Myelomeningocele Clinical Trial
Official title:
Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | June 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 16 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Urology, Aarhus University Hospital, Section Skejby | Aarhus | Aarhus N |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bladder capacity and pressures: measures from cystometry | at 4 weeks and 6 months | No | |
Secondary | Urinary continence: score from an incontinence rating scale | 2 days before and 4 weeks and 6 months after | No | |
Secondary | Constipation: score on the Bristol scale | 4 weeks | No |
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