Toxin Retrospective Study

Neurogenic Bladder Clinical Trial

— NDOTOX  

Official title:

Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042052
• Other study ID #: 1637154
• Status: Completed
• Phase: N/A
• First received: January 27, 2017
• Last updated: February 1, 2017
• Start date: January 1, 2014
• Est. completion date: June 1, 2016

Study information

• Verified date: February 2017
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: June 1, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic

Intervention

Drug:
• detrusor infection of Botulinum toxin
detrusor injection

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure ratio	Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.	3 years of follow up
Primary	Failure ratio	Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.	5 years of follow up
Primary	Failure ratio	Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.	Seven years of follow up
Primary	withdrawal ratio	Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.	3 years of follow up
Primary	withdrawal ratio	Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.	5 years of follow up
Primary	Withdrawal ratio	Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.	7 years of follow up
Secondary	Risk factors for failures based on and clinical, radiological and urodynamic parameters	univariate analysis and multivariate analysis using Cox model	3 years
Secondary	Risk factors for failures based on and clinical, radiological and urodynamic parameters	univariate analysis and multivariate analysis using Cox model	5 years
Secondary	Risk factors for failures based on and clinical, radiological and urodynamic parameters	univariate analysis and multivariate analysis using Cox model	7 years