Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myelomeningocele; Bladder, Neurogenic
Intervention: Botulinum A toxin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s): Bettina Jorgensen, MD, Principal Investigator, Affiliation: Department of Urology, Aarhus University Hospital
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.
Clinical Details
Official title: Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Bladder capacity and pressures: measures from cystometry
Secondary outcome: Urinary continence: score from an incontinence rating scaleConstipation: score on the Bristol scale
Detailed description:
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.
Eligibility
Minimum age: 2 Years.
Maximum age: 16 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Urology, Aarhus University Hospital, Section Skejby, Aarhus, Aarhus N 8200, Denmark
Additional Information
Starting date: May 2005
Last updated: February 19, 2009
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