Spina Bifida
Conditions
Interventions
Botulinum toxin A will be injected in the bladder at the age of approximately 5 months during a short-term narcosis (10 minutes). These injections will be repeated every 9 months during the study peri
Sponsors
Erasmus MC, Dept. Urology
Eligibility
Inclusion criteria
Inclusion criteria: The study group exists of newborns with MMC who are treated with the standard treatment (CIC and anticholinergics). The minimal age at inclusion is 3 months. This is because of the minimal diameter of the urethra which is necessary for cystoscopy. The historical control group exists of MMC patients who have not been treated with Botox and who were born between 1998 and 2008.
Exclusion criteria
Exclusion criteria: - Patients with swallowing or breathing problems for which medical treatment is or was necessary. - Muscle diseases such as myasthenia gravis, amyotrophic lateral sclerosis or the Syndrome of Eaton-Lambert. For the historical group the database of (parents of) patients who object against the use of their medical records for research purposes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| End filling pressure of the bladder(determined by means of urodynamic testing) after 5 years of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Clinical parameters: o Number of urinary tract infections o Frequency of intermittent catheterisation o Bladder volumes (with intermittent catheterisation) - Urodynamic parameters: o Bladder capacity o Bladder overactivities o Compliance of the bladder - Number and nature of operative interventions to the urinary tract. | — |
Contacts
Public ContactJ.R. Scheepe
Kinderuroloog Erasmus MC – Sophia Postbus 2060
Outcome results
None listed