A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections (NCT07387315)
A Randomized, Placebo Controlled Trial of Nitrous Oxide/Oxygen Plus Standard Care Versus Standard Care Alone During In-office Intradetrusor onabotulinumtoxinA (Botox) Injections
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Cincinnati Urogynecology Associates — Cincinnati, Ohio
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Cincinnati Urogynecology Associates — Cincinnati, Ohio
- Trihealth (Good Samaritan Hospital, Bethesda North Hospital) — Cincinnati, Ohio
📞 Contact the Study Coordinator
Phone: (513) 463-4300
Email: colton_mabis@trihealth.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease — Decatur, Georgia
- Add-On ZIDA Sock Therapy for Overactive Bladder — Charleston, South Carolina
- Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder — Bethesda, Maryland
Explore by condition: All Overactive Bladder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.