Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Children's Hospital | OTHER |
Not provided
Not provided
Not provided
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 (20-50%) 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.
Randomization is performed according to a 1:1 block model immediately before the start of UDS. Patients are randomized to receive oxygen followed by SANO or SANO followed by oxygen. The procedural team and patient are blinded to the treatment. Muscarinic medications are stopped 24 hours prior to UDS, and patients provide a urine sample to confirm negative cultures. In this study, the Nitrouseal® system is utilized to administer adjustable amounts of N2O (20-50%) using a single-use disposable mask. The system scavenges exhaled N2O and limits the maximum amount of N2O to 50%. After fitting the Nitrouseal mask, the patients are instructed on how to communicate with hand signals throughout the study to titrate the level of gas being administered. Patients receive SANO during catheter placement to determine their preferred N2O level. Following a "washout" period of two minutes, patients undergo two UDS fills following the randomization scheme. Residual urine is removed between runs using the UDS catheter.
UDS are performed according to the 2012 AUA/SUFU Adult Urodynamic Guidelines. All UDS are performed on a Laborie Aquarius XT machine (Laborie Medical, Portsmouth, NH) using 7 Fr dual lumen fluid urethral catheters, 9 Fr dual lumen fluid-filled rectal catheters, and EMG gel patch electrodes. Filling is performed at 50 cc/min with normal saline at room temperature. During the voiding phase, patients are positioned to be sitting or standing according to their comfort.
An intention-to-treat analysis is performed on 19 participants. Maximum cystometric capacity is measured as the primary outcome. Secondary outcomes include patient-reported pain and anxiety measured at baseline and immediately before maximum capacity during each UDS run using the Visual Analog Scale for Pain (VAS-P; range 0-10) and the Visual Analog Scale for Anxiety (VAS-A; range 0-10).
The blinded UDS operator assesses patient responsiveness (ability to communicate) and tolerance on a 3-point Likert scale: worse than expected, as expected, or better than expected. Standard UDS parameters per International Continence Society terminology, including first sensation, first desire, strong desire, MCC, bladder compliance (volume/Pdet Max during filling), detrusor overactivity, detrusor sphincter dyssynergia, inability to void, maximum flow rate, Pdet during maximum flow rate, voided volume, post-voided residual, and voided percentage, are compared for significant differences between the SANO and Oxygen runs.
Post-procedure patient surveys are administered to assess personal experience of catheter placement, desire to have SANO for future UDS, and satisfaction with N2O levels. Finally, electronic medical records are monitored for Clavien-Dindo graded complications for up to 30 days following the UDS.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygen First Arm | Active Comparator | 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. In OXYGEN FIRST arm, each patient undergoes two consecutive UDS runs. The first UDS run is performed with Oxygen. There is a washout period of 2 minutes between the runs. The second UDS run is performed with the predefined participant-preferred level of SANO. Oxygen Run: 100% oxygen at 10 Liters/minute Self-Administered Nitrous Oxide Run: Nitrous oxide administered at previously determined concentration of nitrous oxide (20-50%) |
|
| SANO First Arm | Active Comparator | 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. In SANO FIRST arm, each patient undergoes two consecutive UDS runs. The first UDS run is performed with the predefined participant-preferred level of SANO. There is a washout period of 2 minutes between the runs. The second UDS run is performed with Oxygen. Self-Administered Nitrous Oxide Run: Nitrous oxide administered at previously determined concentration of nitrous oxide (20-50%) Oxygen Run: 100% oxygen at 10 Liters/minute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Administered Nitrous Oxide | Drug | Nitrous oxide administered at concentrations of minimal sedation (20-50%) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bladder Capacity | Maximum liquid volume the bladder can hold, measured in milliliters (mL) during urodynamic study (UDS). | Measured at max bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-minute washout; each run lasts ~15-45 minutes depending on individual bladder fill rate |
| 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 maximum bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heidi Rayala, MD, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17114560 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Internal Review Board approval was obtained (IRB 2022P-000826) and outcomes were reported in accordance with CONSORT guidelines. Male and female patients aged 21-85 years, scheduled for UDS, were recruited for study participation from January to March 2023. Patients with medical contraindications to N2O were excluded from the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OXYGEN FIRST Arm | 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. In OXYGEN FIRST arm, each patient undergoes two consecutive UDS runs. The first UDS run is performed with Oxygen. There is a washout period of 2 minutes between the runs. The second UDS run is performed with the predefined participant-preferred level of SANO. |
