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

Study Overview
=================
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.

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

Conditions
-----------------
Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Drug: Self-Administered Nitrous Oxide
* Other: Oxygen


Participation Criteria
=================
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: Inner ear, bariatric or eye surgery within the last 2 weeks, Current emphysematous blebs, Severe B-12 deficiency, Bleomycin chemotherapy within the past year, Heart attack within the past year, Stroke within the past year, Class III or higher heart failure

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SANO (1), Oxygen (2)<br>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<br>* Nitrous oxide administered at concentrations of mild sedation (20-50%)<br>* Other names: nitrous oxide;Other: Oxygen<br>* 100% oxygen at 10 Liters/minute<br>|
| Experimental: Oxygen (1), SANO (2)<br>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<br>* Nitrous oxide administered at concentrations of mild sedation (20-50%)<br>* Other names: nitrous oxide;Other: Oxygen<br>* 100% oxygen at 10 Liters/minute<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder capacity | Maximum liquid the bladder may hold as measured in milliliters | Measured at time of max fill during each UDS run | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Post void residual | Amount of liquid left in bladder after voiding, as measured in milliliters | Measured at end of void during each UDS run | 
| Max flow rate | Maximum rate of void, as measured in milliliters per second | Measured during the void at the end of each UDS run | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urodynamic study, nitrous oxide, neurogenic bladder, overactive bladder, ambulatory, patient experience of care