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Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder

Observational Study on the Effect of Anticholinergic on the Autonomic System in Women With OAB

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01409512
Enrollment
30
Registered
2011-08-04
Start date
2011-09-30
Completion date
2013-09-30
Last updated
2011-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Heart rate variability, anti cholinergic medication

Brief summary

The aim of the study is to evaluate changes in autonomic nervous system following treatment with anticholinergic medication for OAB symptoms. Heart variability as a measure of the functioning of the autonomic nervous system will be recorded before and three months following treatment with solifenacin succinate 10 mg daily.

Detailed description

30 women with clinical diagnosis of overactive bladder will be recruited for the study. An ECG strip for fifteen minutes at rest will be recorded through a 12-bit analog/digital data acquisition card (National Instruments, Austin TX) with a sampling frequency of 200 Hz and stored in a computer for offline studies. The digitized ECG signals will than processed and analyzed via dedicated robust software to detect the R wave peaks. The R point of each QRS complex was defined and the interval between two consecutive R points (the R-R interval) was computed. All R-R intervals will be visually inspected and manually edited if necessary to exclude background noise and artifacts. The edited segments accounts for less than 1% in each patient. A clean 2-5-min segment (preferably unedited) will be used for the analyses. An autoregressive model with the order of 16 was will be used to estimate the power spectrum densities of HRV. The power spectra are quantified by measuring the area under the following frequency bands: low-frequency (LF) (0.04-0.15 Hz) known to represents sympathetic activity, and high-frequency (HF) (0.15-0.4 Hz) which represents parasympathetic activity.

Interventions

PROCEDUREECG recording

At baseline and following 3 months on anticholinergic medications patients, ECG recording will be conducted.

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Clinical diagnosis of OAB

Exclusion criteria

1\) stress urinary incontinence and voiding symptoms, 2) pregnancy, 3) pathological conditions that can interfere with the ANS, (e.g. coronary heart disease, heart failure, or other cardiac conditions, hypertension, neurological diseases or diabetes , 4) medications that can interfere with the ANS, including beta-receptor agonists or antagonists, antiarrhythmic agents or antihypertensive drugs, anticholinergic agents or adrenergic alpha-antagonists, tricyclic or serotoninergic antidepressants.

Design outcomes

Primary

MeasureTime frame
Changes in heart variability following treatment with Solifenacin succinate 10 mg24 months

Secondary

MeasureTime frame
Correlation between changes in clinical symptoms of OAB abd changes in heart rate variability24 months

Countries

Israel

Contacts

Primary ContactDalia Kesner, MD
DALIAKE@clalit.org.il
Backup ContactLior Lowenstein, MD
Lowensteinmd@gmail.com0502061434

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026