Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Toxin Retrospective Study (NDOTOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 27, 2017
First Posted Date February 3, 2017
Last Update Posted Date February 3, 2017
Actual Study Start Date January 1, 2014
Actual Primary Completion Date May 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 1, 2017)
  • Risk factors for failures based on and clinical, radiological and urodynamic parameters [ Time Frame: 3 years ]
    univariate analysis and multivariate analysis using Cox model
  • Risk factors for failures based on and clinical, radiological and urodynamic parameters [ Time Frame: 5 years ]
    univariate analysis and multivariate analysis using Cox model
  • Risk factors for failures based on and clinical, radiological and urodynamic parameters [ Time Frame: 7 years ]
    univariate analysis and multivariate analysis using Cox model
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Toxin Retrospective Study
Official Title Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity
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 .

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Neurogenic Bladder
Intervention Drug: detrusor infection of Botulinum toxin
detrusor injection
Study Groups/Cohorts 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

Intervention: Drug: detrusor infection of Botulinum toxin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 1, 2017)
292
Original Actual Enrollment Same as current
Actual Study Completion Date June 1, 2016
Actual Primary Completion Date May 1, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03042052
Other Study ID Numbers 1637154
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre d'Investigation Clinique et Technologique 805
Study Sponsor Centre d'Investigation Clinique et Technologique 805
Collaborators Not Provided
Investigators
Study Chair: EVEN Alexia, MD HOPITAL RAYMOND POINCARE
PRS Account Centre d'Investigation Clinique et Technologique 805
Verification Date February 2017