Bladder Disorder, NeurogenicHRV/BotoxNCT01337024
Heart Rate Variability (HRV) in Patients With Neurogenic Detrusor Overactivity (NDO) Before and After Botulinum Neurotoxin Type A (BoNT/A) Intradetrusor Injections
An observational study of Bladder Disorder, Neurogenic, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
Heart rate variability (HRV) is an important indicator of cardiac autonomic function and predictor of cardiac mortality and of all-cause mortality. In this study the investigators examined changes of the HRV in patients with neurogenic detrusor overactivity (NDO) undergoing botulinum neurotoxin type A intradetrusor… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Disorder, Neurogenic
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2010to Mar 2012
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two groups, one control group without treatment, one group with NDO and treated with BoNT/A, both measured with ECG
Who may be able to join
- patient with neurogenic detrusor overactivity
- written informed consent
- Medical indication for BoNT/A injections
- able to learn or conduct clean intermittent self-catheterization
Who cannot join
- No written informed consent
- Pregnancy
- Cancer of infection of the lower urinary tract
- Cardiac pacemaker
- Previous heart attack, angina pectoris
- Medication with effect on HRV
Show all 9Show fewer
- Previous cardiosurgery
- Cardiac arrhythmia
- Skin disease not allowing application of ECG-electrodes
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: Heart Rate Variability in Patients With Neurogenic Detrusor Overactivity Before and After Botulinum Neurotoxin Type A Intradetrusor Injections
Heart rate variability (HRV) is an important indicator of cardiac autonomic function and predictor of cardiac mortality and of all-cause mortality. In this study the investigators examined changes of the HRV in patients with neurogenic detrusor overactivity (NDO) undergoing botulinum neurotoxin type A intradetrusor injections (BoNT/A).
Read the detailed description
BoNT/A is a common treatment in patients with NDO. Possible known side effects are urinary retention or increased post void residual. Systemic side effects seems to be rare. However this has not been investigated in detail. Although in very small amounts, BoNT/A can enter the systemic circulation during intradetrusor injections and might cause distant effects on other neuro-muscular systems, i.e. the heart. Aim of this trial is to asses potential systemic adverse effects of BoNT/A on the heart following intradetrusor injections for NDO. Potential effects on the cardiac autonomic function can be detected using HRV analysis. Patients without relevant preexisting disorders of cardiac function and proven NDO are included. During four separate visits, all subjects receive two ECG measurements before (Visit 1 and 2) and two ECG measurements following BoNT/A intradetrusor injections (Visit 3 and 4). We investigate three different groups: 1) patients not receiving BoNT/A intradetrusor injections (= control group), 2) patients receiving intradetrusor injections with 100 units BoNT/A, and 3) patients receiving intradetrusor injections with 300 units BoNT/A.
- Conditions
- Bladder Disorder, Neurogenic
- Keywords
- HRV, NDO, BoNT/A,, adverse effects
- Medical subject headings
- Urinary Bladder, Neurogenic
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 |
|---|---|---|
| Control group | Healthy volunteers, examined with ECG without any treatment (controls) | |
| 100 BoNT/A | patients with neurogenic detrusor overactivity, examined with ECG, injection of 100 units BoNT/A | |
| 300 BoNT/A | patients with neurogenic detrusor overactivity, examined with ECG, injection of 300 units BoNT/A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in frequency and time
Changes in frequency (low frequency (LF), high frequency (HF), low frequency/highfrequency (LF/HF)) and time (domain parameters. This include the root mean square of differences of successive NN (normal to normal, i.e. interval between two R peaks) intervals (RMSSD), and the standard deviation of the NN intervals (SDNN)
Measured: The outcome measures (VLF, LF and HF, SDNN and RMSSD are measured with an ECG recording during 10 minutes, at four different time points (two times before, and two times following the BoNT/A application
Secondary outcomes (1)
Adverse events related to BoNT/A injection (urinary tract infection, urinary retention, increasing postvoiding urine, need for intermittend catheterization
Measured: This outcome measured will be evaluated at visit 4 (six weeks, following the BoNT/A application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Disorder, NeurogenicStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337024
- Sponsor's protocol ID
- EK09/2008
- Acronym
- HRV/Botox
- Status last verified
- Jan 2013
- First submitted
- 15 Apr 2011
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability in Patients With Neurogenic Detrusor Overactivity Before and After Botulinum Neurotoxin Type A Intradetrusor Injections
- ClinicalTrials.gov ID
- NCT01337024
- Acronym / sponsor ID
- HRV/Botox / EK09/2008
- Conditions
- Bladder Disorder, Neurogenic
- Keywords
- HRV, NDO, BoNT/A,, adverse effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Apr 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.
Heart rate variability (HRV) is an important indicator of cardiac autonomic function and predictor of cardiac mortality and of all-cause mortality. In this study the investigators examined changes of the HRV in patients with neurogenic detrusor overactivity (NDO) undergoing botulinum neurotoxin type A intradetrusor injections (BoNT/A).
Detailed description
BoNT/A is a common treatment in patients with NDO. Possible known side effects are urinary retention or increased post void residual. Systemic side effects seems to be rare. However this has not been investigated in detail. Although in very small amounts, BoNT/A can enter the systemic circulation during intradetrusor injections and might cause distant effects on other neuro-muscular systems, i.e. the heart. Aim of this trial is to asses potential systemic adverse effects of BoNT/A on the heart following intradetrusor injections for NDO. Potential effects on the cardiac autonomic function can be detected using HRV analysis. Patients without relevant preexisting disorders of cardiac function and proven NDO are included. During four separate visits, all subjects receive two ECG measurements before (Visit 1 and 2) and two ECG measurements following BoNT/A intradetrusor injections (Visit 3 and 4). We investigate three different groups: 1) patients not receiving BoNT/A intradetrusor injections (= control group), 2) patients receiving intradetrusor injections with 100 units BoNT/A, and 3) patients receiving intradetrusor injections with 300 units BoNT/A.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Healthy volunteers, examined with ECG without any treatment (controls) |
| 100 BoNT/A | – | –patients with neurogenic detrusor overactivity, examined with ECG, injection of 100 units BoNT/A |
| 300 BoNT/A | – | –patients with neurogenic detrusor overactivity, examined with ECG, injection of 300 units BoNT/A |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups, one control group without treatment, one group with NDO and treated with BoNT/A, both measured with ECG
Key inclusion criteria (4 listed)
- patient with neurogenic detrusor overactivity
- written informed consent
- Medical indication for BoNT/A injections
- able to learn or conduct clean intermittent self-catheterization
Key exclusion criteria (9 listed)
- No written informed consent
- Pregnancy
- Cancer of infection of the lower urinary tract
- Cardiac pacemaker
- Previous heart attack, angina pectoris
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
Changes in frequency and time
Time frame: The outcome measures (VLF, LF and HF, SDNN and RMSSD are measured with an ECG recording during 10 minutes, at four different time points (two times before, and two times following the BoNT/A application
Changes in frequency (low frequency (LF), high frequency (HF), low frequency/highfrequency (LF/HF)) and time (domain parameters. This include the root mean square of differences of successive NN (normal to normal, i.e. interval between two R peaks) intervals (RMSSD), and the standard deviation of the NN intervals (SDNN)
1 secondary outcome
Adverse events related to BoNT/A injection (urinary tract infection, urinary retention, increasing postvoiding urine, need for intermittend catheterization
Time frame: This outcome measured will be evaluated at visit 4 (six weeks, following the BoNT/A application
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 17 May 2016.
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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 Bladder Disorder, Neurogenic, run by Balgrist University Hospital 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 4 inclusion and 9 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 17 May 2016. 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?
Changes in frequency and time (time frame: The outcome measures (VLF, LF and HF, SDNN and RMSSD are measured with an ECG recording during 10 minutes, at four different time points (two times before, and two times following the BoNT/A application). 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 17 May 2016.