Heart Rate Variability (HRV) in Patients With Neurogenic Detrusor Overactivity (NDO) Before and After Botulinum Neurotoxin Type A (BoNT/A) Intradetrusor Injections (HRV/Botox)

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Thomas M Kessler, Balgrist University Hospital
ClinicalTrials.gov Identifier:
NCT01337024
First received: April 15, 2011
Last updated: January 7, 2013
Last verified: January 2013
  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
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

Resource links provided by NLM:


Further study details as provided by Balgrist University Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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
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

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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:
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
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014