[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566645":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Assistance Publique Hopitaux De Marseille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"general anesthesia","ACTIVE_COMPARATOR","REZUM procedure under general anesthesia",[13],"Procedure: water vapor therapy under general anesthesia",{"label":15,"type":10,"description":16,"interventionNames":17},"Local anesthesia","REZUM procedure under local anesthesia",[18],"Procedure: water vapor therapy under local anesthesia",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","water vapor therapy under general anesthesia","Water vapor procedure will be performe under conscious intravenous sedation with anesthesia team",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"water vapor therapy under local anesthesia","Water vapor procedure will be performe under local anethesia administrated with Schelin® catheter via the trans-urethral route : injection of 20cc of lidocaine 2% intra-prostatically via the schelin catheter at 4 injection points (3cc at 1h, 3cc at 11h, 7cc at 4h, and 7cc at 8h).",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Michael Baboudjian, MD","CONTACT","04.91.96.87.18","michael.baboudjian@ap-hm.fr",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Service d'urologie, Hôpital Nord (AP-HM)","RECRUITING","Marseille","13015","France","FR",{"type":45,"coordinates":46},"Point",[47,48],5.38107,43.29695,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":52,"phoneExt":25,"email":35},"+33 4 91 96 87 18",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100566645","local-anesthesia-with-schelin-catheter-in-rezum-treatment-a-randomized-controlled-trial-100566645",false,"NCT06657872","Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial","LOCALVAPOR","Inclusion Criteria:\n\n* Patients referred for symptomatic benign prostatic hyperplasia (BPH)\n* Men between 45 and 80 years of age\n* IPSS \\> 13\n* Qmax \\\u003C15 ml\u002Fs\n* Prostate volume between 30 and 80 g on ultrasound\n* Patient able to understand study details, benefits and risks\n* Patient able to give informed consent\n* Beneficiary of or affiliated to the French social security system\n* Patient having signed an informed consent form\n\nExclusion Criteria:\n\n* Patients with a history of prostate cancer\n* Patient with history of BPH surgery\n* Patients with a history of neurological bladder disease\n* Patient with history of urethral stricture\n* Patient with history of penile implants\n* Patient with history of pelvic irradiation\n* Patient with a symptomatic urinary tract infection in the 10 days prior to surgery\n* Presence of bladder stones on ultrasonography\n* Patient allergic to lidocaine 2% or any medication used in the pre-operative protocol (anxiolytics, analgesics and non-steroidal anti-inflammatory drugs)\n* Patient under guardianship or curatorship\n* Protected patient, deprived of liberty\n* Patient with a neurological and\u002For psychiatric disorder making it impossible to understand the terms of the study and to sign an informed consent form","MALE","18 Years","80 Years",{"count":66,"type":67},24,"ESTIMATED","INTERVENTIONAL",[70],"NA","In a pilot study, water vapor therapy (RezumTM, Boston Scientific Corporation, Marlborough, MA) was proposed as a minimally invasive procedure for benign prostatic hyperplasia, but often requiring oral ± intravenous sedation or a transrectal prostatic block. Therefore, pain management during Rezum therapy remains a challenge and may lead to the use of pain control protocols and general anesthesia, limiting in some ways the concept of a minimally invasive ambulatory surgical approach. The Schelin® catheter (ProstaLund AB, Lund, Sweden), approved by the European Medicines Agency, is a device for injecting analgesic drugs directly into the prostate via the trans-urethral route, providing more effective local anesthesia and avoiding the need for transrectal route or general anesthesia. This catheter is therefore of crucial importance in offering to our patients an ultra-minimally invasive treatment, associated with a reduction in room occupancy time, outpatient surgery time, a procedure performed independently of the anesthesia team, and for the patient, an accelerated post-operative recovery. Our hypothesis is that the REZUM procedure under local anesthesia could be associated with a \\>20% reduction in operating room occupancy time compared to procedures performed under general anesthesia.",[73],"Benign Prostatic Hyperplasia",[75,76,9,77],"REZUM","MIST","local anesthesia","2026-02-10",{"date":80,"type":81},"2026-02-11","ACTUAL",{"date":83,"type":81},"2025-03-24",{"date":85,"type":67},"2026-11-24",{"name":5,"class":6},1]