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Trial record 44 of 303 for:    "Parkes Weber syndrome" OR "Vascular Malformations"

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

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ClinicalTrials.gov Identifier: NCT03280316
Recruitment Status : Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
ou tongwen, 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.

Condition or disease Intervention/treatment Phase
Spinal Vascular Disorder Nos Overactive Bladder Procedure: surgery Procedure: sacral neuromodulation Procedure: botulinum toxin A injection Drug: M receptor antagonist Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Comparison Between Different Management Strategies for Consistent Overactive Bladder (OAB) in Patients With Spinal Vascular Malformations After Surgery
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019


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 Name: Tolterodine




Primary Outcome Measures :
  1. bladder function [ Time Frame: 3 months and 12 months ]
    bladder function change in urodynamics



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280316


Contacts
Contact: zhenhua shang, M.D 17801117318 shangzhenhua16@126.com

Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
Study Director: tongwen ou, M.D Xuanwu Hospital, Beijing

Responsible Party: ou tongwen, Director of Urology, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03280316     History of Changes
Other Study ID Numbers: otw-20170909
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ou tongwen, Xuanwu Hospital, Beijing:
Spinal Vascular Disorder
Overactive Bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Vascular Diseases
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Cardiovascular Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Tolterodine Tartrate
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Urological Agents