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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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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).

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Detailed Description

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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

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Bladder Disorder, Neurogenic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

Healthy volunteers, examined with ECG without any treatment (controls)

No interventions assigned to this group

100 BoNT/A

patients with neurogenic detrusor overactivity, examined with ECG, injection of 100 units BoNT/A

No interventions assigned to this group

300 BoNT/A

patients with neurogenic detrusor overactivity, examined with ECG, injection of 300 units BoNT/A

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes