A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Not Applicable
Completed
- Conditions
- Spinal Cord Injury
- Interventions
- Registration Number
- NCT01477736
- Lead Sponsor
- Centro de Reabilitação e Readaptação Dr. Henrique Santillo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botulinum toxin A Oxybutynin - Botulinum toxin A Botulinum toxin A - oxybutynin Oxybutynin - oxybutynin Botulinum toxin A -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire Beginning and 24 weeks of the study
Trial Locations
- Locations (1)
UNICAMP, Division of Urology
🇧🇷Campinas, Sao Paulo, Brazil