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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
Sponsor:
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

Brief Summary:
The hypothesis is that the intrinsic electrical activity of the urinary bladder in response to filling is detectable and can be mapped. This is a pilot study to evaluate the feasibility of using cardiac electrical mapping catheters to measure bladder voltage in patients at the time of routine urodynamic and cystoscopic evaluation.

Condition or disease Intervention/treatment Phase
Electrical Evaluation of Urinary Bladder Procedure: Electrical mapping of the urinary bladder Not Applicable

Detailed Description:

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)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
Experimental: All subjects
Electrical mapping of the urinary bladder
Procedure: Electrical mapping of the urinary bladder



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is a female > = 18 years old.
  • Subject is willing and able to provide informed consent.
  • Subject has subjective and objective evidence for urinary urgency (with or without incontinence), stress incontinence, or mixed incontinence (with features of both urgency and stress).
  • Subject requires urodynamic/cystoscopic studies to complete their workup.

Exclusion Criteria:

  • Active urinary tract infection
  • Pregnant women
  • Patients on anticholinergic medicine for overactive bladder
  • Patients with history of intravesical botulinum toxin injections
  • Patients with a sacral neuromodulator implant
  • Patients with a history of urinary tract malignancy

Information from the National Library of Medicine

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


Locations
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Sponsors and Collaborators
Englewood Hospital and Medical Center
Investigators
Principal Investigator: Michael Vardy, MD Englewood Hospital and Medical Center

Additional Information:
Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT02041442     History of Changes
Other Study ID Numbers: E-13-529
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016

Keywords provided by Englewood Hospital and Medical Center:
overactive bladder
cystoscopy