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

Capital Medical University

Status: Unknown

Conditions: Spinal Vascular Disorder Nos; Overactive Bladder

Treatments: Procedure: surgery; Procedure: botulinum toxin A injection; Drug: M receptor antagonist; Procedure: sacral neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03280316

otw-20170909

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

patients with SVMs undergoing SNM

Experimental group

Description:

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

Treatment:

Procedure: sacral neuromodulation

Procedure: surgery

patients with SVMs receiving BTXA

Experimental group

Description:

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

Treatment:

Procedure: botulinum toxin A injection

Procedure: surgery

patients with SVMs receiving drug

Experimental group

Description:

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

Treatment:

Drug: M receptor antagonist

Procedure: surgery