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Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00175123
Enrollment
30
Registered
2005-09-15
Start date
2005-05-31
Completion date
2008-06-30
Last updated
2009-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder, Neurogenic, Myelomeningocele

Keywords

Myelomeningocele, Neurogenic Bladder, Intervention, Botulinum A toxin, Oxybutynin

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 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.

Interventions

Intravesical injection. 12 IE/kg b.w.

Sponsors

Aarhus University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
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

Design outcomes

Primary

MeasureTime frame
Bladder capacity and pressures: measures from cystometryat 4 weeks and 6 months

Secondary

MeasureTime frame
Urinary continence: score from an incontinence rating scale2 days before and 4 weeks and 6 months after
Constipation: score on the Bristol scale4 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026