Efficacy Comparison Between Different Management Strategies for Consistent OAB in Patients With SVMs After Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2023-12-31

Brief Summary

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The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB in patients with SVMs after surgery.

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Detailed Description

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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. The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB (Overactive Bladder) in patients with SVMs after surgery.

Conditions

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Spinal Vascular Disorder Nos Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients with SVMs undergoing SNM

patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)

Group Type EXPERIMENTAL

surgery

Intervention Type PROCEDURE

patients with SVMs receive surgery

sacral neuromodulation

Intervention Type PROCEDURE

sacral neuromodulation (SNM) with InterStimTM

patients with SVMs receiving BTXA

patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection

Group Type EXPERIMENTAL

surgery

Intervention Type PROCEDURE

patients with SVMs receive surgery

botulinum toxin A injection

Intervention Type PROCEDURE

BOTOX

patients with SVMs receiving drug

patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist

Group Type EXPERIMENTAL

surgery

Intervention Type PROCEDURE

patients with SVMs receive surgery

M receptor antagonist

Intervention Type DRUG

Tolterodine

Interventions

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surgery

patients with SVMs receive surgery

Intervention Type PROCEDURE

sacral neuromodulation

sacral neuromodulation (SNM) with InterStimTM

Intervention Type PROCEDURE

botulinum toxin A injection

BOTOX

Intervention Type PROCEDURE

M receptor antagonist

Tolterodine

Intervention Type DRUG

Other Intervention Names

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Tolterodine

Eligibility Criteria

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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,and 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
* patients have consistent OAB after surgery

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