Uro-NIRS Clinical Study - Full Text View

Sponsors and Collaborators:	Weill Medical College of Cornell University Urodynamix Technologies Inc. Laborie
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00706407

Purpose

The purpose of this experiment is to confirm the results of previous testing of Urodynamix's Uro-NIRS device. Together Urodynamix and Laborie have created a device that includes standard Laborie medical equipment and the experimental Urodynamix device. Collectively this integrated device is considered an investigational device, and the results from this study may be used to support a submission to the US Food and Drug Administration for the approval of the integrated device.

This research is being done because we want to test the ability of the integrated Laborie and Urodynamix device to provide a non-invasive method to provide additional information to assist with the diagnosis of or treatment plan of patients suffering from urinary problems. The current technologies rely solely on the measurement of internal pressures of the bladder, which involves the insertion of catheter into the subject's urethra.

Condition	Intervention	Phase
Lower Urinary Tract Symptoms Overactive Bladder	Device: Fully integrated Uro-NIRS:UDS	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Uro-NIRS Clinical Study

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

Comparison to standard urodynamics [ Time Frame: Once ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	April 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

As part of standard care subjects will be undergoing a standard bladder pressure diagnostic procedure. This standard procedure will involve the insertion of a catheter (a plastic tube) into the urethra and the measurement of pressure within the bladder. For subjects taking part in this study, the health of the bladder will measured by using light instead of pressure. A patch, the size of cell phone or deck of playing cards, will be taped to the skin in the middle of the abdomen, above the bladder. Using laser light that is 300 billion times weaker than the light from a regular household 100-Watt light bulb, the Laborie and Urodynamix device will take measurements through the skin without inserting anything into the body.

Detailed Description:

This is a study of the fully integrated Uro-NIRS:UDS device (Laborie Triton or Laborie Dorado and Urodynamix's Non-Invasive Urodynamics device - Uro-NIRS), to confirm the results using the fully integrated Uro-NIRS:UDS device as compared to the stand-alone URO-NIRS device and UDS device. The study will evaluate male patients with lower urinary tract symptoms (LUTS) and female subjects with over-active bladder (OAB).

The Uro-NIRS unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome from the detrusor muscle from the human bladder wall. This process is similar to what is used for cerebral and muscle oxygenation monitoring (e.g., pulse oximetry). Previous clinical feasibility studies have identified the correlation between the changes in haemoglobin and cytochrome and the pressure values obtained during urodynamics procedures and uroflow procedures.

For this study the Uro-NIRS results specifically will not be used by the urologist/nurse to guide in patient management and treatment decisions, but rather will only be used to collect measurements from the patient. The Uro-NIRS sensor patch will be adhered to skin surface where their bladder is located.

The study will be conducted by the two principal investigators at the two clinical study sites who will collectively enrol a minimum of 50 subjects, with a minimum of 35 male subjects and a maximum of 15 female subjects. The study enrolment objective is to equally enrol male subjects into three categories: unequivocal, obstructed and unobstructed. Female subjects shall all have OAB.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects must be 18 years of age or older.
Subjects are patients of one of the institutions and are currently scheduled for UDS
Male subjects must have LUTS
Female subjects must have OAB
Subjects must give their informed consent prior to enrollment.

Exclusion Criteria:

The patient has an existing health condition which the investigators feel will not allow for safe or accurate measurements with the Uro-NIRS:UDS device.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706407

Contacts

Contact: Celeste Egan, NP

212-746-1626

cae2005@med.cornell.edu

Locations

United States, New York
New York-Presbyterian Hospital Weill Cornell Medical Center	Recruiting
New York, New York, United States, 10065

Sponsors and Collaborators

Weill Medical College of Cornell University

Urodynamix Technologies Inc.

Laborie

Investigators

Principal Investigator:

Alexis Te, M.D.

Cornell University

More Information

Responsible Party:	Weill Cornell Medical College ( Alexis Te, M.D. )
Study ID Numbers:	0709009413
Study First Received:	June 2, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00706407
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009