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The goal of this clinical trial is to assess if a mix of nitrous oxide and oxygen can improve pain control during bladder Botox injections. The primary question it aims to answer is: Does using nitrous oxide lower the overall level of pain during the procedure?
Researchers will compare a 50:50 nitrous oxide/oxygen mixture (administered with the Pro-Nox system) plus standard care (with lidocaine in the bladder) to sham mask plus standard care to see if nitrous oxide works better for lowering pain.
Participants will:
This study will assess if a 50:50 nitrous oxide and oxygen mixture can lower pain in women undergoing in-office bladder onabotulinumtoxinA (Botox) injections. Many people report pain during this procedure, and pain is a common reason not to repeat the procedure. Nitrous oxide is a fast-acting inhaled analgesic that is used commonly in the office setting.
This randomized controlled trial will compare nitrous oxide/oxygen plus standard care with sham mask plus standard care. Participants assigned to the nitrous oxide group will receive nitrous oxide via the Pro-Nox device during the procedure. Both, participants assigned to the nitrous oxide group and the standard care alone group, will receive the usual lidocaine instilled in the bladder for at least 15 minutes.
The study will measure participants overall pain during the procedure. It will also assess peak pain, overall anxiety, satisfaction, willingness to repeat, interest in using nitrous oxide in future bladder Botox procedures, and side effects. Nitrous oxide is expected to wear off within minutes, allowing participants to leave the clinic without restrictions.
This research study would be first randomized-controlled trial to evaluate nitrous oxide for pain management during this common in-office procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Mask Plus Standard Care | Active Comparator | The sham mask plus standard care group will receive a mask that is connected to the Pro-Nox system but with the valves turned completely off; therefore they will inhale room air plus standard care: intravesical instillation of 1-2% lidocaine solution (30-50 mL) with at least 15 minutes dwell time before the procedure. |
|
| Nitrous Oxide Plus Standard Care | Experimental | Participants in this group will receive standard care plus 50:50 mix of inhaled nitrous oxide/oxygen self-administered using the Pro-Nox system during the bladder Botox procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pro-Nox Nitrous Oxide/Oxygen Delivery System | Drug | The Pro-Nox system delivers a fixed 50:50 mixture of nitrous oxide and oxygen for patient self-administered inhaled analgesia. Participants will self-administer nitrous oxide throughout the in-office bladder Botox procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Pain (10-point NRS) | Patient self-reported overall pain during the procedure on an 11-point numeric rating scale. | At least 3 minutes after completion of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Pain (10-point NRS) | Patient self-reported peak pain during the procedure on an 11-point numeric rating scale. | At least 3 minutes after completion of the procedure. |
| Peak Pain Timing | Patient self-reported timing of peak pain during the procedure, as it corresponds to different steps during the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Nitrous Interest (5-point Likert) | Patient self-reported interest in use of nitrous oxide for pain and anxiety management in a future procedure, on a 5-point Likert scale. | At least 3 minutes after completion of the procedure. |
| Adverse Effects |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colton H Mabis, MD | Contact | 5134634300 | colton_mabis@trihealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Urogynecology Associates | Cincinnati | Ohio | 45220 | United States | ||
| Trihealth (Good Samaritan Hospital, Bethesda North Hospital) |
Do not plan to share individual participant data with other researchers.
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The participants will be masked to sham mask versus mask with nitrous oxide/oxygen. Masking of the investigators would not be feasible given the use of participant self-administered inhaled nitrous oxide gas.
|
| Standard Care for Bladder Botox Injection | Drug | Standard care includes intravesical instilled 1-2% lidocaine with a dwell time of at least 15 minutes before the procedure. |
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| Sham Mask | Other | The Sham Mask will involve that participant using the same mask as that of the Nitrous Oxide group, but connected to a Pro-Nox system that is turned completely off. They will therefore receive room air through the mask. |
|
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| At least 3 minutes after completion of the procedure. |
| Overall Anxiety (10-point NRS) | Patient self-reported overall anxiety during the procedure on an 11-point numeric rating scale. | At least 3 minutes after completion of the procedure. |
| Satisfaction with Pain Management (10-point NRS) | Patient self-reported satisfaction with pain management during the procedure on an 11-point numeric rating scale. | At least 3 minutes after completion of the procedure. |
| Willingness to Repeat (5-point Likert) | Patient self-reported willingness to repeat under similar pain and anxiety management conditions, on a 5-point Likert scale. | At least 3 minutes after completion of the procedure. |
Physician reported adverse events encountered peri-operatively.
| Immediately following the procedure. Completed by performing surgeon. |
| Blinding Assessment | Patient self-reported perceived treatment assignment (nitrous oxide/oxygen vs sham mask), recorded as nitrous oxide, sham mask, or unsure. | At least 3 minutes after completion of the procedure. |
| Cincinnati |
| Ohio |
| 45220 |
| United States |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D001750 | Urinary Bladder, Neurogenic |
| D053202 | Urinary Incontinence, Urge |
| D010146 | Pain |
| D014549 | Urinary Incontinence |
| D059952 | Pelvic Floor Disorders |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| 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 |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D014555 | Urination Disorders |
| D011248 | Pregnancy Complications |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D010100 | Oxygen |
| D059039 | Standard of Care |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D018011 | Chalcogens |
| D004602 | Elements |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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