Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

• Status: Unknown status
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborator: Aarhus University Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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