ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03280186
Recruitment Status : Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
ou tongwen, Xuanwu Hospital, Beijing

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.

Condition or disease Intervention/treatment Phase
Spinal Vascular Disorder Nos Neurogenic Bladder Dysfunction Nos Procedure: surgery Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measurement of Bladder Function Change In Patients With Spinal Vascular Malformations Before and After Surgical Intervention
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Patients With SVMs
Patients with SVMs will be included in the group and undergo surgery.
Procedure: surgery
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 Measures :
  1. bladder function change in urodynamics [ Time Frame: postoperative 3 months and 12 months ]
    bladder function will be better in urodynamics after surgery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280186


Contacts
Contact: Zhenhua Shang, M.D 17801117318 shangzhenhua16@126.com

Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
Study Director: Tongwen Ou, M.D Xuanwu Hospital, Beijing

Responsible Party: ou tongwen, Director of Urology, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03280186     History of Changes
Other Study ID Numbers: otw-20170908
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by ou tongwen, Xuanwu Hospital, Beijing:
Spinal Vascular Malformations
Bladder
Surgical intervention
Urodynamics

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Vascular Malformations
Vascular Diseases
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities