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

• Status: Completed
• Trial end date: 2023-03-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Boston Children's Hospital
• Treatments: Nitrous Oxide

Criteria

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