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

• Conditions: Overactive Bladder
• Interventions: Procedure: ECG recording

• Registration Number: NCT01409512
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-03
• Last Update Submitted: 2011-08-03
• Study First Posted: 2011-08-04
• Last Update Posted: 2011-08-04
• Study Start: 2011-09
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with OAB	ECG recording	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).

Primary Outcome Measures

Name	Time	Method
Changes in heart variability following treatment with Solifenacin succinate 10 mg	24 months

Secondary Outcome Measures

Name	Time	Method
Correlation between changes in clinical symptoms of OAB abd changes in heart rate variability	24 months

Trial Locations

Locations (1)

Zvolon Medical Center; 🇮🇱 Haifa, Israel