[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523126":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":83,"collaborators":85,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":39,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":39,"enrollmentInfo":99,"targetDuration":39,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":115,"overallStatus":37,"whyStopped":39,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"InnoCon Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Electrical stimulation","EXPERIMENTAL","Electrical stimulation to the dorsal genital nerve.",[13],"Device: UCon-Bar",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","UCon-Bar","The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for either 4 weeks or 12 weeks using UCon with the Bar electrode",[9],[21],"Electrical stimulation to the dorsal genital nerve (DGN stimulation)",[23],{"name":24,"affiliation":25,"role":26},"Peter Christensen, MD","Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Dianna Mærsk Knudsen","CONTACT","40517712","+45","dmk@innoconmedical.dk",[35,55,69],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Aarhus University Hospital","RECRUITING","Aarhus",null,"8200","Denmark","DK",{"type":44,"coordinates":45},"Point",[46,47],10.21076,56.15674,{"lat":47,"lon":46},[50,53],{"name":24,"role":30,"phone":51,"phoneExt":32,"email":52},"20375471","petchris@rm.dk",{"name":54,"role":26,"phone":39,"phoneExt":39,"email":39},"Jakob Jakobsen, MD",{"facility":56,"status":37,"city":57,"state":39,"zip":58,"country":41,"countryCode":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Herlev Hospital","Herlev","2730",{"type":44,"coordinates":60},[61,62],12.43998,55.72366,{"lat":62,"lon":61},[65],{"name":66,"role":30,"phone":67,"phoneExt":32,"email":68},"Niels Klarskov, MD","38 68 14 06","Niels.Klarskov@regionh.dk",{"facility":70,"status":37,"city":71,"state":39,"zip":72,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Odense University Hospital","Odense","5000",{"type":44,"coordinates":74},[75,76],10.38831,55.39594,{"lat":76,"lon":75},[79],{"name":80,"role":30,"phone":81,"phoneExt":32,"email":82},"Mark Bremholm Ellebæk, MD","40 88 05 11","Mark.Ellebaek1@rsyd.dk",{"type":84,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[86,88,89],{"name":36,"class":87},"OTHER",{"name":70,"class":87},{"name":56,"class":87},"100523126","safety-and-performance-of-ucon-bar-electrode-for-the-treatment-of-overactive-bladder-oab-and-bowel-dysfunction-bd-100523126",false,"NCT06091566","Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)","Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study","Inclusion Criteria:\n\n1. Participant is female\n2. Participant is ≥ 18 years of age.\n3. Participant is diagnosed with OAB or BD.\n\n   OAB: Urinary urgency usually with one or more of the following:\n\n   i. Urinary urgency incontinence (≥1 per\u002Fweek). ii. Urinary frequency (≥8 voiding\u002Fday without polyuria). iii. Nocturia (≥2 voiding\u002Fnight without nocturnal polyuria).\n\n   BD: One or more of the following:\n\n   i. Faecal urgency (≥3 urgencies pr. week) together with registration of urgency in St. Mark´s and a St. Mark´s score ≥9.\n\n   ii. Faecal incontinence (urge\u002Fpassive) (≥1 per\u002Fweek).\n4. Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.\n\nExclusion Criteria:\n\n1. Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participants´ participation in the investigation).\n2. Participant has an active infection in the genital area.\n3. Participant has an implanted pacemaker, implantable drug pump or other active medical devices (any medical device that uses electrical energy or other sources of power to make it function).\n4. Participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception during the clinical investigation.\n5. Participant is enrolled or planning to enrol in another conflicting clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks of enrolment.\n6. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.\n7. Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region.\n8. Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.\n9. Participant does not speak or understand Danish.\n\n   * The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.","FEMALE","18 Years",{"count":100,"type":101},20,"ESTIMATED","INTERVENTIONAL",[104],"NA","UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder\u002Fbowel musculature e.g., suppress undesired bladder\u002Fbowel activity to relieve the symptoms of the patient.\n\nThis clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.",[107,108,109,110,111,112,113,114],"Urinary Incontinence","Urinary Incontinence, Urge","Fecal Incontinence","Fecal Incontinence With Fecal Urgency","Nocturia","Urinary Frequency More Than Once at Night","Bowel Disorders Functional","Incontinence, Nighttime Urinary",[107,109,116,117,118],"Urge incontinence","Neurostimulation","Dorsal Genital Nerve","2026-02-16",{"date":121,"type":122},"2026-02-18","ACTUAL",{"date":124,"type":122},"2024-01-12",{"date":126,"type":101},"2027-01-01",{"name":5,"class":6},3]