Overactive Bladder SyndromeNCT01042119
Intravesical Injection of Botox for Treating Therapy Refractory Overactive Bladder in Females
An observational study of Overactive Bladder Syndrome, run by University of Zurich at 1 site in Switzerland.
Trial summary
The neurotoxin Botox (botulinum neurotoxin type A) is shown to be effective in the treatment of therapy refractory overactive bladder syndrome. Our data suggests a longer during efficacy than known from the use in striated muscle. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Jun 2010
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients who received at our clinic treatment with intravesical injection of Botox for idiopathic overactive bladder syndrome
Who may be able to join
- intravesical treatment with Botox at our clinic
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich, Clinic for Gynaecology
Zurich, 8091
About this study
Official title: Short- and Longterm Results After Intravesical Injection of Botulinum Neurotoxin Type A for Treating Therapy Refractory Overactive Bladder in Females - a Retrospective Study
The neurotoxin Botox (botulinum neurotoxin type A) is shown to be effective in the treatment of therapy refractory overactive bladder syndrome. Our data suggests a longer during efficacy than known from the use in striated muscle.
The aim of our study is to analyze short- and longterm efficacy after Botox treatment and to evaluate risk factors for non-responders and side effects such as urinary retention.
- Conditions
- Overactive Bladder Syndrome
- Keywords
- botulinum neurotoxin type A, BoNT/A, Botox, overactive bladder syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Botox | patients who received intravesical injections of botulinum neurotoxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of effect of Botox
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- David A Scheiner, MD, Principal investigator, University Hospital of Zurich, Clinic for Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042119
- Sponsor's protocol ID
- FHKUSZ15-2009
- Status last verified
- Jun 2010
- First submitted
- 4 Jan 2010
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Longterm Results After Intravesical Injection of Botulinum Neurotoxin Type A for Treating Therapy Refractory Overactive Bladder in Females - a Retrospective Study
- ClinicalTrials.gov ID
- NCT01042119
- Acronym / sponsor ID
- FHKUSZ15-2009
- Conditions
- Overactive Bladder Syndrome
- Keywords
- botulinum neurotoxin type A, BoNT/A, Botox, overactive bladder syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Jan 2010 (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 neurotoxin Botox (botulinum neurotoxin type A) is shown to be effective in the treatment of therapy refractory overactive bladder syndrome. Our data suggests a longer during efficacy than known from the use in striated muscle.
The aim of our study is to analyze short- and longterm efficacy after Botox treatment and to evaluate risk factors for non-responders and side effects such as urinary retention.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botox | – | –patients who received intravesical injections of botulinum neurotoxin type A |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who received at our clinic treatment with intravesical injection of Botox for idiopathic overactive bladder syndrome
Key inclusion criteria (1 listed)
- intravesical treatment with Botox at our clinic
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
duration of effect of Botox
Time frame: 1 year
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 24 Jun 2010.
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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.
David A Scheiner, MD principal investigator
University Hospital of Zurich, Clinic for Gynaecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome, run by University of Zurich at 1 site in Switzerland.
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 0 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 24 Jun 2010. 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 Switzerland. 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?
duration of effect of Botox (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2010.