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Status unknownNCT03280186Updated Apr 29, 2020

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

An interventional study of surgery in Spinal Vascular Disorder Nos and Neurogenic Bladder Dysfunction Nos, sponsored by Xuanwu Hospital, Beijing. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Spinal Vascular Disorder Nos
  • Neurogenic Bladder Dysfunction Nos

Keywords

  • Spinal Vascular Malformations
  • Bladder
  • Surgical intervention
  • Urodynamics
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Patients With SVMs

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

    Procedure: surgery

Interventions

  • Proceduresurgery

    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.

05

What researchers measure

Primary outcomes

  1. bladder function change in urodynamics

    bladder function will be better in urodynamics after surgery.

    Time frame: postoperative 3 months and 12 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03280186
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
ou tongwen (Director of Urology, Xuanwu Hospital, Beijing) — Principal investigator
First posted
Sep 12, 2017
Start date
Jan 2022 (estimated)
Primary completion
Oct 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Apr 29, 2020

Study contacts

Zhenhua Shang, M.D
Contact
shangzhenhua16@126.com
17801117318
Tongwen Ou, M.D
study director · Xuanwu Hospital, Beijing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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