[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"erectile-function\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:erectile-function":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100579264","efficacy-of-intraoperative-arista-polysaccharide-application-on-the-postoperative-blood-loss-in-patients-undergoing-rarp-for-the-treatment-of-prostate-cancer-100579264",false,"NCT06822036","EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER","PROSPECTIVE RANDOMIZED CONTROLLED TRIAL EVALUATING THE EFFICACY OF INTRAOPERATIVE ARISTA™ AH POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING ROBOTIC ASSISTED RADICAL PROSTATECTOMY FOR THE TREATMENT OF PROSTATE CANCER","ARISTA","Inclusion Criteria:\n\n* Age range ≥ 45 to ≥68 yrs\n* Biopsy proven prostate cancer treated with robotic-assisted radical prostatectomy\n* Intrafascial nerve sparing surgery (unilaterally or bilaterally)\n* Preoperative urinary continence\n* Group A Preoperative unassisted International Index of Erectile function (IIEF)-5 score range 8-16 (i.e. moderate (8-11) and mild to moderate (12-16))\n\nExclusion Criteria:\n\n* Severe intellectual limitations preventing to fully understand the study concept and its content\n* High risk prostate cancer (PSA ≥ 20 ng\u002Fml or biopsy Gleason-Score ≥ 8 or suspected T4)\n* Suspected bone or visceral metastases at preoperative imaging Neoadjuvant androgen deprivation therapy\n* Any prior local therapy of the prostate (including subvesical deobstruction or radiation therapy)\n* Any prior chemotherapy or colon\u002Frectal surgery\n* Any prior pelvic trauma that required surgical intervention\n* Depression or other psychological or neurological disease (dementia, schizophrenia, bipolar disorder etc.)\n* Peyronie's disease\n* Polyneuropathia\n* IPSS Score \\>19 and QoL \\>3\n* Bilateral secondary (complete or partial) resection of the neurovascular bundle\n* No contraindications for phosphodiesterase type 5 inhibitor intake (i.e. suited for most penile rehabilitation regimes)\n* Any endocrine function disorder (not including diabetes)\n\nSURGICAL AND PERIOPERATIVE EXLUSION CRITERIA:\n\n* Accessory pudendal arteries (APA) preservation, if an APA is identified\n* For a) nerve sparing and b) controlling bleeding in the area of the prostate bed and neurovascular bundles after prostate removal, no monopolar thermal application are allowed but suturing and clip application is allowed. For secondary resection of the neurovascular bundle and controlling bleeding, mono- or bipolar thermal application, clip application and suturing is allowed.\n* No surgical revision within 7d after RARP (Clavien Dindo classified complication ≥3b)\n* No definitive anastomotic partial or complete rupture (identified via cystogram within 30d after RARP)","MALE","45 Years","68 Years",{"count":21,"type":22},362,"ESTIMATED","INTERVENTIONAL",[25],"NA","We perform a multicenter randomized controlled prospective study with superiority trial design, in which the polysaccharide ARISTA™ AH hemostat agent is applied to the neurovascular bundle areas after prostate removal, during Robot-assisted radical prostatectomy.\n\nWe examine if such agent leads to a relevant clinical improvement indicated by higher postoperative hemoglobin levels compared to the control group. As an exploratory co-primary endpoint of interest, we examine erectile function after Robot-assisted radical prostatectomy based on IIEF-5 score between groups 3, 6 and 12 months after Robot-assisted radical prostatectomy",[28,29,30],"Prostate Cancer (Adenocarcinoma)","Blood Loss, Postoperative","Erectile Function",[32,33,34,35],"prostate cancer","blood loss","potency rates","ARISTA™ AH","RECRUITING","2026-05-27",{"date":39,"type":40},"2026-05-29","ACTUAL",{"date":42,"type":40},"2025-01-16",{"date":44,"type":22},"2027-01-30",{"name":46,"class":47},"St. Antonius Hospital Gronau","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100638916","phase-2-a-single-arm-dose-escalation-of-an-intraurethral-alprostadil-paste-for-erectile-dysfunction-100638916","NCT07601646","A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction","Phase 2 Clinical Trial of ST-04 Intraurethral Paste for Erectile Dysfunction","Inclusion Criteria:\n\n* Have had a confirmed clinical diagnosis of ED for more than three months based upon IIEF\n* Have failed PDE5 inhibitor therapy (inability to achieve an erection with adequate rigidity to allow penetrative sex)\n* Ability to take oral medication (sildenafil) and be willing to adhere to the study intervention regimen\n* Engaged in heterosexual relationship with partner for a minimum of 6 months\n\nExclusion Criteria:\n\n* History of unstable medical or psychiatric condition that, in the opinion of the principal investigator, could impact the patient's ability to complete the study investigations or protocol.\n* Spinal cord injury, or penile anatomical abnormalities\n* Cardiovascular conditions that prevent sexual activity (NYHA Class II or higher, any angina, or uncontrolled CHF or severe coronary artery disease)\n* History of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study\n* Use of anti-androgens, or oral or injectable androgens\n* Documented hypotension or known orthostatic hypotension\n* Use of oral, topical or sublingual nitrates within 3 months prior to enrollment into the study\n* Hepatic (Child-Pugh Class C) or renal failure (eGFR \\\u003C 30)\n* Inadequate response to intracavernosal injection therapy previously\n* Peyronie's disease or Meatal stenosis","21 Years","75 Years",{"count":58,"type":22},83,[60],"PHASE2","This is a single arm dose escalation trial of a mucoadhesive intraurethral polymer suspension of alprostadil (ST-04) and will investigate the efficacy of 3 dose levels of ST-04 in adult males with a clinical diagnosis of Erectile Dysfunction (ED). This study aims to determine if ST-04, with or without sildenafil, will improve erectile function (EF) compared to baseline.\n\nParticipants in this study will receive ST-04, a new formulation containing the vasodilator, alprostadil which is known to be an effective drug in treating erectile dysfunction. ST-04 will be dispersed along the urethra, forming a hydrogel which adheres to the lining of the urethra with the goal of penile tumescence and erection. Participants may receive up to 3 dose level escalations of ST-04 over a 12-week period, for a total of up to 11 administrations of ST-04. Dose escalation may also be done with and without sildenafil.",[63,64,30],"Erectile Dysfunction (ED)","Erectile Dysfunctions",[66,30,67,68],"Erectile Dysfunction","Alprostadil","Sildenafil","2026-05-20",{"date":71,"type":40},"2026-05-22",{"date":73,"type":22},"2026-05",{"date":75,"type":22},"2027-05",{"name":77,"class":47},"Ryan Flannigan, MD",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":56,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100571243","phase-3-low-intensity-extracorporeal-shockwave-therapy-on-penile-rehabilitation-after-robot-assisted-surgical-treatment-of-genitourinary-cancers-100571243","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","18 Years",{"count":88,"type":22},158,[90],"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.",[93,30,94],"Prostate Carcinoma","Genito Urinary Cancer",[32,96,97,98],"erectile function","rehabilitation","genitourinary cancers","2024-11-30",{"date":101,"type":40},"2024-12-05",{"date":103,"type":40},"2024-08-31",{"date":105,"type":22},"2026-08-31",{"name":107,"class":47},"Regina Elena Cancer Institute",2]