Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium
1 other identifier
observational
55
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2014
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2014
CompletedFirst Submitted
Initial submission to the registry
February 25, 2014
CompletedFirst Posted
Study publicly available on registry
February 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2015
CompletedResults Posted
Study results publicly available
December 15, 2017
CompletedDecember 15, 2017
May 1, 2017
1.7 years
February 25, 2014
March 14, 2017
May 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Anticholinergic Drug Use
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.
Baseline, 9 Months
Study Arms (1)
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.
Interventions
botulinum toxin Type A (BOTOX®) prescribed as standard of care in clinical practice.
Eligibility Criteria
Patients with incontinence from NDO due to spinal injury or MS treated as per standard of care in clinical practice.
You may qualify if:
- 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.
You may not qualify if:
- Diagnosis of urinary incontinence less than 9 months.
- No anticholinergic drug use in the last 9 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (6)
UZA
Edegem, 2650, Belgium
CHU de Liège
Esneux, 4130, Belgium
UZ Gent
Ghent, 9000, Belgium
Centre Hospitalier Regional de Huy
Huy, 4500, Belgium
UZ Leuven
Leuven, 3000, Belgium
Maria Ziekenhuis Noord-Limburg
Overpelt, 3900, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2014
First Posted
February 27, 2014
Study Start
January 28, 2014
Primary Completion
September 30, 2015
Study Completion
September 30, 2015
Last Updated
December 15, 2017
Results First Posted
December 15, 2017
Record last verified: 2017-05