Trial Outcomes & Findings for A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters (NCT NCT05883332)
NCT ID: NCT05883332
Last Updated: 2026-03-12
Results Overview
Maximum liquid volume the bladder can hold, measured in milliliters (mL) during urodynamic study (UDS).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
Measured at max bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-minute washout; each run lasts ~15-45 minutes depending on individual bladder fill rate
Results posted on
2026-03-12
Participant Flow
Internal Review Board approval was obtained (IRB 2022P-000826) and outcomes were reported in accordance with CONSORT guidelines. Male and female patients aged 21-85 years, scheduled for UDS, were recruited for study participation from January to March 2023. Patients with medical contraindications to N2O were excluded from the study.
Participant milestones
| Measure |
OXYGEN FIRST Arm
All participants will receive self-administered nitrous oxide (SANO) at a range of 25-50% immediately before and during catheter placements. At this time, a participant-preferred level of SANO will be determined.
In OXYGEN FIRST arm, each patient undergoes two consecutive UDS runs. The first UDS run is performed with Oxygen. There is a washout period of 2 minutes between the runs. The second UDS run is performed with the predefined participant-preferred level of SANO.
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SANO FIRST Arm
All participants will receive self-administered nitrous oxide (SANO) at a range of 25-50% immediately before and during catheter placements. At this time, a participant-preferred level of SANO will be determined.
In SANO FIRST arm, each patient undergoes two consecutive UDS runs. The first UDS run is performed with the predefined participant-preferred level of SANO. There is a washout period of 2 minutes between the runs. The second UDS run is performed with Oxygen.
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|---|---|---|
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Overall Study
STARTED
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10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters
Baseline characteristics by cohort
| Measure |
Oxygen First, Then SANO
n=10 Participants
This is a randomized, two-period crossover trial. Participants in this group are randomized to Oxygen first, then SANO. Each participant serves as their own control. All participants will receive self-administered nitrous oxide (SANO) at a range of 25-50% immediately before and during catheter placements. At this time, a participant-preferred level of SANO will be determined.
Participants in this sequence undergo two consecutive urodynamic study (UDS) runs. The first UDS run is conducted using 100% oxygen at 10 L/min. After a 2-minute washout period, the second UDS run is conducted using self-administered nitrous oxide (SANO) at the participant's preferred concentration (20-50%), which was determined during catheter placement.
Run 1: Oxygen (100% at 10 L/min)
Run 2: Self-administered nitrous oxide (20-50%)
|
SANO First, Then Oxygen
n=9 Participants
This is a randomized, two-period crossover trial. Participants in this group are randomized to SANO first, then Oxygen. Each participant serves as their own control. All participants will receive self-administered nitrous oxide (SANO) at a range of 25-50% immediately before and during catheter placements. At this time, a participant-preferred level of SANO will be determined.
Participants in this sequence undergo two consecutive UDS runs. The first UDS run is conducted using self-administered nitrous oxide (SANO) at the participant's preferred concentration (20-50%). After a 2-minute washout period, the second UDS run is conducted using 100% oxygen at 10 L/min.
Run 1: Self-administered nitrous oxide (20-50%)
Run 2: Oxygen (100% at 10 L/min)
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Total
n=19 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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52 years
n=9 Participants
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65 years
n=9 Participants
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61 years
n=18 Participants
|
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Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
7 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
12 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
18 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=9 Participants
|
9 participants
n=9 Participants
|
19 participants
n=18 Participants
|
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VAS-P (Visual Analog Scale for Pain)
|
1.5 units on a scale
n=9 Participants
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1.0 units on a scale
n=9 Participants
|
1.0 units on a scale
n=18 Participants
|
|
VAS-A (Visual Analog Scale for Anxiety)
|
1.35 units on a scale
n=9 Participants
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2.0 units on a scale
n=9 Participants
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2.0 units on a scale
n=18 Participants
|
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Prior Foley Catheter Experience
|
5 Participants
n=9 Participants
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7 Participants
n=9 Participants
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12 Participants
n=18 Participants
|
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Prior UDS Experience
|
2 Participants
n=9 Participants
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3 Participants
n=9 Participants
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5 Participants
n=18 Participants
|
|
Baseline PCS (Pain Catastrophizing Scale)
|
10.5 units on a scale
n=9 Participants
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10. units on a scale
n=9 Participants
|
10 units on a scale
n=18 Participants
|
|
Baseline STAI (State-Trait Anxiety Inventory)
|
18 units on a scale
n=9 Participants
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15 units on a scale
n=9 Participants
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16 units on a scale
n=18 Participants
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PRIMARY outcome
Timeframe: Measured at max bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-minute washout; each run lasts ~15-45 minutes depending on individual bladder fill rateMaximum liquid volume the bladder can hold, measured in milliliters (mL) during urodynamic study (UDS).