| FG001 | SANO FIRST Arm | 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. In SANO FIRST arm, each patient undergoes two consecutive UDS runs. The first UDS run is performed with the predefined participant-preferred level of SANO. There is a washout period of 2 minutes between the runs. The second UDS run is performed with Oxygen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Oxygen First, Then SANO | This is a randomized, two-period crossover trial. Participants in this group are randomized to Oxygen first, then SANO. Each participant serves as their own control. 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. Participants in this sequence undergo two consecutive urodynamic study (UDS) runs. The first UDS run is conducted using 100% oxygen at 10 L/min. After a 2-minute washout period, the second UDS run is conducted using self-administered nitrous oxide (SANO) at the participant's preferred concentration (20-50%), which was determined during catheter placement. Run 1: Oxygen (100% at 10 L/min) Run 2: Self-administered nitrous oxide (20-50%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bladder Capacity | Maximum liquid volume the bladder can hold, measured in milliliters (mL) during urodynamic study (UDS). | Posted | Median | Inter-Quartile Range | milliliters | Measured at max bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-minute washout; each run lasts ~15-45 minutes depending on individual bladder fill rate |
|
30 days post-procedure
Electronic medical records were monitored for Clavien-Dindo graded complications for up to 30 d after UDS.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxygen UDS Run | All participants underwent urodynamic studies (UDS) using 100% oxygen at 10 L/min. In this crossover study, participants received both oxygen and self-administered nitrous oxide (SANO) in randomized order. This arm includes outcome data collected during the oxygen UDS runs for all participants (N=19). |
Not provided
Not provided
Study limitations:
Patients were recruited from a single tertiary institution. The study was powered to assess urodynamic capacity outcomes, and the small sample size may have limited the interpretation of other outcomes of interest.
Recruitment was limited to adult patients, so the findings may need to be confirmed in a pediatric population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heidi Rayala | Beth Is | 617-667-3739 | hrayala@bidmc.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2022 | Aug 14, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2024 | Mar 19, 2025 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 21, 2022 | Apr 11, 2023 | ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D001750 | Urinary Bladder, Neurogenic |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
Not provided
Not provided
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.
Not provided
Not provided
The participant and operating urodynamic study practitioner will be blinded to whether SANO or oxygen is given during the study fills. UDS measurements will be assessed by a blinded urologist.
| Oxygen | Other | 100% oxygen at 10 Liters/minute |
|
| 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 maximum bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
| Post Void Residual | Amount of liquid left in bladder after voiding, as measured in milliliters | Measured immediately after voiding during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
| Max Flow Rate | Maximum rate of void, as measured in milliliters per second | Measured at time of maximum urinary flow during voiding in each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
| Detrusor Overactivity | Pressure sensors (which are located on the UDS catheter within the bladder) measure bladder contractions that should not normally occur while a bladder fills. Detrusor overactivity (DO) was assessed during each UDS run using pressure sensors in accordance with 2012 AUA/SUFU guidelines. The diagnosis is based on the qualitative observation of involuntary detrusor contractions during filling in a binary fashion (presence or absence of DO). Outcomes are reported as the number of Participants that exhibited DO in the specified UDS run. (The clinical determination of DO is qualitative: urodynamicists assess whether observed pressure rises represent true involuntary detrusor contractions by correlating pressure changes with patient symptoms, excluding artifacts (cough, movement, abdominal straining), and evaluating the pattern and context of the pressure rise) | Measured during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
| 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 at time of maximum urinary flow during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
