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

Neurogenic Bladder Dysfunction Nos Clinical Trial

Official title:

Measurement of Bladder Function Change In Patients With Spinal Vascular Malformations Before and After Surgical Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03280186
• Other study ID #: otw-20170908
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2022
• Est. completion date: December 2022

Study information

• Verified date: April 2020
• Source: Xuanwu Hospital, Beijing
• Contact: Zhenhua Shang, M.D
• Phone: 17801117318
• Email: shangzhenhua16[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Bladder Dysfunction Nos
• Spinal Vascular Disorder Nos
• Urinary Bladder, Neurogenic
• Vascular Diseases
• Vascular Malformations

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bladder function change in urodynamics	bladder function will be better in urodynamics after surgery.	postoperative 3 months and 12 months