Overactive BladderPhase 2NCT00213577
NEUROTOX: Two Dosages of Type A Botulinic Toxin in Neurogenic Overactive Bladder
A Phase 2 study testing type A botulinum toxin in people with Overactive Bladder, run by University Hospital, Rouen at 1 site in France.
Trial summary
The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- type A botulinum toxin
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2003to Oct 2007
- Phase
- Phase 2
- 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
- Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic
Who cannot join
- Pregnancy
- Bladder cancer
- Symptomatic urinary infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Tolerance of 2 Dosages of Type A Botulinic Toxin in Neurogenic Areactive Bladder Resistant to Oral Medical Treatment
The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.
- Conditions
- Overactive Bladder
- Being tested
- type A botulinum toxin
- Keywords
- overactive neurogenic bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
type A botulinum toxinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
complete urinary continence at baseline, and days 30, 90, 180, and 360
Secondary outcomes (4)
number of mictions or self catheterizations a day
number of leakages, urgency adverse events
guarding times
urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionSep 2007
- Study completionOct 2007
Why it stopped: the study has concluded normally;
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 Overactive BladderStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Investigators
- Philippe GRISE, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213577
- Sponsor's protocol ID
- 2003/112/HP
- Status last verified
- Mar 2015
- First submitted
- 13 Sep 2005
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grise P, Ruffion A, Denys P, Egon G, Chartier Kastler E. Efficacy and tolerability of botulinum toxin type A in patients with neurogenic detrusor overactivity and without concomitant anticholinergic therapy: comparison of two doses. Eur Urol. 2010 Nov;58(5):759-66. doi: 10.1016/j.eururo.2010.06.035. Epub 2010 Jul 3.
PubMed 20674149
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerance of 2 Dosages of Type A Botulinic Toxin in Neurogenic Areactive Bladder Resistant to Oral Medical Treatment
- ClinicalTrials.gov ID
- NCT00213577
- Acronym / sponsor ID
- 2003/112/HP
- Conditions
- Overactive Bladder
- Keywords
- overactive neurogenic bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study has concluded normally;
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 21 Sep 2005 (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 determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic
Key exclusion criteria (3 listed)
- Pregnancy
- Bladder cancer
- Symptomatic urinary infection
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 |
|---|---|---|
| type A botulinum toxin | Drug | – |
Primary outcome
complete urinary continence at baseline, and days 30, 90, 180, and 360
4 secondary outcomes
number of mictions or self catheterizations a day
number of leakages, urgency adverse events
guarding times
urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure
Results and safety
The study was stopped early (reason given: the study has concluded normally;). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Derived from this study: PubMed 20674149Grise P, Ruffion A, Denys P, Egon G, Chartier Kastler E. Efficacy and tolerability of botulinum toxin type A in patients with neurogenic detrusor overactivity and without concomitant anticholinergic therapy: comparison of two doses. Eur Urol. 2010 Nov;58(5):759-66. doi: 10.1016/j.eururo.2010.06.035. Epub 2010 Jul 3.
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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.
Philippe GRISE, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing type A botulinum toxin in people with Overactive Bladder, run by University Hospital, Rouen at 1 site in France.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 24 Mar 2015. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the study has concluded normally;). Results are not available in the source record.
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?
complete urinary continence at baseline, and days 30, 90, 180, and 360. 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 NCT00213577, 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 24 Mar 2015.