[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458043":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":64,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Charitable Union for the Research and Education of Peyronie's Disease","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","Men will begin utilizing PTT 30-60 minutes daily for 5-7 days weekly beginning 1 month post-prostatectomy until 6 months. After 6 months, they will have the option to continue to use the therapy for 3 additional months or discontinue at their discretion.",[13,14],"Device: RestoreX 1-6 months (randomized phase)","Device: RestoreX 6-9 months (open label phase)",{"label":16,"type":17,"description":18,"interventionNames":19},"Control","ACTIVE_COMPARATOR","Men will not utilize PTT for the first 6 months post-prostatectomy. Beginning at 6 months, they may utilize PTT if they desire (open label) until 9 months post-prostatectomy.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","RestoreX 1-6 months (randomized phase)","Study participants are recommended utilize the device for 30-60 minutes, 5-7 days a week starting at 1 month post-prostatectomy and continuing until 6 months.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"RestoreX 6-9 months (open label phase)","Both the treatment and control arms will be allowed to use the therapy from 6-9 months post-prostatectomy (open label phase). Only straight traction will be used (no counterbending).",[16,9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Landon Trost, MD","CONTACT","801-655-0015","landontrost@gmail.com",{"name":38,"role":34,"phone":35,"phoneExt":26,"email":39},"Benjamin Green, BA","bengreen927@gmail.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Male Fertility and Peyronie's Clinic","RECRUITING","Orem","Utah","84057","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-111.69465,40.2969,{"lat":53,"lon":52},[56,59,62],{"name":33,"role":34,"phone":57,"phoneExt":26,"email":58},"888-655-0015","trost.landon@mfp.clinic",{"name":60,"role":61,"phone":26,"phoneExt":26,"email":26},"Benjamin D. Green, Economics\u002FMA","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":26,"phoneExt":26,"email":26},"Holli Burgon",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Landon Trost","MD","100458043","efficacy-of-restorex-penile-traction-therapy-in-preserving-erectile-function-post-prostatectomy-100458043",false,"NCT05244486","Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy","Inclusion Criteria:\n\n* Undergoing bilateral nerve-sparing prostatectomy\n* \\>18 years old\n* Have a regular sexual partner for at least 6 months prior to study enrollment\n\nExclusion Criteria:\n\n* Requiring adjuvant radiation therapy or androgen deprivation \u002F androgen blockade post-operatively (by the time of enrollment)\n* Baseline severe erectile dysfunction as measured by the IIEF-EFD\n* Urethral complications from prostatectomy at the time of baseline visit including contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vesicourethral anastomosis intra-operatively","MALE","18 Years",{"count":77,"type":78},200,"ESTIMATED","INTERVENTIONAL",[81],"NA","Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months. Secondary outcomes include differences in questionnaire outcomes at 3, 6, and 9 months.",[84],"Erectile Dysfunction Following Radical Prostatectomy",[86],"Penile traction therapy","2025-02-12",{"date":89,"type":90},"2025-02-13","ACTUAL",{"date":92,"type":90},"2022-03-12",{"date":94,"type":78},"2030-09-14",{"name":5,"class":6},1]