Diagnostic Utility of Tetra-NIRS in Conjunction With Urodynamic Studies

• 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 UDS). [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  

Device: TETRA - NIRS
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.

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: