About this trial
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
Eligibility criteria
Qualifiers
Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pro-Nox Nitrous Oxide/Oxygen Delivery System
- Standard Care for Bladder Botox Injection
- Sham Mask