Electrophysiologic Mapping of the Bladder

NCT ID: NCT02041442

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-06-30

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.

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.

Conditions

Electrical Evaluation of Urinary Bladder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All subjects

Electrical mapping of the urinary bladder

Group Type: EXPERIMENTAL

Electrical mapping of the urinary bladder

Intervention Type: PROCEDURE

Interventions

Electrical mapping of the urinary bladder

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Englewood Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Vardy, MD

Role: PRINCIPAL_INVESTIGATOR

Englewood Hospital and Medical Center

Locations

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Countries

United States

Other Identifiers

E-13-529

Identifier Type: -

Identifier Source: org_study_id