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

NCT01337024 | Completed

• 1 other identifier: EK09/2008
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bladder Disorder, Neurogenic

Keywords

HRV; NDO; BoNT/A,; adverse effects

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• patient with neurogenic detrusor overactivity
• written informed consent
• Medical indication for BoNT/A injections
• able to learn or conduct clean intermittent self-catheterization

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

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

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 18, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 17, 2016

Record last verified: 2013-01

Locations

CH (1)