Diagnostic Utility of Tetra-NIRS in Conjunction With Urodynamic Studies
| Status: | Terminated |
|---|---|
| Conditions: | Other Indications, Overactive Bladder |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2009 |
| End Date: | February 2012 |
The Purpose of This Experiment is to Validate the Previous Clinical Study Results Using the Tetra-NIRS (Near Infrared Spectroscopy) as Compared to the Conventional UDS in the Voiding Procedure. This Evaluation Will Use a Commercially Available Tetra-NIRS Device.
The purpose of this evaluation is to validate the previous clinical study results using the
Tetra-NIRS as compared to the conventional UDS in the voiding procedure. The experiment will
use a commercially available Tetra-NIRS device.
The hypothesis is that the commercially available Tetra-NIRS device, in the clinical
environment, provides data to enhance the analysis using the standard urodynamics equipment
(stand-alone Urodynamic procedure).
Tetra-NIRS as compared to the conventional UDS in the voiding procedure. The experiment will
use a commercially available Tetra-NIRS device.
The hypothesis is that the commercially available Tetra-NIRS device, in the clinical
environment, provides data to enhance the analysis using the standard urodynamics equipment
(stand-alone Urodynamic procedure).
This is a study of the commercially available Tetra-NIRS device to confirm the results
collected using the commercially available Tetra-NIRS device. The study will evaluate male
patients with lower urinary tract symptoms (LUTS). The study will also include and evaluate
female subjects with over-active bladder (OAB).
The Tetra-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 Tetra-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 Tetra-NIRS sensor patch will be adhered to skin
surface where their bladder is located.
For this reproducibility study a minimum of 30 male subjects with LUTS scheduled to undergo
a urodynamics procedure are to be enrolled. Up to 20 female subjects with OAB will be
enrolled. The investigators will attempt to equally enrol male subjects into each of the two
categories including obstructed and non-obstructed groups (equivocal subjects will be
determined by the investigator). Refer to Appendix A for additional information on sample
size justification.
The investigators should seek to enroll a minimum of 10% of the subjects with a Body Mass
Index (BMI) > 30, where BMI is calculated:
collected using the commercially available Tetra-NIRS device. The study will evaluate male
patients with lower urinary tract symptoms (LUTS). The study will also include and evaluate
female subjects with over-active bladder (OAB).
The Tetra-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 Tetra-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 Tetra-NIRS sensor patch will be adhered to skin
surface where their bladder is located.
For this reproducibility study a minimum of 30 male subjects with LUTS scheduled to undergo
a urodynamics procedure are to be enrolled. Up to 20 female subjects with OAB will be
enrolled. The investigators will attempt to equally enrol male subjects into each of the two
categories including obstructed and non-obstructed groups (equivocal subjects will be
determined by the investigator). Refer to Appendix A for additional information on sample
size justification.
The investigators should seek to enroll a minimum of 10% of the subjects with a Body Mass
Index (BMI) > 30, where BMI is calculated:
Inclusion Criteria:
- The selection of subjects enrolled for testing must meet the following 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 enrolment.
Exclusion Criteria:
- The patient has an existing health condition which the investigators feel will not
allow for safe or accurate measurements with the Tetra-NIRS device.
We found this trial at
2
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