[{"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":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":18,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":18,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":18,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"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","penile-vibratory-stimulation-in-the-prevention-of-sexual-dysfunction-and-urinary-incontinence-after-radical-prostatectomy-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":67,"type":68},100,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74,75],"Erectile Dysfunction Following Radical Prostatectomy","Incontinence","2024-03-08",{"date":78,"type":79},"2024-03-12","ACTUAL",{"date":81,"type":79},"2024-02-01",{"date":83,"type":68},"2026-10",{"name":5,"class":6},1]