Lower Urinary Tract SymptomsPhase 4NCT05883332

A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters

A Phase 4 study testing Self-Administered Nitrous Oxide and Oxygen in people with Lower Urinary Tract Symptoms, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Lower Urinary Tract Symptoms
What is being tested?: Self-Administered Nitrous Oxide and Oxygen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 10 Jan 2023to 9 Mar 2023
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 21 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Scheduled for urodynamic study
Aged 21 to 85 years
Suitable for inflation of nitrous oxide/oxygen with willingness to undergo two urodynamic study runs during the procedure
Access to an email and computer

Who cannot join

Perioral facial hair impeding good mask seal
Learning disabilities and/or inability to cognitively complete survey questions
Has any of the following medical conditions:
Inner ear, bariatric or eye surgery within the last 2 weeks,
Current emphysematous blebs,
Severe B-12 deficiency,

Show all 10Show fewer

Bleomycin chemotherapy within the past year,
Heart attack within the past year,
Stroke within the past year,
Class III or higher heart failure

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

A urodynamic study (UDS) is a common procedure done to learn more about the cause of urinary symptoms. For some patients, UDS can be associated with anxiety or discomfort. Nitrous oxide (or laughing-gas) is a well-known sedative which is frequently used in dental offices and for pediatric procedures to reduce anxiety and pain. This study is being done to see if giving low-dose (20-50%) nitrous oxide at the time of UDS affects the measurements taken during the procedure, such as how much volume your bladder can hold, and pressures during urination. If the measurements are the same with and without self-administered nitrous oxide (SANO), it could be suggested that nitrous oxide may be a useful way of reducing patient anxiety and pain during UDS.

Read the detailed description

Randomization is performed according to a 1:1 block model immediately before the start of UDS. Patients are randomized to receive oxygen followed by SANO or SANO followed by oxygen. The procedural team and patient are blinded to the treatment. Muscarinic medications are stopped 24 hours prior to UDS, and patients provide a urine sample to confirm negative cultures. In this study, the Nitrouseal® system is utilized to administer adjustable amounts of N2O (20-50%) using a single-use disposable mask. The system scavenges exhaled N2O and limits the maximum amount of N2O to 50%. After fitting the Nitrouseal mask, the patients are instructed on how to communicate with hand signals throughout the study to titrate the level of gas being administered. Patients receive SANO during catheter placement to determine their preferred N2O level. Following a "washout" period of two minutes, patients undergo two UDS fills following the randomization scheme. Residual urine is removed between runs using the UDS catheter.

UDS are performed according to the 2012 AUA/SUFU Adult Urodynamic Guidelines. All UDS are performed on a Laborie Aquarius XT machine (Laborie Medical, Portsmouth, NH) using 7 Fr dual lumen fluid urethral catheters, 9 Fr dual lumen fluid-filled rectal catheters, and EMG gel patch electrodes. Filling is performed at 50 cc/min with normal saline at room temperature. During the voiding phase, patients are positioned to be sitting or standing according to their comfort.

An intention-to-treat analysis is performed on 19 participants. Maximum cystometric capacity is measured as the primary outcome. Secondary outcomes include patient-reported pain and anxiety measured at baseline and immediately before maximum capacity during each UDS run using the Visual Analog Scale for Pain (VAS-P; range 0-10) and the Visual Analog Scale for Anxiety (VAS-A; range 0-10).

The blinded UDS operator assesses patient responsiveness (ability to communicate) and tolerance on a 3-point Likert scale: worse than expected, as expected, or better than expected. Standard UDS parameters per International Continence Society terminology, including first sensation, first desire, strong desire, MCC, bladder compliance (volume/Pdet Max during filling), detrusor overactivity, detrusor sphincter dyssynergia, inability to void, maximum flow rate, Pdet during maximum flow rate, voided volume, post-voided residual, and voided percentage, are compared for significant differences between the SANO and Oxygen runs.

Post-procedure patient surveys are administered to assess personal experience of catheter placement, desire to have SANO for future UDS, and satisfaction with N2O levels. Finally, electronic medical records are monitored for Clavien-Dindo graded complications for up to 30 days following the UDS.

Conditions: Lower Urinary Tract Symptoms
Being tested: Self-Administered Nitrous Oxide, Oxygen
Keywords: urodynamic study, nitrous oxide, neurogenic bladder, overactive bladder, ambulatory, patient experience of care
Medical subject headings: Lower Urinary Tract Symptoms, Urinary Bladder, Neurogenic, Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Self-Administered Nitrous OxideDrug
Also called nitrous oxide
Nitrous oxide administered at concentrations of minimal sedation (20-50%)
OxygenOther
100% oxygen at 10 Liters/minute

Study groups in NCT05883332
Study group	Role	What they receive
Oxygen First Arm	Active comparator	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. Oxygen Run: 100% oxygen at 10 Liters/minute Self-Administered Nitrous Oxide Run: Nitrous oxide administered at previously determined concentration of nitrous oxide (20-50%) Receives: Drug: Self-Administered Nitrous Oxide; Other: Oxygen
SANO First Arm	Active comparator	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. Self-Administered Nitrous Oxide Run: Nitrous oxide administered at previously determined concentration of nitrous oxide (20-50%) Oxygen Run: 100% oxygen at 10 Liters/minute Receives: Drug: Self-Administered Nitrous Oxide; Other: Oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

Bladder Capacity
Maximum liquid volume the bladder can hold, measured in milliliters (mL) during urodynamic study (UDS).
Measured: 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

Secondary outcomes (6)

