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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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ClinicalTrials.gov Identifier: NCT01337024
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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 injections (BoNT/A).

Condition or disease
Bladder Disorder, Neurogenic

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

Study Type : Observational
Actual Enrollment : 36 participants
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
Study Start Date : March 2010
Primary Completion Date : March 2012
Study Completion Date : March 2012

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Two groups, one control group without treatment, one group with NDO and treated with BoNT/A, both measured with ECG
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337024


Locations
Switzerland
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zürich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
Swiss National Science Foundation
More Information

Responsible Party: Thomas M. Kessler, PD Dr. med., Neuro Urology, Spinal Cord Injury Center & Research, University of Zurich, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT01337024     History of Changes
Other Study ID Numbers: EK09/2008
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: January 2013

Keywords provided by Balgrist University Hospital:
HRV
NDO
BoNT/A,
adverse effects

Additional relevant MeSH terms:
Urinary Bladder Diseases
Urinary Bladder, Neurogenic
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents