A Phase 4 interventional study of Pro-Nox Nitrous Oxide/Oxygen Delivery System and Standard Care for Bladder Botox Injection in Overactive Bladder, Neurogenic Bladder and Urge Incontinence, sponsored by TriHealth Inc.. Not yet recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by TriHealth Inc. · Phase 4, Interventional, and Treatment
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:
This study will assess if a 50:50 nitrous oxide and oxygen mixture can lower pain in women undergoing in-office bladder onabotulinumtoxinA (Botox) injections. Many people report pain during this procedure, and pain is a common reason not to repeat the procedure. Nitrous oxide is a fast-acting inhaled analgesic that is used commonly in the office setting.
This randomized controlled trial will compare nitrous oxide/oxygen plus standard care with sham mask plus standard care. Participants assigned to the nitrous oxide group will receive nitrous oxide via the Pro-Nox device during the procedure. Both, participants assigned to the nitrous oxide group and the standard care alone group, will receive the usual lidocaine instilled in the bladder for at least 15 minutes.
The study will measure participants overall pain during the procedure. It will also assess peak pain, overall anxiety, satisfaction, willingness to repeat, interest in using nitrous oxide in future bladder Botox procedures, and side effects. Nitrous oxide is expected to wear off within minutes, allowing participants to leave the clinic without restrictions.
This research study would be first randomized-controlled trial to evaluate nitrous oxide for pain management during this common in-office procedure.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 96 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The sham mask plus standard care group will receive a mask that is connected to the Pro-Nox system but with the valves turned completely off; therefore they will inhale room air plus standard care: intravesical instillation of 1-2% lidocaine solution (30-50 mL) with at least 15 minutes dwell time before the procedure.
Drug: Standard Care for Bladder Botox Injection · Other: Sham Mask
Participants in this group will receive standard care plus 50:50 mix of inhaled nitrous oxide/oxygen self-administered using the Pro-Nox system during the bladder Botox procedure.
Drug: Pro-Nox Nitrous Oxide/Oxygen Delivery System · Drug: Standard Care for Bladder Botox Injection
Drug pages: Nitrous Oxide · Oxygen
The Pro-Nox system delivers a fixed 50:50 mixture of nitrous oxide and oxygen for patient self-administered inhaled analgesia. Participants will self-administer nitrous oxide throughout the in-office bladder Botox procedure.
Also known as: Pro-Nox, Nitrous oxide/oxygen 50:50 mixture, Nitrous oxide/oxygen, Nitrous, Nitrous oxide, Nitrous oxide analgesia
Standard care includes intravesical instilled 1-2% lidocaine with a dwell time of at least 15 minutes before the procedure.
Also known as: Intravesical lidocaine, Lidocaine, Standard care, Standard analgesia, Local analgesia
The Sham Mask will involve that participant using the same mask as that of the Nitrous Oxide group, but connected to a Pro-Nox system that is turned completely off. They will therefore receive room air through the mask.
Also known as: Placebo, Room Air
Overall Pain (10-point NRS)
Patient self-reported overall pain during the procedure on an 11-point numeric rating scale.
Time frame: At least 3 minutes after completion of the procedure.
Peak Pain (10-point NRS)
Patient self-reported peak pain during the procedure on an 11-point numeric rating scale.
Time frame: At least 3 minutes after completion of the procedure.
Peak Pain Timing
Patient self-reported timing of peak pain during the procedure, as it corresponds to different steps during the procedure.
Time frame: At least 3 minutes after completion of the procedure.
Overall Anxiety (10-point NRS)
Patient self-reported overall anxiety during the procedure on an 11-point numeric rating scale.
Time frame: At least 3 minutes after completion of the procedure.
Satisfaction with Pain Management (10-point NRS)
Patient self-reported satisfaction with pain management during the procedure on an 11-point numeric rating scale.
Time frame: At least 3 minutes after completion of the procedure.
Willingness to Repeat (5-point Likert)
Patient self-reported willingness to repeat under similar pain and anxiety management conditions, on a 5-point Likert scale.
Time frame: At least 3 minutes after completion of the procedure.
Nitrous Interest (5-point Likert)
Patient self-reported interest in use of nitrous oxide for pain and anxiety management in a future procedure, on a 5-point Likert scale.
Time frame: At least 3 minutes after completion of the procedure.
Adverse Effects
Physician reported adverse events encountered peri-operatively.
Time frame: Immediately following the procedure. Completed by performing surgeon.
Blinding Assessment
Patient self-reported perceived treatment assignment (nitrous oxide/oxygen vs sham mask), recorded as nitrous oxide, sham mask, or unsure.
Time frame: At least 3 minutes after completion of the procedure.
Plan to share: No — Do not plan to share individual participant data with other researchers.
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Nov 2026, 9 months later.
Of 42 non-industry phase 4 interventional studies under Urinary Bladder, Overactive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 9 months is below that.
Counting every sponsor, half of 54 studies reached it within 23 months; a quarter within 15 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Nitrous Oxide · Oxygen