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Toxin Retrospective Study (NDOTOX)

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ClinicalTrials.gov Identifier: NCT03042052
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Study Description
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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.

Condition or disease Intervention/treatment
Neurogenic Bladder 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 Design
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Study Type : Observational
Actual Enrollment : 292 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : June 1, 2016
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. failure ratio [ Time Frame: 3 years of follow up ]
    Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.

  2. Failure ratio [ Time Frame: 5 years of follow up ]
    Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.

  3. Failure ratio [ Time Frame: Seven years of follow up ]
    Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.

  4. withdrawal ratio [ Time Frame: 3 years of follow up ]
    Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.

  5. withdrawal ratio [ Time Frame: 5 years of follow up ]
    Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.

  6. Withdrawal ratio [ Time Frame: 7 years of follow up ]
    Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.


Secondary Outcome Measures :
  1. Risk factors for failures based on and clinical, radiological and urodynamic parameters [ Time Frame: 3 years ]
    univariate analysis and multivariate analysis using Cox model

  2. Risk factors for failures based on and clinical, radiological and urodynamic parameters [ Time Frame: 5 years ]
    univariate analysis and multivariate analysis using Cox model

  3. Risk factors for failures based on and clinical, radiological and urodynamic parameters [ Time Frame: 7 years ]
    univariate analysis and multivariate analysis using Cox model


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042052


Locations
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France
Hopital Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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Study Chair: EVEN Alexia, MD HOPITAL RAYMOND POINCARE
More Information
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Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03042052     History of Changes
Other Study ID Numbers: 1637154
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Botulinum Toxins
 Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs