[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653182":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":35,"interventions":48,"overallOfficials":27,"centralContacts":59,"locations":66,"responsibleParty":82,"collaborators":27,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":27,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":27,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":109,"whyStopped":27,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Benha University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score","Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5), a 5-item self-administered questionnaire assessing erectile function and intercourse-related sexual performance. Each item is scored from 1 to 5, giving a total score ranging from 5 to 25, with higher scores indicating better erectile function. Scores are interpreted as: 22-25, no erectile dysfunction; 17-21, mild erectile dysfunction; 12-16, mild-to-moderate erectile dysfunction; 8-11, moderate erectile dysfunction; and 5-7, severe erectile dysfunction. Change from baseline in the total IIEF-5 score will be compared between the treatment groups.","Baseline and 4, 12, and 24 weeks after intervention",{"measure":14,"description":15,"timeFrame":12},"Change From Baseline in Erection Hardness Score (EHS)","Erection hardness will be assessed using the Erection Hardness Score (EHS), a single-item scale ranging from 0 to 4, with higher scores indicating greater erection rigidity. Scores are defined as follows: 0, penis does not enlarge; 1, penis is larger but not hard; 2, penis is hard but not hard enough for penetration; 3, penis is hard enough for penetration but not completely rigid; and 4, penis is completely hard and fully rigid. Change from baseline in the EHS will be compared between the treatment groups.",[17,20,23],{"measure":18,"description":19,"timeFrame":12},"Change From Baseline in Penile Peak Systolic Velocity","Peak systolic velocity (PSV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile arterial blood flow following treatment.",{"measure":21,"description":22,"timeFrame":12},"Change From Baseline in Penile End-Diastolic Velocity","End-diastolic velocity (EDV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile hemodynamics following treatment.",{"measure":24,"description":25,"timeFrame":26},"Patient Satisfaction With Treatment","Patient satisfaction with treatment will be assessed using a 5-point Likert scale. Participants will rate their overall satisfaction as: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Higher scores indicate greater treatment satisfaction. Satisfaction scores will be compared between the two treatment groups.","4, 12, and 24 weeks after intervention",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"RANDOMIZED","PARALLEL","Participants will be randomized in parallel to receive either platelet-rich plasma injections alone or platelet-rich plasma injections combined with low-intensity extracorporeal shock wave therapy.","TREATMENT",{"masking":34,"maskingDescription":27,"whoMasked":27},"NONE",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Platelet-Rich Plasma Alone","ACTIVE_COMPARATOR","Participants will receive platelet-rich plasma (PRP) injections alone. PRP will be prepared from approximately 20 mL of autologous blood using a double-spin method, targeting a platelet concentration of 3-5 times baseline. PRP will be administered by intracavernosal injection at two sites. Participants will receive three PRP injections over 6 weeks, with one injection every 2 weeks.",[41],"Biological: Platelet-Rich Plasma",{"label":43,"type":44,"description":45,"interventionNames":46},"Platelet-Rich Plasma Plus Li-ESWT","EXPERIMENTAL","Participants will receive the same PRP injection regimen as the PRP-alone group combined with low-intensity extracorporeal shock wave therapy (Li-ESWT). Li-ESWT will be administered at an energy density of 0.15 mJ\u002Fmm² with 2,000 shocks per session to the penile shaft with or without the crura. Participants will receive six Li-ESWT sessions over 6 weeks, with one session per week. PRP injections will be administered before Li-ESWT sessions according to the study protocol.",[47],"Device: Low-Intensity Extracorporeal Shock Wave Therapy",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":27},"BIOLOGICAL","Platelet-Rich Plasma","Autologous platelet-rich plasma will be prepared from