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

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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

September 8, 2017
September 12, 2017
September 13, 2017
January 2018
October 2019   (Final data collection date for primary outcome measure)
bladder function change in urodynamics [ Time Frame: postoperative 3 months and 12 months ]
bladder function will be better in urodynamics after surgery.
Same as current
Complete list of historical versions of study NCT03280186 on ClinicalTrials.gov Archive Site
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Measurement of Bladder Function Change In Patients With SVMs Before and After Surgical Intervention
Measurement of Bladder Function Change In Patients With Spinal Vascular Malformations Before and After Surgical Intervention
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Spinal Vascular Disorder Nos
  • Neurogenic Bladder Dysfunction Nos
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.
Experimental: Patients With SVMs
Patients with SVMs will be included in the group and undergo surgery.
Intervention: Procedure: surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
Same as current
December 2019
October 2019   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact: Zhenhua Shang, M.D 17801117318 shangzhenhua16@126.com
Not Provided
 
 
NCT03280186
otw-20170908
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
ou tongwen, Xuanwu Hospital, Beijing
Xuanwu Hospital, Beijing
Not Provided
Study Director: Tongwen Ou, M.D Xuanwu Hospital, Beijing
Xuanwu Hospital, Beijing
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP