The Current “Gold Standard” in Bladder Diagnostics
The current standard of care for studying the function and condition of the lower urinary tract and bladder is a series of tests called urodynamic studies.
Traditional urodynamics are performed under the care and supervision of specialized healthcare professionals, as they are highly invasive (simultaneous urethral and rectal catheterization) and may require anesthesia.
Traditional Procedure:
- Patient arrives with full bladder
- Patient is prepared for the exam
- Uroflowmetry procedure is initiated
- Patient voids, urine flow & residual volume are measured
- Patient is prepared for catheter insertion
- Insertion of catheters in rectum and urethra
- Urodynamics pump fills bladder
- Internal bladder pressure is monitored during fill/void cycle
- Patient voids through urethral catheter
- Collection and analysis of data
Average time: 60 min
View of the rectal and urethral catheters connected to monitoring system.
Urodynamic testing requires the patient to endure a series of uncomfortable and often painful catheter insertions. During the procedure, a catheter is inserted into the bladder via the urethra, and a pump pushes liquid into the patient's bladder through the catheter. This procedure, known as cystometry (CMG), determines how much pressure the patient’s bladder can withstand.
Due to the unnatural setting and the urethral catheter, the normal flow of urine is compromised. Catheterization may also cause trauma to the urethra and urinary tract infections. Following the test, patients typically experience discomfort for several hours.
Traditional urodynamic studies also involve significant costs, since a nurse trained in catheterization is required and a urologist must interpret the results. Urodynamic (UDS)* equipment is expensive, and each study requires extensive consumable costs.
* UDS® is a registered trademark of Laborie Medical Technologies.
Urodynamix's NIRS Bladder Monitor, a New Standard in Bladder Diagnostics
Urodynamix’s URO-NIRS technology is a non-invasive device comprising an optical sensor that is placed on the abdomen over the bladder. The sensor is attached to an external control unit, and projects specific wavelengths of near infrared light through the skin over the bladder to gather data about bladder health and function during a non-invasive uroflow exam. The test is painless, easily administered and more efficient that conventional urodynamics.
NIRS Procedure:
- Patient arrives with full bladder
- Optical sensor attached to abdomen
- Patient monitored during uroflow (natural voiding)
- Urine flow & residual volume are measured
- Collection and analysis of data
Est. Time: 5 min 
Prototype NIRS console with optical sensor.
Based on published clinical data, Urodynamix beleives that NIRS can provide the same diagnostic capabilities as current invasive, catheter-based procedures.
Pending regulatory approvals, the Tetra(TM) Bladder Monitor System will be marketed worldwide by Laborie Medical Technologies beginning in 2008.
User Benefits
Urodynamix believes that NIRS will provide a non-invasive, low-cost diagnostic alternative for a variety of applications in UI and urology. The company projects that the URO-NIRS suite of products will gain broad market acceptance for the following reasons:
- The current standard of care for diagnosis and monitoring of bladder diasease is invasive and painful and requires the use of catheters. NIRS urodynamics is safe, non-invasive and easy to use.
- Up to 50% of patients referred for urodynamics currently decline due to anxiety, fear or embarrassment. The availability of a non-invasive diagnostic device should significantly increase the number of patients that submit to urodynamics study.
- NIRS devices are portable and can be easily operated in a variety of primary and acute care settings, therefore medical professionals will for the first time be able to make direct, non-invasive, measurements of detrusor physiology.
- NIRS should allow complete urodynamic studies to be performed in primary care settings at reduced cost. The move from acute care to primary care will provide significant benefits in overall access and provide lower costs of service.
|
