[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647314":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":42,"locations":48,"responsibleParty":66,"collaborators":70,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":31,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":101,"whyStopped":31,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Medipol University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intracavernosal Urine-Derived Exosomes (USC-Exos)","EXPERIMENTAL","Participants randomized to this arm will receive targeted intracavernosal injections of cell-free, urine-derived exosomes. The intervention aims to evaluate the proangiogenic and regenerative effects of the exosome secretome on the cavernous tissue following radical prostatectomy.",[13],"Biological: Urine-Derived Exosomes (USC-Exos)",{"label":15,"type":10,"description":16,"interventionNames":17},"Rectal Medical Ozone Therapy","Participants randomized to this arm will receive protocolized systemic rectal medical ozone insufflation. This arm evaluates the systemic antioxidant, anti-inflammatory, and tissue oxygenation benefits of ozone therapy on post-operative erectile functional recovery.",[18],"Procedure: Rectal Medical Ozone Insufflation",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard Penile Rehabilitation","ACTIVE_COMPARATOR","Participants randomized to this arm will receive the current standard of care for post-prostatectomy penile rehabilitation. This serves as the active control group to benchmark the efficacy of the experimental regenerative therapies.",[24],"Drug: Daily Phosphodiesterase type 5 (PDE5) Inhibitor",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","Urine-Derived Exosomes (USC-Exos)","A single (or protocol-specified sequenced) bilateral intracavernosal injection of a sterile, cell-free urine-derived exosome suspension (e.g., 2 cc) into the corpus cavernosum, performed under clinical setting conditions.",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"PROCEDURE","Rectal Medical Ozone Insufflation","Administration of a standardized medical ozone and oxygen gas mixture (e.g., 30-40 µg\u002FmL concentration) via rectal insufflation. The treatment will be administered for a predetermined number of sessions (e.g., 10 sessions spanning over 5 weeks) using a certified medical ozone generator.",[15],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":31},"DRUG","Daily Phosphodiesterase type 5 (PDE5) Inhibitor","Oral administration of a daily low-dose PDE5 inhibitor (e.g., Tadalafil 5 mg once daily) for a continuous duration of 6 months, aligning with standard clinical guidelines for post-operative erectile dysfunction management.",[20],[43],{"name":44,"role":45,"phone":46,"phoneExt":31,"email":47},"Ali ihsan Memmi","CONTACT","90 537 999 0941","alimemmi@gmail.com",[49],{"facility":50,"status":31,"city":51,"state":52,"zip":31,"country":53,"countryCode":31,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Başakşehir Çam Sakura City Hospital","Istanbul","Başakşehir","Turkey (Türkiye)",{"type":55,"coordinates":56},"Point",[57,58],28.94966,41.01384,{"lat":58,"lon":57},[61,63],{"name":44,"role":45,"phone":62,"phoneExt":31,"email":47},"905379220997",{"name":64,"role":65,"phone":31,"phoneExt":31,"email":31},"Ali ihsan Memmi, MD","PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":69,"oldNameTitle":31,"oldOrganization":31},"Ali Ihsan Memmi","MD","Istanbul Medipol University Hospital",[71,74],{"name":72,"class":73},"Başakşehir Çam & Sakura City Hospital","OTHER_GOV",{"name":69,"class":6},"100647314","intracavernosal-exosomes-vs-rectal-ozone-for-post-rarp-erectile-dysfunction-100647314",false,"NCT07707505","Intracavernosal Exosomes vs. Rectal Ozone for Post-RARP Erectile Dysfunction","Intracavernosal Exosomes Versus Rectal Ozone Therapy for Erectile Dysfunction Following Robotic-Assisted Radical Prostatectomy","REHAB-RARP","Inclusion Criteria:\n\n* History of Robotic-Assisted Radical Prostatectomy (ns-RARP) for localized prostate cancer.\n* Normal preoperative erectile function (retrospective IIEF-5 score \\> 21).\n* Presence of a stable, sexually active heterosexual relationship.\n* Inadequate response or intolerance to maximum dose, on-demand oral Phosphodiesterase type 5 inhibitors (PDE5i).\n\nExclusion Criteria:\n\n* History of adjuvant or salvage pelvic radiotherapy \u002F androgen deprivation therapy (ADT).\n* Presence of severe anatomical penile deformities (e.g., active phase Peyronie's disease).\n* Uncontrolled endocrinological (e.g., HbA1c \\> 8.5%) or cardiovascular comorbidities.\n* History of major cardiovascular events (myocardial infarction, stroke) within the preceding 6 months.\n* Current use of systemic anticoagulants (excluding low-dose prophylactic aspirin).\n* Concomitant use of any intraurethral alprostadil, vacuum erection devices (VED), or testosterone replacement therapy during the study period.","MALE","45 Years","75 Years",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"NA","This prospective, randomized, controlled trial aims to evaluate and compare the therapeutic efficacy of intracavernosal urine-derived exosomes and systemic rectal ozone therapy in patients experiencing erectile dysfunction (ED) post-robotic-assisted radical prostatectomy (RARP). Patients will be randomized into two distinct intervention arms. The primary objective is to assess the functional recovery of the erectile tissue via the International Index of Erectile Function (IIEF-5) over a 6-month follow-up period. Secondary endpoints include penile hemodynamic alterations and overall health-related quality of life.",[94],"Erectile Dysfunction Following Radical Prostatectomy",[96,97,98,99,100],"Exosomes","Rectal Ozone Insufflation","Robotic-Assisted Radical Prostatectomy","Penile Rehabilitation","Extracellular Vesicles","NOT_YET_RECRUITING","2026-07-11",{"date":104,"type":105},"2026-07-16","ACTUAL",{"date":107,"type":88},"2026-08-01",{"date":109,"type":88},"2027-04-01",{"name":5,"class":6},1]