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

May 16, 2016 updated by: Balgrist University Hospital

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8008
        • Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Time Frame
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
This outcome measured will be evaluated at visit 4 (six weeks, following the BoNT/A application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Collaborators

Swiss National Science Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (ESTIMATE)

April 18, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK09/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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