[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"erectile-dysfunction-with-diabetes-mellitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:erectile-dysfunction-with-diabetes-mellitus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,73,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100629860","phase-2-mesenchymal-stem-cell-and-exosome-therapy-for-diabetic-erectile-dysfunction-100629860",false,"NCT07480161","Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction","Safety and Efficiacy of Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction: A Randomized Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n* Male patients aged 25 to 75 years\n* Diagnosis of erectile dysfunction for at least 6 months\n* Type 1 or Type 2 diabetes mellitus for at least 5 years\n* Inadequate response to medical treatment, including phosphodiesterase type-5 (PDE-5) inhibitors and\u002For intracavernosal prostaglandin E1 therapy\n* Candidates for penile prosthesis implantation due to treatment-resistant erectile dysfunction\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Penile anatomical deformities\n* Active infection or skin lesion on the penis\n* Bleeding disorders or coagulation abnormalities\n* Previous penile prosthesis implantation, penile vascular surgery, or pelvic surgery\n* Untreated hypogonadism\n* Unstable cardiovascular disease\n* History of malignancy\n* Autoimmune disease\n* Use of immunosuppressive therapy\n* Presence of systemic or local infection\n* Uncontrolled diabetes mellitus","MALE","25 Years","75 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The goal of this prospective randomized controlled clinical study is to evaluate the effectiveness and safety of intracavernosal injections of umbilical cord-derived mesenchymal stem cells (MSCs) and umbilical cord-derived MSC-derived exosomes in men aged 25 to 75 years with diabetic erectile dysfunction (ED) who have not responded adequately to conventional medical treatments such as phosphodiesterase type-5 (PDE-5) inhibitors.\n\nDiabetes mellitus is a major risk factor for erectile dysfunction and is associated with endothelial dysfunction, impaired smooth muscle relaxation, neuropathy, and increased fibrosis within penile tissue. Although many patients respond to standard pharmacological treatments, diabetic patients often demonstrate reduced responsiveness to these therapies. Regenerative medicine approaches, including stem cell therapy and stem cell-derived exosomes, have emerged as potential therapeutic strategies due to their regenerative, angiogenic, neuroprotective, and anti-fibrotic effects.\n\nThe main questions this study aims to answer are:\n\n* Whether intracavernosal administration of mesenchymal stem cells or MSC-derived exosomes improves erectile function, as measured by changes in the International Index of Erectile Function-5 (IIEF-5) and Erectile Hardness Score (EHS).\n* Whether penile hemodynamics improve following treatment, as assessed by penile Doppler ultrasonography parameters including peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI).\n\nParticipants will be randomly assigned to one of three groups:\n\n* Intracavernosal placebo injection\n* Intracavernosal injection of umbilical cord-derived mesenchymal stem cells (5×10⁶ cells)\n* Intracavernosal injection of umbilical cord-derived mesenchymal stem cell-derived exosomes (75 μg) All interventions will be administered as a single intracavernosal injection under controlled clinical conditions.\n\nParticipants will undergo baseline evaluation including medical history, physical examination, erectile function assessment using the IIEF-5 questionnaire, and penile Doppler ultrasonography. Follow-up evaluations will be conducted at 1, 3, 6, and 12 months after treatment to assess changes in erectile function, penile vascular parameters, and treatment-related adverse events.\n\nThe study will also monitor potential side effects such as pain, bruising, hematoma, edema, or other complications related to the intracavernosal injection procedure.\n\nParticipants will be recruited from patients presenting to the urology outpatient clinic with diabetic erectile dysfunction. Eligible participants must have a diagnosis of erectile dysfunction for at least six months, a history of diabetes mellitus for at least five years, and insufficient response to standard medical therapy. Patients with penile anatomical deformities, active infections, malignancy, unstable cardiovascular disease, autoimmune disease, or other contraindications to intracavernosal treatment will be excluded.",[28],"Erectile Dysfunction With Diabetes Mellitus",[30,31,32,33,34,35,36,37],"Diabetic Erectile Dysfunction","Mesenchymal Stem Cells","Stem Cell Therapy","Exosome Therapy","Intracavernosal Injection","Regenerative Medicine","Cell-Based Therapy","Erectile dysfunction","RECRUITING","2026-03-14",{"date":41,"type":42},"2026-03-18","ACTUAL",{"date":44,"type":42},"2025-12-29",{"date":46,"type":21},"2028-12-29",{"name":48,"class":49},"Ankara City Hospital Bilkent","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":50},"100560933","phase-2-evaluation-of-efficacy-of-botulinum-toxin-a-plus-oral-tadalafil-5-mg-in-diabetic-men-with-erectile-dysfunction-100560933","NCT06583590","Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction","Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction Not Responding to Approved Oral or Intracorporeal Vasoactive Treatments.","Inclusion Criteria:\n\n* Adult controlled diabetic married men who proved to be vasculogenic ED by Penile Duplex.