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Measurement of Bladder Function Change In Patients With SVMs Before and After Surgical Intervention

Primary Purpose

Spinal Vascular Disorder Nos, Neurogenic Bladder Dysfunction Nos

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgery
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 Malformations, Bladder, Surgical intervention, Urodynamics

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, 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

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 Type

    Experimental

    Arm Label

    Patients With SVMs

    Arm Description

    Patients with SVMs will be included in the group and undergo surgery.

    Outcomes

    Primary Outcome Measures

    bladder function change in urodynamics
    bladder function will be better in urodynamics after surgery.

    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
    NCT03280186
    Brief Title
    Measurement of Bladder Function Change In Patients With SVMs Before and After Surgical Intervention
    Official Title
    Measurement of Bladder Function Change In Patients With Spinal Vascular Malformations Before and After Surgical Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    December 2022 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators goal is to create a better understanding of patient with SVMs reported outcomes for bladder management strategies before and 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Vascular Disorder Nos, Neurogenic Bladder Dysfunction Nos
    Keywords
    Spinal Vascular Malformations, Bladder, Surgical intervention, Urodynamics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients With SVMs
    Arm Type
    Experimental
    Arm Description
    Patients with SVMs will be included in the group and undergo surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    surgery
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    bladder function change in urodynamics
    Description
    bladder function will be better in urodynamics after surgery.
    Time Frame
    postoperative 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, 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 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

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    Measurement of Bladder Function Change In Patients With SVMs Before and After Surgical Intervention

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