<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/NCT04483570</url>
  </required_header>
  <id_info>
    <org_study_id>H-1809-029-969</org_study_id>
    <nct_id>NCT04483570</nct_id>
  </id_info>
  <brief_title>Urological Deterioration in Secondary Tethered Cord Syndrome and Clue to Detect It</brief_title>
  <official_title>Urological Deterioration in Secondary Tethered Cord Syndrome and Clue to Detect It</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Secondary tethered cord syndrome (STCS) has been diagnosed with signs of progressive&#xD;
      deterioration in urological or neuroorthopedic systems following primary tethering surgery.&#xD;
      However, there is no convincing urological diagnostic clue for STCS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tethered cord syndrome (TCS) refers to various problems involving neurologic, orthopedic, and&#xD;
      urologic systems, seen as a result of chronic traction of the spinal cord in patients with&#xD;
      spinal dysraphism. Evidence for neural injury is often assumed irreversible, so untethering&#xD;
      is justified to maintain neural function and prevent further neural damage. Unfortunately,&#xD;
      some patients experienced an aggravation of symptoms following untethering. The probable&#xD;
      causes are assumed to be the neural injury before or during operation, which was revealed&#xD;
      along with dysplastic neural function, neural compression by increasing syrinx and secondary&#xD;
      tethered cord syndrome (STCS) in which postoperative neural adhesion or syrinx limit motion&#xD;
      of spinal and elicit ischemic changes as the spine grows during puberty. The Secondary&#xD;
      Tethered Cord Syndrome is reported as 19% of cases and causes significant progressive&#xD;
      morbidities in those who affected.&#xD;
&#xD;
      Unfortunately, the detection of STCS is not as simple as it thought. Although magnetic&#xD;
      resonance imaging (MRI) often reveals that the cord seems to get straightened, this does not&#xD;
      necessarily mean that is a significant tethering or cord associated with progressive nerve&#xD;
      damage. The variable course of progression and involvement of multiple systems such as lower&#xD;
      extremity, bladder, bowel, and back would not allow a single specialist to draw conclusions&#xD;
      about the presence of secondary tethered cord syndrome. Moreover, the untethering procedure&#xD;
      of STCS may not always be safe and effective. Given the fact that a significant number of 'no&#xD;
      improvement' or new onset complications following redo-untethering, the surgery could not be&#xD;
      attempted without clear evidence. This explains the reason there is only a limited number of&#xD;
      relevant studies so far.&#xD;
&#xD;
      In this study, it aims to delinate the genuine features of secondary tethered cord syndrome&#xD;
      by selecting and analyzing only cases with symptom improvements. Furthermore, it described&#xD;
      their natural history and time course of urological deterioration and characterized by the&#xD;
      urodynamic changes before and after the redo-untethering.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2011</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</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>Pre-operative evaluation: Dysfunctional voiding</measure>
    <time_frame>Baseline</time_frame>
    <description>Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre-operative evaluation: Presence of Urinary Tract Infection (UTI)</measure>
    <time_frame>Baseline</time_frame>
    <description>Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VUD (Video Urodynamic Studies)</measure>
    <time_frame>Baseline</time_frame>
    <description>Measuring maximal cystometric capacity, compliance, estimated bladder capacity before the operation of the secondary tethered cord syndrome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VUD (Video Urodynamic Studies)</measure>
    <time_frame>1 year after the operation</time_frame>
    <description>Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VUD (Video Urodynamic Studies)</measure>
    <time_frame>2 years after the operation</time_frame>
    <description>Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">54</enrollment>
  <condition>Neurogenic Bladder</condition>
  <condition>Tethered Spinal Cord Syndrome</condition>
  <arm_group>
    <arm_group_label>Secondary Tethered Cord Syndrome</arm_group_label>
    <description>Children with signs of progressive deterioration in urological or neuroorthopedic system, and suspected Secondary Tethered Cord Syndrome (STCS) following primary untethering surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Redo-tethering operation</intervention_name>
    <arm_group_label>Secondary Tethered Cord Syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with signs of progressive deterioration in urological or neuroorthopedic system,&#xD;
        and suspected Secondary Tethered Cord Syndrome (STCS) following primary untethering&#xD;
        surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Children with signs of progressive deterioration in urological or neuroorthopedic system&#xD;
        following primary untethering surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Children without signs of progressive in urological or neuroorthopedic system following&#xD;
        primary untethering surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kwanjin Park, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Kwanjin Park</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Neurogenic</mesh_term>
    <mesh_term>Neural Tube Defects</mesh_term>
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not plan to share IPD</ipd_description>
  </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/NCT04483570
org study id: H-1809-029-969
nct id: NCT04483570
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Secondary tethered cord syndrome (STCS) has been diagnosed with signs of progressive
      deterioration in urological or neuroorthopedic systems following primary tethering surgery.
