[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635690":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":44,"responsibleParty":120,"collaborators":34,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":34,"enrollmentInfo":132,"targetDuration":34,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":146,"overallStatus":149,"whyStopped":34,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intermittent Clean Self-Catheterization (ICSC)","EXPERIMENTAL","ICSC is a technique of intermittent bladder emptying performed several times a day by the patient themselves.",[13],"Procedure: ICSC",{"label":15,"type":16,"description":17,"interventionNames":18},"Indwelling Catheter (IDC)","ACTIVE_COMPARATOR","IDC is a continuous bladder drainage technique that allows for constant urine removal via a catheter left in place in the bladder.",[19],"Procedure: IDC",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","ICSC","ICSC consists of temporary urinary drainage performed by the patient themselves, following therapeutic education provided by a trained nurse. Patients use sterile, single-use catheters to empty their bladder 5 to 6 times a day. This method reduces the risk of infectious complications associated with indwelling catheters, while maintaining a good level of patient autonomy and a satisfactory quality of life. The necessary equipment is provided, and regular follow-ups are organised to monitor the tolerance and effectiveness of the procedure.",[9],[27],"Intermittent Clean Self-Catheterization",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"IDC","IDC involves inserting a urinary catheter connected to a continuous drainage system, which is left in place until surgery. The method is simple to perform and widely used in cases of acute urinary retention. However, it is associated with an increased risk of bacterial colonisation and urinary tract infections, particularly when the catheter is left in place for a prolonged period.",[15],[33],"Indwelling Catheter",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Clément KLEIN, Dr","CONTACT","0033 5 56 79 55 97","clement.klein@chu-bordeaux.fr",{"name":42,"role":38,"phone":39,"phoneExt":34,"email":43},"Grégoire ROBERT, Pr.","gregoire.robert@chu-bordeaux.fr",[45,63,77,92,106],{"facility":46,"status":34,"city":47,"state":34,"zip":34,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"CHU d'Angers","Angers","France","FR",{"type":51,"coordinates":52},"Point",[53,54],-0.55202,47.47156,{"lat":54,"lon":53},[57,61],{"name":58,"role":38,"phone":59,"phoneExt":34,"email":60},"Souhil LEBDAI, Dr","0033 2 41 35 35 09","SoLebdai@chu-angers.fr",{"name":58,"role":62,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"facility":64,"status":34,"city":65,"state":34,"zip":34,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Centre d'Urologie Bordeaux Saint Gatien","Bourdeaux",{"type":51,"coordinates":67},[68,69],5.13611,44.58582,{"lat":69,"lon":68},[72,76],{"name":73,"role":38,"phone":74,"phoneExt":34,"email":75},"Clément MICHIELS, Dr","0033 5 56 11 61 44","clement.michiels@gmail.com",{"name":73,"role":62,"phone":34,"phoneExt":34,"email":34},{"facility":78,"status":34,"city":79,"state":34,"zip":34,"country":48,"countryCode":49,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"APHP la Pitié-Salpêtrière","Paris",{"type":51,"coordinates":81},[82,83],2.3488,48.85341,{"lat":83,"lon":82},[86,90],{"name":87,"role":38,"phone":88,"phoneExt":34,"email":89},"Ugo PINAR","0033 1 84 82 80 63","ugo.pinar@aphp.fr",{"name":91,"role":62,"phone":34,"phoneExt":34,"email":34},"Ugo PINAR, Dr",{"facility":93,"status":34,"city":94,"state":34,"zip":34,"country":48,"countryCode":49,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Hôpital Prive Francheville","Périgueux",{"type":51,"coordinates":96},[97,98],0.71439,45.18691,{"lat":98,"lon":97},[101,105],{"name":102,"role":38,"phone":103,"phoneExt":34,"email":104},"Richard MALLET, Dr","0033 6 22 47 16 45","richard.mallet1@gmail.com",{"name":102,"role":62,"phone":34,"phoneExt":34,"email":34},{"facility":107,"status":34,"city":108,"state":34,"zip":34,"country":48,"countryCode":49,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"CHU de Toulouse Rangueil","Toulouse",{"type":51,"coordinates":110},[111,112],1.44367,43.60426,{"lat":112,"lon":111},[115,119],{"name":116,"role":38,"phone":117,"phoneExt":34,"email":118},"Xavier GAME, Pr","0033 5 61 32 31 06","game.x@chu-toulouse.fr",{"name":116,"role":62,"phone":34,"phoneExt":34,"email":34},{"type":121,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100635690","comparing-clean-intermittent-self-catheterization-and-indwelling-catheterization-for-the-management-of-urinary-retention-before-bph-surgery-100635690",false,"NCT07555964","Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.","Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.l","CATHETERS","Inclusion Criteria:\n\n* Men over 50 years old;\n* Confirmed diagnosis of benign prostatic hyperplasia (BPH);\n* Prostate volume greater than 40 grams;\n* Presence of acute urinary retention with failure to wean from the catheter despite medical treatment with alpha-blocker for at least 48 hours\n* Indication for surgical management of BPH;\n* Patient affiliated with or a beneficiary of a social security scheme;\n* Signed informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Patient with a history of prostate surgery (including BPH surgery), prostatic artery embolization or Urolift implant placement are not considered a history of prostate surgery;\n* Patient with symptomatic urethral stricture;\n* Patient with a bladder emptying disorder of neurogenic origin;\n* Patient with an anatomical contraindication to ICSC (urethral stricture, false urethral route);\n* Patient who had urine drainage by suprapubic catheter\n* Patient with motor, neurological, anatomical, or cognitive difficulties preventing the education or learning of ICSC;\n* Patient contraindicated for surgical management of their BPH;\n* Patient unable to understand the research documents and provide informed consent;\n* Persons subject to legal protection measures or placed under judicial protection.","MALE","50 Years",{"count":133,"type":134},106,"ESTIMATED","INTERVENTIONAL",[137],"NA","The CATHETERS trial is a multicenter, randomized, open-label superiority study comparing two methods of managing urinary retention before surgery for benign prostatic hyperplasia (BPH): clean intermittent self-catheterization (ICSC) versus indwelling catheter (IDC). The primary objective is to determine whether ICSC reduces the occurrence of infectious complications (urinary bacterial colonization requiring antibiotic therapy, urinary tract infection, or urosepsis) compared to IDC in men awaiting BPH surgery. A total of 106 patients will be enrolled across multiple centers in France, with follow-up extending to three months after surgery.",[140,141,142,143,144,145],"Prostatic Hyperplasia","Urinary Retention","Urinary Catheterization","Intermittent Urethral Catheterization","Urinary Tract Infections","Surgical Procedures",[147,23,29,148],"BPH","Urinary Tractus Infection","NOT_YET_RECRUITING","2026-04-21",{"date":152,"type":153},"2026-04-29","ACTUAL",{"date":155,"type":134},"2026-04-24",{"date":157,"type":134},"2028-04-24",{"name":5,"class":6},5]