[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622722":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":51,"centralContacts":52,"locations":58,"responsibleParty":77,"collaborators":51,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":51,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":51,"enrollmentInfo":88,"targetDuration":51,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":106,"overallStatus":118,"whyStopped":51,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"TriHealth Inc.","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Drug: Standard Care for Bladder Botox Injection","Other: Sham Mask",{"label":16,"type":17,"description":18,"interventionNames":19},"Nitrous Oxide Plus Standard Care","EXPERIMENTAL","Participants in this group will receive standard care plus 50:50 mix of inhaled nitrous oxide\u002Foxygen self-administered using the Pro-Nox system during the bladder Botox procedure.",[20,13],"Drug: Pro-Nox Nitrous Oxide\u002FOxygen Delivery System",[22,34,44],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Pro-Nox Nitrous Oxide\u002FOxygen 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.",[16],[28,29,30,31,32,33],"Pro-Nox","Nitrous oxide\u002Foxygen 50:50 mixture","Nitrous oxide\u002Foxygen","Nitrous","Nitrous oxide","Nitrous oxide analgesia",{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"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.",[16,9],[39,40,41,42,43],"Intravesical lidocaine","Lidocaine","Standard care","Standard analgesia","Local analgesia",{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"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.",[9],[49,50],"Placebo","Room Air",null,[53],{"name":54,"role":55,"phone":56,"phoneExt":51,"email":57},"Colton H Mabis, MD","CONTACT","5134634300","colton_mabis@trihealth.com",[59,72],{"facility":60,"status":51,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":51},"Cincinnati Urogynecology Associates","Cincinnati","Ohio","45220","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-84.51439,39.12711,{"lat":70,"lon":69},{"facility":73,"status":51,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":74,"geoPoint":76,"contacts":51},"Trihealth (Good Samaritan Hospital, Bethesda North Hospital)",{"type":67,"coordinates":75},[69,70],{"lat":70,"lon":69},{"type":78,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100622722","phase-4-a-randomized-placebo-controlled-trial-of-nitrous-oxide-during-in-office-bladder-botox-injections-100622722",false,"NCT07387315","A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections","A Randomized, Placebo Controlled Trial of Nitrous Oxide\u002FOxygen Plus Standard Care Versus Standard Care Alone During In-office Intradetrusor onabotulinumtoxinA (Botox) Injections","Inclusion Criteria:\n\n* Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.\n\nExclusion Criteria:\n\n* Known\u002Fsuspected vitamin B12 or folate deficiency or high-risk state (e.g., pernicious anemia, malabsorption, post-bariatric or strict vegan without supplementation)\n* currently pregnant\n* severe\u002Funstable pulmonary disease or baseline hypoxemia requiring supplemental home oxygen\n* eye or ear surgery in the last six weeks\n* trapped-air conditions (e.g., untreated pneumothorax, bowel obstruction)\n* severe active otitis\u002Fsinus disease\n* inability to follow directions\n* history of adverse reaction to nitrous oxide","FEMALE","18 Years",{"count":89,"type":90},96,"ESTIMATED","INTERVENTIONAL",[93],"PHASE4","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?\n\nResearchers will compare a 50:50 nitrous oxide\u002Foxygen 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.\n\nParticipants will:\n\n* Receive their bladder Botox injection in the office setting\n* Either use nitrous oxide\u002Foxygen plus standard care during the procedure, or sham mask plus standard care\n* Answer brief questions about pain, anxiety, satisfaction, and willingness to repeat the procedure",[96,97,98,99,100,101,102,103,104,105],"Overactive Bladder","Neurogenic Bladder","Urge Incontinence","Pain","Urinary Incontinence","Urinary Bladder, Overactive","Urinary Bladder, Neurogenic","Urinary Bladder Neurogenesis","Urinary Incontinence, Urge","Pelvic Floor Disorders",[96,100,98,107,108,109,110,111,112,113,114,115,116,117],"Intradetrusor Injection","OnabotulinumtoxinA","Botox","Bladder Botox","Botulinum Toxins, Type A","Pain Management","Analgesia","Nitrous Oxide","Office-based Procedures","Urogynecology","Pelvic Floor Disorder","NOT_YET_RECRUITING","2026-01-28",{"date":121,"type":122},"2026-02-04","ACTUAL",{"date":124,"type":90},"2026-02",{"date":126,"type":90},"2026-12",{"name":5,"class":6},2]