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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
Sponsor:
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
History of Changes

September 9, 2005
February 19, 2009
May 2005
March 2008   (final data collection date for primary outcome measure)
Bladder capacity and pressures: measures from cystometry [ Time Frame: at 4 weeks and 6 months ] [ Designated as safety issue: No ]
Bladder capacity and pressures;measures from cystometri at 4 weeks and 6 month.
Complete list of historical versions of study NCT00175123 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Urine continence;score from a incontinence rating scale, 2 days before and 4 weeks and 6 months after.
  • Constipation;score on the Bristol scale
Not Provided
Not Provided
 
Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
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.

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Myelomeningocele
  • Bladder, Neurogenic
Drug: Botulinum A toxin
Intravesical injection. 12 IE/kg b.w.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
June 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
2 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00175123
Botox, J.nr.2612-2319, J.nr.20030155
No
Bettina Jorgensen, MD, Aarhus University
University of Aarhus
Aarhus University Hospital
Principal Investigator: Bettina Jorgensen, MD Department of Urology, Aarhus University Hospital
University of Aarhus
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP