Electrophysiologic Mapping of the Bladder
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|ClinicalTrials.gov Identifier: NCT02041442|
Recruitment Status : Terminated (study to be redesigned based on initial results)
First Posted : January 22, 2014
Last Update Posted : June 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Electrical Evaluation of Urinary Bladder||Procedure: Electrical mapping of the urinary bladder||Not Applicable|
This pilot study is looking at the possibility of adapting some of the tools and techniques used by cardiac electrophysiologists (doctors specializing in the electrical activity of the heart) to help diagnose and treat Overactive Bladder. The rationale for this approach is based on the similarities of the two organs. In simple terms, the heart and bladder are both hollow muscular organs that expand and contract to hold and move fluid.
In an electrophysiology study looking at cardiac (heart) arrhythmia (irregular heartbeat), the cardiologist places one or more electrode catheters (thin hollow tube with an electrical conductor on the end) through a vein or artery in the leg or arm to contact heart tissue. By recording the electrical activity at multiple sites of the heart, the catheter allows for mapping of the electrical activity and the arrhythmia mechanism.
In this study, investigators will use the same electrode catheter to contact bladder tissue, introduce a low frequency current, and map the electrical activity of the bladder. A sterile cardiac electrical mapping catheter will be used to make contact with the walls of the bladder and introduce a low frequency current starting with the trigone and then the four quadrants of the dome. Electrical activity will be recorded for each volumetric milestone at each location. It is hoped that the information from this electrophysiological testing of the bladder may eventually lead to treatment of areas of electrical abnormality of interest. No actual treatment of the bladder will be done as part of this pilot study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot of Electrophysiologic Mapping of the Urinary Bladder|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: All subjects
Electrical mapping of the urinary bladder
Procedure: Electrical mapping of the urinary bladder
- Change in electrical activity [ Time Frame: 3 months ]goal of this pilot study is to determine whether electrical activity can be recorded from different areas of the bladder using cardiac surface electrodes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041442
|United States, New Jersey|
|Englewood Hospital and Medical Center|
|Englewood, New Jersey, United States, 07631|
|Principal Investigator:||Michael Vardy, MD||Englewood Hospital and Medical Center|