Clinical Trial: Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele

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 Summary: 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.
Sponsor: University of Aarhus

Current Primary Outcome: Bladder capacity and pressures: measures from cystometry [ Time Frame: at 4 weeks and 6 months ]

Original Primary Outcome: Bladder capacity and pressures;measures from cystometri at 4 weeks and 6 month.

Current Secondary Outcome:

  • Urinary continence: score from an incontinence rating scale [ Time Frame: 2 days before and 4 weeks and 6 months after ]
  • Constipation: score on the Bristol scale [ Time Frame: 4 weeks ]


Original Secondary Outcome:

  • Urine continence;score from a incontinence rating scale, 2 days before and 4 weeks and 6 months after.
  • Constipation;score on the Bristol scale


Information By: University of Aarhus

Dates:
Date Received: September 9, 2005
Date Started: May 2005
Date Completion: June 2008
Last Updated: February 19, 2009
Last Verified: February 2009