[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447872":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":60,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":90,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Botox injections","EXPERIMENTAL","Patients randomised to the intervention arm will be treated with injection of 100 units of botox in 10 ml sterile saline close to superficial inguinal ring.",[13],"Drug: Botulinum toxin type A",{"label":15,"type":16,"description":17,"interventionNames":18},"Sterile saline injections","PLACEBO_COMPARATOR","Patients randomised to the control arm will be treated with injection of 10 ml sterile saline close to superficial inguinal ring.",[19],"Other: Sterile saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Botulinum toxin type A","The group will receive a solution of 100 units BTX with 10 ml sterile saline close to the superficial inguinal ring.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sterile saline","The group will receive a solution of 10 ml sterile saline close to the superficial inguinal ring.",[15],[32],{"name":33,"affiliation":34,"role":35},"Mads H Poulsen, MD, PhD","Assistant professor","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Nicolai S Schiellerup, MD","CONTACT","+45 61692160","Nicolai.Skov.Schiellerup@rsyd.dk",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},"Hanne Kobberø, MD","Hanne.Kobberoe2@rsyd.dk",[46],{"facility":5,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Odense C","Fyn","5000","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],10.39538,55.40841,{"lat":56,"lon":55},[59],{"name":43,"role":39,"phone":26,"phoneExt":26,"email":26},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Nicolai Skov Schiellerup","Principal investigator","100447872","phase-4-evaluation-of-botox-treatment-on-chronical-scrotal-pain-100447872",false,"NCT05112081","Evaluation of Botox Treatment on Chronical Scrotal Pain","Evaluation of Botox Treatment in Patients With Chronic Scrotal Pain: a Randomized Double Blinded Control Trial","Inclusion Criteria:\n\n1. Age of 18 - 70 years\n2. Unilateral or bilateral scrotal pain \\> 3 months\n3. No other identifiable cause of pain\n4. Insufficient effect of conservative treatment\n5. A positive effect of local anesthesia spermatic cord block\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Interest in trying to conceive with partner in the following 6 months\n3. Local infection near the proposed injection site\n4. History with an allergic reaction to BTX and \u002F or human serum albumin\n5. History of motor neuron disease or hemostatic disorder\n6. Active urogenital cancer\n7. Current use of botox injections which would result in a total dose of botox higher than 300 IE in the span of 3 months","MALE","18 Years","70 Years",{"count":75,"type":76},50,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","The aim of the study is to evaluate the effect of botox injections at the spermatic cord in patients with chronical scrotal pain.\n\nA lot of patients experiences depressive symptoms and a lot feel isolated. The etiology if not fully understood and the condition poses a challenge for physicians.\n\nThe is no efficient minimal invasive treatment for these patients, and in severe cases patients are having there testicle removed.\n\nBy inject botox around the spermatic cord the investigators hope to relieve some of the pain in these patients and offer patients a new minimal invasive treatment.\n\nThe investigators aim to include 50 patients in this study, There will be randomised 1:1 to either the intervention arm (Botox) or control arm (sterile saline). Both patients and physicians will be blinded to the treatment.\n\nPatients will undergo a thorough physical examination and will be asked to fill out questionaries to asses their quality of life.\n\nAfter inclusion, patients will be followed closely for three months with physical examination and questionnaires.\n\nAfter three months, patients in the control arm will have the opportunity to cross over to the intervention arm.\n\nData will be reported continuously.",[82,83],"Scrotum Disease","Chronic Pain",[85,86,87,88,89],"Chronical scrotal pain","CSP","Botox","BTX","minimal invasive procedure","NOT_YET_RECRUITING","2022-04-19",{"date":93,"type":94},"2022-04-20","ACTUAL",{"date":96,"type":76},"2022-06-01",{"date":98,"type":76},"2026-06-30",{"name":62,"class":6},1]