Lower Urinary Tract SymptomsUro-NIRSNCT00706407
Uro-NIRS Clinical Study
A study testing Fully integrated Uro-NIRS:UDS in people with Lower Urinary Tract Symptoms and Overactive Bladder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms, Overactive Bladder
- What is being tested?
- Fully integrated Uro-NIRS:UDS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York-Presbyterian Hospital Weill Cornell Medical Center
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Lower Urinary Tract Symptoms, Overactive Bladder
- Being tested
- Fully integrated Uro-NIRS:UDS
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully integrated Uro-NIRS:UDSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Fully integrated Uro-NIRS:UDS | Experimental | Not described Receives: Device: Fully integrated Uro-NIRS:UDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at 3 and 6 months, post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Urodynamix Technologies, Laborie Medical Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Alexis Te, M.D., Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706407
- Sponsor's protocol ID
- 0709009413
- Acronym
- Uro-NIRS
- Status last verified
- Mar 2018
- First submitted
- 2 Jun 2008
- Last updated
- 13 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uro-NIRS Clinical Study
- ClinicalTrials.gov ID
- NCT00706407
- Acronym / sponsor ID
- Uro-NIRS / 0709009413
- Conditions
- Lower Urinary Tract Symptoms, Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Urodynamix Technologies, Laborie Medical Technologies Inc.
- Study start
- Apr 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fully integrated Uro-NIRS:UDS | Experimental | Device: Fully integrated Uro-NIRS:UDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fully integrated Uro-NIRS:UDSAs 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. | Device | Fully integrated Uro-NIRS:UDS |
Primary outcome
Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Te, M.D. principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully integrated Uro-NIRS:UDS in people with Lower Urinary Tract Symptoms and Overactive Bladder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis (time frame: Assessed at 3 and 6 months, post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.