A Long-Term Extension Study of OnabotulinumtoxinA for Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Status:	Recruiting
Conditions:	Overactive Bladder, Urology
Therapuetic Areas:	Gastroenterology, Nephrology / Urology
Healthy:	No
Age Range:	5 - 19
Updated:	9/8/2018
Start Date:	January 6, 2014
End Date:	January 31, 2021
Contact:	Clinical Trials Registry Team
Email:	IR-CTRegistration@allergan.com
Phone:	1-800-347-4500

Long-term Extension Study of BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age

This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA for the
treatment of urinary incontinence due to neurogenic detrusor overactivity in patients who
successfully completed Study 191622-120.

Inclusion Criteria:

- Successfully completed participation in Study 191622-120

- Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120

- Regularly using clean intermittent catheterization to empty the bladder

Exclusion Criteria:

- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

- Current or planned use of a baclofen pump

- Current or planned use of an electrostimulation/neuromodulation device for urinary
incontinence

- Use of an indwelling catheter for urinary incontinence instead of using clean
intermittent catheterization to empty the bladder

- Previous or current use of botulinum toxin therapy of any serotype for any urological
condition, or treatment with botulinum toxin of any serotype for any other condition
since entering study 191622-120

We found this trial at

sites

Cedars-Sinai Medical Center

8700 Beverly Blvd # 8211
Los Angeles, California 90048

(1-800-233-2771)