Uro-NIRS Clinical Study
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Overactive Bladder |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | April 2008 |
| End Date: | May 2010 |
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.
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.
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.
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.
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.
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