A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Oxybutynin
Botulinum toxin A
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Neurogenic bladder, Urodynamic, Quality of life
Eligibility 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
Sites / Locations
- UNICAMP, Division of Urology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Botulinum toxin A
oxybutynin
Arm Description
Outcomes
Primary Outcome Measures
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 Measures
The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire
Full Information
NCT ID
NCT01477736
First Posted
November 19, 2011
Last Updated
November 19, 2011
Sponsor
Centro de Reabilitação e Readaptação Dr. Henrique Santillo
1. Study Identification
Unique Protocol Identification Number
NCT01477736
Brief Title
A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Official Title
A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro de Reabilitação e Readaptação Dr. Henrique Santillo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Neurogenic bladder, Urodynamic, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin A
Arm Type
Active Comparator
Arm Title
oxybutynin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Intervention Description
5 mg of immediate-release oxybutynin orally 3 times daily
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A
Intervention Description
300 U intradetrusor injection
Primary Outcome Measure Information:
Title
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
Time Frame
Beginning and 24 weeks of the study
Secondary Outcome Measure Information:
Title
The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire
Time Frame
Beginning and 24 weeks of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RUITER S FERREIRA, Dr.
Organizational Affiliation
Division of Urology of State University of Campinas, Division of Urology of Centro de Reabilitaçao e Readapatacao Dr. Henrique Santillo
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNICAMP, Division of Urology
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083887
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
17988791
Citation
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.
Results Reference
background
Links:
URL
http://crer.org.br
Description
Related Info
URL
http://fcm.unicamp.br
Description
Related Info
Learn more about this trial
A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
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