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

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03280186

Collaborator

(none)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Vascular Disorder Nos Neurogenic Bladder Dysfunction Nos	Procedure: surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

bladder function change in urodynamics [postoperative 3 months and 12 months]
bladder function will be better in urodynamics after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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