Clinical trial NCT03042052: Toxin Retrospective Study
Official title: Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Bladder
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from neurogenic detrusor overactivity managed by detrusor injections of Botulinum toxin A and performing clean intermittent catheterization

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 .

Eligibility criteria: 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

Primary outcomes:
measure: failure ratio
timeFrame: 3 years of follow up
measure: Failure ratio
timeFrame: 5 years of follow up
measure: Failure ratio
timeFrame: Seven years of follow up
measure: withdrawal ratio
timeFrame: 3 years of follow up
measure: withdrawal ratio
timeFrame: 5 years of follow up
measure: Withdrawal ratio
timeFrame: 7 years of follow up
Secondary outcomes:
measure: Risk factors for failures based on and clinical, radiological and urodynamic parameters
timeFrame: 3 years
measure: Risk factors for failures based on and clinical, radiological and urodynamic parameters
timeFrame: 5 years
measure: Risk factors for failures based on and clinical, radiological and urodynamic parameters
timeFrame: 7 years
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
affiliation: HOPITAL RAYMOND POINCARE
name: EVEN Alexia, MD
role: STUDY_CHAIR
References: