Heart Rate Variability (HRV) in Patients With Neurogenic Detrusor Overactivity (NDO) Before and After Botulinum Neurotoxin Type A (BoNT/A) Intradetrusor Injections (HRV/Botox)
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Purpose
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).
| Condition |
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Bladder Disorder, Neurogenic |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Heart Rate Variability in Patients With Neurogenic Detrusor Overactivity Before and After Botulinum Neurotoxin Type A Intradetrusor Injections |
- 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 ] [ Designated as safety issue: No ]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)
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | March 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Control group
Healthy volunteers, examined with ECG without any treatment (controls)
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100 BoNT/A
patients with neurogenic detrusor overactivity, examined with ECG, injection of 100 units BoNT/A
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300 BoNT/A
patients with neurogenic detrusor overactivity, examined with ECG, injection of 300 units BoNT/A
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Two groups, one control group without treatment, one group with NDO and treated with BoNT/A, both measured with ECG
Inclusion Criteria:
- patient with neurogenic detrusor overactivity
- written informed consent
- Medical indication for BoNT/A injections
- able to learn or conduct clean intermittent self-catheterization
Exclusion Criteria:
- 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
- Previous cardiosurgery
- Cardiac arrhythmia
- Skin disease not allowing application of ECG-electrodes
Contacts and Locations| Switzerland | |
| Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital | |
| Zürich, Switzerland, 8008 | |
More Information
No publications provided
| Responsible Party: | Thomas M Kessler, executive physician, Balgrist University Hospital |
| ClinicalTrials.gov Identifier: | NCT01337024 History of Changes |
| Other Study ID Numbers: | EK09/2008 |
| Study First Received: | April 15, 2011 |
| Last Updated: | January 7, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by Balgrist University Hospital:
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HRV NDO BoNT/A, adverse effects |
Additional relevant MeSH terms:
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Urinary Bladder Diseases Urinary Bladder, Neurogenic Urologic Diseases Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Botulinum Toxins, Type A Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013