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

Allergan6 sites in 1 country55 target enrollmentJanuary 28, 2014

ConditionsUrinary Incontinence

Overview

Phase: N/A
Intervention: Not specified
Conditions: Urinary Incontinence
Sponsor: Allergan
Enrollment: 55
Locations: 6
Primary Endpoint: Change From Baseline in Anticholinergic Drug Use
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 28, 2014

End Date

September 30, 2015

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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.