NCT01409512

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 4, 2011

Status Verified

August 1, 2011

Enrollment Period

2 years

First QC Date

August 3, 2011

Last Update Submit

August 3, 2011

Conditions

Overactive Bladder

Keywords

Heart rate variability, anti cholinergic medication

Outcome Measures

Primary Outcomes (1)

  • Changes in heart variability following treatment with Solifenacin succinate 10 mg

    24 months

Secondary Outcomes (1)

  • Correlation between changes in clinical symptoms of OAB abd changes in heart rate variability

    24 months

Study Arms (1)

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

Interventions

ECG recordingPROCEDURE

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

Also known as: Electro cardiogram recording
Women with OAB

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Clinical diagnosis of OAB

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zvolon Medical Center

Haifa, 34987, Israel

Location

Related Publications (4)

  • 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.

    PMID: 19058189BACKGROUND

  • 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.

    PMID: 20423739BACKGROUND

  • 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.

    PMID: 20140437BACKGROUND

  • 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. doi: 10.1016/j.juro.2007.08.036. Epub 2007 Oct 15.

    PMID: 17937953BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lior Lowensrtein, MD

    Rambam Health Care Campus

    STUDY CHAIR

Central Study Contacts

Dalia Kesner, MD

CONTACT

DALIAKE@clalit.org.il

Lior Lowenstein, MD

CONTACT

0502061434Lowensteinmd@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 4, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

August 4, 2011

Record last verified: 2011-08

Locations

IL(1)