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NCT Number: NCT07387315

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 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

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Key information

Conditions

Overactive Bladder Agnosia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurobehavioral Manifestations Neurogenic Bladder Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Perceptual Disorders Pregnancy Complications Signs and Symptoms Urge Incontinence Urinary Bladder Diseases Urinary Bladder Neurogenesis Urinary Bladder, Neurogenic Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cincinnati Urogynecology Associates, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Pro-Nox Nitrous Oxide/Oxygen Delivery System

Drug

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.

Other names: Pro-Nox, Nitrous oxide/oxygen 50:50 mixture, Nitrous oxide/oxygen, Nitrous, Nitrous oxide, Nitrous oxide analgesia

Standard Care for Bladder Botox Injection

Drug

Standard care includes intravesical instilled 1-2% lidocaine with a dwell time of at least 15 minutes before the procedure.

Other names: Intravesical lidocaine, Lidocaine, Standard care, Standard analgesia, Local analgesia

Sham Mask

Other

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.

Other names: Placebo, Room Air

Primary outcomes

  1. 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.

Secondary outcomes

  1. Peak Pain (10-point NRS)

    Time frame: At least 3 minutes after completion of the procedure.

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

  2. Peak Pain Timing

    Time frame: At least 3 minutes after completion of the procedure.

    Patient self-reported timing of peak pain during the procedure, as it corresponds to different steps during the procedure.

  3. Overall Anxiety (10-point NRS)

    Time frame: At least 3 minutes after completion of the procedure.

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

  4. Satisfaction with Pain Management (10-point NRS)

    Time frame: At least 3 minutes after completion of the procedure.

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

  5. Willingness to Repeat (5-point Likert)

    Time frame: At least 3 minutes after completion of the procedure.

    Patient self-reported willingness to repeat under similar pain and anxiety management conditions, on a 5-point Likert scale.

Other outcomes

  1. Nitrous Interest (5-point Likert)

    Time frame: At least 3 minutes after completion of the procedure.

    Patient self-reported interest in use of nitrous oxide for pain and anxiety management in a future procedure, on a 5-point Likert scale.

  2. Adverse Effects

    Time frame: Immediately following the procedure. Completed by performing surgeon.

    Physician reported adverse events encountered peri-operatively.

  3. Blinding Assessment

    Time frame: At least 3 minutes after completion of the procedure.

    Patient self-reported perceived treatment assignment (nitrous oxide/oxygen vs sham mask), recorded as nitrous oxide, sham mask, or unsure.

Study contacts

Contact information is provided by the study sponsor or research team.

Colton H Mabis, MD

CONTACT

[email protected]

5134634300

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

A Randomized, Placebo Controlled Trial of Nitrous Oxide/Oxygen Plus Standard Care Versus Standard Care Alone During In-office Intradetrusor onabotulinumtoxinA (Botox) Injections

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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