\n* Men who had shown an insufficient response for at least 3 months to the registered PDE5-Is at the highest approved dose, either on-demand or daily, or to PGE1 ICIs.\n* Severe erectile dysfunction (erection hardness score ≤ E3 after intracavernosal injection of PGE-1).\n\nExclusion Criteria:\n\n* Men who had cardiovascular disease interfering with sexual activity.\n* Men with history of an unstable psychiatric conditions\n* Presence of penile anatomical abnormalities that would significantly impair erectile function.\n* History of spinal or pelvic radical surgery.","21 Years",{"count":60,"type":21},32,[24,25],"Study is aiming to evaluate safety, efficacy and durability of intracavernosal injection (ICI) of Botulinum toxin A plus oral tadalafil in controlled diabetic men with refractory Erectile Dysfunction.",[28],"2024-11-30",{"date":66,"type":42},"2024-12-03",{"date":68,"type":42},"2024-08-01",{"date":70,"type":21},"2025-12-01",{"name":72,"class":49},"Aswan University Hospital",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":84,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100533065","impact-of-glycemic-control-on-penile-duplex-results-100533065","NCT06220968","Impact of Glycemic Control on Penile Duplex Results","Impact of Glycemic Control on Erectile Function and Penile Doppler in Patients With Erectile Dysfunction","Inclusion Criteria:\n\n* Married Male patients diagnosed with erectile dysfunction.\n* Age from 30 to 55 years.\n* Documented history of DM.\n* Regular sexual life with cooperative wife.\n\nExclusion Criteria:\n\n* Patients with congenital anomalies like hypospadius and curvature.\n* History of pelvic or spine surgery.\n* Single patient.\n\n  . Thyroid disorders.\n* Other sexual disorders.\n* Primary ED.\n* History of Peyronie's disease or priapism.","30 Years","55 Years",{"count":83,"type":21},100,"3 Months","OBSERVATIONAL","The study aimed at evaluating the impact of glycemic control on the erectile function , penile Doppler, and cavernosal blood NO and glutathione levels among a group of diabetic patients with erectile dysfunction.",[28],"NOT_YET_RECRUITING","2024-09-04",{"date":91,"type":42},"2024-09-19",{"date":93,"type":21},"2025-01",{"date":95,"type":21},"2025-03",{"name":97,"class":49},"Assiut University",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":50},"100556111","phase-3-genetic-factors-of-erectile-dysfunction-degree-and-response-to-tadalafil-treatment-in-patients-with-diabetes-100556111","NCT06520839","Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes","EDGEN","Inclusion Criteria:\n\n* We will include in the study 90 patients with diabetes and erectile dysfunction. We will use the IIEF-5 questionnaire to confirm the diagnosis of erectile dysfunction. Patients between the ages of 40 and 65 who score 21 points or less on the IIEF-5 scale will be included in the study.\n\nExclusion Criteria:\n\n* patients receiving any form of organic nitrate in regular therapy or as necessary due to ischemic heart disease, patients who have already suffered a cardiovascular event (heart attack, stroke, manifest peripheral arterial disease), users of illegal drugs, alcoholics, demented patients , patients with psychiatric diseases, patients with pancreatogenic form of diabetes, patients with glucocorticoids and immunosuppressants induced form of diabetes and patients with monogenic form of diabetes. Patients with hypogonadism, prostate malignancy, patients with a psychogenic form of erectile dysfunction, patients with premalignant and malignant genital lesions, patients with Peyronie's disease, patients after injury, surgery and radiation in the pelvic area and patients with congenital diseases of the penis will also be excluded from the research. We will also exclude from the research patients who withdraw from participation in the research during the research for personal or any other reasons.","40 Years","65 Years",{"count":20,"type":21},[25],"The goal of this clinical trial is to examine the genetic markers of erectile dysfunction degree in patients with diabetes and find new predictive models based on genetic factors, with which we will be able to more accurately address the adequacy of treatment in patients with diabetes, and thus have a long-term impact to reduce side effects of treatment. We will look for a predictive model based on genetic analysis to determine in the future patients with a good response to treatment with phosphodiesterase type 5 inhibitors, in our case tadalafil 5 mg daily. The main questions it aims to answer are:\n\n1. Genetic alterations in the NO signaling pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.\n2. Genetic alterations in the folate pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.\n3. Genetic factors of the vascular wall influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.\n4. Genetic changes in the pathways of tadalafil metabolism and action influence the response to the treatment of erectile dysfunction in patients with diabetes.\n\nParticipants will take the drug tadalafil 5 mg every day for three months. The level of erectile dysfunction will be assessed with the IIEF-5 questionnaire at the beginning of the study and after three months of taking the drug.",[28],[112,113],"Erectile Dysfunction","Diabetes Mellitus","2024-07-22",{"date":116,"type":42},"2024-07-25",{"date":118,"type":42},"2024-05-17",{"date":120,"type":21},"2024-12",{"name":122,"class":49},"University Medical Centre Ljubljana"]