NCT03042052

Toxin Retrospective Study

Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 292 (actual)
• Sponsor: Centre d'Investigation Clinique et Technologique 805 · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Neurogenic Bladder

Interventions

Type	Name	Description
DRUG	detrusor infection of Botulinum toxin	detrusor injection

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2017-02-03
• Last updated: 2017-02-03

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study