| BG001 | SANO First, Then Oxygen | This is a randomized, two-period crossover trial. Participants in this group are randomized to SANO first, then Oxygen. Each participant serves as their own control. 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. Participants in this sequence undergo two consecutive UDS runs. The first UDS run is conducted using self-administered nitrous oxide (SANO) at the participant's preferred concentration (20-50%). After a 2-minute washout period, the second UDS run is conducted using 100% oxygen at 10 L/min. Run 1: Self-administered nitrous oxide (20-50%) Run 2: Oxygen (100% at 10 L/min) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| VAS-P (Visual Analog Scale for Pain) | Measure Description: The Visual Analog Scale for Pain (VAS-P) is a validated tool that measures the intensity of a patient's pain. Participants are asked to rate their pain on a continuous scale ranging from 0 to 10, where: 0 represents "no pain" 10 represents "worst imaginable pain" Scores are captured as a single numeric value representing the patient's self-reported pain intensity at a specific time point. Scale range: Minimum score = 0; Maximum score = 10 Directionality: Higher scores indicate worse pain outcomes (greater pain intensity). Unit of Measure: Scores on a scale | Median | Inter-Quartile Range | units on a scale |
|
| VAS-A (Visual Analog Scale for Anxiety) | The Visual Analog Scale for Anxiety (VAS-A) measures self-reported anxiety intensity on a scale from 0 to 10, where 0 = no anxiety and 10 = worst imaginable anxiety. Scores are recorded as a single numeric value. Higher scores indicate worse anxiety outcomes (greater intensity). Scale range: 0-10 Unit of Measure: Scores on a scale | Median | Inter-Quartile Range | units on a scale |
|
| Prior Foley Catheter Experience | Count of Participants | Participants |
|
| Prior UDS Experience | Count of Participants | Participants |
|
| Baseline PCS (Pain Catastrophizing Scale) | The Pain Catastrophizing Scale (PCS) measures negative thoughts and feelings related to pain. It includes 13 items scored from 0 ("not at all") to 4 ("all the time"), summed for a total score ranging from 0 to 52. Higher scores indicate greater levels of pain catastrophizing. Scale range: 0-52 Unit of Measure: Scores on a scale | Median | Inter-Quartile Range | units on a scale |
|
| Baseline STAI (State-Trait Anxiety Inventory) | The State-Trait Anxiety Inventory (STAI) measures anxiety using two 20-item subscales: State Anxiety (current feelings) and Trait Anxiety (general disposition). Each item is rated from 1 to 4, with total subscale scores ranging from 20 to 80. Higher scores indicate greater anxiety. Scale range: 20-80 (per subscale) Unit of Measure: Scores on a scale | Median | Inter-Quartile Range | units on a scale |
|
All participants underwent UDS using self-administered nitrous oxide (SANO) at their preferred concentration (20-50%). In this crossover study, participants received both interventions in randomized order. This arm includes outcome data collected during the SANO UDS runs for all participants (N=19). |
|
|
| 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]) | Posted | Median | Inter-Quartile Range | units on a scale | Measured at maximum bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
|
|
|
| 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]) | Posted | Median | Inter-Quartile Range | units on a scale | Measured at maximum bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
|
|
|
| Secondary | Post Void Residual | Amount of liquid left in bladder after voiding, as measured in milliliters | Posted | Median | Inter-Quartile Range | milliliters | Measured immediately after voiding during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
|
|
|
| Secondary | Max Flow Rate | Maximum rate of void, as measured in milliliters per second | Posted | Median | Inter-Quartile Range | mL/sec | Measured at time of maximum urinary flow during voiding in each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
|
|
|
| Secondary | Detrusor Overactivity | Pressure sensors (which are located on the UDS catheter within the bladder) measure bladder contractions that should not normally occur while a bladder fills. Detrusor overactivity (DO) was assessed during each UDS run using pressure sensors in accordance with 2012 AUA/SUFU guidelines. The diagnosis is based on the qualitative observation of involuntary detrusor contractions during filling in a binary fashion (presence or absence of DO). Outcomes are reported as the number of Participants that exhibited DO in the specified UDS run. (The clinical determination of DO is qualitative: urodynamicists assess whether observed pressure rises represent true involuntary detrusor contractions by correlating pressure changes with patient symptoms, excluding artifacts (cough, movement, abdominal straining), and evaluating the pattern and context of the pressure rise) | Posted | Count of Participants | Participants | Measured during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
|
|
|
| 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). | Posted | Median | Inter-Quartile Range | cmH20 | Measured at time of maximum urinary flow during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity. |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | SANO UDS Run | All participants underwent UDS using self-administered nitrous oxide (SANO) at their preferred concentration (20-50%). In this crossover study, participants received both interventions in randomized order. This arm includes outcome data collected during the SANO UDS runs for all participants (N=19). | 0 | 19 | 0 | 19 | 0 | 19 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |
| D018011 | Chalcogens |
| D004602 | Elements |