<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/NCT03280186</url>
  </required_header>
  <id_info>
    <org_study_id>otw-20170908</org_study_id>
    <nct_id>NCT03280186</nct_id>
  </id_info>
  <brief_title>Measurement of Bladder Function Change In Patients With SVMs Before and After Surgical Intervention</brief_title>
  <official_title>Measurement of Bladder Function Change In Patients With Spinal Vascular Malformations Before and After Surgical Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</source>
  <oversight_info>
    <has_dmc>No</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>
      The investigators goal is to create a better understanding of patient with SVMs reported&#xD;
      outcomes for bladder management strategies before and after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spinal Vascular malformations (SVMs) are complex neurosurgical lesions and account for 3%-4%&#xD;
      of all intradural spinal cord mass lesions, which can influence the function of bladder.&#xD;
      However, no study show the relationship of the SVMs and bladder function. The investigators&#xD;
      goal is to create a better understanding of patient reported outcomes for bladder management&#xD;
      strategies before and after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2022</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bladder function change in urodynamics</measure>
    <time_frame>postoperative 3 months and 12 months</time_frame>
    <description>bladder function will be better in urodynamics after surgery.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Spinal Vascular Disorder Nos</condition>
  <condition>Neurogenic Bladder Dysfunction Nos</condition>
  <arm_group>
    <arm_group_label>Patients With SVMs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with SVMs will be included in the group and undergo surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgery</intervention_name>
    <description>The minimally invasive surgical treatment methods and new techniques will be adopted such as spinal superselective angiography, preoperative embolization, intraoperative electrophysiological monitoring, intraoperative angiography, etc.</description>
    <arm_group_label>Patients With SVMs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - patient diagnosed with spinal vascular diseases including intradural arteriovenous&#xD;
        malformation, intradural arteriovenous fistula, dural arteriovenous fistula, extradural&#xD;
        arteriovenous malformation, paravertebral arteriovenous malformation, paravertebral&#xD;
        arteriovenous fistula, cobbs' syndrome, other spinal arteriovenous metameric syndromes&#xD;
        involve the spinal cord. patient not received surgical or interventional treatment before&#xD;
        patient with normal cardiac, renal and hepatic function patient capable of understanding&#xD;
        the content of the patient information / Informed Consent Form patient willing and able to&#xD;
        participate in the registry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - patient received surgical treatment or interventional treatment before patient is&#xD;
        pregnant patient allergic to iodine patient unable to complete follow-up patient with&#xD;
        cerebral lesions patient with other spinal lesions patient with cardiac, renal or hepatic&#xD;
        dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tongwen Ou, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Xuanwu Hospital, Beijing</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhenhua Shang, M.D</last_name>
    <phone>17801117318</phone>
    <email>shangzhenhua16@126.com</email>
  </overall_contact>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>April 28, 2020</last_update_submitted>
  <last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xuanwu Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>ou tongwen</investigator_full_name>
    <investigator_title>Director of Urology</investigator_title>
  </responsible_party>
  <keyword>Spinal Vascular Malformations</keyword>
  <keyword>Bladder</keyword>
  <keyword>Surgical intervention</keyword>
  <keyword>Urodynamics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Neurogenic</mesh_term>
    <mesh_term>Vascular Malformations</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
  </condition_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/NCT03280186
org study id: otw-20170908
nct id: NCT03280186
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators goal is to create a better understanding of patient with SVMs reported
      outcomes for bladder management strategies before and after surgery.
Spinal Vascular malformations (SVMs) are complex neurosurgical lesions and account for 3%-4%
      of all intradural spinal cord mass lesions, which can influence the function of bladder.
      However, no study show the relationship of the SVMs and bladder function. The investigators
      goal is to create a better understanding of patient reported outcomes for bladder management
      strategies before and after surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: bladder function change in urodynamics
time frame: postoperative 3 months and 12 months
description: bladder function will be better in urodynamics after surgery.
arm group label: Patients With SVMs
arm group type: Experimental
description: Patients with SVMs will be included in the group and undergo surgery.
intervention type: Procedure
intervention name: surgery
description: The minimally invasive surgical treatment methods and new techniques will be adopted such as spinal superselective angiography, preoperative embolization, intraoperative electrophysiological monitoring, intraoperative angiography, etc.
arm group label: Patients With SVMs
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Tongwen Ou, M.D
role: Study Director
affiliation: Xuanwu Hospital, Beijing
last name: Zhenhua Shang, M.D
phone: 17801117318
email: shangzhenhua16@126.com
responsible party type: Principal Investigator
investigator affiliation: Xuanwu Hospital, Beijing
investigator full name: ou tongwen
investigator title: Director of Urology
mesh term: Urinary Bladder, Neurogenic
mesh term: Vascular Malformations
mesh term: Vascular Diseases
sharing ipd: No