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

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 (25-50%) 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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: Drug: Self-Administered Nitrous Oxide; Other: Oxygen

Detailed Description

The urodynamic study (UDS) procedure will consist of catheter placement and two "runs". Before the start of the procedure, a study staff member will assist the participant with putting on a plastic gas mask. SANO and oxygen will be given through this mask. The dose will be adjusted based on the participant's comfort level but they will not be able to request more gas than allowed. SANO will be administered during catheter placement at the start of the UDS. During the two runs, the participant will either receive SANO (run 1) then oxygen (run 2), or oxygen (run 1) then SANO (run 2).

Before the day of the UDS, participants will be asked questions related to demographics and medical history to determine study eligibility and experience of the treatment. During the UDS, participants will be asked to describe their anxiety and pain levels. Afterwards, they will be asked to complete a 15-20 minute structured interview with a study staff member to learn more about patient experience during UDS.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Perioral facial hair impeding good mask seal
• Learning disabilities and/or inability to cognitively complete survey questions

• Has any of the following medical conditions:

  1. Inner ear, bariatric or eye surgery within the last 2 weeks,
  2. Current emphysematous blebs,
  3. Severe B-12 deficiency,
  4. Bleomycin chemotherapy within the past year,
  5. Heart attack within the past year,
  6. Stroke within the past year,
  7. Class III or higher heart failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SANO (1), Oxygen (2); 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. At the start of the first UDS run, SANO will continue at the participant-preferred level that was determined during catheter placement, ensuring that the patient is relaxed but still conversant through the procedure. At the end of the first UDS run, SANO will be turned down to 0%. Participants will then receive 100% oxygen at 10 liters/minute for the duration of their second UDS run.	Drug: Self-Administered Nitrous Oxide; Nitrous oxide administered at concentrations of mild sedation (20-50%); Other Names: nitrous oxide; Other: Oxygen; 100% oxygen at 10 Liters/minute
Experimental: Oxygen (1), SANO (2); 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. After catheter placement, SANO will be turned down to 0%. Participants will receive 100% oxygen at 10 liters/minute for the duration of their first UDS run. At the end of the first UDS run, SANO will start at the participant-preferred level that was determined during catheter placement, ensuring that the patient is relaxed but still conversant through the procedure. SANO will be given for the duration of their second UDS run.	Drug: Self-Administered Nitrous Oxide; Nitrous oxide administered at concentrations of mild sedation (20-50%); Other Names: nitrous oxide; Other: Oxygen; 100% oxygen at 10 Liters/minute

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder capacity	Maximum liquid the bladder may hold as measured in milliliters	Measured at time of max fill during each UDS run

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 at time of max fill during each UDS run
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 at time of max fill during each UDS run
Post void residual	Amount of liquid left in bladder after voiding, as measured in milliliters	Measured at end of void during each UDS run
Max flow rate	Maximum rate of void, as measured in milliliters per second	Measured during the void at the end of each UDS run
Detrusor overactivity	Pressure sensors (which are located on the UDS catheter within the bladder) measure any bladder contractions that should not normally occur while a bladder fills. Outcome pressures will be measured in centimeters (cm) of water (H2O).	Measured during each UDS run
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 during each UDS run

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Boston Children's Hospital
• Investigators: Principal Investigator: Heidi Rayala, MD, PhD, Beth Israel Deaconess Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): March 2, 2023
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: overactive bladder; ambulatory; nitrous oxide; urodynamic study; neurogenic bladder; patient experience of care
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: 2022P-000826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes