Clinical trial NCT01337024: Heart Rate Variability (HRV) in Patients With Neurogenic Detrusor Overactivity (NDO) Before and After Botulinum Neurotoxin Type A (BoNT/A) Intradetrusor Injections
Official title: Heart Rate Variability in Patients With Neurogenic Detrusor Overactivity Before and After Botulinum Neurotoxin Type A Intradetrusor Injections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Disorder, Neurogenic
Keywords: HRV
NDO
BoNT/A,
adverse effects
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2011-04-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in frequency and time
timeFrame: 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:
measure: Adverse events related to BoNT/A injection (urinary tract infection, urinary retention, increasing postvoiding urine, need for intermittend catheterization
timeFrame: This outcome measured will be evaluated at visit 4 (six weeks, following the BoNT/A application
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Study officials:
References: