Nitrous Oxide for Pain During Bladder Botox Injections

This study is testing if a mix of nitrous oxide and oxygen (Pro-Nox system) can reduce pain during in-office bladder Botox injections for conditions like overactive bladder or urge incontinence. You would receive your Botox injection and either use the Pro-Nox system with standard care (lidocaine in the bladder) or a sham mask with standard care. Researchers want to see if using nitrous oxide lowers your overall pain during the procedure. The study is currently unclear on its status and plans to enroll 96 adult women who are at least 18 years old and scheduled for this procedure. You cannot participate if you are pregnant or have certain health conditions like severe lung disease or vitamin B12 deficiency.

Study design
This is a randomized controlled trial comparing two groups: one receiving nitrous oxide/oxygen plus standard care, and another receiving a sham mask plus standard care. The study plans to enroll 96 participants.
What's involved
You would receive your bladder Botox injection in the office setting and answer brief questions about pain, anxiety, satisfaction, and willingness to repeat the procedure.
Compensation
Not stated in the trial record.
Follow-up
Overall pain will be measured at least 3 minutes after the procedure is completed.

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NCT07387315

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

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
TriHealth Inc.
~96 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Pro-Nox Nitrous Oxide/Oxygen Delivery SystemStandard Care for Bladder Botox InjectionSham Mask

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Pain (10-point NRS)
Measured over At least 3 minutes after completion of the procedure.
Overactive Bladder
Neurogenic Bladder
Urge Incontinence
Pain
Urinary Incontinence
Urinary Bladder, Overactive
Urinary Bladder, Neurogenic
Urinary Bladder Neurogenesis
Urinary Incontinence, Urge
Pelvic Floor Disorders
2 sites across 1 states
Ohio2

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.

Exclusion

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
  • Overall Pain (10-point NRS)At least 3 minutes after completion of the procedure.

    Patient self-reported overall pain during the procedure on an 11-point numeric rating scale.