<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/NCT03280316</url>
  </required_header>
  <id_info>
    <org_study_id>otw-20170909</org_study_id>
    <nct_id>NCT03280316</nct_id>
  </id_info>
  <brief_title>Efficacy Comparison Between Different Management Strategies for Consistent OAB in Patients With SVMs After Surgery</brief_title>
  <official_title>Efficacy Comparison Between Different Management Strategies for Consistent Overactive Bladder (OAB) in Patients With Spinal Vascular Malformations After Surgery</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>
    <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 compare the efficacy of three different management strategies&#xD;
      (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB&#xD;
      in patients with SVMs 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. The&#xD;
      investigators' goal is to compare the efficacy of three different management strategies&#xD;
      (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB&#xD;
      (Overactive Bladder) in patients with SVMs after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 2023</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bladder function</measure>
    <time_frame>3 months and 12 months</time_frame>
    <description>bladder function change in urodynamics</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Spinal Vascular Disorder Nos</condition>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>patients with SVMs undergoing SNM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with SVMs receiving BTXA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with SVMs receiving drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgery</intervention_name>
    <description>patients with SVMs receive surgery</description>
    <arm_group_label>patients with SVMs receiving BTXA</arm_group_label>
    <arm_group_label>patients with SVMs receiving drug</arm_group_label>
    <arm_group_label>patients with SVMs undergoing SNM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sacral neuromodulation</intervention_name>
    <description>sacral neuromodulation (SNM) with InterStimTM</description>
    <arm_group_label>patients with SVMs undergoing SNM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>botulinum toxin A injection</intervention_name>
    <description>BOTOX</description>
    <arm_group_label>patients with SVMs receiving BTXA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>M receptor antagonist</intervention_name>
    <description>Tolterodine</description>
    <arm_group_label>patients with SVMs receiving drug</arm_group_label>
    <other_name>Tolterodine</other_name>
  </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,and other spinal arteriovenous metameric&#xD;
             syndromes involve the spinal cord.&#xD;
&#xD;
               -  patient not received surgical or interventional treatment before&#xD;
&#xD;
               -  patient with normal cardiac, renal and hepatic function&#xD;
&#xD;
               -  patient capable of understanding the content of the patient information /&#xD;
                  Informed Consent Form&#xD;
&#xD;
               -  patient willing and able to participate in the registry&#xD;
&#xD;
               -  patients have consistent OAB after surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  •patient received surgical treatment or interventional treatment before&#xD;
&#xD;
               -  patient is pregnant&#xD;
&#xD;
               -  patient allergic to iodine&#xD;
&#xD;
               -  patient unable to complete follow-up&#xD;
&#xD;
               -  patient with cerebral lesions&#xD;
&#xD;
               -  patient with other spinal lesions&#xD;
&#xD;
               -  patient with cardiac, renal or hepatic 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 Disorder</keyword>
  <keyword>Overactive Bladder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tolterodine Tartrate</mesh_term>
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</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/NCT03280316
org study id: otw-20170909
nct id: NCT03280316
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators' goal is to compare the efficacy of three different management strategies
      (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB
      in patients with SVMs 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. The
      investigators' goal is to compare the efficacy of three different management strategies
      (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB
      (Overactive Bladder) in patients with SVMs after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: bladder function
time frame: 3 months and 12 months
description: bladder function change in urodynamics
arm group label: patients with SVMs undergoing SNM
arm group type: Experimental
description: patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)
arm group label: patients with SVMs receiving BTXA
arm group type: Experimental
description: patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection
arm group label: patients with SVMs receiving drug
arm group type: Experimental
description: patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist
intervention type: Procedure
intervention name: surgery
description: patients with SVMs receive surgery
arm group label: patients with SVMs receiving BTXA
arm group label: patients with SVMs receiving drug
arm group label: patients with SVMs undergoing SNM
intervention type: Procedure
intervention name: sacral neuromodulation
description: sacral neuromodulation (SNM) with InterStimTM
arm group label: patients with SVMs undergoing SNM
intervention type: Procedure
intervention name: botulinum toxin A injection
description: BOTOX
arm group label: patients with SVMs receiving BTXA
intervention type: Drug
intervention name: M receptor antagonist
description: Tolterodine
arm group label: patients with SVMs receiving drug
other name: Tolterodine
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, Overactive
mesh term: Vascular Diseases
mesh term: Tolterodine Tartrate
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No