Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
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| ClinicalTrials.gov Identifier: NCT00175123 |
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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
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Sponsor:
University of Aarhus
Collaborator:
Aarhus University Hospital
Information provided by:
University of Aarhus
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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 |
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 (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
Genetics Home Reference related topics:
Spina bifida
MedlinePlus related topics:
Botox
Intervention Details:
- Drug: Botulinum A toxin
Intravesical injection. 12 IE/kg b.w.
Primary Outcome Measures :
- Bladder capacity and pressures: measures from cystometry [ Time Frame: at 4 weeks and 6 months ]
Secondary Outcome Measures :
- Urinary continence: score from an incontinence rating scale [ Time Frame: 2 days before and 4 weeks and 6 months after ]
- Constipation: score on the Bristol scale [ Time Frame: 4 weeks ]
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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
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
| Denmark | |
| Department of Urology, Aarhus University Hospital, Section Skejby | |
| Aarhus, Aarhus N, Denmark, 8200 | |
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
| Principal Investigator: | Bettina Jorgensen, MD | Department of Urology, Aarhus University Hospital |
| Responsible Party: | Bettina Jorgensen, MD, Aarhus University |
| ClinicalTrials.gov Identifier: | NCT00175123 History of Changes |
| 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:
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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 Signs and Symptoms Neural Tube Defects Nervous System Malformations Congenital Abnormalities Spinal Dysraphism |
Botulinum Toxins, Type A onabotulinumtoxinA 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 |