Prevention of bladder dysfunction in acute spinal cord injury with Onabotulinumtoxin A
- Conditions
- Bladder dysfunction after acute spinal cord injuryTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-002211-25-NO
- Lead Sponsor
- Oslo University Hospital, Dept of Urology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Acute spinal cord injury within 4 weeks of the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
No former neurological disease
Not willing to give informed consent
Age below 18 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate if intravesical injection of Botox can prevent the development of bladder dysfunction after spinal cord injury;Secondary Objective: Monitor patients for complications;Primary end point(s): Development of detrusor overactivity<br>Change in urodynamic parameters<br>;Timepoint(s) of evaluation of this end point: After 3, 6, 9 and 12 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Complications;Timepoint(s) of evaluation of this end point: 3, 6, 9 and 12 months