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| Sponsored by: |
Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00849225 |
Purpose
The purpose of this experiment 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lower Urinary Tract Symptoms Overactive Bladder |
Device: Tetra-NIRS device |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Tetra-NIRS Clinical STudy |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
This is a study of the commercially available Tetra-NIRS device (the integration of Laborie UDS and Urodynamix's Non-Invasive Urodynamics device - Uro-NIRS), 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
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.
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Medical Center, Dept. of Urologic Surgery | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | Roger R. Dmochowski, MD | Vanderbilt University Medical Center, Dept of Urologic Surgery |
More Information
| Responsible Party: | Vanderbilt University Medical Center ( Roger R. Dmochowski, MD, Principal Investigator ) |
| Study ID Numbers: | 090120 |
| Study First Received: | February 19, 2009 |
| Last Updated: | July 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00849225 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Incontinence Urinary incontinence urodynamics |
|
Signs and Symptoms Urinary Bladder, Overactive Cystocele |
Urologic Diseases Urinary Bladder Diseases Urinary Incontinence |
|
Signs and Symptoms Urological Manifestations Urinary Bladder, Overactive Urologic Diseases Urinary Bladder Diseases |
