- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00175123
Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
February 19, 2009 updated by: University of Aarhus
Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Aarhus N
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Aarhus, Aarhus N, Denmark, 8200
- Department of Urology, Aarhus University Hospital, Section Skejby
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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
2 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bladder capacity and pressures: measures from cystometry
Time Frame: at 4 weeks and 6 months
|
at 4 weeks and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urinary continence: score from an incontinence rating scale
Time Frame: 2 days before and 4 weeks and 6 months after
|
2 days before and 4 weeks and 6 months after
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Constipation: score on the Bristol scale
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bettina Jorgensen, MD, Department of Urology, Aarhus University Hospital
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
May 1, 2005
Primary Completion (Anticipated)
March 1, 2008
Study Completion (Anticipated)
June 1, 2008
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
February 20, 2009
Last Update Submitted That Met QC Criteria
February 19, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Urologic Diseases
- Urinary Bladder Diseases
- Neurologic Manifestations
- Congenital Abnormalities
- Nervous System Malformations
- Neural Tube Defects
- Spinal Dysraphism
- Urinary Bladder, Neurogenic
- Meningomyelocele
- Spina Bifida Cystica
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- Botox
- J.nr.2612-2319
- J.nr.20030155
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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