EUCTR2014-004641-27-BE
Active, Not Recruiting
Phase 1
BOTOX in the treatment of urinary incontinence due to neurogenic detrusor overactivity in patients 3 months - 17 years - Botox treatment
ZLeuven0 sites30 target enrollmentApril 21, 2015
Conditionsrinary incontinence due to neurogenic detrusor overactivityMedDRA version: 18.0Level: PTClassification code 10029279Term: Neurogenic bladderSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsBotox
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- rinary incontinence due to neurogenic detrusor overactivity
- Sponsor
- ZLeuven
- Enrollment
- 30
- Status
- Active, Not Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male or female, \= 0 and \= 17 years of age at the moment of signing the informed consent
- •\- Patient with neurogenic bladder dysfunction shown during urodynamic investigation with or without overactive detrusor contraction
- •\- Neurogenic detrusor overactivity caused by;
- •\* spinal dysrafie, more specifically spina bifida (e.g. myelomeningocele, meningocele) and all forms of tethered cord
- •\* Acquired neurogenic detrusor overactivity due to spinal cord injury
- •\- Regular intermittent sondage to empty the bladder
- •\- more than 4 episodes of urine incontinence over two days in the miction diary
- •\- the neurogenic bladder dysfunction is not sufficiently controlled with anticholinergics only
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
Exclusion Criteria
- •\- occurence of uncontrolled systemic diseases
- •\- occurence of malignancies
- •\- spinal cord surgery during the past 6 months
- •\- additional pelvic or urologic abnormalities (open bladder neck, urethra stricture/urethra valve
- •\- predominance of stress incontinence
Outcomes
Primary Outcomes
Not specified
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