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

NCT07387315 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 23-130
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Neurogenic Bladder; Urge Incontinence; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Bladder, Neurogenic; Urinary Bladder Neurogenesis; Urinary Incontinence, Urge; Pelvic Floor Disorders; Overactive Bladder; Pain

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

Outcome Measures

Primary Outcomes (1)

• Overall Pain (10-point NRS)

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

  At least 3 minutes after completion of the procedure.

Secondary Outcomes (5)

• Peak Pain (10-point NRS)

  At least 3 minutes after completion of the procedure.

• Peak Pain Timing

  At least 3 minutes after completion of the procedure.

• Overall Anxiety (10-point NRS)

  At least 3 minutes after completion of the procedure.

• Satisfaction with Pain Management (10-point NRS)

  At least 3 minutes after completion of the procedure.

• Willingness to Repeat (5-point Likert)

  At least 3 minutes after completion of the procedure.

Other Outcomes (3)

• Nitrous Interest (5-point Likert)

  At least 3 minutes after completion of the procedure.

• Adverse Effects

  Immediately following the procedure. Completed by performing surgeon.

• Blinding Assessment

  At least 3 minutes after completion of the procedure.

Study Arms (2)

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.

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.

Drug: Pro-Nox Nitrous Oxide/Oxygen Delivery System; Drug: Standard Care for Bladder Botox Injection

Interventions

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.

Also known as: Pro-Nox, Nitrous oxide/oxygen 50:50 mixture, Nitrous oxide/oxygen, Nitrous, Nitrous oxide, Nitrous oxide analgesia

Nitrous Oxide Plus Standard Care

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.

Also known as: Intravesical lidocaine, Lidocaine, Standard care, Standard analgesia, Local analgesia

Nitrous Oxide Plus Standard Care; Sham Mask Plus Standard Care

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.

Also known as: Placebo, Room Air

Sham Mask Plus Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (2)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Trihealth (Good Samaritan Hospital, Bethesda North Hospital)

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Bladder, Neurogenic; Urinary Incontinence, Urge; Pain; Urinary Incontinence; Pelvic Floor Disorders; Agnosia

Interventions

Nitrous Oxide; Oxygen; Standard of Care; Lidocaine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Urination Disorders; Pregnancy Complications; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Colton H Mabis, MD

CONTACT

5134634300; colton_mabis@trihealth.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be masked to sham mask versus mask with nitrous oxide/oxygen. Masking of the investigators would not be feasible given the use of participant self-administered inhaled nitrous oxide gas.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)