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

April 28, 2020 updated by: ou tongwen, Xuanwu Hospital, Beijing

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with SVMs undergoing SNM
patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)
Procedure: surgery
patients with SVMs receive surgery
Procedure: sacral neuromodulation
sacral neuromodulation (SNM) with InterStimTM
Experimental: patients with SVMs receiving BTXA
patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection
Procedure: surgery
patients with SVMs receive surgery
Procedure: botulinum toxin A injection
BOTOX
Experimental: patients with SVMs receiving drug
patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist
Procedure: surgery
patients with SVMs receive surgery
Drug: M receptor antagonist
Tolterodine
Other Names:
  • Tolterodine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bladder function
Time Frame: 3 months and 12 months
bladder function change in urodynamics
3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Study Director: Tongwen Ou, M.D, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • otw-20170909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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