Spinal Vascular Disorder NosNCT03280186
Measurement of Bladder Function Change In Patients With SVMs Before and After Surgical Intervention
A study testing surgery in people with Spinal Vascular Disorder Nos and Neurogenic Bladder Dysfunction Nos, run by Xuanwu Hospital, Beijing.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Vascular Disorder Nos, Neurogenic Bladder Dysfunction Nos
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
- Being tested
- surgery
- Keywords
- Spinal Vascular Malformations, Bladder, Surgical intervention, Urodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients With SVMs | Experimental | Patients with SVMs will be included in the group and undergo surgery. Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder function change in urodynamics
bladder function will be better in urodynamics after surgery.
Measured: postoperative 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startJan 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Vascular Disorder NosStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ou tongwen, Xuanwu Hospital, Beijing
- Investigators
- Tongwen Ou, M.D, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280186
- Sponsor's protocol ID
- otw-20170908
- Status last verified
- Apr 2020
- First submitted
- 8 Sep 2017
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Bladder Function Change In Patients With Spinal Vascular Malformations Before and After Surgical Intervention
- ClinicalTrials.gov ID
- NCT03280186
- Acronym / sponsor ID
- otw-20170908
- Keywords
- Spinal Vascular Malformations, Bladder, Surgical intervention, Urodynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With SVMs | Experimental | Procedure: surgeryPatients with SVMs will be included in the group and undergo surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryThe minimally invasive surgical treatment methods and new techniques will be adopted such as spinal superselective angiography, preoperative embolization, intraoperative electrophysiological monitoring, intraoperative angiography, etc. | Procedure or surgery | Patients With SVMs |
Primary outcome
bladder function change in urodynamics
Time frame: postoperative 3 months and 12 months
bladder function will be better in urodynamics after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tongwen Ou, M.D study director
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Spinal Vascular Disorder Nos and Neurogenic Bladder Dysfunction Nos, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenhua Shang, M.D (17801117318, shangzhenhua16@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bladder function change in urodynamics (time frame: postoperative 3 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.