Spinal Cord Injury
Conditions
Keywords
Neurogenic bladder, Urodynamic, Quality of life
Brief summary
The purpose of this study is to compare the effects of oral oxybutynin and intradetrusor injections of botulinum toxin type A on urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity following spinal cord injury.
Interventions
DRUGOxybutynin
5 mg of immediate-release oxybutynin orally 3 times daily
DRUGBotulinum toxin A
300 U intradetrusor injection
Sponsors
Centro de Reabilitação e Readaptação Dr. Henrique Santillo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Spinal cord injury * Detrusor overactivity * Age over 18 years * Spinal cord injury at least 12 months duration * Undergoing regular clean intermittent catheterisation
Exclusion criteria
* Pregnancy * Desire to become pregnant during the study period * Breastfeeding * Blood coagulation disorder * Neuromuscular transmission disorder * Use of any intravesical pharmacologic agents * Previous use of botulinum toxin A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcome measure was the variation mean in the number of episodes of urinary incontinence per 24 hours, maximum cystometric capacity, maximum detrusor pressure and bladder compliance | Beginning and 24 weeks of the study |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire | Beginning and 24 weeks of the study |
Countries
Brazil
Outcome results
None listed