Overactive BladderPhase 4NCT07387315
A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections
A Phase 4 study testing Pro-Nox Nitrous Oxide/Oxygen Delivery System in people with Overactive Bladder and Neurogenic Bladder, run by TriHealth Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder, Neurogenic Bladder, Urge Incontinence
- What is being tested?
- Pro-Nox Nitrous Oxide/Oxygen Delivery System
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2026to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
Trihealth (Good Samaritan Hospital, Bethesda North Hospital)
Cincinnati, Ohio, 45220
About this study
Official title: A Randomized, Placebo Controlled Trial of Nitrous Oxide/Oxygen Plus Standard Care Versus Standard Care Alone During In-office Intradetrusor onabotulinumtoxinA (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 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.
Read more
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
Read the detailed description
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.
- Conditions
- Overactive Bladder, Neurogenic Bladder, Urge Incontinence, Pain, Urinary Incontinence, Urinary Bladder, Overactive
- Being tested
- Pro-Nox Nitrous Oxide/Oxygen Delivery System, Standard Care for Bladder Botox Injection, Sham Mask
- Keywords
- Overactive Bladder, Urinary Incontinence, Urge Incontinence, Intradetrusor Injection, OnabotulinumtoxinA, Botox, Bladder Botox, Botulinum Toxins, Type A, Pain Management, Analgesia, Nitrous Oxide, Office-based Procedures, Urogynecology, Pelvic Floor Disorder
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Bladder, Neurogenic, Urinary Incontinence, Urge, Pain, Urinary Incontinence, Pelvic Floor Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-Nox Nitrous Oxide/Oxygen Delivery SystemDrug
Also called Pro-Nox, Nitrous oxide/oxygen 50:50 mixture, Nitrous oxide/oxygen, Nitrous
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.
Standard Care for Bladder Botox InjectionDrug
Also called Intravesical lidocaine, Lidocaine, Standard care, Standard analgesia
Standard care includes intravesical instilled 1-2% lidocaine with a dwell time of at least 15 minutes before the procedure.
Sham MaskOther
Also called Placebo, Room Air
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham Mask Plus Standard Care | Active comparator | 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. Receives: Drug: Standard Care for Bladder Botox Injection; Other: Sham Mask |
| Nitrous Oxide Plus Standard Care | Experimental | 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. Receives: Drug: Pro-Nox Nitrous Oxide/Oxygen Delivery System; Drug: Standard Care for Bladder Botox Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Pain (10-point NRS)
Patient self-reported overall pain during the procedure on an 11-point numeric rating scale.
Measured: At least 3 minutes after completion of the procedure.
Secondary outcomes (5)
Peak Pain (10-point NRS)
Patient self-reported peak pain during the procedure on an 11-point numeric rating scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At least 3 minutes after completion of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387315
- Sponsor's protocol ID
- 23-130
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Do not plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Trial of Nitrous Oxide/Oxygen Plus Standard Care Versus Standard Care Alone During In-office Intradetrusor onabotulinumtoxinA (Botox) Injections
- ClinicalTrials.gov ID
- NCT07387315
- Acronym / sponsor ID
- 23-130
- Conditions
- Overactive Bladder, Neurogenic Bladder, Urge Incontinence, Pain, Urinary Incontinence, Urinary Bladder, Overactive
- Keywords
- Overactive Bladder, Urinary Incontinence, Urge Incontinence, Intradetrusor Injection, OnabotulinumtoxinA, Botox, Bladder Botox, Botulinum Toxins, Type A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Mask Plus Standard Care | Active comparator | Drug: Standard Care for Bladder Botox Injection, Other: Sham MaskThe 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. |
| Nitrous Oxide Plus Standard Care | Experimental | Drug: Pro-Nox Nitrous Oxide/Oxygen Delivery System, Drug: Standard Care for Bladder Botox InjectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro-Nox Nitrous Oxide/Oxygen Delivery SystemAlso: Pro-Nox, Nitrous oxide/oxygen 50:50 mixture, Nitrous oxide/oxygen, NitrousThe 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. | Drug | Nitrous Oxide Plus Standard Care |
| Standard Care for Bladder Botox InjectionAlso: Intravesical lidocaine, Lidocaine, Standard care, Standard analgesiaStandard care includes intravesical instilled 1-2% lidocaine with a dwell time of at least 15 minutes before the procedure. | Drug | Nitrous Oxide Plus Standard Care, Sham Mask Plus Standard Care |
| Sham MaskAlso: Placebo, Room AirThe 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. | Other | Sham Mask Plus Standard Care |
Primary outcome
Overall Pain (10-point NRS)
Time frame: At least 3 minutes after completion of the procedure.
Patient self-reported overall pain during the procedure on an 11-point numeric rating scale.
5 secondary outcomes
Peak Pain (10-point NRS)
Time frame: At least 3 minutes after completion of the procedure.
Peak Pain Timing
Time frame: At least 3 minutes after completion of the procedure.
Overall Anxiety (10-point NRS)
Time frame: At least 3 minutes after completion of the procedure.
Satisfaction with Pain Management (10-point NRS)
Time frame: At least 3 minutes after completion of the procedure.
Willingness to Repeat (5-point Likert)
Time frame: At least 3 minutes after completion of the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. Do not plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pro-Nox Nitrous Oxide/Oxygen Delivery System in people with Overactive Bladder and Neurogenic Bladder, run by TriHealth Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colton H Mabis, MD (5134634300, colton_mabis@trihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Pain (10-point NRS) (time frame: At least 3 minutes after completion of the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.