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

NCT05883332 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2022P-000826
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

urodynamic study; nitrous oxide; neurogenic bladder; overactive bladder; ambulatory; patient experience of care

Outcome Measures

Primary Outcomes (1)

• Bladder Capacity

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

  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

  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

  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

  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

  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

  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.

Study Arms (2)

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%)

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

Drug: Self-Administered Nitrous Oxide; Other: Oxygen

Interventions

Self-Administered Nitrous Oxide DRUG

Nitrous oxide administered at concentrations of minimal sedation (20-50%)

Also known as: nitrous oxide

Oxygen First Arm; SANO First Arm

Oxygen OTHER

100% oxygen at 10 Liters/minute

Oxygen First Arm; SANO First Arm

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 17114560 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive

Interventions

Nitrous Oxide; Oxygen

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Heidi Rayala
• Organization: Beth Is

hrayala@bidmc.harvard.edu

617-667-3739

Study Officials

• Heidi Rayala, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participant and operating urodynamic study practitioner will be blinded to whether SANO or oxygen is given during the study fills. UDS measurements will be assessed by a blinded urologist.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 31, 2023
• Study Start: January 10, 2023
• Primary Completion: March 2, 2023
• Study Completion: March 9, 2023
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)