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

NCT ID: NCT03280186

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Spinal Vascular Disorder Nos; Neurogenic Bladder Dysfunction Nos

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients With SVMs

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

Group Type: EXPERIMENTAL

surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

ou tongwen

Director of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tongwen Ou, M.D

Role: STUDY_DIRECTOR

Xuanwu Hospital, Beijing

Central Contacts

Zhenhua Shang, M.D

Role: CONTACT

shangzhenhua16@126.com

17801117318

Other Identifiers

otw-20170908

Identifier Type: -

Identifier Source: org_study_id