Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
Primary Purpose
Myelomeningocele, Bladder, Neurogenic
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Botulinum A toxin
Sponsored by
About this trial
This is an interventional prevention trial for Myelomeningocele focused on measuring Myelomeningocele, Neurogenic Bladder, Intervention, Botulinum A toxin, Oxybutynin
Eligibility 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
Sites / Locations
- Department of Urology, Aarhus University Hospital, Section Skejby
Outcomes
Primary Outcome Measures
Bladder capacity and pressures: measures from cystometry
Secondary Outcome Measures
Urinary continence: score from an incontinence rating scale
Constipation: score on the Bristol scale
Full Information
NCT ID
NCT00175123
First Posted
September 9, 2005
Last Updated
February 19, 2009
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00175123
Brief Title
Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
Official Title
Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
June 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelomeningocele, Bladder, Neurogenic
Keywords
Myelomeningocele, Neurogenic Bladder, Intervention, Botulinum A toxin, Oxybutynin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Botulinum A toxin
Intervention Description
Intravesical injection. 12 IE/kg b.w.
Primary Outcome Measure Information:
Title
Bladder capacity and pressures: measures from cystometry
Time Frame
at 4 weeks and 6 months
Secondary Outcome Measure Information:
Title
Urinary continence: score from an incontinence rating scale
Time Frame
2 days before and 4 weeks and 6 months after
Title
Constipation: score on the Bristol scale
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Jorgensen, MD
Organizational Affiliation
Department of Urology, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Aarhus University Hospital, Section Skejby
City
Aarhus
State/Province
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
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Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
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