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

NCT07387315 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-02-04

No results posted yet for this study

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

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

Interventions

DRUG

Pro-Nox Nitrous Oxide/Oxygen Delivery System

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.

DRUG

Standard Care for Bladder Botox Injection

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

OTHER

Sham Mask

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.

Sponsors & Collaborators

  • TriHealth Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07387315 on ClinicalTrials.gov