Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Aarhus.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Aarhus
Collaborator:
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00175123
First received: September 9, 2005
Last updated: February 19, 2009
Last verified: February 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Myelomeningocele Bladder, Neurogenic |
Drug: Botulinum A toxin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
spina bifida
MedlinePlus related topics:
Botox
Drug Information available for:
OnabotulinumtoxinA
U.S. FDA Resources
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- Bladder capacity and pressures: measures from cystometry [ Time Frame: at 4 weeks and 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Urinary continence: score from an incontinence rating scale [ Time Frame: 2 days before and 4 weeks and 6 months after ] [ Designated as safety issue: No ]
- Constipation: score on the Bristol scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Botulinum A toxin
Intravesical injection. 12 IE/kg b.w.
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.
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years (Child) |
| Genders Eligible for Study: | Both |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175123
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| 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 |
| Study First Received: | September 9, 2005 |
| Last Updated: | February 19, 2009 |
| Health Authority: | Denmark: Danish Medicines Agency United States: Institutional Review Board |
Keywords provided by University of Aarhus:
|
Myelomeningocele Neurogenic Bladder Intervention Botulinum A toxin Oxybutynin |
Additional relevant MeSH terms:
|
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 IncobotulinumtoxinA AbobotulinumtoxinA OnabotulinumtoxinA 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 |
ClinicalTrials.gov processed this record on September 26, 2016