[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506789":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":60,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":18,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":18,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Northwestern University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intra-detrusor OnabotulinumtoxinA Injection","EXPERIMENTAL","Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.",[13],"Drug: OnabotulinumtoxinA",{"label":15,"type":16,"description":17,"interventionNames":18},"No intra-detrusor OnabotulinumtoxinA Injection","NO_INTERVENTION","Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","OnabotulinumtoxinA","Intra-detrusor OnabotulinumtoxinA is commonly known as botox",[9],[26],"Botox",[28],{"name":29,"affiliation":5,"role":30},"Amy Krambeck, MD","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Alyssa McDonald","CONTACT","312-695-8146","Alyssa.McDonald@northwestern.edu",{"name":38,"role":34,"phone":35,"phoneExt":18,"email":39},"Allaa Fadl-Alla","Allaa.Fadlalla@northwestern.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Northwestern Medicine","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-87.65005,41.85003,{"lat":53,"lon":52},[56],{"name":33,"role":34,"phone":18,"phoneExt":18,"email":18},{"type":30,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Amy Krambeck","Professor of Urology",[61,63,65],{"name":62,"class":6},"University of Calgary",{"name":64,"class":6},"Ohio State University",{"name":66,"class":6},"University of Alberta","100506789","phase-2-examining-the-effects-of-intra-detrusor-botox-at-time-of-holep-in-men-with-overactive-bladder-symptoms-100506789",false,"NCT05878951","Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms","A Multicenter Randomized Controlled Trial Examining the Effects of Intra-detrusor Botulinum Toxin at Time of Holmium Laser Enucleation of the Prostate (HoLEP) in Men With Overactive Bladder (OAB) Symptoms","Inclusion Criteria:\n\n* Males 18 -89 undergoing HoLEP\n* Component of OAB symptoms including frequency, nocturia, urgency, and\u002For urge related incontinence\n* Willing to sign the Informed Consent Form\n* Able to read, understand, and complete patient questionnaires.\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity to OnabotulinumtoxinA injections\n* Patients having a concurrent ureteroscopy +\u002F- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP\n* Anticipated need for perineal urethrostomy at the time of HoLEP\n* Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy\n* Patients who lack decisional capacity\n* Active urinary tract infection","MALE","18 Years","89 Years",{"count":78,"type":79},66,"ESTIMATED","INTERVENTIONAL",[82,83],"PHASE2","PHASE3","The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.",[86,87,88,89],"Urinary Incontinence","Overactive Bladder Syndrome","Overactive Bladder","Urologic Diseases","2026-06-02",{"date":92,"type":93},"2026-06-04","ACTUAL",{"date":95,"type":93},"2023-07-13",{"date":97,"type":79},"2026-12-31",{"name":5,"class":6},1]