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

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
TriHealth Inc.
12 trials monitored
See 1 trial at risk
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
Trial Details
NCT Number NCT07387315
Lead Sponsor TriHealth Inc.
Conditions
(from sponsor)		 Overactive Bladder, Neurogenic Bladder, Urge Incontinence, Pain, Urinary Incontinence, Urinary Bladder, Overactive, Urinary Bladder, Neurogenic, Urinary Bladder Neurogenesis +2 more
Related terms Agnosia, Pain, Pelvic Floor Disorders, Urinary Bladder, Neurogenic, Urinary Bladder, Overactive, Urinary Incontinence, Urinary Incontinence, Urge
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov