[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054171":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":72,"collaborators":32,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":32,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":32,"enrollmentInfo":83,"targetDuration":32,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Axonics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients diagnosed with OAB and\u002For FI who are candidates for Axonics SNM (PNE) procedure","EXPERIMENTAL","External trial system used evaluated whether patients with OAB or FI will be responsive to sacral neuromodulation.",[13],"Device: Axonics External Trial System (ETS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Axonics External Trial System (ETS)","A temporary electrode wire is passed through the S3 foramen with or without fluoroscopic guidance. The wire is then connected to an external pulse generator (EPG) and is worn for a trial period ranging from 3-7 days.",[9],[21],"Basic or Advanced Trial",[23],{"name":24,"affiliation":25,"role":26},"Ailsa Wilson Edwards, MD","Calvary North Adelaide Hospital","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Erum Shaikh","CONTACT","657.626.4310",null,"Erum.Shaikh@bsci.com",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Gita Ghadimi, OD","949-981-4366","Gita.Ghadimi@bsci.com",[39,57],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Calvary North Adelaide Hospital\u002FBetter Bladders","RECRUITING","North Adelaide","South Australia","5006","Australia","AU",{"type":48,"coordinates":49},"Point",[50,51],138.59141,-34.90733,{"lat":51,"lon":50},[54,56],{"name":55,"role":30,"phone":32,"phoneExt":32,"email":32},"Darcy Noll, MD",{"name":24,"role":26,"phone":32,"phoneExt":32,"email":32},{"facility":58,"status":41,"city":59,"state":60,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Epworth Freemasons Hospital","East Melbourne","Victoria","3002",{"type":48,"coordinates":63},[64,65],144.9879,-37.81667,{"lat":65,"lon":64},[68,70],{"name":69,"role":30,"phone":32,"phoneExt":32,"email":32},"Grace Wood",{"name":71,"role":26,"phone":32,"phoneExt":32,"email":32},"Sandra Elmer, MD",{"type":73,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100054171","aquarius-pilot-study-to-evaluate-the-new-axonics-trial-system-100054171",false,"NCT07335484","Aquarius Pilot Study to Evaluate the New Axonics Trial System","Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)","Inclusion Criteria:\n\n* 18 years or older\n* Provides written informed consent prior to trial procedures\n* Primary indication of OAB (UUI\u002FUF) or chronic FI who are considered candidates for an Axonics PNE procedure as assessed by the physician per product IFU\n\nExclusion Criteria:\n\n* Any participant that the study Investigator deems to be a poor candidate for any reason, including, but not limited to, inability to complete a baseline bladder or bowel diary or to be compliant with study visits\n* Planned changes to current regimen of medications during the trial period that could impact bladder or bowel function\n* Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)\n* Current symptomatic urinary tract infection (UTI)","ALL","18 Years",{"count":84,"type":85},75,"ESTIMATED","INTERVENTIONAL",[88],"NA","Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and\u002For fecal incontinence (FI).",[91,92,93,94],"Urinary Urge Incontinence (UUI)","Urinary Frequency (UF)","Fecal Incontinence (FI)","Overactive Bladder (OAB)",[96,97,98],"Peripheral nerve evaluation","External trial system","Pilot study","2026-07-10",{"date":101,"type":102},"2026-07-13","ACTUAL",{"date":104,"type":102},"2026-04-30",{"date":106,"type":85},"2026-12",{"name":5,"class":6},2]