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Urinary Bladder, OveractiveBOREALNCT02673047

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

An observational study of Urinary Bladder, Overactive and Urinary Bladder, Neurogenic, run by Allergan at 50 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
botulinum toxin Type A
Type of treatment
Injection or infusion
How many people
474 participants
Where
50 sitesFrance
Study dates
Feb 2016to Aug 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • -Patients not residing in France.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

France50 sites

  • Site D'Aix En Provence

    Aix-en-Provence, 13616

  • CL Toulouse Lautrec

    Albi, 81000

  • CHU Angers

    Angers, 49033

  • CH Angouleme

    Angoulême, 16959

  • CH Avranches Granville

    Avranches, 50300

  • CH Bagnols Sur Ceze

    Bagnols-sur-Cèze, 30200

  • CH Belfort

    Belfort, 90016

  • CHU Besancon

    Besançon, 25030

  • CL Saint Augustin

    Bordeaux, 33000

  • CHU Bordeaux

    Bordeaux, 33076

  • CH de Cahors

    Cahors, 46000

  • CH Châlons-en-Champagne

    Châlons-en-Champagne, 51000

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003

  • CH Colmar

    Colmar, 68024

  • CHU Mondor (APHP)

    Créteil, 94010

  • CH Hopale Ctre Calot/Helio

    Cucq, 62780

  • CHU Dijon

    Dijon, 21079

  • CHI E.Durkheim Plateau de La Justice

    Épinal, 88021

  • CH Raymond Poincare (APHP)

    Garches, 92380

  • CH Renee Sabran Hyeres (HCL)

    Giens-Hyeres, 83406

  • GH de la Rochelle Ré-Aunis

    La Rochelle, 17000

  • CH Bicêtre (APHP)

    Le Kremlin-Bicêtre, 94270

  • CH Le Mans

    Le Mans, 72037

  • CHU Limoges

    Limoges, 87042

  • CL Mutualiste Porte de L'Orient

    Lorient, 56100

  • CH de la Conception (APHM)

    Marseille, 13005

  • CH Mont de Marsan

    Mont-de-Marsan, 40000

  • CL Beau Soleil

    Montpellier, 34070

  • CHU Montpellier

    Montpellier, 34090

  • CH Mulhouse

    Mulhouse, 68100

  • CHU Nimes

    Nîmes, 30029

  • GH Saint Joseph

    Paris, 75014

  • CH Tenon (APHP)

    Paris, 75020

  • CH Lyon Sud (HCL)

    Pierre-Bénite, 69495

  • CH de Pontoise

    Pointoise Cedex, 95301

  • USLD de Lusignan

    Poitiers, 86021

  • CH Annecy

    Pringy, 74374

  • SIH Privas La Voulte

    Privas, 07007

  • Polyclinique Les Bleuets

    Reims, 51100

  • CHU de Rennes

    Rennes, 35033

  • CHU de Rouen

    Rouen, 76031

  • CL de L'Alliance Saint Cyr/Loire

    Saint Cyr/Loire, 37540

  • CH Saint-Avold

    Saint-Avold, 57500

  • CL Mutualiste Chirurgicale

    Saint-Etienne, 42100

  • CH de Saintonge (Saintes)

    Saintes, 17108

  • Hôpital Civil / Nouvel Hôpital Civil

    Strasbourg, 67000

  • CH Foch

    Suresnes, 92150

  • Clinique de l'Ormeau Pyrénées

    Tarbes, 65000

  • CHU Toulouse

    Toulouse, 31059

  • CHU Tours

    Tours, 37044

Other trials in France

About this study

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.

Medical subject headings
Urinary Bladder, Overactive, Urinary Bladder, Neurogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • botulinum toxin Type ABiological

    Also called Botox®, onabotulinumtoxinA

    Botulinum toxin Type A (Botox®) injection as prescribed as standard of care in clinical practice.

Study groups in NCT02673047
Study groupRoleWhat they receive
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.
Receives: Biological: botulinum toxin Type A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Patients Prescribed Botox® in Clinical Practice

    Measured: Day 1

Secondary outcomes (16)

  1. Treatments Previously Prescribed

    Measured: Day 1

  2. Number of Sites Injected

    Measured: Day 1

  3. Total Dose of Botox® Used

    Measured: Day 1

  4. Types of Anaesthesia and Antibiotic Prophylaxis Used

    Measured: Day 1

  5. Cytobacteriological Examination of the Urine

    Measured: Day 1

  6. Total Number of Botox® Cycles in Non-naive Patients (previously received Botox®)

    Measured: Day 1

  7. Length of Botox® Treatment in Non-naive Patients

    Measured: Day 1

  8. Time Since Last Botox® Injection in Non-naive Patients

    Measured: Day 1

  9. Characteristics of Injector Sites (Locations)

    Measured: Day 1

  10. Characteristics of Injector Physicians

    Measured: Day 1

  11. Characteristics of Patients

    Measured: Day 1

  12. Number of Patients by Pathology History

    Measured: Day 1

  13. Number of Patients by Medical and Surgical History

    Measured: Day 1

  14. Reduction of Number of Daily Urinary Incontinence Episodes in Non-naive Patients

    Measured: Day 1

  15. Percentage of Continent Patients in Non-naive Patients

    Measured: Day 1

  16. Number of Adverse Events during the Visit

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
474 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02673047
Sponsor's protocol ID
MAF/AGN/NS/OAB/006
Acronym
BOREAL
Status last verified
Oct 2016
First submitted
1 Feb 2016
Last updated
24 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Bladder, Overactive and Urinary Bladder, Neurogenic, run by Allergan at 50 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Patients Prescribed Botox® in Clinical Practice (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02673047.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.

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