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
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|