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NCT07387315 · ClinicalTrials.gov registry record · Phase 4
A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections
A Phase 4 study, sponsored by TriHealth.
- Not yet
- Registry status
- Phase 4
- Development phase
- 96
- Enrollment target
NCT07387315: Clinical Trial Phase 4 study, sponsored by TriHealth.
NCT07387315 is a Phase 4 study that has not yet begun recruiting, run by TriHealth. The registered enrollment target is 96 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07387315, a Phase 4 study, has not yet begun recruiting, sponsored by TriHealth.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 96 participants
- Enrollment target
Study Summary
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
Primary Outcome
Patient self-reported overall pain during the procedure on an 11-point numeric rating scale.
Interventions
- DRUG Pro-Nox Nitrous Oxide/Oxygen Delivery System
- DRUG Standard Care for Bladder Botox Injection
- OTHER Sham Mask
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2026-02 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What is known before NCT07387315 opens enrollment
NCT07387315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Pro-Nox Nitrous Oxide/Oxygen Delivery System is the first listed.
NCT07387315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07387315 about?
NCT07387315 is a clinical study titled "A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections". 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 nitr...
What is the current status of trial NCT07387315?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 96 participants. The study started on 2026-02. Estimated completion is 2026-12.
What interventions are being tested in trial NCT07387315?
The interventions under investigation include: Pro-Nox Nitrous Oxide/Oxygen Delivery System (DRUG), Standard Care for Bladder Botox Injection (DRUG), Sham Mask (OTHER).
Who is sponsoring clinical trial NCT07387315?
This trial is sponsored by TriHealth, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07387315's enrollment target sits among peer trials
96 863rd of 2000 higher than 1,132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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