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

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ClinicalTrials.gov Identifier: NCT02072928
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment
Urinary Incontinence Biological: botulinum toxin Type A

Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Other
Actual Study Start Date : January 28, 2014
Actual Primary Completion Date : September 30, 2015
Actual Study Completion Date : September 30, 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Biological: botulinum toxin Type A
botulinum toxin Type A (BOTOX®) prescribed as standard of care in clinical practice.
Other Names:
  • onabotulinumtoxinA
  • BOTOX®




Primary Outcome Measures :
  1. Change From Baseline in Anticholinergic Drug Use [ Time Frame: Baseline, 9 Months ]
    Anticholinergic drug use was collected the 9 months before the baseline Botox® treatment and the 9 months following the baseline Botox® treatment. Total anticholinergic drug use in the 9 months following the baseline Botox® treatment is noted.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with incontinence from NDO due to spinal injury or MS treated as per standard of care in clinical practice.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072928


Locations
Belgium
UZA
Edegem, Belgium, 2650
CHU de Liège
Esneux, Belgium, 4130
UZ Gent
Ghent, Belgium, 9000
Centre Hospitalier Regional de Huy
HUY, Belgium, 4500
UZ Leuven
Leuven, Belgium, 3000
Maria Ziekenhuis Noord-Limburg
Overpelt, Belgium, 3900
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02072928     History of Changes
Other Study ID Numbers: MAF/AGN/NS/OAB/005
First Posted: February 27, 2014    Key Record Dates
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents