Trial Outcomes & Findings for Uro-NIRS Clinical Study (NCT NCT00706407)
NCT ID: NCT00706407
Last Updated: 2018-03-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Assessed at 3 and 6 months, post operatively
Results posted on
2018-03-13
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uro-NIRS Clinical Study
Baseline characteristics by cohort
| Measure |
Obstructed
n=26 Participants
All patients who had data analyzed
|
Unobstructed
n=7 Participants
Patients with obstruction
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
NA years
STANDARD_DEVIATION NA • n=99 Participants
|
NA years
STANDARD_DEVIATION NA • n=107 Participants
|
67 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
United States
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26 participants
n=99 Participants
|
7 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
International Prostate Symptom Score (IPSS)
|
19 units on a scale
STANDARD_DEVIATION 7 • n=99 Participants
|
18 units on a scale
STANDARD_DEVIATION 7 • n=107 Participants
|
19 units on a scale
STANDARD_DEVIATION 7 • n=206 Participants
|
|
Quality of Life (QoL)
|
5 units on a scale
STANDARD_DEVIATION 1 • n=99 Participants
|
4 units on a scale
STANDARD_DEVIATION 1 • n=107 Participants
|
4 units on a scale
STANDARD_DEVIATION 1 • n=206 Participants
|
|
Prostate Volume
|
53 ml
STANDARD_DEVIATION 42 • n=99 Participants
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28 ml
STANDARD_DEVIATION 23 • n=107 Participants
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48 ml
STANDARD_DEVIATION 39 • n=206 Participants
|
|
Prostate Specific Antigen (PSA)
|
2.3 ng/ml
STANDARD_DEVIATION 2.4 • n=99 Participants
|
0.6 ng/ml
STANDARD_DEVIATION 0.8 • n=107 Participants
|
2.0 ng/ml
STANDARD_DEVIATION 2.3 • n=206 Participants
|
|
Qmax (Free Flow Study)
|
9.3 ml/sec
STANDARD_DEVIATION 5.2 • n=99 Participants
|
12.4 ml/sec
STANDARD_DEVIATION 6.6 • n=107 Participants
|
10.0 ml/sec
STANDARD_DEVIATION 5.5 • n=206 Participants
|
|
Voided Volume (Free Flow Study)
|
173 ml
STANDARD_DEVIATION 92 • n=99 Participants
|
299 ml
STANDARD_DEVIATION 230 • n=107 Participants
|
197 ml
STANDARD_DEVIATION 134 • n=206 Participants
|
|
Postvoid residual volume (PVR) (Free Flow Study)
|
162 ml
STANDARD_DEVIATION 206 • n=99 Participants
|
157 ml
STANDARD_DEVIATION 113 • n=107 Participants
|
161 ml
STANDARD_DEVIATION 188 • n=206 Participants
|
|
Qmax (Pressure flow study)
|
5.7 ml/sec
STANDARD_DEVIATION 3.7 • n=99 Participants
|
10.4 ml/sec
STANDARD_DEVIATION 5.0 • n=107 Participants
|
6.7 ml/sec
STANDARD_DEVIATION 4.4 • n=206 Participants
|
|
Voided Volume (Pressure flow study)
|
150 ml
STANDARD_DEVIATION 104 • n=99 Participants
|
283 ml
STANDARD_DEVIATION 171 • n=107 Participants
|
179 ml
STANDARD_DEVIATION 131 • n=206 Participants
|
|
Postvoid Residual Volume (PVR) (Pressure flow study)
|
292 ml
STANDARD_DEVIATION 213 • n=99 Participants
|
270 ml
STANDARD_DEVIATION 209 • n=107 Participants
|
287 ml
STANDARD_DEVIATION 209 • n=206 Participants
|
|
Pdet at Qmax (Pressure flow study)
|
83 cm H2O
STANDARD_DEVIATION 24 • n=99 Participants
|
33 cm H2O
STANDARD_DEVIATION 13 • n=107 Participants
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72 cm H2O
STANDARD_DEVIATION 31 • n=206 Participants
|
|
Max Detrusor pressure (Pdet) (Pressure flow study)
|
90 cm H2O
STANDARD_DEVIATION 29 • n=99 Participants
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43 cm H2O
STANDARD_DEVIATION 12 • n=107 Participants
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80 cm H2O
STANDARD_DEVIATION 32 • n=206 Participants
|
|
Bladder Outlet Obstruction (BOO) Index (Pressure flow study)
|
78 units on a scale
STANDARD_DEVIATION 28 • n=99 Participants
|
16 units on a scale
STANDARD_DEVIATION 10 • n=107 Participants
|
64 units on a scale
STANDARD_DEVIATION 36 • n=206 Participants
|
PRIMARY outcome
Timeframe: Assessed at 3 and 6 months, post operativelyThe 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.
Outcome measures
| Measure |
Number Obstructed
n=26 Participants
Free Flow and pressure flow NIRS patterns
|
Number Unobstructed
n=7 Participants
Free Flow and Pressure flow NIRS patterns
|
Totals
n=33 Participants
Total number of participants included
|
|---|---|---|---|
|
Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis
Pressure Flow NIRS Downward
|
11 participants
|
3 participants
|
14 participants
|
|
Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis
Free Flow NIRS Downward
|
9 participants
|
4 participants
|
13 participants
|
|
Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis
Free Flow NIRS Flat
|
4 participants
|
1 participants
|
5 participants
|
|
Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis
Free Flow NIRS Upward
|
13 participants
|
2 participants
|
15 participants
|
|
Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis
Pressure Flow NIRS Flat
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis
Pressure Flow NIRS Upward
|
5 participants
|
2 participants
|
7 participants
|
Adverse Events
Obstructed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unobstructed
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place