Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder
Recruitment status was Not yet recruiting
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Observational Study on the Effect of Anticholinergic on the Autonomic System in Women With OAB|
- Changes in heart variability following treatment with Solifenacin succinate 10 mg [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Correlation between changes in clinical symptoms of OAB abd changes in heart rate variability [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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).
Procedure: ECG recording
At baseline and following 3 months on anticholinergic medications patients, ECG recording will be conducted.
Other Name: Electro cardiogram recording
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409512
|Contact: Dalia Kesner, MD||DALIAKE@clalit.org.il|
|Contact: Lior Lowenstein, MD||0502061434||Lowensteinmd@gmail.com|
|Zvolon Medical Center||Not yet recruiting|
|Haifa, Israel, 34987|
|Contact: Lior Lowenstein, MD 97248542612 LowensteinMD@gmail.com|
|Principal Investigator: Dalia Kesner, MD|
|Sub-Investigator: Lior Lowenstein, MD|
|Sub-Investigator: Eyal Goldshmith, MD|
|Sub-Investigator: Talma Rosen, RN|
|Study Chair:||Lior Lowensrtein, MD||Rambam Health Care Campus|