Intra-Urodynamic Study (UDS) Pain
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])
Measured: 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.
Intra-Urodynamic Study (UDS) Anxiety
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])
Measured: 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.
Post Void Residual
Amount of liquid left in bladder after voiding, as measured in milliliters
Measured: 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.
Max Flow Rate
Maximum rate of void, as measured in milliliters per second
Measured: 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.
Detrusor Overactivity
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)
Measured: 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.
Detrusor Pressure at Maximum Flow
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).
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 20239 Mar 2023

First posted31 May 2023
Study start10 Jan 2023
Primary completion2 Mar 2023
Study completion9 Mar 2023

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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Model description: Each participant will undergo urodynamic study (UDS) with two fills. The participant will receive SANO during one fill, and oxygen during the other fill. Participants will be randomized to the order in which they receive SANO or oxygen.
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05883332
Sponsor's protocol ID: 2022P-000826
Status last verified: Mar 2026
First submitted: 14 Apr 2023
Last updated: 12 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Herd DW, McAnulty KA, Keene NA, Sommerville DE. Conscious sedation reduces distress in children undergoing voiding cystourethrography and does not interfere with the diagnosis of vesicoureteric reflux: a randomized controlled study. AJR Am J Roentgenol. 2006 Dec;187(6):1621-6. doi: 10.2214/AJR.05.1216.
PubMed 17114560

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters
ClinicalTrials.gov ID: NCT05883332
Acronym / sponsor ID: 2022P-000826
Conditions: Lower Urinary Tract Symptoms
Keywords: urodynamic study, nitrous oxide, neurogenic bladder, overactive bladder, ambulatory, patient experience of care
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Collaborators: Boston Children's Hospital
Study start: 10 Jan 2023 (actual)
Primary completion: 2 Mar 2023 (actual)
Study completion: 9 Mar 2023 (actual)
First posted: 31 May 2023 (actual)
Results: Posted 12 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: Each participant will undergo urodynamic study (UDS) with two fills. The participant will receive SANO during one fill, and oxygen during the other fill. Participants will be randomized to the order in which they receive SANO or oxygen.

Arm	Type	Receives
Oxygen First Arm	Active comparator	Drug: Self-Administered Nitrous Oxide, Other: OxygenAll 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. Oxygen Run: 100% oxygen at 10 Liters/minute Self-Administered Nitrous Oxide Run: Nitrous oxide administered at previously determined concentration of nitrous oxide (20-50%)
SANO First Arm	Active comparator	Drug: Self-Administered Nitrous Oxide, Other: OxygenAll 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. Self-Administered Nitrous Oxide Run: Nitrous oxide administered at previously determined concentration of nitrous oxide (20-50%) Oxygen Run: 100% oxygen at 10 Liters/minute

Who may qualify

Ages: 21 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Scheduled for urodynamic study
Aged 21 to 85 years
Suitable for inflation of nitrous oxide/oxygen with willingness to undergo two urodynamic study runs during the procedure
Access to an email and computer

Key exclusion criteria (10 listed)

Perioral facial hair impeding good mask seal
Learning disabilities and/or inability to cognitively complete survey questions
Has any of the following medical conditions:

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
Self-Administered Nitrous OxideAlso: nitrous oxideNitrous oxide administered at concentrations of minimal sedation (20-50%)	Drug	Oxygen First Arm, SANO First Arm
Oxygen100% oxygen at 10 Liters/minute	Other	Oxygen First Arm, SANO First Arm

Primary outcome

Bladder Capacity
Time frame: 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
Maximum liquid volume the bladder can hold, measured in milliliters (mL) during urodynamic study (UDS).

6 secondary outcomes

Intra-Urodynamic Study (UDS) Pain
Time frame: 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.
Intra-Urodynamic Study (UDS) Anxiety
Time frame: 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.
Post Void Residual
Time frame: 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.
Max Flow Rate
Time frame: 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.
Detrusor Overactivity
Time frame: 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.
Detrusor Pressure at Maximum Flow
Time frame: 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.

Results and safety

Results posted to the registry on 12 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OXYGEN FIRST Arm	10	10
SANO FIRST Arm	9	9

Primary outcome: Bladder Capacity

Time frame: 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. Median (Inter-Quartile Range). Unit: milliliters

Measure	Oxygen UDS Run (N=19) n = 19	SANO UDS Run (N=19) n = 19
Value	363 (282 to 553)	402 (307 to 530)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days post-procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxygen UDS Run	0 of 19 (0%)	0 of 19 (0%)	0 of 19
SANO UDS Run	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): Study limitations: Patients were recruited from a single tertiary institution. The study was powered to assess urodynamic capacity outcomes, and the small sample size may have limited the interpretation of other outcomes of interest. Recruitment was limited to adult patients, so the findings may need to be confirmed in a pediatric population.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17114560Herd DW, McAnulty KA, Keene NA, Sommerville DE. Conscious sedation reduces distress in children undergoing voiding cystourethrography and does not interfere with the diagnosis of vesicoureteric reflux: a randomized controlled study. AJR Am J Roentgenol. 2006 Dec;187(6):1621-6. doi: 10.2214/AJR.05.1216.
Individual participant dataSharing planned: No

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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.

Heidi Rayala, MD, PhD principal investigator

Beth Israel Deaconess Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Self-Administered Nitrous Oxide and Oxygen in people with Lower Urinary Tract Symptoms, run by Beth Israel Deaconess Medical Center 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 4 inclusion and 10 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 12 Mar 2026. 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.

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 12 Mar 2026). 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?

Bladder Capacity (time frame: 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). 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 NCT05883332, 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 12 Mar 2026.