Viewing Study NCT03042052



Ignite Creation Date: 2024-05-06 @ 9:41 AM
Last Modification Date: 2024-10-26 @ 12:18 PM
Study NCT ID: NCT03042052
Status: COMPLETED
Last Update Posted: 2017-02-03
First Post: 2017-01-27

Brief Title: Toxin Retrospective Study
Sponsor: Centre dInvestigation Clinique et Technologique 805
Organization: Centre dInvestigation Clinique et Technologique 805

Study Overview

Official Title: Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity
Status: COMPLETED
Status Verified Date: 2017-02
Last Known Status: None
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: NDOTOX
Brief Summary: Aims of this study were to assess the long-term outcomes of detrusor injection of OnabotulinumtoxinA Botox injection associated with clean intermittent-catheterization CIC for the treatment of neurogenic detrusor overactivity NDO and to identify risk factors for failure
Detailed Description: Neurogenic detrusor overactivity NDO remains a major concern for patients with neurological diseases Fifty to eighty percent of patients with multiple sclerosis MS or traumatic spinal cord injury SCI and more than 60 of patients with myelomeningocele suffer from urinary incontinence episodes UI due to NDO NDO is characterized by involuntary detrusor contractions during the filling phase leading to leakage and increase in bladder pressure which can precipitate renal failure Detrusor injection of OnabotulinumtoxinA Botox is licensed worldwide and recommended as a second line therapy for the treatment of urinary incontinence due to NDO after failure of anticholinergic drugs Grade A

These recommendations are based on the results of international multicentric randomized controlled trials

These studies established not only clinical benefits with a significant decrease of urinary incontinence episodes but also urodynamic benefits

There are very few data about the real prevalence of failure of Botox in the long term

Thus aims of this study were to assess the long-term outcomes of detrusor injections of Botox associated with clean intermittent-catheterization CIC for the treatment of NDO and to identify risk factors for failure

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None