Electrophysiologic Mapping of the Bladder

June 2, 2016 updated by: Englewood Hospital and Medical Center

Pilot of Electrophysiologic Mapping of the Urinary Bladder

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All subjects
Electrical mapping of the urinary bladder
Procedure: Electrical mapping of the urinary bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Englewood Hospital and Medical Center

Investigators

  • Principal Investigator: Michael Vardy, MD, Englewood Hospital and Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-13-529

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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