The goal of the study is to investigate the difference between heart rate variability in patients with overactive bladder and patients with stress incontinence without overactive bladder, and also the difference in heart rate variability with empty…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in LF/HF ratio between patients with IOAB and SUI
Difference in LF/HF between full and empty bladder in patients in both groups
Secondary outcome
Difference in total power (TP), SDNN, RMSSD, VLF, HF and LF between patients
with IOAB and SUI
Difference in total power (TP), SDNN, RMSSD, VLF, HF and LF between full and
empty bladder in patients in both groups
Background summary
Symptoms of overactive bladders syndrome are: frequency, urgency, nyctuia, with
or without incontinence. The cause of idiopathic overactive bladder syndrome is
unknown. There are indications pointing to a dysbalance of the autonomic nerve
system. Previous studies have shown an overactivity of the parasympathethic
system with empty bladder and overactivity of the sympathethic system with full
bladder. In patients with stress incontinence there was a lack of sympathethic
activity with full bladder.
The heart rate normally varies from beat to beat en the extent of variability
reflects cardiac condition, but also the balance of the autonomous nerve
system. Variability of the heart rate can be calculated with special software
from a simple ECG.
Study objective
The goal of the study is to investigate the difference between heart rate
variability in patients with overactive bladder and patients with stress
incontinence without overactive bladder, and also the difference in heart rate
variability with empty bladder and full bladder in these two groups.
Study design
The study will be performed in female patients diagnosed with overactive
bladder or stress incontinence.
A ten minute ECG will be performed in rest with empty bladder (just after
voiding). Then the patient will be offered some drinks en when she has the
feeling of a full bladder (urge to void), the second ECG will be recorded.
Imediately afterwards the patient is allowed to void and the voided volume will
be measured.
The ECG will be analysed according to the time domain method and the frequency
domain method. The following parameters will be determined: total power, SDNN,
RMSSD, the very low frequency (VLF) band, thelow frequency (LF) band and
thehigh frequency (HF) band, The ration between LF and HF is a measure of
autonomic nerve system balance.
Study burden and risks
During one visits 2 ECG's will be recorded. The time span between the 2 ECG's
will depend on the speed of bladder filling. In between the measurements the
patient is free to do an activity of choice. The ECG is not burdensome,
invasive or harmful. Use of caffeine containing drinks and physical exercise
are discouraged before the measurements.
heidelberglaan 100
3584 cx utrecht
NL
heidelberglaan 100
3584 cx utrecht
NL
Listed location countries
Age
Inclusion criteria
Female sex
Age 18 - 75 years
Diagnosis of idiopathic overactive bladder or stress incontinence
Exclusion criteria
Antimuscarinic medication
Neurologic disease
cardiac disease
Medication influencing heart rate
Pregnancy
Urinary tract infection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33014.041.10 |