Clinical trial NCT05883332: A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters
Official title: A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Urinary Tract Symptoms
Keywords: urodynamic study
nitrous oxide
neurogenic bladder
overactive bladder
ambulatory
patient experience of care
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2023-05-31
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Bladder capacity
timeFrame: Measured at time of max fill during each UDS run
Secondary outcomes:
measure: Intra-Urodynamic Study (UDS) pain
timeFrame: Measured at time of max fill during each UDS run
measure: Intra-Urodynamic Study (UDS) anxiety
timeFrame: Measured at time of max fill during each UDS run
measure: Post void residual
timeFrame: Measured at end of void during each UDS run
measure: Max flow rate
timeFrame: Measured during the void at the end of each UDS run
measure: Detrusor overactivity
timeFrame: Measured during each UDS run
measure: Detrusor pressure at maximum flow
timeFrame: Measured during each UDS run
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Heidi Rayala, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.