approximately 20 mL of the participant's blood using a double-spin centrifugation method, targeting a platelet concentration of 3-5 times baseline. PRP will be administered by intracavernosal injection at two sites, with three injections given over 6 weeks at 2-week intervals.",[37],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":27},"DEVICE","Low-Intensity Extracorporeal Shock Wave Therapy","Low-intensity extracorporeal shock wave therapy will be delivered to the penile shaft with or without treatment of the crura using an energy density of 0.15 mJ\u002Fmm² and 2,000 shocks per session. Participants will receive six sessions over 6 weeks, at a frequency of one session per week.",[43],[60],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},"Tamer A Diab, MD","CONTACT","01003583264","+2","Tamer.diab@fmed.bu.edu.com",[67],{"facility":68,"status":27,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Benha University Hospital","Banhā","Qalyubia Governorate","13511","Egypt","EG",{"type":75,"coordinates":76},"Point",[77,78],31.1842,30.45977,{"lat":78,"lon":77},[81],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Tamer Abd El-Wahab Diab","Associate Professor of Urology","100653182","platelet-rich-plasma-alone-versus-prp-plus-low-intensity-shock-wave-therapy-for-erectile-dysfunction-100653182",false,"NCT07783347","Platelet-Rich Plasma Alone Versus PRP Plus Low-Intensity Shock Wave Therapy for Erectile Dysfunction","Effect of Platelet-Rich Plasma Injection Alone Versus Combined Platelet-Rich Plasma and Low-Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction","Inclusion Criteria:\n\n* Male participants aged 30-65 years.\n* Diagnosis of erectile dysfunction for at least 3 months.\n* Mild to moderate erectile dysfunction, defined by an International Index of Erectile Function-5 (IIEF-5) score of 8-21.\n* In a stable heterosexual relationship for at least 6 months.\n* Sexually active, with at least one sexual attempt per week.\n\nExclusion Criteria:\n\n* Severe erectile dysfunction, defined as IIEF-5 score \\\u003C8.\n* Primary psychogenic erectile dysfunction based on clinical history with or without psychosexual assessment.\n* Anatomical penile abnormalities, including Peyronie's disease.\n* History of radical pelvic surgery or pelvic radiotherapy.\n* Uncontrolled diabetes mellitus, defined as HbA1c \\>9%.\n* Uncontrolled hypertension, defined as blood pressure \\>160\u002F100 mmHg.\n* Recent myocardial infarction or stroke within the previous 6 months.\n* Unstable angina.\n* New York Heart Association class III-IV heart failure.\n* Severe hepatic impairment.\n* Severe renal impairment.\n* Hypogonadism, defined as total testosterone \\\u003C300 ng\u002FdL.\n* Hyperprolactinemia.\n* Untreated thyroid disease.\n* Current use of nitrates or nitric oxide donors.\n* Current use of alpha-blockers, unless the participant is on a stable low dose.\n* Current use of other phosphodiesterase type 5 inhibitors.","MALE","30 Years","65 Years",{"count":97,"type":98},80,"ESTIMATED","INTERVENTIONAL",[101],"NA","Erectile dysfunction is a common condition that may result from vascular, neurological, hormonal, psychological, or medication-related factors. Platelet-rich plasma (PRP) and low-intensity extracorporeal shock wave therapy (Li-ESWT) are regenerative treatment approaches that may improve erectile function through mechanisms involving angiogenesis, tissue repair, and improvement of penile vascular function.\n\nThis randomized prospective study will compare the efficacy and safety of PRP injection alone with combined PRP injection and Li-ESWT in men with erectile dysfunction. A total of 80 participants will be randomly assigned to two groups. One group will receive PRP injections alone, while the other group will receive PRP injections combined with Li-ESWT. Participants will be followed after treatment to assess changes in erectile function, erection hardness, penile blood flow, patient satisfaction, and treatment-related adverse events.\n\nThe study hypothesis is that adding Li-ESWT to PRP therapy will result in greater improvement in erectile function than PRP therapy alone.",[104],"Erectile Dysfunction",[51,106,56,107,108],"Erectile Function","Penile Hemodynamics","Regenerative Therapy","NOT_YET_RECRUITING","2026-08-20",{"date":112,"type":113},"2026-08-24","ACTUAL",{"date":115,"type":98},"2026-09-01",{"date":117,"type":98},"2027-03-01",{"name":5,"class":6},1]