Official Title: “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 Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study

Study Primary Completion Date: March 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Botulinum A toxin
  • Intravesical injection. 12 IE/kg b.w.

Primary Measures

• Bladder capacity and pressures: measures from cystometry
  • Time Frame: at 4 weeks and 6 months
    Safety Issue?: No

Secondary Measures

• Urinary continence: score from an incontinence rating scale
  • Time Frame: 2 days before and 4 weeks and 6 months after
    Safety Issue?: No
• Constipation: score on the Bristol scale
  • Time Frame: 4 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Aarhus

Overall Clinical Trial Officials and Contacts

Bettina Jorgensen, MD Principal Investigator Department of Urology, Aarhus University Hospital  

Overall Contact: Bettina Jorgensen, MD +45 89495511 bettina.jorgensen@ki.au.dk

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00175123

Study ID Number: Botox

ClinicalTrials.gov Identifier: NCT00175123

Health Authority: Denmark: Danish Medicines Agency