Spinal Cord InjuryNCT01477736
A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
A study testing Oxybutynin and Botulinum toxin A in people with Spinal Cord Injury, run by Centro de Reabilitação e Readaptação Dr. Henrique Santillo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Oxybutynin and Botulinum toxin A
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury
- Detrusor overactivity
- Age over 18 years
- Spinal cord injury at least 12 months duration
- Undergoing regular clean intermittent catheterisation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinal Cord Injury
- Being tested
- Oxybutynin, Botulinum toxin A
- Keywords
- Neurogenic bladder, Urodynamic, Quality of life
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninDrug
5 mg of immediate-release oxybutynin orally 3 times daily
Botulinum toxin ADrug
300 U intradetrusor injection
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin A | Active comparator | Not described Receives: Drug: Oxybutynin; Drug: Botulinum toxin A |
| oxybutynin | Active comparator | Not described Receives: Drug: Oxybutynin; Drug: Botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Beginning and 24 weeks of the study
Secondary outcomes (1)
The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire
Measured: Beginning and 24 weeks of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Reabilitação e Readaptação Dr. Henrique Santillo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruiter Silva Ferreira, Centro de Reabilitação e Readaptação Dr. Henrique Santillo
- Investigators
- RUITER S FERREIRA, Dr., Principal investigator, Division of Urology of State University of Campinas, Division of Urology of Centro de Reabilitaçao e Readapatacao Dr. Henrique Santillo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477736
- Sponsor's protocol ID
- OXITBALM
- Status last verified
- Nov 2011
- First submitted
- 19 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17988791
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT01477736
- Acronym / sponsor ID
- OXITBALM
- Conditions
- Spinal Cord Injury
- Keywords
- Neurogenic bladder, Urodynamic, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centro de Reabilitação e Readaptação Dr. Henrique SantilloUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A | Active comparator | Drug: Oxybutynin, Drug: Botulinum toxin A |
| oxybutynin | Active comparator | Drug: Oxybutynin, Drug: Botulinum toxin A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Spinal cord injury
- Detrusor overactivity
- Age over 18 years
- Spinal cord injury at least 12 months duration
- Undergoing regular clean intermittent catheterisation
Key exclusion criteria (7 listed)
- Pregnancy
- Desire to become pregnant during the study period
- Breastfeeding
- Blood coagulation disorder
- Neuromuscular transmission disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxybutynin5 mg of immediate-release oxybutynin orally 3 times daily | Drug | Botulinum toxin A, oxybutynin |
| Botulinum toxin A300 U intradetrusor injection | Drug | Botulinum toxin A, oxybutynin |
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
Time frame: Beginning and 24 weeks of the study
1 secondary outcome
The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire
Time frame: Beginning and 24 weeks of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Background: PubMed 17988791Karsenty 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 InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RUITER S FERREIRA, Dr. principal investigator
Division of Urology of State University of Campinas, Division of Urology of Centro de Reabilitaçao e Readapatacao Dr. Henrique Santillo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxybutynin and Botulinum toxin A in people with Spinal Cord Injury, run by Centro de Reabilitação e Readaptação Dr. Henrique Santillo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.