Toxin Retrospective Study (NDOTOX)

Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity

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.

Study Overview

• Status: Completed
• Conditions: Neurogenic Bladder
• Intervention / Treatment: Drug: detrusor infection of Botulinum toxin

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 Type: Observational
• Enrollment (Actual): 292

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Hôpital Raymond Poincaré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients suffering from NDO managed with Botox; 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	Drug: detrusor infection of Botulinum toxin; detrusor injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for failures based on and clinical, radiological and urodynamic parameters	univariate analysis and multivariate analysis using Cox model	3 years
Risk factors for failures based on and clinical, radiological and urodynamic parameters	univariate analysis and multivariate analysis using Cox model	5 years
Risk factors for failures based on and clinical, radiological and urodynamic parameters	univariate analysis and multivariate analysis using Cox model	7 years

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Investigators: Study Chair: EVEN Alexia, MD, Hôpital Raymond Poincaré

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urinary Bladder, Neurogenic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 1637154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No