Skip to main content
OpenTrials
Completed

NCT Number: NCT01337024

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bladder Disorder, Neurogenic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Zurich, Canton of Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: HRV/Botox

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 18, 2011
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.