BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 8 to 17 Years of Age

Allergan Limited0 sites114 target enrollmentJune 6, 2013

Overview

No summary available.

Registry

who.int

Start Date

June 6, 2013

End Date

October 11, 2018

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. written informed consent has been obtained from the legally authorized representative and written minor assent has been obtained, in accordance with local laws and institutional review board (IRB)/independent ethics committee (IEC) requirements.
•2\. written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information (US sites) and written Data Protection consent (European sites).
•3\. male or female, aged \= 8 years to \= 17 years of age at the time of informed consent.
•4\. patient has NDO based on either:
•\- presence of an IDC during the urodynamic assessment performed in the screening period or on day 1 (prior to randomization), or
•\- documented presence of an IDC from an historical urodynamic assessment within 12 months of screening
•5\. patient has NDO due to either:
•\- spinal dysraphism, which includes spina bifida and all forms of tethered cord (eg, myelomeningocele, meningocele), or
•\- acquired NDO from a spinal cord injury, with the injury having occurred at least 6 months prior to screening, or
•\- acquired NDO due to transverse myelitis with diagnosis at least 18 monthsprior to screening

•1\. patient has an uncontrolled systemic disease, previous or current diagnosis of malignancy.
•2\. patient has had surgery of the spinal cord within 6 months of screening.
•3\. patient has a history or evidence of any pelvic or urological abnormalities, except NDO, including:
•o bladder neck surgery resulting in an open bladder neck, or reconstructive surgery of the lower urinary tract (eg, urostomy, urinary diversion)
•o anatomical evidence of bladder outlet obstruction, urethral or urethral valve obstruction/stricture at screening
•o surgery of the urinary tract (including minimally invasive surgery) within 6 months of screening (except those listed above which are exclusionary for any time period).
•o circumcision within 1 month of screening
•4\. patient has cerebral palsy
•5\. patient has uncontrolled epilepsy, defined as:
•o more than 1 generalized seizure per month within 3 months prior to screening, or history of prolonged seizures or repetitive seizure activity requiring administration of a rescue benzodiazepine (oral, rectal, etc) more than once a month, seizures lasting more than 10 minutes, status epilepticus, or epilepsy with autonomic involvement within 9 months