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Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium

NCT ID: NCT02072928

Last Updated: 2017-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-28

Study Completion Date

2015-09-30

Brief Summary

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This study will evaluate the impact of BOTOX® treatment on anticholinergic drug use in patients with urinary incontinence from Neurogenic Detrusor Overactivity (NDO) due to spinal injury or Multiple Sclerosis (MS) who are prescribed BOTOX® as standard of care in clinical practice.

Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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BOTOX®

Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.

botulinum toxin Type A

Intervention Type BIOLOGICAL

botulinum toxin Type A (BOTOX®) prescribed as standard of care in clinical practice.

Interventions

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botulinum toxin Type A

botulinum toxin Type A (BOTOX®) prescribed as standard of care in clinical practice.

Intervention Type BIOLOGICAL

Other Intervention Names

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onabotulinumtoxinA BOTOX®

Eligibility Criteria

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Inclusion Criteria

* Patients prescribed BOTOX® for urine incontinence from NDO due to spinal injury or MS as standard of care in clinical practice in Belgium
* Previous treatment with anticholinergic drugs ineffective
* Last BOTOX® treatment ≥18 months.

Exclusion Criteria

* Diagnosis of urinary incontinence less than 9 months.
* No anticholinergic drug use in the last 9 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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UZA

Edegem, , Belgium

Site Status

CHU de Liège

Esneux, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

Centre Hospitalier Regional de Huy

Huy, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Maria Ziekenhuis Noord-Limburg

Overpelt, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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MAF/AGN/NS/OAB/005

Identifier Type: -

Identifier Source: org_study_id