<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03042052</url>
  </required_header>
  <id_info>
    <org_study_id>1637154</org_study_id>
    <nct_id>NCT03042052</nct_id>
  </id_info>
  <brief_title>Toxin Retrospective Study</brief_title>
  <acronym>NDOTOX</acronym>
  <official_title>Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aims of this study were to assess the long-term outcomes of detrusor injection of&#xD;
      OnabotulinumtoxinA (Botox® injection) associated with clean intermittent-catheterization&#xD;
      (CIC) for the treatment of neurogenic detrusor overactivity (NDO) and to identify risk&#xD;
      factors for failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neurogenic detrusor overactivity (NDO) remains a major concern for patients with neurological&#xD;
      diseases. Fifty to eighty percent of patients with multiple sclerosis (MS) or traumatic&#xD;
      spinal cord injury (SCI) and more than 60% of patients with myelomeningocele suffer from&#xD;
      urinary incontinence episodes (UI) due to NDO. NDO is characterized by involuntary detrusor&#xD;
      contractions during the filling phase, leading to leakage and increase in bladder pressure,&#xD;
      which can, precipitate renal failure. Detrusor injection of OnabotulinumtoxinA (Botox®), is&#xD;
      licensed worldwide and recommended as a second line therapy for the treatment of urinary&#xD;
      incontinence due to NDO after failure of anticholinergic drugs (Grade A).&#xD;
&#xD;
      These recommendations are based on the results of international multicentric, randomized&#xD;
      controlled trials.&#xD;
&#xD;
      These studies established not only clinical benefits, with a significant decrease of urinary&#xD;
      incontinence episodes, but also urodynamic benefits.&#xD;
&#xD;
      There are very few data about the real prevalence of failure of Botox® in the long term.&#xD;
&#xD;
      Thus, aims of this study were to assess the long-term outcomes of detrusor injections of&#xD;
      Botox® associated with clean intermittent-catheterization (CIC) for the treatment of NDO and&#xD;
      to identify risk factors for failure .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">June 1, 2016</completion_date>
  <primary_completion_date type="Actual">May 1, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>failure ratio</measure>
    <time_frame>3 years of follow up</time_frame>
    <description>Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Failure ratio</measure>
    <time_frame>5 years of follow up</time_frame>
    <description>Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Failure ratio</measure>
    <time_frame>Seven years of follow up</time_frame>
    <description>Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>withdrawal ratio</measure>
    <time_frame>3 years of follow up</time_frame>
    <description>Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>withdrawal ratio</measure>
    <time_frame>5 years of follow up</time_frame>
    <description>Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Withdrawal ratio</measure>
    <time_frame>7 years of follow up</time_frame>
    <description>Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors for failures based on and clinical, radiological and urodynamic parameters</measure>
    <time_frame>3 years</time_frame>
    <description>univariate analysis and multivariate analysis using Cox model</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factors for failures based on and clinical, radiological and urodynamic parameters</measure>
    <time_frame>5 years</time_frame>
    <description>univariate analysis and multivariate analysis using Cox model</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factors for failures based on and clinical, radiological and urodynamic parameters</measure>
    <time_frame>7 years</time_frame>
    <description>univariate analysis and multivariate analysis using Cox model</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">292</enrollment>
  <condition>Neurogenic Bladder</condition>
  <arm_group>
    <arm_group_label>Patients suffering from NDO managed with Botox</arm_group_label>
    <description>Doses used were 300 units Botox® from January 2001 to January 2011 and 200 units after 2011&#xD;
Frequency depended on patient's symptoms&#xD;
Duration was an outcome of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>detrusor infection of Botulinum toxin</intervention_name>
    <description>detrusor injection</description>
    <arm_group_label>Patients suffering from NDO managed with Botox</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from neurogenic detrusor overactivity managed by detrusor injections of&#xD;
        Botulinum toxin A and performing clean intermittent catheterization&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NDO due to MS, SCI or spina-bifida.&#xD;
&#xD;
          -  follow-up ≥3 years from the first Botox® injection.&#xD;
&#xD;
          -  Performing clean intermittent catheterization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bladder surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>EVEN Alexia, MD</last_name>
    <role>Study Chair</role>
    <affiliation>HOPITAL RAYMOND POINCARE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Raymond Poincare</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Neurogenic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03042052
org study id: 1637154
nct id: NCT03042052
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
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 .
observational model: Cohort
time perspective: Retrospective
measure: failure ratio
time frame: 3 years of follow up
description: Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
measure: Failure ratio
time frame: 5 years of follow up
description: Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
measure: Failure ratio
time frame: Seven years of follow up
description: Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
measure: withdrawal ratio
time frame: 3 years of follow up
description: Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
measure: withdrawal ratio
time frame: 5 years of follow up
description: Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
measure: Withdrawal ratio
time frame: 7 years of follow up
description: Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
measure: Risk factors for failures based on and clinical, radiological and urodynamic parameters
time frame: 3 years
description: univariate analysis and multivariate analysis using Cox model
measure: Risk factors for failures based on and clinical, radiological and urodynamic parameters
time frame: 5 years
description: univariate analysis and multivariate analysis using Cox model
measure: Risk factors for failures based on and clinical, radiological and urodynamic parameters
time frame: 7 years
description: univariate analysis and multivariate analysis using Cox model
arm group label: Patients suffering from NDO managed with Botox
description: 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 type: Drug
intervention name: detrusor infection of Botulinum toxin
description: detrusor injection
arm group label: Patients suffering from NDO managed with Botox
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: EVEN Alexia, MD
role: Study Chair
affiliation: HOPITAL RAYMOND POINCARE
facility: 
country: France
responsible party type: Sponsor
mesh term: Urinary Bladder, Neurogenic
mesh term: Botulinum Toxins
sharing ipd: No