Outcome measures
| Measure |
Oxygen UDS Run
n=19 Participants
All participants underwent urodynamic studies (UDS) using 100% oxygen at 10 L/min. In this crossover study, participants received both oxygen and self-administered nitrous oxide (SANO) in randomized order. This arm includes outcome data collected during the oxygen UDS runs for all participants (N=19).
|
SANO UDS Run
n=19 Participants
All participants underwent UDS using self-administered nitrous oxide (SANO) at their preferred concentration (20-50%). In this crossover study, participants received both interventions in randomized order. This arm includes outcome data collected during the SANO UDS runs for all participants (N=19).
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|---|---|---|
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Bladder Capacity
|
363 milliliters
Interval 282.0 to 553.0
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402 milliliters
Interval 307.0 to 530.0
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SECONDARY outcome
Timeframe: Measured at maximum bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.Pain experienced at time of max fill during each UDS run as measured by a Visual Analog Scale for Pain (VAS-P) (range: 0 \[no pain\] - 10 \[worst pain\])
Outcome measures
| Measure |
Oxygen UDS Run
n=19 Participants
All participants underwent urodynamic studies (UDS) using 100% oxygen at 10 L/min. In this crossover study, participants received both oxygen and self-administered nitrous oxide (SANO) in randomized order. This arm includes outcome data collected during the oxygen UDS runs for all participants (N=19).
|
SANO UDS Run
n=19 Participants
All participants underwent UDS using self-administered nitrous oxide (SANO) at their preferred concentration (20-50%). In this crossover study, participants received both interventions in randomized order. This arm includes outcome data collected during the SANO UDS runs for all participants (N=19).
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|---|---|---|
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Intra-Urodynamic Study (UDS) Pain
|
2 units on a scale
Interval 0.0 to 3.0
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0.7 units on a scale
Interval 0.0 to 1.3
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SECONDARY outcome
Timeframe: Measured at maximum bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.Anxiety experienced at time of max fill during each UDS run as measured by a Visual Analog Scale for Anxiety (VAS-A) (range: 0 \[no anxiety\] - 10 \[worst anxiety\])
Outcome measures
| Measure |
Oxygen UDS Run
n=19 Participants
All participants underwent urodynamic studies (UDS) using 100% oxygen at 10 L/min. In this crossover study, participants received both oxygen and self-administered nitrous oxide (SANO) in randomized order. This arm includes outcome data collected during the oxygen UDS runs for all participants (N=19).
|
SANO UDS Run
n=19 Participants
All participants underwent UDS using self-administered nitrous oxide (SANO) at their preferred concentration (20-50%). In this crossover study, participants received both interventions in randomized order. This arm includes outcome data collected during the SANO UDS runs for all participants (N=19).
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|---|---|---|
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Intra-Urodynamic Study (UDS) Anxiety
|
2.0 units on a scale
Interval 0.0 to 2.9
|
1 units on a scale
Interval 0.0 to 2.2
|
SECONDARY outcome
Timeframe: Measured immediately after voiding during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.Amount of liquid left in bladder after voiding, as measured in milliliters
Outcome measures
| Measure |
Oxygen UDS Run
n=19 Participants
All participants underwent urodynamic studies (UDS) using 100% oxygen at 10 L/min. In this crossover study, participants received both oxygen and self-administered nitrous oxide (SANO) in randomized order. This arm includes outcome data collected during the oxygen UDS runs for all participants (N=19).
|
SANO UDS Run
n=19 Participants
All participants underwent UDS using self-administered nitrous oxide (SANO) at their preferred concentration (20-50%). In this crossover study, participants received both interventions in randomized order. This arm includes outcome data collected during the SANO UDS runs for all participants (N=19).
