NCT01409512

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
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder

Interventions

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

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-08-04
• Last updated: 2011-08-04

Locations

1 site across 1 country: Israel