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Status unknownNCT03280316Updated Apr 29, 2020

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

An interventional study of surgery and sacral neuromodulation in Spinal Vascular Disorder Nos and Overactive Bladder, sponsored by Xuanwu Hospital, Beijing. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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. 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.

02

Conditions studied

  • Spinal Vascular Disorder Nos
  • Overactive Bladder

Keywords

  • Spinal Vascular Disorder
  • Overactive Bladder
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    patients with SVMs undergoing SNM

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

    Procedure: surgery · Procedure: sacral neuromodulation

  • Experimental
    patients with SVMs receiving BTXA

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

    Procedure: surgery · Procedure: botulinum toxin A injection

  • Experimental
    patients with SVMs receiving drug

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

    Procedure: surgery · Drug: M receptor antagonist

Interventions

  • Proceduresurgery

    patients with SVMs receive surgery

  • Proceduresacral neuromodulation

    sacral neuromodulation (SNM) with InterStimTM

  • Procedurebotulinum toxin A injection

    BOTOX

  • DrugM receptor antagonist

    Tolterodine

    Also known as: Tolterodine

05

What researchers measure

Primary outcomes

  1. bladder function

    bladder function change in urodynamics

    Time frame: 3 months and 12 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03280316
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
ou tongwen (Director of Urology, Xuanwu Hospital, Beijing) — Principal investigator
First posted
Sep 12, 2017
Start date
Jan 2023 (estimated)
Primary completion
Oct 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Apr 29, 2020

Study contacts

zhenhua shang, M.D
Contact
shangzhenhua16@126.com
17801117318
tongwen ou, M.D
study director · Xuanwu Hospital, Beijing

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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