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

Overactive Bladder Clinical Trial

Official title:

Observational Study on the Effect of Anticholinergic on the Autonomic System in Women With OAB

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01409512
• Other study ID #: 117/2011
• Status: Not yet recruiting
• Phase: N/A
• First received: August 3, 2011
• Last updated: August 3, 2011
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: August 2011
• Source: Rambam Health Care Campus
• Contact: Dalia Kesner, MD
• Email: DALIAKE[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Procedure:
• ECG recording
At baseline and following 3 months on anticholinergic medications patients, ECG recording will be conducted.

Locations

Country	Name	City	State
Israel	Zvolon Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Hubeaux K, Deffieux X, Ismael SS, Raibaut P, Amarenco G. Autonomic nervous system activity during bladder filling assessed by heart rate variability analysis in women with idiopathic overactive bladder syndrome or stress urinary incontinence. J Urol. 2007 Dec;178(6):2483-7. Epub 2007 Oct 15. — View Citation

Liao WC, Jaw FS. A noninvasive evaluation of autonomic nervous system dysfunction in women with an overactive bladder. Int J Gynaecol Obstet. 2010 Jul;110(1):12-7. doi: 10.1016/j.ijgo.2010.03.007. Epub 2010 Apr 25. — View Citation

Mehnert U, Knapp PA, Mueller N, Reitz A, Schurch B. Heart rate variability: an objective measure of autonomic activity and bladder sensations during urodynamics. Neurourol Urodyn. 2009;28(4):313-9. doi: 10.1002/nau.20641. — View Citation

Schiffers M, Sauermann P, Schurch B, Mehnert U. The effect of tolterodine 4 and 8 mg on the heart rate variability in healthy subjects. World J Urol. 2010 Oct;28(5):651-6. doi: 10.1007/s00345-010-0513-y. Epub 2010 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in heart variability following treatment with Solifenacin succinate 10 mg		24 months	No
Secondary	Correlation between changes in clinical symptoms of OAB abd changes in heart rate variability		24 months	No