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

Overactive Bladder Clinical Trial

Official title:

Efficacy Comparison Between Different Management Strategies for Consistent Overactive Bladder (OAB) in Patients With Spinal Vascular Malformations After Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03280316
• Other study ID #: otw-20170909
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: December 2023

Study information

• Verified date: April 2020
• Source: Xuanwu Hospital, Beijing
• Contact: zhenhua shang, M.D
• Phone: 17801117318
• Email: shangzhenhua16[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Spinal Vascular Disorder Nos
• Urinary Bladder, Overactive
• Vascular Diseases

Intervention

Procedure:
• surgery
patients with SVMs receive surgery
• sacral neuromodulation
sacral neuromodulation (SNM) with InterStimTM
• botulinum toxin A injection
BOTOX

Drug:
• M receptor antagonist
Tolterodine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bladder function	bladder function change in urodynamics	3 months and 12 months