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

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05883332
• Other study ID #: 2022P-000826
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

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