[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531529":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":18,"id":57,"slug":18,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":18,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":18,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Herlev and Gentofte Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","The group randomized to use the vibrator for 9 months",[13],"Device: Penile vibrator",{"label":15,"type":16,"description":17,"interventionNames":18},"Controls","NO_INTERVENTION","Usual standard treatment",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Penile vibrator","In addition to standard treatment with PDE5-inhibitors the intervention is daily stimulation for five minutes with the vibrator for 9 months",[9],[26],{"name":27,"affiliation":28,"role":29},"Mikkel Fode, MD, PhD","Department of Urology, Herlev and Gentofte University Hospital","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Helene R Andersen, MD","CONTACT","+4538681507","helene.reif.andersen@regionh.dk",[37],{"facility":5,"status":38,"city":39,"state":18,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Herlev","2730","Denmark","DK",{"type":44,"coordinates":45},"Point",[46,47],12.43998,55.72366,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":52,"phoneExt":18,"email":53},"Mette LK Schmidt, PHD","+4538681100","Mette.Ladefoged.Kopp.Schmidt@regionh.dk",{"type":29,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Helene Reif Andersen","PhD fellow","100531529",false,"NCT06200987","Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy","Planned Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy: a Randomized Controlled Study","Inclusion Criteria:\n\n* Men who are undergoing nerve-sparing radical prostatectomy\n* Pre operative erectile function of IIEF-EF \\> 25\n* Sexually active . Continent before surgery defined as a score of 0 on the ICIQ-SF questionnaire\n\nExclusion Criteria:\n\n* Urinary incontinent before surgery\n* Comorbidity that prevents the patient from taking PDE5-inhibitors\n* Disease in the penis or in the penile skin (Peyronies, phimosis)\n* Problems using the vibrator ie impaired function of the hands","MALE","18 Years",{"count":66,"type":67},100,"ESTIMATED","INTERVENTIONAL",[70],"NA","To investigate if post-operative penile vibration stimulation kan be used to reduce or prevent sexual dysfunction and urinary incontinence after radical prostatectomy. This will be done in a randomized, controlled, non-blinded study. Men that undergo nerve preserving surgery for prostate cancer is allocated into an intervention group and a control group. A total of 100 men will be included for a power of 80%. The intervention group will be instructed to use the \"Ferticare 2.0\" vibrator for at least five minutes a day with an amplitude of 1 mm and frequency of 90 Hz (these settings were found in a pilot study) for a total of 9 months.\n\nBoth groups will do the standard pelvic floor training program and both groups will be offered regular phosphodiesterase-5-inhibitor treatment. Before surgery, 3, 6 and 10 months after the patients will have to fill out four different questionnaires regarding sexual and urinary function, including IIEF-EF, EHS, \"neglected side effects\" and ICIQ-SF. (10 months is due to a wash-out period of 1 month after the intervention).\n\nThe collected data will be analysed and the primary goal is to see if there is a significant difference in average spontaneous IIEF-EF score in the two groups 10 months after the surgery.",[73,74],"Erectile Dysfunction Following Radical Prostatectomy","Incontinence","2024-03-08",{"date":77,"type":78},"2024-03-12","ACTUAL",{"date":80,"type":78},"2024-02-01",{"date":82,"type":67},"2026-10",{"name":5,"class":6},1]