[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urinary-bladder-neurogenesis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urinary-bladder-neurogenesis":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"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":19,"type":20},96,"ESTIMATED","INTERVENTIONAL",[23],"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",[26,27,28,29,30,31,32,33,34,35],"Overactive Bladder","Neurogenic Bladder","Urge Incontinence","Pain","Urinary Incontinence","Urinary Bladder, Overactive","Urinary Bladder, Neurogenic","Urinary Bladder Neurogenesis","Urinary Incontinence, Urge","Pelvic Floor Disorders",[26,30,28,37,38,39,40,41,42,43,44,45,46,47],"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":51,"type":52},"2026-02-04","ACTUAL",{"date":54,"type":20},"2026-02",{"date":56,"type":20},"2026-12",{"name":58,"class":59},"TriHealth Inc.","OTHER",2]