A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections
Starting soon · Phase 4 · Has a placebo group
Conditions studied: Overactive Bladder, Neurogenic Bladder, Urge Incontinence, Pain, Urinary Incontinence, Urinary Bladder, Overactive, Urinary Bladder, Neurogenic, Urinary Bladder Neurogenesis, Urinary Incontinence, Urge, Pelvic Floor Disorders
In brief
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
Key facts
- Study ID
- NCT07387315
- Run by
- TriHealth Inc.
- People needed
- 96
- Starts
- 2026-02-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-02-04
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.
You may not qualify if…
- 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
Where it is running
- Cincinnati Urogynecology Associates — Cincinnati, Ohio, United States
- Trihealth (Good Samaritan Hospital, Bethesda North Hospital) — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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