[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489381":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":86,"collaborators":88,"id":95,"slug":31,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":31,"enrollmentInfo":103,"targetDuration":31,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":48,"whyStopped":31,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Group A","Ialuril therapy for 6 months followed by nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months. In between therapies there is a 4 week wash-out period.",[12,13],"Device: Ialuril 50ml Prefill","Drug: Nitrofurantoin",{"label":15,"type":6,"description":16,"interventionNames":17},"Group B","Nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months followed by Ialuril therapy for 6 months. In between therapies there is a 4 week wash-out period.",[12,13],[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Ialuril 50ml Prefill","50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 6 months",[9,15],[25],"HA-CS",{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Nitrofurantoin","nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. ( In case of resistance\u002Fintolerance\u002Fallergy for nitrofurantoin alternatively trimethoprim 100mg daily)",[9,15],null,[33],{"name":34,"affiliation":5,"role":35},"Dick Janssen, MD, PhD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},"CONTACT","+31 6 41856516","dick.janssen@radboudumc.nl",{"name":42,"role":38,"phone":43,"phoneExt":31,"email":44},"Cléo Baars, MD","+31 6 15400527","cleo.baars@radboudumc.nl",[46,63,76],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Radboudumc","RECRUITING","Nijmegen","Gelderland","6525 GA","Netherlands",{"type":54,"coordinates":55},"Point",[56,57],5.85278,51.8425,{"lat":57,"lon":56},[60,62],{"name":34,"role":38,"phone":61,"phoneExt":31,"email":40},"+31641856516",{"name":42,"role":38,"phone":43,"phoneExt":31,"email":44},{"facility":64,"status":48,"city":65,"state":31,"zip":31,"country":52,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Rijnstate ziekenhuis","Arnhem",{"type":54,"coordinates":67},[68,69],5.91111,51.98,{"lat":69,"lon":68},[72],{"name":73,"role":38,"phone":74,"phoneExt":31,"email":75},"Michael van Balken","+31880058888","mvanbalken@rijnstate.nl",{"facility":77,"status":48,"city":49,"state":31,"zip":31,"country":52,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Canisius wilhelmina ziekenhuis",{"type":54,"coordinates":79},[56,57],{"lat":57,"lon":56},[82],{"name":83,"role":38,"phone":84,"phoneExt":31,"email":85},"Rianne Hendriks","+31243658961","r.hendriks@cwz.nl",{"type":87,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[89,92],{"name":90,"class":91},"IBSA Institut Biochimique SA","INDUSTRY",{"name":93,"class":94},"Goodlife Pharma B.V.","UNKNOWN","100489381",false,"NCT05652374","Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study","GT RACING","Inclusion Criteria:\n\n1. Adult female patients (\\>18 years) who had at least 3 symptomatic UTI's in the previous year with no adequate curable therapeutic options (e.g. bladder stones)\n2. At least one UTI's must be confirmed with a positive culture and antibiogram, further UTI's must be confirmed with a urine sediment with positive nitrite or a positive culture.\n\nExclusion Criteria:\n\n1. Male\n2. \\\u003C 18 years\n3. Pregnant\n4. Already on GAG therapy\n5. Already on prophylactic antibiotics\n6. Started or stopped cranberry\u002Fd-mannose therapy or vaginal estrogenic creme in the last two months\n7. Had Gentamicin or other antibiotic instillations in the previous 2 months\n8. Allergic to \\>3 regular used antibiotics in Dutch guidelines (ed. Nitrofurantoin, trimethoprim, Fosfomycin)\n9. A urinary fistula\n10. Urinary stones\n11. Urogenital cancer\n12. Bladder Pain Syndrome - Interstitial Cystitis\n13. Chronic pelvic pain\n14. Had a STD untreated or treated in the previous 2 months\n15. A urinary diversion\n16. An Indwelling catheter\n17. A suprapubic catheter\n18. Performing \\>1\u002Fday self-catheterization\n19. A residue after voiding (PVR) of \\>200ml\n20. Unable (also legal) to give informed consent\n21. Recurrent urosepsis\n22. Multiresistant bacteria in previous urine cultures\n23. Contra-indications and interactions for Nitrofurantoin: severe kidney disfunction (GFR \\\u003C 30), lung- or liver problems or neuropathy after previous use of nitrofurantoin, acute porphyria, known G6PD deficiency, use of magnesium trisilicate.\n24. Contra-indications and interactions for trimethoprim: severe kidney or liver dysfunction, blood count abnormality, use of vitamin K antagonists, use of folic acid antagonists, use of ace inhibitors\n25. Severe lung\u002Frespiratory disfunction (reduced lung capacity, lung cancer, fibrosis, COPD)\n26. Does not tolerate catheterization","FEMALE","18 Years",{"count":104,"type":105},100,"ESTIMATED","INTERVENTIONAL",[108],"PHASE4","The GT RACING is a study comparing the efficacy of HA-CS bladder installations with prophylactic antibiotics in the prevention of recurrent urinary tract infections (rUTI).",[111],"Recurrent Urinary Tract Infection",[113,114],"GAG therapy","Prophylactic antibiotics","2024-11-14",{"date":117,"type":118},"2024-11-18","ACTUAL",{"date":120,"type":118},"2022-10-20",{"date":122,"type":105},"2027-10",{"name":5,"class":6},3]