A Phase 4 interventional study of Botulinum A toxin in Myelomeningocele and Bladder, Neurogenic, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2009-02-20.
Sponsored by University of Aarhus · Phase 4, Interventional, and Prevention
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.
185 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.
This study's planned enrollment of 30 is below the median of 36 across 124 interventional studies indexed under Urinary Bladder, Neurogenic.
Browse Urinary Bladder, Neurogenic studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravesical injection. 12 IE/kg b.w.
Bladder capacity and pressures: measures from cystometry
Time frame: at 4 weeks and 6 months
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
This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Aarhus