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

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05883332
Collaborator
Boston Children's Hospital (Other)
19
Enrollment
1
Location
2
Arms
1.9
Actual Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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 (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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Self-Administered Nitrous Oxide
  • Other: Oxygen
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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 (Participant, Care Provider, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Supportive Care
Official Title:
A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters
Actual Study Start Date :
Jan 10, 2023
Actual Primary Completion Date :
Mar 2, 2023
Actual Study Completion Date :
Mar 9, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Bladder capacity [Measured at time of max fill during each UDS run]

      Maximum liquid the bladder may hold as measured in milliliters

    Secondary Outcome Measures

    1. Intra-Urodynamic Study (UDS) pain [Measured at time of max fill during each UDS run]

      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])

    2. Intra-Urodynamic Study (UDS) anxiety [Measured at time of max fill during each UDS run]

      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])

    3. Post void residual [Measured at end of void during each UDS run]

      Amount of liquid left in bladder after voiding, as measured in milliliters

    4. Max flow rate [Measured during the void at the end of each UDS run]

      Maximum rate of void, as measured in milliliters per second

    5. Detrusor overactivity [Measured during each UDS run]

      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).

    6. Detrusor pressure at maximum flow [Measured during each UDS run]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center
    • Boston Children's Hospital

    Investigators

    • Principal Investigator: Heidi Rayala, MD, PhD, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Heidi Rayala, Assistant Professor of Surgery, Beth Israel Deaconess Medical Center
    ClinicalTrials.gov Identifier:
    NCT05883332
    Other Study ID Numbers:
    • 2022P-000826
    First Posted:
    May 31, 2023
    Last Update Posted:
    May 31, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Heidi Rayala, Assistant Professor of Surgery, Beth Israel Deaconess Medical Center
    urodynamic study
    nitrous oxide
    neurogenic bladder
    overactive bladder
    ambulatory
    patient experience of care
    Additional relevant MeSH terms:
    Lower Urinary Tract Symptoms
    Nitrous Oxide

    Study Results

    No Results Posted as of May 31, 2023