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

Not Applicable

• Conditions: Spinal Vascular Disorder Nos; Overactive Bladder
• Interventions: Procedure: surgery; Procedure: sacral neuromodulation; Procedure: botulinum toxin A injection; Drug: M receptor antagonist

• Registration Number: NCT03280316
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

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. 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.

Study Timeline

• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29
• Study Start: 2023-01
• Primary Completion: 2023-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with SVMs undergoing SNM	surgery	patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)
patients with SVMs undergoing SNM	sacral neuromodulation	patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)
patients with SVMs receiving BTXA	surgery	patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection
patients with SVMs receiving BTXA	botulinum toxin A injection	patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection
patients with SVMs receiving drug	surgery	patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist
patients with SVMs receiving drug	M receptor antagonist	patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist

Primary Outcome Measures

Name	Time	Method
bladder function	3 months and 12 months	bladder function change in urodynamics