Lower Urinary Tract SymptomsPhase 4NCT00871975
Tetra-NIRS Clinical Study
A Phase 4 study testing Urodynamics + TETRA - NIRS in people with Lower Urinary Tract Symptoms and Overactive Bladder, run by Laborie Medical Technologies Inc. at 3 sites in 3 countries.
Trial summary
The purpose of this evaluation is to validate the previous clinical study results using a Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS) testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS equipment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Urinary Tract Symptoms, Overactive Bladder
- What is being tested?
- Urodynamics + TETRA - NIRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2009to Feb 2012
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The selection of subjects enrolled for testing must meet the following 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 enrolment.
Who cannot join
- The patient has an existing health condition which the investigators feel will not allow for safe or accurate measurements with the Tetra-NIRS device.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London
About this study
Official title: Diagnostic Utility of Tetra-NIRS in Conjunction With Urodynamic Studies
The purpose of this evaluation is to validate the previous clinical study results using a Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS) testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS equipment.
The hypothesis is that the Tetra-NIRS device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamic procedure).
Read the detailed description
This is a study of the commercially available Tetra-NIRS device to compare the results collected against conventional urodynamics. The study will evaluate male patients with lower urinary tract symptoms (LUTS) as well as 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 of the bladder, and bladder pressure values obtained during urodynamics procedures and uroflow procedures.
For this study the Tetra-NIRS results 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 for the purposes of this study. The Tetra-NIRS sensor patch will be adhered externally to the skin surface where the bladder is located.
For this study, a minimum of 30 male subjects with LUTS and 30 female subjects with OAB scheduled to undergo a urodynamics procedure are to be enrolled. Up to 20 female subjects with OAB will be enrolled. The investigators will attempt to equally enrol male subjects into each of the two categories including obstructed and non-obstructed groups according to prostate hyperplasia (equivocal subjects will be determined by the investigator).
- Conditions
- Lower Urinary Tract Symptoms, Overactive Bladder
- Being tested
- Urodynamics + TETRA - NIRS
- Keywords
- LUTS, OAB
- 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.
Urodynamics + TETRA - NIRSDevice
Urodynamics will be performed as per standard of care for patients enrolled, whereby one catheter is inserted into the bladder and one in the rectum to analyze bladder filling, storage and voiding conditions via pressures measured and urine flow rates detected by a uroflowmeter. Tetra-NIRS will be concurrently performed where Tetra-NIRS unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome. A patch is applied externally to measure these changes in the detrusor muscle of 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 a correlation between the changes in haemoglobin and cytochrome and the pressure values obtained during urodynamics procedures.
| Study group | Role | What they receive |
|---|---|---|
| Urodynamics + Tetra | Experimental | All patients were recruited to the same arm and receive Urodynamics testing as part of the routine diagnostic work-up, plus the Tetra-NIRS intervention. Receives: Device: Urodynamics + TETRA - NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics
The Tetra-NIRS device provides a linear pattern similar to the pressures obtained during urodynamics. The NIRS output shows relative change in hemoglobin concentrations (oxygenated and deoxygenated) where the numerical value does not actually indicate the concentration, so there is no unit of measure. The numerical output is used to track change over time, or trendline analysis. A qualified interpreter studied tracings for significant changes (+/-2 Hb units) in the NIRS patterning during detrusor overactivity events. As well, under its' approved intended use, Tetra-NIRS trendline analysis was compared against urodynamics during voiding in males, such that a downward trend during voiding indicates urethral obstruction, and an upward trend indicates an unobstructed urethra.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Low enrollment exceeding trial deadlines
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laborie Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sender Herschorn, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871975
- Sponsor's protocol ID
- C001-C0015 TETRA-NIRS
- Status last verified
- Jun 2016
- First submitted
- 26 Mar 2009
- Last updated
- 19 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data are highly reliant on expert interpretation on a case-by-case basis.
Publications
Mastoroudes H, Giarenis I, Vella M, Srikrishna S, Robinson D, Cardozo L, Karrouze I, Campbell A, Macnab A. Use of near infrared spectroscopy as an alternative to videourodynamics to detect detrusor overactivity in women with the overactive bladder syndrome. Urology. 2012 Sep;80(3):547-50. doi: 10.1016/j.urology.2012.05.036. Epub 2012 Jul 26.
PubMed 22840868
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of Tetra-NIRS in Conjunction With Urodynamic Studies
- ClinicalTrials.gov ID
- NCT00871975
- Acronym / sponsor ID
- C001-C0015 TETRA-NIRS
- Conditions
- Lower Urinary Tract Symptoms, Overactive Bladder
- Keywords
- LUTS, OAB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment exceeding trial deadlines
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Laborie Medical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Posted 19 Jul 2016
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 evaluation is to validate the previous clinical study results using a Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS) testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS equipment.
The hypothesis is that the Tetra-NIRS device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamic procedure).
Detailed description
This is a study of the commercially available Tetra-NIRS device to compare the results collected against conventional urodynamics. The study will evaluate male patients with lower urinary tract symptoms (LUTS) as well as 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 of the bladder, and bladder pressure values obtained during urodynamics procedures and uroflow procedures.
For this study the Tetra-NIRS results 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 for the purposes of this study. The Tetra-NIRS sensor patch will be adhered externally to the skin surface where the bladder is located.
For this study, a minimum of 30 male subjects with LUTS and 30 female subjects with OAB scheduled to undergo a urodynamics procedure are to be enrolled. Up to 20 female subjects with OAB will be enrolled. The investigators will attempt to equally enrol male subjects into each of the two categories including obstructed and non-obstructed groups according to prostate hyperplasia (equivocal subjects will be determined by the investigator).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urodynamics + Tetra | Experimental | Device: Urodynamics + TETRA - NIRSAll patients were recruited to the same arm and receive Urodynamics testing as part of the routine diagnostic work-up, plus the Tetra-NIRS intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The selection of subjects enrolled for testing must meet the following criteria:
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 Tetra-NIRS 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 |
|---|---|---|
| Urodynamics + TETRA - NIRSUrodynamics will be performed as per standard of care for patients enrolled, whereby one catheter is inserted into the bladder and one in the rectum to analyze bladder filling, storage and voiding conditions via pressures measured and urine flow rates detected by a uroflowmeter. Tetra-NIRS will be concurrently performed where Tetra-NIRS unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome. A patch is applied externally to measure these changes in the detrusor muscle of 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 a correlation between the changes in haemoglobin and cytochrome and the pressure values obtained during urodynamics procedures. | Device | Urodynamics + Tetra |
Primary outcome
Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics
Time frame: 1 Year
The Tetra-NIRS device provides a linear pattern similar to the pressures obtained during urodynamics. The NIRS output shows relative change in hemoglobin concentrations (oxygenated and deoxygenated) where the numerical value does not actually indicate the concentration, so there is no unit of measure. The numerical output is used to track change over time, or trendline analysis. A qualified interpreter studied tracings for significant changes (+/-2 Hb units) in the NIRS patterning during detrusor overactivity events. As well, under its' approved intended use, Tetra-NIRS trendline analysis was compared against urodynamics during voiding in males, such that a downward trend during voiding indicates urethral obstruction, and an upward trend indicates an unobstructed urethra.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22840868Mastoroudes H, Giarenis I, Vella M, Srikrishna S, Robinson D, Cardozo L, Karrouze I, Campbell A, Macnab A. Use of near infrared spectroscopy as an alternative to videourodynamics to detect detrusor overactivity in women with the overactive bladder syndrome. Urology. 2012 Sep;80(3):547-50. doi: 10.1016/j.urology.2012.05.036. Epub 2012 Jul 26.
- Individual participant dataSharing planned: No. Data are highly reliant on expert interpretation on a case-by-case basis.
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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.
Sender Herschorn, MD principal investigator
Sunnybrook Health Sciences Centre
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Urodynamics + TETRA - NIRS in people with Lower Urinary Tract Symptoms and Overactive Bladder, run by Laborie Medical Technologies Inc. at 3 sites in 3 countries.
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 6 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: stopped early, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada, United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2016). 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 With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00871975, which also lists 1 linked publication.
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 19 Jul 2016.