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Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00175123
Recruitment Status : Unknown
Verified February 2009 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : February 20, 2009
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
University of Aarhus

Study Description
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Brief Summary:
The purpose of this study is to examine how injection of botulinum toxin in the bladder affects bladder function. The trial is carried out in children born with malformation of the spinal cord and subsequent overactive bladders. The purpose of treating the bladder (with different drugs) is to prevent damage to the kidneys and renal function. The aim of this study is to compare a conventionally used drug (oxybutynin) with botulinum toxin. The hypothesis of the study is that botulinum toxin is equal to oxybutynin in the treatment of overactive bladder.

Condition or disease Intervention/treatment Phase
Myelomeningocele Bladder, Neurogenic Drug: Botulinum A toxin Phase 4

Detailed Description:
Neurogenic bladder is often seen in children with myelomeningocele, tumors in the spinal canal, or a traumatized spinal cord. The majority of the patients have high pressure bladders which can lead to reflux and frequent infections in the urinary tract. Although children experience insufficient bladder emptying, many of them also experience urinary incontinence and have to perform clean intermittent catheterization (CIC). If no intervention is made, the children are at high risk of renal deterioration.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele
Study Start Date : May 2005
Estimated Primary Completion Date : March 2008
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Intervention Details:
  • Drug: Botulinum A toxin
    Intravesical injection. 12 IE/kg b.w.

Outcome Measures
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Primary Outcome Measures :
  1. Bladder capacity and pressures: measures from cystometry [ Time Frame: at 4 weeks and 6 months ]

Secondary Outcome Measures :
  1. Urinary continence: score from an incontinence rating scale [ Time Frame: 2 days before and 4 weeks and 6 months after ]
  2. Constipation: score on the Bristol scale [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Myelomeningocele
  • Neurogenic bladder with untreated leak point pressures > 40 mmH2O
  • Treated with oxybutynin or other parasympatholytics

Exclusion Criteria:

  • Acute urinary tract infection
  • Compromised neuromuscular transmission
Contacts and Locations
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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): NCT00175123


Locations
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Denmark
Department of Urology, Aarhus University Hospital, Section Skejby
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Principal Investigator: Bettina Jorgensen, MD Department of Urology, Aarhus University Hospital
More Information
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Responsible Party: Bettina Jorgensen, MD, Aarhus University
ClinicalTrials.gov Identifier: NCT00175123    
Other Study ID Numbers: Botox
J.nr.2612-2319
J.nr.20030155
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009
Keywords provided by University of Aarhus:
Myelomeningocele
Neurogenic Bladder
Intervention
Botulinum A toxin
Oxybutynin
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Meningomyelocele
Spina Bifida Cystica
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Spinal Dysraphism
 Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents