH Angoulême
  • Avranches, France, 50300
    • CH Avranches Granville
  • Bagnols-Sur-Ceze, France, 30200
    • CH Bagnols sur Ceze
  • Belfort Cedex, France, 90016
    • CH Belfort
  • Besancon Cedex, France, 25030
    • CHU Besancon
  • Bordeaux, France, 33000
    • CL Saint Augustin
  • Bordeaux Cedex, France, 33076
    • CHU Bordeaux
  • Cahors, France, 46000
    • CH de Cahors
  • Chalons-En-Champagne, France, 51000
    • CH Châlons-en-Champagne
  • Clermont-Ferrand, France, 63003
    • CHU Clermont Ferrand
  • Colmar Cedex, France, 68024
    • CH Colmar
  • Creteil, France, 94010
    • CHU Mondor (APHP)
  • Cucq, France, 62780
    • CH Hopale Ctre Calot/Helio
  • Dijon Cedex, France, 21079
    • CHU Dijon
  • Epinal Cedex, France, 88021
    • CHI E.Durkheim Plateau de La Justice
  • Garches, France, 92380
    • CH Raymond Poincare (APHP)
  • Giens-Hyeres, France, 83406
    • CH Renee Sabran Hyeres (HCL)
  • La Rochelle, France, 17000
    • GH de la Rochelle Ré-Aunis
  • Le Kremlin-Bicetre, France, 94270
    • CH Bicêtre (APHP)
  • Le Mans Cedex 9, France, 72037
    • CH Le Mans
  • Limoges Cedex, France, 87042
    • CHU Limoges
  • Lorient, France, 56100
    • CL Mutualiste Porte de L'Orient
  • Marseille, France, 13005
    • CH de la Conception (APHM)
  • Mont de Marsan, France, 40000
    • CH Mont de Marsan
  • Montpellier, France, 34070
    • CL Beau Soleil
  • Montpellier, France, 34090
    • CHU Montpellier
  • Mulhouse, France, 68100
    • CH Mulhouse
  • Nimes, France, 30029
    • CHU Nîmes
  • Paris, France, 75014
    • GH Saint Joseph
  • Paris, France, 75020
    • CH Tenon (APHP)
  • Pierre-Benite Cedex, France, 69495
    • CH Lyon Sud (HCL)
  • Pointoise Cedex, France, 95301
    • CH de Pontoise
  • Poitiers Cedex, France, 86021
    • USLD de Lusignan
  • Pringy Cedex, France, 74374
    • CH Annecy
  • Privas, France, 07007
    • SIH Privas La Voulte
  • Reims, France, 51100
    • Polyclinique Les Bleuets
  • Rennes Cedex, France, 35033
    • CHU de Rennes
  • Rouen Cedex, France, 76031
    • CHU de Rouen
  • Saint Cyr/Loire, France, 37540
    • CL de L'Alliance Saint Cyr/Loire
  • Saint-Avold, France, 57500
    • CH Saint-Avold
  • Saint-Etienne, France, 42100
    • CL Mutualiste Chirurgicale
  • Saintes Cedex, France, 17108
    • CH de Saintonge (Saintes)
  • Strasbourg, France, 67000
    • Hopital Civil / Nouvel Hopital Civil
  • Suresnes, France, 92150
    • CH Foch
  • Tarbes, France, 65000
    • Clinique de l'Ormeau Pyrénées
  • Toulouse Cedex 9, France, 31059
    • CHU Toulouse
  • Tours Cedex 09, France, 37044
    • CHU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients treated with Botox® for urinary incontinence associated with NDO or IOAB in clinical practice.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Patients not residing in France.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: botulinum toxin Type A; Botulinum toxin Type A (Botox®) injection as prescribed as standard of care in clinical practice.; Other Names: Botox®; onabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target Patients Prescribed Botox® in Clinical Practice	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Total Number of Botox® Cycles in Non-naive Patients (previously received Botox®)	Day 1
Length of Botox® Treatment in Non-naive Patients	Day 1
Time Since Last Botox® Injection in Non-naive Patients	Day 1
Characteristics of Injector Sites (Locations)	Day 1
Characteristics of Injector Physicians	Day 1
Characteristics of Patients	Day 1
Number of Patients by Pathology History	Day 1
Number of Patients by Medical and Surgical History	Day 1
Reduction of Number of Daily Urinary Incontinence Episodes in Non-naive Patients	Day 1
Percentage of Continent Patients in Non-naive Patients	Day 1
Number of Adverse Events during the Visit	Day 1

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Urinary Bladder, Overactive; Urinary Bladder, Neurogenic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: MAF/AGN/NS/OAB/006