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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05883332
Other study ID # 2022P-000826
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 10, 2023
Est. completion date March 9, 2023

Study information

Verified date May 2023
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date March 9, 2023
Est. primary completion date March 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Self-Administered Nitrous Oxide
Nitrous oxide administered at concentrations of mild sedation (20-50%)
Other:
Oxygen
100% oxygen at 10 Liters/minute

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Bladder capacity Maximum liquid the bladder may hold as measured in milliliters Measured at time of max fill during each UDS run
Secondary 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
Secondary 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
Secondary Post void residual Amount of liquid left in bladder after voiding, as measured in milliliters Measured at end of void during each UDS run
Secondary Max flow rate Maximum rate of void, as measured in milliliters per second Measured during the void at the end of each UDS run
Secondary 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
Secondary 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
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