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Efficacy Comparison Between Different Management Strategies for Consistent OAB in Patients With SVMs After Surgery

Primary Purpose

Spinal Vascular Disorder Nos, Overactive Bladder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgery
sacral neuromodulation
botulinum toxin A injection
M receptor antagonist
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Vascular Disorder Nos focused on measuring Spinal Vascular Disorder, Overactive Bladder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • •Patient diagnosed with spinal vascular diseases including Intradural arteriovenous malformation,Intradural arteriovenous fistula,Dural arteriovenous fistula,Extradural arteriovenous malformation,Paravertebral arteriovenous malformation,Paravertebral arteriovenous fistula,cobbs' syndrome,and other spinal arteriovenous metameric syndromes involve the spinal cord.

    • patient not received surgical or interventional treatment before
    • patient with normal cardiac, renal and hepatic function
    • patient capable of understanding the content of the patient information / Informed Consent Form
    • patient willing and able to participate in the registry
    • patients have consistent OAB after surgery

Exclusion Criteria:

  • •patient received surgical treatment or interventional treatment before

    • patient is pregnant
    • patient allergic to iodine
    • patient unable to complete follow-up
    • patient with cerebral lesions
    • patient with other spinal lesions
    • patient with cardiac, renal or hepatic dysfunction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    patients with SVMs undergoing SNM

    patients with SVMs receiving BTXA

    patients with SVMs receiving drug

    Arm Description

    patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)

    patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection

    patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist

    Outcomes

    Primary Outcome Measures

    bladder function
    bladder function change in urodynamics

    Secondary Outcome Measures

    Full Information

    First Posted
    September 8, 2017
    Last Updated
    April 28, 2020
    Sponsor
    Xuanwu Hospital, Beijing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03280316
    Brief Title
    Efficacy Comparison Between Different Management Strategies for Consistent OAB in Patients With SVMs After Surgery
    Official Title
    Efficacy Comparison Between Different Management Strategies for Consistent Overactive Bladder (OAB) in Patients With Spinal Vascular Malformations After Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xuanwu Hospital, Beijing

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Vascular Disorder Nos, Overactive Bladder
    Keywords
    Spinal Vascular Disorder, Overactive Bladder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with SVMs undergoing SNM
    Arm Type
    Experimental
    Arm Description
    patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)
    Arm Title
    patients with SVMs receiving BTXA
    Arm Type
    Experimental
    Arm Description
    patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection
    Arm Title
    patients with SVMs receiving drug
    Arm Type
    Experimental
    Arm Description
    patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist
    Intervention Type
    Procedure
    Intervention Name(s)
    surgery
    Intervention Description
    patients with SVMs receive surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    sacral neuromodulation
    Intervention Description
    sacral neuromodulation (SNM) with InterStimTM
    Intervention Type
    Procedure
    Intervention Name(s)
    botulinum toxin A injection
    Intervention Description
    BOTOX
    Intervention Type
    Drug
    Intervention Name(s)
    M receptor antagonist
    Other Intervention Name(s)
    Tolterodine
    Intervention Description
    Tolterodine
    Primary Outcome Measure Information:
    Title
    bladder function
    Description
    bladder function change in urodynamics
    Time Frame
    3 months and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: •Patient diagnosed with spinal vascular diseases including Intradural arteriovenous malformation,Intradural arteriovenous fistula,Dural arteriovenous fistula,Extradural arteriovenous malformation,Paravertebral arteriovenous malformation,Paravertebral arteriovenous fistula,cobbs' syndrome,and other spinal arteriovenous metameric syndromes involve the spinal cord. patient not received surgical or interventional treatment before patient with normal cardiac, renal and hepatic function patient capable of understanding the content of the patient information / Informed Consent Form patient willing and able to participate in the registry patients have consistent OAB after surgery Exclusion Criteria: •patient received surgical treatment or interventional treatment before patient is pregnant patient allergic to iodine patient unable to complete follow-up patient with cerebral lesions patient with other spinal lesions patient with cardiac, renal or hepatic dysfunction
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    zhenhua shang, M.D
    Phone
    17801117318
    Email
    shangzhenhua16@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    tongwen ou, M.D
    Organizational Affiliation
    Xuanwu Hospital, Beijing
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy Comparison Between Different Management Strategies for Consistent OAB in Patients With SVMs After Surgery

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