      However, there is no convincing urological diagnostic clue for STCS.
Tethered cord syndrome (TCS) refers to various problems involving neurologic, orthopedic, and
      urologic systems, seen as a result of chronic traction of the spinal cord in patients with
      spinal dysraphism. Evidence for neural injury is often assumed irreversible, so untethering
      is justified to maintain neural function and prevent further neural damage. Unfortunately,
      some patients experienced an aggravation of symptoms following untethering. The probable
      causes are assumed to be the neural injury before or during operation, which was revealed
      along with dysplastic neural function, neural compression by increasing syrinx and secondary
      tethered cord syndrome (STCS) in which postoperative neural adhesion or syrinx limit motion
      of spinal and elicit ischemic changes as the spine grows during puberty. The Secondary
      Tethered Cord Syndrome is reported as 19% of cases and causes significant progressive
      morbidities in those who affected.

      Unfortunately, the detection of STCS is not as simple as it thought. Although magnetic
      resonance imaging (MRI) often reveals that the cord seems to get straightened, this does not
      necessarily mean that is a significant tethering or cord associated with progressive nerve
      damage. The variable course of progression and involvement of multiple systems such as lower
      extremity, bladder, bowel, and back would not allow a single specialist to draw conclusions
      about the presence of secondary tethered cord syndrome. Moreover, the untethering procedure
      of STCS may not always be safe and effective. Given the fact that a significant number of 'no
      improvement' or new onset complications following redo-untethering, the surgery could not be
      attempted without clear evidence. This explains the reason there is only a limited number of
      relevant studies so far.

      In this study, it aims to delinate the genuine features of secondary tethered cord syndrome
      by selecting and analyzing only cases with symptom improvements. Furthermore, it described
      their natural history and time course of urological deterioration and characterized by the
      urodynamic changes before and after the redo-untethering.
observational model: Cohort
time perspective: Retrospective
measure: Pre-operative evaluation: Dysfunctional voiding
time frame: Baseline
description: Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation.
measure: Pre-operative evaluation: Presence of Urinary Tract Infection (UTI)
time frame: Baseline
description: Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation
measure: VUD (Video Urodynamic Studies)
time frame: Baseline
description: Measuring maximal cystometric capacity, compliance, estimated bladder capacity before the operation of the secondary tethered cord syndrome.
measure: VUD (Video Urodynamic Studies)
time frame: 1 year after the operation
description: Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome
measure: VUD (Video Urodynamic Studies)
time frame: 2 years after the operation
description: Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome
arm group label: Secondary Tethered Cord Syndrome
description: Children with signs of progressive deterioration in urological or neuroorthopedic system, and suspected Secondary Tethered Cord Syndrome (STCS) following primary untethering surgery.
intervention type: Procedure
intervention name: Redo-tethering operation
arm group label: Secondary Tethered Cord Syndrome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Months
maximum age: 23 Years
healthy volunteers: No
last name: Kwanjin Park, MD, PHD
role: Principal Investigator
affiliation: Seoul National University Hospital
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Kwanjin Park
investigator title: Associate Professor
mesh term: Urinary Bladder, Neurogenic
mesh term: Neural Tube Defects
mesh term: Spinal Cord Injuries
mesh term: Syndrome
sharing ipd: No
ipd description: Not plan to share IPD