Neurogenic Bladder, Overactive Bladder, Pain, Pelvic Floor Disorders, Urge Incontinence, Urinary Bladder Neurogenesis, Urinary Bladder, Neurogenic, Urinary Bladder, Overactive, Urinary Incontinence, Urinary Incontinence, Urge
Conditions
Keywords
Overactive Bladder, Urinary Incontinence, Urge Incontinence, Intradetrusor Injection, OnabotulinumtoxinA, Botox, Bladder Botox, Botulinum Toxins, Type A, Pain Management, Analgesia, Nitrous Oxide, Office-based Procedures, Urogynecology, Pelvic Floor Disorder
Brief summary
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: * Receive their bladder Botox injection in the office setting * Either use nitrous oxide/oxygen plus standard care during the procedure, or sham mask plus standard care * Answer brief questions about pain, anxiety, satisfaction, and willingness to repeat the procedure
Detailed description
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.
Interventions
DRUGPro-Nox Nitrous Oxide/Oxygen Delivery System
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.
DRUGStandard Care for Bladder Botox Injection
Standard care includes intravesical instilled 1-2% lidocaine with a dwell time of at least 15 minutes before the procedure.
OTHERSham Mask
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.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.
Exclusion criteria
* Known/suspected vitamin B12 or folate deficiency or high-risk state (e.g., pernicious anemia, malabsorption, post-bariatric or strict vegan without supplementation) * currently pregnant * severe/unstable pulmonary disease or baseline hypoxemia requiring supplemental home oxygen * eye or ear surgery in the last six weeks * trapped-air conditions (e.g., untreated pneumothorax, bowel obstruction) * severe active otitis/sinus disease * inability to follow directions * history of adverse reaction to nitrous oxide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Pain (10-point NRS) | At least 3 minutes after completion of the procedure. | Patient self-reported overall pain during the procedure on an 11-point numeric rating scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Pain (10-point NRS) | At least 3 minutes after completion of the procedure. | Patient self-reported peak pain during the procedure on an 11-point numeric rating scale. |
| Peak Pain Timing | At least 3 minutes after completion of the procedure. | Patient self-reported timing of peak pain during the procedure, as it corresponds to different steps during the procedure. |
| Overall Anxiety (10-point NRS) | At least 3 minutes after completion of the procedure. | Patient self-reported overall anxiety during the procedure on an 11-point numeric rating scale. |
| Satisfaction with Pain Management (10-point NRS) | At least 3 minutes after completion of the procedure. | Patient self-reported satisfaction with pain management during the procedure on an 11-point numeric rating scale. |
| Willingness to Repeat (5-point Likert) | At least 3 minutes after completion of the procedure. | Patient self-reported willingness to repeat under similar pain and anxiety management conditions, on a 5-point Likert scale. |
Countries
United States
Contacts
CONTACTColton H Mabis, MD
Outcome results
None listed