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|---|---|---|
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Post Void Residual
|
132 milliliters
Interval 0.0 to 221.0
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57 milliliters
Interval 0.0 to 207.0
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SECONDARY outcome
Timeframe: Measured at time of maximum urinary flow during voiding in each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.Maximum rate of void, as measured in milliliters per second
Outcome measures
| Measure |
Oxygen UDS Run
n=19 Participants
All participants underwent urodynamic studies (UDS) using 100% oxygen at 10 L/min. In this crossover study, participants received both oxygen and self-administered nitrous oxide (SANO) in randomized order. This arm includes outcome data collected during the oxygen UDS runs for all participants (N=19).
|
SANO UDS Run
n=19 Participants
All participants underwent UDS using self-administered nitrous oxide (SANO) at their preferred concentration (20-50%). In this crossover study, participants received both interventions in randomized order. This arm includes outcome data collected during the SANO UDS runs for all participants (N=19).
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|---|---|---|
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Max Flow Rate
|
11 mL/sec
Interval 4.9 to 13.0
|
11 mL/sec
Interval 5.1 to 19.0
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SECONDARY outcome
Timeframe: Measured during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.Pressure sensors (which are located on the UDS catheter within the bladder) measure bladder contractions that should not normally occur while a bladder fills. Detrusor overactivity (DO) was assessed during each UDS run using pressure sensors in accordance with 2012 AUA/SUFU guidelines. The diagnosis is based on the qualitative observation of involuntary detrusor contractions during filling in a binary fashion (presence or absence of DO). Outcomes are reported as the number of Participants that exhibited DO in the specified UDS run. (The clinical determination of DO is qualitative: urodynamicists assess whether observed pressure rises represent true involuntary detrusor contractions by correlating pressure changes with patient symptoms, excluding artifacts (cough, movement, abdominal straining), and evaluating the pattern and context of the pressure rise)
Outcome measures
| Measure |
Oxygen UDS Run
n=19 Participants
All participants underwent urodynamic studies (UDS) using 100% oxygen at 10 L/min. In this crossover study, participants received both oxygen and self-administered nitrous oxide (SANO) in randomized order. This arm includes outcome data collected during the oxygen UDS runs for all participants (N=19).
|
SANO UDS Run
n=19 Participants
All participants underwent UDS using self-administered nitrous oxide (SANO) at their preferred concentration (20-50%). In this crossover study, participants received both interventions in randomized order. This arm includes outcome data collected during the SANO UDS runs for all participants (N=19).
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|---|---|---|
|
Detrusor Overactivity
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Measured at time of maximum urinary flow during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.Pressure sensors (which are located on the UDS catheter within the bladder) measure the strength of the bladder contraction while the individual is urinating. Outcome pressures will be measured in centimeters (cm) of water (H2O).
Outcome measures
| Measure |
Oxygen UDS Run
n=19 Participants
All participants underwent urodynamic studies (UDS) using 100% oxygen at 10 L/min. In this crossover study, participants received both oxygen and self-administered nitrous oxide (SANO) in randomized order. This arm includes outcome data collected during the oxygen UDS runs for all participants (N=19).
|
SANO UDS Run
n=19 Participants
All participants underwent UDS using self-administered nitrous oxide (SANO) at their preferred concentration (20-50%). In this crossover study, participants received both interventions in randomized order. This arm includes outcome data collected during the SANO UDS runs for all participants (N=19).
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|---|---|---|
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Detrusor Pressure at Maximum Flow
|
45 cmH20
Interval 31.0 to 56.0
|
45 cmH20
Interval 31.0 to 61.0
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Adverse Events
Oxygen UDS Run
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SANO UDS Run
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