A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTriHealth Inc.

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

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators