[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528645":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Yale University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I","EXPERIMENTAL","Participants will get bladder instillations of normal saline for three months and then six months of instillations with chlorohexidine gluconate. After the instillation phase the patients will undergo an observational phase with six months of catheter exchanges without the intervention.",[13],"Device: Bladder instillation with Irrisept",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Bladder instillation with Irrisept","9 months of bladder instillations (3 months of saline and 6 months of chlorohexidine gluconate)",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Joshua Sterling, MD, MSc","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","203-737-3619","joshua.sterling@yale.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Yale New Haven Health","RECRUITING","New Haven","Connecticut","06519","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-72.92816,41.30815,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":48,"phoneExt":20,"email":29},"Joshua Sterling","203-737-8076",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52],{"name":53,"class":54},"Irrimax Corporation","INDUSTRY","100528645","effect-of-chlorhexidine-gluconate-bladder-instillations-in-patients-with-chronic-suprapubic-catheters-on-unplanned-healthcare-encounters-and-quality-of-life-100528645",false,"NCT06163469","Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life","Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters","Inclusion Criteria:\n\n* Indwelling suprapubic catheter with insertion date at least 1 year prior to study enrollment date.\n* History of urinary tract infections, treated for at least 1 positive urine culture in last 6 months\n\nExclusion Criteria:\n\n* Current radiographic evidence of urolithiasis\n* History of vesicoureteral reflux\n* History of renal transplantation\n* History of bladder augmentation\n* Inability to stop use of other rUTI prophylaxis treatments for the duration of their trial enrollment\n* Life expectancy of less than 12 months prior to consent.\n* Known hypersensitivity or allergy to chlorhexidine.\n* Women who are pregnant or breastfeeding.","ALL","18 Years",{"count":65,"type":66},70,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to evaluate the feasibility and tolerability of 0.05% Chlorhexidine Gluconate (CGH) bladder instillations in an outpatient setting at the time of suprapubic catheter (SPC) exchange in patients with history of recurrent urinary tract infections (UTI). The main questions are:\n\n1. is instillation of 150mL of CGH for five-minute duration at the time of SPC exchange feasible in an outpatient setting and tolerable for patients.\n2. does this protocol decrease the rate of unplanned health care visits and improve patient quality of life.\n\nPatients will undergo the treatment protocol during their routine suprapubic catheter exchanges.",[72,73],"Neurogenic Bladder","Urinary Retention",[75,76],"recurrent UTI","bladder irrigation","2026-06-17",{"date":79,"type":80},"2026-06-18","ACTUAL",{"date":82,"type":80},"2024-04-01",{"date":84,"type":66},"2027-12-31",{"name":5,"class":6},1]