Toxin Retrospective Study (NDOTOX)

• ClinicalTrials.gov Identifier: NCT03042052
• Recruitment Status: Completed
• First Posted: February 3, 2017
• Last Update Posted: February 3, 2017
• Sponsor: Centre d'Investigation Clinique et Technologique 805
• 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

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

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