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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overactive Bladder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with OAB

Patients that will be diagnosed as having OAB syndrome by an urogynecologist based on their clinical symptoms (urinary urgency, with or without urinary urgency incontinence, urinary frequency or nocturia).

ECG recording

Intervention Type PROCEDURE

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

Interventions

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ECG recording

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

Intervention Type PROCEDURE

Other Intervention Names

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Electro cardiogram recording

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No