Lower Urinary Tract Symptoms, Overactive Bladder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFully 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 Urodynamix device will take measurements through the skin without inserting anything into the body.
Sponsors
Urodynamix Technologies
Laborie Medical Technologies Inc.
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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 enrollment.
Exclusion criteria
* The patient has an existing health condition which the investigators feel will not allow for safe or accurate measurements with the Uro-NIRS:UDS device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Assessed at 3 and 6 months, post operatively | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Obstructed All patients who had data analyzed | 26 |
| Unobstructed Patients with obstruction | 7 |
| Total | 33 |
Baseline characteristics
| Characteristic | Obstructed | Unobstructed | Total |
|---|---|---|---|
| Age, Continuous | NA years | NA years | 67 years STANDARD_DEVIATION 14 |
| Bladder Outlet Obstruction (BOO) Index (Pressure flow study) | 78 units on a scale STANDARD_DEVIATION 28 | 16 units on a scale STANDARD_DEVIATION 10 | 64 units on a scale STANDARD_DEVIATION 36 |
| International Prostate Symptom Score (IPSS) | 19 units on a scale STANDARD_DEVIATION 7 | 18 units on a scale STANDARD_DEVIATION 7 | 19 units on a scale STANDARD_DEVIATION 7 |
| Max Detrusor pressure (Pdet) (Pressure flow study) | 90 cm H2O STANDARD_DEVIATION 29 | 43 cm H2O STANDARD_DEVIATION 12 | 80 cm H2O STANDARD_DEVIATION 32 |
| Pdet at Qmax (Pressure flow study) | 83 cm H2O STANDARD_DEVIATION 24 | 33 cm H2O STANDARD_DEVIATION 13 | 72 cm H2O STANDARD_DEVIATION 31 |
| Postvoid residual volume (PVR) (Free Flow Study) | 162 ml STANDARD_DEVIATION 206 | 157 ml STANDARD_DEVIATION 113 | 161 ml STANDARD_DEVIATION 188 |
| Postvoid Residual Volume (PVR) (Pressure flow study) | 292 ml STANDARD_DEVIATION 213 | 270 ml STANDARD_DEVIATION 209 | 287 ml STANDARD_DEVIATION 209 |
| Prostate Specific Antigen (PSA) | 2.3 ng/ml STANDARD_DEVIATION 2.4 | 0.6 ng/ml STANDARD_DEVIATION 0.8 | 2.0 ng/ml STANDARD_DEVIATION 2.3 |
| Prostate Volume | 53 ml STANDARD_DEVIATION 42 | 28 ml STANDARD_DEVIATION 23 | 48 ml STANDARD_DEVIATION 39 |
| Qmax (Free Flow Study) | 9.3 ml/sec STANDARD_DEVIATION 5.2 | 12.4 ml/sec STANDARD_DEVIATION 6.6 | 10.0 ml/sec STANDARD_DEVIATION 5.5 |
| Qmax (Pressure flow study) | 5.7 ml/sec STANDARD_DEVIATION 3.7 | 10.4 ml/sec STANDARD_DEVIATION 5 | 6.7 ml/sec STANDARD_DEVIATION 4.4 |
| Quality of Life (QoL) | 5 units on a scale STANDARD_DEVIATION 1 | 4 units on a scale STANDARD_DEVIATION 1 | 4 units on a scale STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 26 participants | 7 participants | 33 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 26 Participants | 7 Participants | 33 Participants |
| Voided Volume (Free Flow Study) | 173 ml STANDARD_DEVIATION 92 | 299 ml STANDARD_DEVIATION 230 | 197 ml STANDARD_DEVIATION 134 |
| Voided Volume (Pressure flow study) | 150 ml STANDARD_DEVIATION 104 | 283 ml STANDARD_DEVIATION 171 | 179 ml STANDARD_DEVIATION 131 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 7 |
| other Total, other adverse events | 0 / 26 | 0 / 7 |
| serious Total, serious adverse events | 0 / 26 | 0 / 7 |
Outcome results
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.
Time frame: Assessed at 3 and 6 months, post operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Number Obstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Free Flow NIRS Flat | 4 participants |
| Number Obstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Pressure Flow NIRS Upward | 5 participants |
| Number Obstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Pressure Flow NIRS Downward | 11 participants |
| Number Obstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Free Flow NIRS Downward | 9 participants |
| Number Obstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Pressure Flow NIRS Flat | 2 participants |
| Number Obstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Free Flow NIRS Upward | 13 participants |
| Number Unobstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Pressure Flow NIRS Upward | 2 participants |
| Number Unobstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Free Flow NIRS Downward | 4 participants |
| Number Unobstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Free Flow NIRS Flat | 1 participants |
| Number Unobstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Free Flow NIRS Upward | 2 participants |
| Number Unobstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Pressure Flow NIRS Downward | 3 participants |
| Number Unobstructed | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Pressure Flow NIRS Flat | 0 participants |
| Totals | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Free Flow NIRS Downward | 13 participants |
| Totals | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Pressure Flow NIRS Flat | 2 participants |
| Totals | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Free Flow NIRS Upward | 15 participants |
| Totals | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Pressure Flow NIRS Upward | 7 participants |
| Totals | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Free Flow NIRS Flat | 5 participants |
| Totals | Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis | Pressure Flow NIRS Downward | 14 participants |