[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585703":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":22,"responsibleParty":44,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":25,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Laborie Medical Technologies Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Subjects indicated for UDS study",null,"The e-Sense® catheters will be used in all subjects to assess primary and secondary objectives. It is a single arm study with no comparative, placebo, sham or control arm.",[13],"Device: eSense 7Fr Single Sensor Bladder Catheter",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","eSense 7Fr Single Sensor Bladder Catheter","Urinary and abdominal catheters inserted into the body to measure pressure for urodynamics.",[9],[21],"eSense 7Fr Abdominal Catheters, eSense 7Fr Dual Sensor Urethral Catheters",[23],{"facility":24,"status":25,"city":26,"state":10,"zip":10,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Bristol Urological Institute","RECRUITING","Bristol","United Kingdom","UK",{"type":30,"coordinates":31},"Point",[32,33],-2.59665,51.45523,{"lat":33,"lon":32},[36,41],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Victoria Garner","CONTACT","+0117 414 8109","victoria.garner@nbt.nhs.uk",{"name":42,"role":43,"phone":10,"phoneExt":10,"email":10},"Andrew Gammie, DPhil CEng CSci","PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100585703","e-sense-normal-values-of-urodynamic-pressures-using-e-sense-catheters-100585703",false,"NCT06905808","e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters","ESNS-01","Inclusion Criteria:\n\n* Subjects medically indicated for Urodynamic procedure between ages 20-35 or \\> 50 years old (equally split male and female)\n* Due to aging and giving birth significantly affecting the urethra:\n* Female subjects 20-35 should be nulliparous.\n* Female subjects \\> 50 years old should have given birth to at least one child vaginally. Further caesarian births would not mean exclusion from the study.\n* Subjects with range of BMI values\n* Subject provides written authorization and\u002For consent per institution or geographical requirements\n\nExclusion Criteria:\n\n* Subjects with cognitive or psychiatric conditions that interfere with or precludes direct and accurate communication regarding the study, giving informed consent\n* Any anal \u002F rectal symptoms and\u002For surgery\n* Pregnant women\n* Subjects with active untreated bladder infections (not including patients with asymptomatic bacteruria)\n* Subjects having greater than 300 mL post void residual on the clinic visit uroflowmetry test","ALL","20 Years",{"count":56,"type":57},40,"ESTIMATED","OBSERVATIONAL","In this post-market observational study, subjects referred to urodynamic testing will be approached to enroll in a clinical study to define the normal range of pressure values utilizing e-Sense® catheters. Urodynamic test results using the study devices will be provided back to the study sponsor for test interpretation and to publish. The urodynamic information collected using the study devices will be used in the UDS test interpretation for each subject enrolled, unless there is a reason to believe the test should be repeated (i.e. inconclusive results).",[61,62],"Lower Urinary Track Symptoms","Urodynamic Exam",[64,61],"Urodynamic","2026-04-23",{"date":67,"type":68},"2026-04-29","ACTUAL",{"date":70,"type":68},"2025-08-15",{"date":72,"type":57},"2026-12",{"name":5,"class":6},1]