This trial is active, not recruiting.

Conditions myelomeningocele, bladder, neurogenic
Treatment botulinum a toxin
Phase phase 4
Sponsor University of Aarhus
Collaborator Aarhus University Hospital
Start date May 2005
End date March 2008
Trial size 30 participants
Trial identifier NCT00175123, Botox, J.nr.20030155, J.nr.2612-2319


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Bladder capacity and pressures: measures from cystometry
time frame: at 4 weeks and 6 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 2 years up to 16 years old.

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

Additional Information

Official title Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele
Principal investigator Bettina Jorgensen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by University of Aarhus.