Toxin Retrospective Study (NDOTOX)

Centre d'Investigation Clinique et Technologique 805

Status: Completed

Conditions: Neurogenic Bladder

Treatments: Drug: detrusor infection of Botulinum toxin

Study type: Observational

Funder types: Other

Identifiers

NCT03042052

1637154

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 292 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• NDO due to MS, SCI or spina-bifida.
• follow-up ≥3 years from the first Botox® injection.
• Performing clean intermittent catheterization

Exclusion criteria

• bladder surgery

Trial design

292 participants in 1 patient group

Patients suffering from NDO managed with Botox

Description:

Doses used were 300 units Botox® from January 2001 to January 2011 and 200 units after 2011 Frequency depended on patient's symptoms Duration was an outcome of the study

Treatment:

Drug: detrusor infection of Botulinum toxin