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

Bladder Disorder, Neurogenic Clinical Trial

— HRV/Botox  

Official title:

Heart Rate Variability in Patients With Neurogenic Detrusor Overactivity Before and After Botulinum Neurotoxin Type A Intradetrusor Injections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337024
• Other study ID #: EK09/2008
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: May 16, 2016
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Disorder, Neurogenic
• Urinary Bladder Diseases
• Urinary Bladder, Neurogenic

Locations

Country	Name	City	State
Switzerland	Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Balgrist University Hospital	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in frequency and time	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	No
Secondary	Adverse events related to BoNT/A injection (urinary tract infection, urinary retention, increasing postvoiding urine, need for intermittend catheterization		This outcome measured will be evaluated at visit 4 (six weeks, following the BoNT/A application	No