Trial Outcomes & Findings for Tetra-NIRS Clinical Study (NCT NCT00871975)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

155 participants

Primary outcome timeframe

1 Year

Results posted on

2016-07-19

Participant Flow

Each site recruited in a Urology clinic setting. All patients were scheduled for Urodynamics testing. Sunnybrook recruitment period spanned Apr 2010 - Feb 2012. Vanderbilt Sept 2009 - May 24 2010. King's College May 2010 - August 2010.

There were no group assignments.

Participant milestones

Participant milestones
Measure	Urodynamics + Tetra-NIRS Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
Overall Study STARTED	155
Overall Study COMPLETED	133
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Urodynamics + Tetra-NIRS Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
Overall Study Technical difficulty w155-1ith equipment	3
Overall Study Catheters could not be inserted	1
Overall Study Patient unable to void/insufficient vol	13
Overall Study Motion artifact, tracing uninterpretable	5

Baseline Characteristics

Tetra-NIRS Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Urodynamics + Tetra-NIRS n=155 Participants Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
Age, Customized Greater than or equal to 18 years	155 participants n=5 Participants
Sex: Female, Male Female	121 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
Region of Enrollment Canada	37 participants n=5 Participants
Region of Enrollment United Kingdom	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: Male and female patients were included, where the urodynamics tracings were compared against the Tetra NIRS tracings.

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.

Outcome measures

Outcome measures
Measure	Urodynamics + Tetra NIRS n=133 Participants Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics True Positive on Tetra-NIRS + UDS	30 participants
Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics True Negatives on Tetra-NIRS + UDS	34 participants
Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics False Positive on Tetra-NIRS + UDS	59 participants
Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics False Negative on Tetra-NIRS + UDS	10 participants

Adverse Events

Urodynamics + Tetra-NIRS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Administrator

LABORIE

Phone: 905 612 1170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place