Prevention of renal and bladder damage in children with spina bifida by means of early injections with Botulinum-Toxin-A (Botox): a pilot study.
- Conditions
- Neurogenic bladder function disease in spina bifida patientsspastic bladder in spina bifida patients.100292991002930510004994
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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.
The exclusion criteria for the study group are:
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>End filling pressure of the bladder (determined by means of urodynamic testing)<br /><br>after 5 years of follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Clinical parameters:<br /><br>o Number of urinary tract infections<br /><br>o Frequency of intermittent catheterisation<br /><br>o Bladder volumes (with intermittent catheterisation)<br /><br>- Urodynamic parameters<br /><br>o Bladder capacity<br /><br>o Bladder overactivities<br /><br>o Compliance of the bladder<br /><br>- Number and nature of operative interventions to the urinary tract.</p><br>