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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
TriHealth Inc.
Study ID
NCT07387315
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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

Key Dates

Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Sham Mask Plus Standard Care
    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.
  • Experimental: Nitrous Oxide Plus Standard Care
    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.

Primary Outcome Measure

Overall Pain (10-point NRS) [ Time Frame: At least 3 minutes after completion of the procedure. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cincinnati Urogynecology AssociatesCincinnatiOhio45220-
Trihealth (Good Samaritan Hospital, Bethesda North Hospital)CincinnatiOhio45220-

Find similar trials in Cincinnati, OH

By research site
Cincinnati Urogynecology Associates· Cincinnati, OHTrihealth (Good Samaritan Hospital, Bethesda North Hospital)· Cincinnati, OH

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