A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
NCT ID: NCT01477736
Last Updated: 2011-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2009-01-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Botulinum toxin A
Oxybutynin
5 mg of immediate-release oxybutynin orally 3 times daily
Botulinum toxin A
300 U intradetrusor injection
oxybutynin
Oxybutynin
5 mg of immediate-release oxybutynin orally 3 times daily
Botulinum toxin A
300 U intradetrusor injection
Interventions
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Oxybutynin
5 mg of immediate-release oxybutynin orally 3 times daily
Botulinum toxin A
300 U intradetrusor injection
Eligibility Criteria
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Inclusion Criteria
* Detrusor overactivity
* Age over 18 years
* Spinal cord injury at least 12 months duration
* Undergoing regular clean intermittent catheterisation
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centro de Reabilitação e Readaptação Dr. Henrique Santillo
OTHER
Responsible Party
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Ruiter Silva Ferreira
Dr
Principal Investigators
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RUITER S FERREIRA, Dr.
Role: PRINCIPAL_INVESTIGATOR
Division of Urology of State University of Campinas, Division of Urology of Centro de Reabilitaçao e Readapatacao Dr. Henrique Santillo
Locations
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UNICAMP, Division of Urology
Campinas, São Paulo, Brazil
Countries
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References
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Karsenty G, Denys P, Amarenco G, De Seze M, Game X, Haab F, Kerdraon J, Perrouin-Verbe B, Ruffion A, Saussine C, Soler JM, Schurch B, Chartier-Kastler E. Botulinum toxin A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review. Eur Urol. 2008 Feb;53(2):275-87. doi: 10.1016/j.eururo.2007.10.013. Epub 2007 Oct 16.
Related Links
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Related Info
Related Info
Other Identifiers
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OXITBALM
Identifier Type: -
Identifier Source: org_study_id