[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571243":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":41,"responsibleParty":76,"collaborators":26,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":26,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Regina Elena Cancer Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"PDE5i + LiESWT","EXPERIMENTAL","Patients receiving LiESWT plus early introduction of PDE5i",[13,14],"Device: Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)","Drug: PDE5 inhibitor (tadalafil)",{"label":16,"type":17,"description":18,"interventionNames":19},"PDE5i alone","ACTIVE_COMPARATOR","Control group, patients receiving PDE5i alone",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)","LiESWT will be performed with PiezoWave2 from Richard Wolf and ELvation® Medical. In a single session 12,000 shocks with an energy flux density of 0.16 mJ\u002Fmm2 will be applied (4,000 over the crura of the penis and 8,000 to the penil shaft). The penis is placed in a dedicated penile holder, stretched, and shockwaves are administered with a linear therapy source (applicator) using the linear shockwave tissue coverage (LSTC-ED®) technique which makes it possible to administer shockwaves homogenously to all of the erectile tissue.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","PDE5 inhibitor (tadalafil)","Phosphodiesterase-5 (PDE5) inhibitors",[9,16],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Giuseppe Simone","CONTACT","0652665005","giuseppe.simone@ifo.it",{"name":39,"role":35,"phone":36,"phoneExt":26,"email":40},"Riccardo Mastroianni","riccardo.mastroianni@ifo.it",[42,61],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"IRCCS \"Regina Elena\" National Cancer Institute","RECRUITING","Rome","RM","00144","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],12.51133,41.89193,{"lat":54,"lon":53},[57,58,59,60],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},{"name":39,"role":35,"phone":36,"phoneExt":26,"email":40},{"name":34,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":39,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":62,"status":44,"city":63,"state":26,"zip":64,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"IRCCS \"Fondazione G. Pascale\" National Cancer Institute","Naples","80131",{"type":51,"coordinates":66},[67,68],14.26811,40.85216,{"lat":68,"lon":67},[71,75],{"name":72,"role":35,"phone":73,"phoneExt":26,"email":74},"Sisto Perdonà","+393356915532","sisto.perdona@pec.it",{"name":72,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Giuseppe SImone","MD","100571243","phase-3-low-intensity-extracorporeal-shockwave-therapy-on-penile-rehabilitation-after-robot-assisted-surgical-treatment-of-genitourinary-cancers-100571243",false,"NCT06717711","Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers","RCT_LiESWT","Inclusion Criteria:\n\n* Patients aged ≤75 yrs;\n* PSA \\\u003C10 ng\u002FmL\n* Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy\n* undergoing nerve sparing RARP;\n* preoperative IIEF-5 score ≥ 17;\n* First PSA (45d after surgery) \\\u003C0.1\n* Prostate Cancer ISUP grade ≤2 pT\\\u003C3b and at final pathology\n* ≥ 18 yrs old;\n* compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;\n* patients able to provide a written informed consent for the trial.\n\nExclusion Criteria:\n\n* anaesthesiologic contraindications to robotic surgery\n* patients submitted to pelvic radiotherapy or androgen deprivation\n* patients reporting major postoperative complications (CD≥3)\n* cardiovascular contraindications to PDE5i medical treatment","MALE","18 Years","75 Years",{"count":91,"type":92},158,"ESTIMATED","INTERVENTIONAL",[95],"PHASE3","This prospective randomized controlled trial (RCT) is designed to provide high level evidence on the efficacy of Low-intensity Extracorporeal Shock Wave Therapy (Li-ESWT) in the treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) erectile dysfunction (ED) in addition to PDE5 inhibitors (PDE5i) versus PDE5i alone. Our hypothesis is that early andrological rehabilitation that combines Li-ESWT and PDE5i could lead to faster and better recovery of valid erections for intercourse, with a greater rate of postoperative International Index of Erectile Function-5 (IIEF-5) compared to patients receiving PDE5i alone.",[98,99,100],"Prostate Carcinoma","Erectile Function","Genito Urinary Cancer",[102,103,104,105],"prostate cancer","erectile function","rehabilitation","genitourinary cancers","2024-11-30",{"date":108,"type":109},"2024-12-05","ACTUAL",{"date":111,"type":109},"2024-08-31",{"date":113,"type":92},"2026-08-31",{"name":5,"class":6},2]