Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175123
Status:
UNKNOWN
Last Update Posted:
2009-02-20
First Post:
2005-09-09
Brief Title:
Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine how injection of botulinum toxin in the bladder affects bladder function The trial is carried out in children born with malformation of the spinal cord and subsequent overactive bladders The purpose of treating the bladder with different drugs is to prevent damage to the kidneys and renal function The aim of this study is to compare a conventionally used drug oxybutynin with botulinum toxin The hypothesis of the study is that botulinum toxin is equal to oxybutynin in the treatment of overactive bladder
Detailed Description:
Neurogenic bladder is often seen in children with myelomeningocele tumors in the spinal canal or a traumatized spinal cord The majority of the patients have high pressure bladders which can lead to reflux and frequent infections in the urinary tract Although children experience insufficient bladder emptying many of them also experience urinary incontinence and have to perform clean intermittent catheterization CIC If no intervention is made the children are at high risk of renal deterioration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Jnr20030155 | None | None | None |
| Jnr2612-2319 | None | None | None |