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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01409512
First received: August 3, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Overactive Bladder
Procedure: ECG recording

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Changes in heart variability following treatment with Solifenacin succinate 10 mg [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between changes in clinical symptoms of OAB abd changes in heart rate variability [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
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)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients were 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).

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409512

Contacts
Contact: Dalia Kesner, MD DALIAKE@clalit.org.il
Contact: Lior Lowenstein, MD 0502061434 Lowensteinmd@gmail.com

Locations
Israel
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         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Chair: Lior Lowensrtein, MD Rambam Health Care Campus
  More Information

Publications:
Responsible Party: Dalia Kesner, Kupat Hulim Clalit
ClinicalTrials.gov Identifier: NCT01409512     History of Changes
Other Study ID Numbers: 117/2011
Study First Received: August 3, 2011
Last Updated: August 3, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
Heart rate variability, anti cholinergic medication

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014