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| Name | Class |
|---|---|
| Urodynamix Technologies | INDUSTRY |
| Laborie Medical Technologies Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fully integrated Uro-NIRS:UDS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fully integrated Uro-NIRS:UDS | Device | As part of standard care subjects will be undergoing a standard bladder pressure diagnostic procedure. This standard procedure will involve the insertion of a catheter (a plastic tube) into the urethra and the measurement of pressure within the bladder. For subjects taking part in this study, the health of the bladder will measured by using light instead of pressure. A patch, the size of cell phone or deck of playing cards, will be taped to the skin in the middle of the abdomen, above the bladder. Using laser light that is 300 billion times weaker than the light from a regular household 100-Watt light bulb, the Laborie and Urodynamix device will take measurements through the skin without inserting anything into the body. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | The correlation of the NIRS pattern itself (independent of Qmax and PVR) to BOO. We looked at if the use of the NIRS is a comparable predictor for BOO in patients who were obstructed and those who weren't. The goal of the NIRS is to provide a non-invasive means to diagnose BOO. According to the NIRS algorithm, a downward NIRS pattern related to a higher probability of obstruction and and upward pattern relates to a higher probability of non obstruction. | Assessed at 3 and 6 months, post operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexis Te, M.D. | Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York-Presbyterian Hospital Weill Cornell Medical Center | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fully Integrated Uro-NIRS:UDS | As part of standard care subjects will be undergoing a standard bladder pressure diagnostic procedure. This standard procedure will involve the insertion of a catheter (a plastic tube) into the urethra and the measurement of pressure within the bladder. For subjects taking part in this study, the health of the bladder will measured by using light instead of pressure. A patch, the size of cell phone or deck of playing cards, will be taped to the skin in the middle of the abdomen, above the bladder. Using laser light that is 300 billion times weaker than the light from a regular household 100-Watt light bulb, the Laborie and Urodynamic device will take measurements through the skin without inserting anything into the body. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Obstructed | All patients who had data analyzed |
| BG001 | Unobstructed | Patients with obstruction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | The correlation of the NIRS pattern itself (independent of Qmax and PVR) to BOO. We looked at if the use of the NIRS is a comparable predictor for BOO in patients who were obstructed and those who weren't. The goal of the NIRS is to provide a non-invasive means to diagnose BOO. According to the NIRS algorithm, a downward NIRS pattern related to a higher probability of obstruction and and upward pattern relates to a higher probability of non obstruction. | Posted | Number | participants | Assessed at 3 and 6 months, post operatively |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Obstructed | Those with BOO | 0 |
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Study limitations include sample size and the lack of a control group without LUTS.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexis Te | Weill Cornell Medical College | 646-962-4811 | aet2005@med.cornell.edu |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
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|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| International Prostate Symptom Score (IPSS) | International Prostate Symptom Score (IPSS) is a 7 point scale used to screen, track and manage symptoms associated with BPH. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic) | Mean | Standard Deviation | units on a scale |
|
| Quality of Life (QoL) | Quality of Life (QoL) is a one point scale used to assess how their symptoms affect their quality of life on the IPSS. A score ranges from 1 to 6, with 6 being the worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Prostate Volume | Mean | Standard Deviation | ml |
|
| Prostate Specific Antigen (PSA) | Prostate Specific Antigen (PSA) is a protein that is produced by the cells in the prostate. A PSA test measures these levels in a man's blood. | Mean | Standard Deviation | ng/ml |
|
| Qmax (Free Flow Study) | Maximum flow rate (Qmax) is the the maximum recorded flow rate | Mean | Standard Deviation | ml/sec |
|
| Voided Volume (Free Flow Study) | Mean | Standard Deviation | ml |
|
| Postvoid residual volume (PVR) (Free Flow Study) | Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition. | Mean | Standard Deviation | ml |
|
| Qmax (Pressure flow study) | Mean | Standard Deviation | ml/sec |
|
| Voided Volume (Pressure flow study) | Mean | Standard Deviation | ml |
|
| Postvoid Residual Volume (PVR) (Pressure flow study) | Measure Description: Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition. | Mean | Standard Deviation | ml |
|
| Pdet at Qmax (Pressure flow study) | Pdet is detrusor pressure at maximum flow rate (Qmax) | Mean | Standard Deviation | cm H2O |
|
| Max Detrusor pressure (Pdet) (Pressure flow study) | Detrusor pressure (Pdet) -- is that component of vesical pressure that is created by forces in the bladder wall (passive and active). | Mean | Standard Deviation | cm H2O |
|
| Bladder Outlet Obstruction (BOO) Index (Pressure flow study) | BOOI is a mathematical index of out-let resistance used to help in the diagnosis of men with Benign Prostatic Hyperplasia. Higher values represent an increased amount of bladder outlet obstruction. | Mean | Standard Deviation | units on a scale |
|
Free Flow and Pressure flow NIRS patterns |
| OG002 | Totals | Total number of participants included |
|
|
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Unobstructed | Those without BOO | 0 | 7 | 0 | 7 | 0 | 7 |
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| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |