A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Information source: Centro de Reabilitação e Readaptação Dr. Henrique Santillo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Cord Injury
Intervention: Oxybutynin (Drug); Botulinum toxin A (Drug)
Phase: N/A
Status: Completed
Sponsored by: Centro de Reabilitação e Readaptação Dr. Henrique Santillo Official(s) and/or principal investigator(s): RUITER S FERREIRA, Dr., Principal Investigator, Affiliation: Division of Urology of State University of Campinas, Division of Urology of Centro de Reabilitaçao e Readapatacao Dr. Henrique Santillo
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.
Clinical Details
Official title: A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
UNICAMP, Division of Urology, Campinas, Sao Paulo 13083887, Brazil
Additional Information
Related publications: Karsenty G, Denys P, Amarenco G, De Seze M, Gamé 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. Epub 2007 Oct 16. Review.
Starting date: January 2009
Last updated: November 19, 2011
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