- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01477736
A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
November 19, 2011 updated by: Ruiter Silva Ferreira, Centro de Reabilitação e Readaptação Dr. Henrique Santillo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sao Paulo
-
Campinas, Sao Paulo, Brazil, 13083887
- UNICAMP, Division of Urology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Botulinum toxin A
|
5 mg of immediate-release oxybutynin orally 3 times daily
300 U intradetrusor injection
|
Active Comparator: oxybutynin
|
5 mg of immediate-release oxybutynin orally 3 times daily
300 U intradetrusor injection
|
What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: Beginning and 24 weeks of the study
|
Beginning and 24 weeks of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire
Time Frame: Beginning and 24 weeks of the study
|
Beginning and 24 weeks of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: RUITER S FERREIRA, Dr., Division of Urology of State University of Campinas, Division of Urology of Centro de Reabilitaçao e Readapatacao Dr. Henrique Santillo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
November 19, 2011
First Submitted That Met QC Criteria
November 19, 2011
First Posted (Estimate)
November 22, 2011
Study Record Updates
Last Update Posted (Estimate)
November 22, 2011
Last Update Submitted That Met QC Criteria
November 19, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Spinal Cord Injuries
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Oxybutynin
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- OXITBALM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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