Electrophysiologic Mapping of the Bladder

Electrical Evaluation of Urinary Bladder Clinical Trial

Official title:

Pilot of Electrophysiologic Mapping of the Urinary Bladder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02041442
• Other study ID #: E-13-529
• Status: Terminated
• Phase: N/A
• First received: January 16, 2014
• Last updated: June 2, 2016
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Englewood Hospital and Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Electrical Evaluation of Urinary Bladder

Intervention

Procedure:
• Electrical mapping of the urinary bladder

Locations

Country	Name	City	State
United States	Englewood Hospital and Medical Center	Englewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Englewood Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in electrical activity	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	No

External Links

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