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
Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.
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
Parallel
Pro-Nox Nitrous Oxide/Oxygen Delivery System
DrugThe 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.
Standard Care for Bladder Botox Injection
DrugStandard care includes intravesical instilled 1-2% lidocaine with a dwell time of at least 15 minutes before the procedure.
Sham Mask
Other interventionThe 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.
Overall Pain (10-point NRS)
Patient self-reported overall pain during the procedure on an 11-point numeric rating scale.
Peak Pain (10-point NRS)
Patient self-reported peak pain during the procedure on an 11-point numeric rating scale.
Peak Pain Timing
Patient self-reported timing of peak pain during the procedure, as it corresponds to different steps during the procedure.
Overall Anxiety (10-point NRS)
Patient self-reported overall anxiety during the procedure on an 11-point numeric rating scale.
Satisfaction with Pain Management (10-point NRS)
Patient self-reported satisfaction with pain management during the procedure on an 11-point numeric rating scale.
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.
Adverse Effects
Physician reported adverse events encountered peri-operatively.
Blinding Assessment
Patient self-reported perceived treatment assignment (nitrous oxide/oxygen vs sham mask), recorded as nitrous oxide, sham mask, or unsure.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
