Neurogenic BladderNCT03388086
Efficacy of Two Onabotulinum Toxin Doses
An observational study of Neurogenic Bladder and Overactive Detrusor, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The changes in bladder function after the injection of Onabotulinum toxin into the detrusor in individuals with neurogenic bladder overactivity will be investigated retrospectively. The records of all patients treated with Onabotulinum toxin injections into the detrusor since 2000 will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neurogenic Bladder, Overactive Detrusor
- What is being tested?
- Injection of Onabotulinum toxin
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2018to 31 Jul 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated with Onabotulinum toxin for neurogenic detrusor overactivity as a result of spinal cord injury
Who may be able to join
- neurogenic detrusor overactivity
- spinal cord injury
- Onabotulinum toxin injections into the detrusor from 2000-2017
Who cannot join
- missing urodynamic values before or after Onabotulinum toxin injections
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Comparing the Efficacy of Two Doses of Onabotulinum Toxin for the Treatment of Neurogenic Detrusor Overactivity - a Retrospective Cohort Study
The changes in bladder function after the injection of Onabotulinum toxin into the detrusor in individuals with neurogenic bladder overactivity will be investigated retrospectively. The records of all patients treated with Onabotulinum toxin injections into the detrusor since 2000 will be evaluated. The changes in the urodynamic values after the injection of 300 units of Onabotulinum toxin will be compared with the changes after the injection of 200 units. Furthermore, the differences in urinary continence, duration between injections, side effects and complications between the two groups will be investigated.
- Conditions
- Neurogenic Bladder, Overactive Detrusor
- Being tested
- Injection of Onabotulinum toxin
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of Onabotulinum toxinDrug
multiple injections of Onabotulinum toxin into the detrusor muscle
| Study group | Role | What they receive |
|---|---|---|
| Onabotulinum 300 units | Not described Receives: Drug: Injection of Onabotulinum toxin | |
| Onabotulinum 200 units | Not described Receives: Drug: Injection of Onabotulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in detrusor pressure post-injection
bladder detrusor pressure during storage phase
Measured: within 3 months before injection; within 2 months after injection
Secondary outcomes (5)
maximum bladder volume
Measured: within 3 months before injection; within 2 months after injection
bladder compliance
The relationship between a change in bladder volume and the change in detrusor pressure (ΔDV/ΔDP).
Measured: within 3 months before injection; within 2 months after injection
reflexive bladder volume
Measured: within 3 months before injection; within 2 months after injection
complications
Measured: within 2 months after injection
presence of urinary incontinence
Measured: within 3 months before injection; within 2 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Feb 2018
- Primary completion30 Apr 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388086
- Sponsor's protocol ID
- 2017-17
- Status last verified
- Aug 2019
- First submitted
- 13 Dec 2017
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Two Doses of Onabotulinum Toxin for the Treatment of Neurogenic Detrusor Overactivity - a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03388086
- Acronym / sponsor ID
- 2017-17
- Conditions
- Neurogenic Bladder, Overactive Detrusor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 2 Jan 2018 (actual)
- 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 changes in bladder function after the injection of Onabotulinum toxin into the detrusor in individuals with neurogenic bladder overactivity will be investigated retrospectively. The records of all patients treated with Onabotulinum toxin injections into the detrusor since 2000 will be evaluated. The changes in the urodynamic values after the injection of 300 units of Onabotulinum toxin will be compared with the changes after the injection of 200 units. Furthermore, the differences in urinary continence, duration between injections, side effects and complications between the two groups will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onabotulinum 300 units | – | Drug: Injection of Onabotulinum toxin |
| Onabotulinum 200 units | – | Drug: Injection of Onabotulinum toxin |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with Onabotulinum toxin for neurogenic detrusor overactivity as a result of spinal cord injury
Key inclusion criteria (3 listed)
- neurogenic detrusor overactivity
- spinal cord injury
- Onabotulinum toxin injections into the detrusor from 2000-2017
Key exclusion criteria (1 listed)
- missing urodynamic values before or after Onabotulinum toxin injections
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 |
|---|---|---|
| Injection of Onabotulinum toxinmultiple injections of Onabotulinum toxin into the detrusor muscle | Drug | Onabotulinum 200 units, Onabotulinum 300 units |
Primary outcome
change in detrusor pressure post-injection
Time frame: within 3 months before injection; within 2 months after injection
bladder detrusor pressure during storage phase
5 secondary outcomes
maximum bladder volume
Time frame: within 3 months before injection; within 2 months after injection
bladder compliance
Time frame: within 3 months before injection; within 2 months after injection
reflexive bladder volume
Time frame: within 3 months before injection; within 2 months after injection
complications
Time frame: within 2 months after injection
presence of urinary incontinence
Time frame: within 3 months before injection; within 2 months after injection
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 6 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neurogenic Bladder and Overactive Detrusor, run by Swiss Paraplegic Research, Nottwil 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 3 inclusion and 1 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 6 Aug 2019. 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?
change in detrusor pressure post-injection (time frame: within 3 months before injection; within 2 months after injection). 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 6 Aug 2019.