Uro-NIRS Clinical Study (Uro-NIRS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- New York-Presbyterian Hospital Weill Cornell Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Fully integrated Uro-NIRS:UDS
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis
Time Frame: Assessed at 3 and 6 months, post operatively
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The correlation of the NIRS pattern itself (independent of Qmax and PVR) to BOO.
We looked at if the use of the NIRS is a comparable predictor for BOO in patients who were obstructed and those who weren't.
The goal of the NIRS is to provide a non-invasive means to diagnose BOO.
According to the NIRS algorithm, a downward NIRS pattern related to a higher probability of obstruction and and upward pattern relates to a higher probability of non obstruction.
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Assessed at 3 and 6 months, post operatively
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Collaborators and Investigators
Investigators
- Principal Investigator: Alexis Te, M.D., Cornell University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0709009413
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