[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"erectile-dysfunction-following-radical-prostatectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:erectile-dysfunction-following-radical-prostatectomy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,50,92,124,149,171,203,221,244,272,304,327,358,380,402],{"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":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100641019","everist-impact-of-image-detected-accessory-pudendal-artery-on-erection-recovery-after-nerve-sparing-prostatectomy-100641019",false,"NCT07597798","EVERiST: Impact of Image Detected Accessory Pudendal Artery on Erection Recovery After Nerve Sparing Prostatectomy","EVERiST: Erectile Function Recovery After Bilateral neuroVascular Bundle Sparing Robot Assisted Radical prostatEctomy in Patients With or Without an Accessory Pudendal aRtery Detected on diagnoSTic Multiparametric MRI: A Feasibility Study","EVERiST","Inclusion Criteria:\n\n* Men diagnosed with cT2-T3a N0 M0 PCa aged between 18 and 79 from all ethnic backgrounds.\n* Patients who underwent a prostate mpMRI before prostate biopsy.\n* Medically fit to undergo RARP.\n* Diagnostic quality prostate biopsies concordant with a diagnostic quality prostate mpMRI adequate to provide a surgical plan.\n* Scheduled for RARP with a recommendation of NVB spare based on multidisciplinary meetings informed by mpMRI, biopsy result and clinical factors.\n* Sexually active men with no to mild ED at baseline based on IIEF-EFD (\\>=24) questionnaire.\n* Preference to preserve erectile function for sexual intercourse.\n* Ability to read English sufficiently to understand PIS and able to give informed consent.\n\nExclusion Criteria:\n\n* Established moderate\u002F severe ED (IIEF-EFD \\\u003C24)\n* Patients who received neo-adjuvant androgen deprivation therapy.\n* Patients with previous surgery for benign prostatic enlargement\n* Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal therapy, chemotherapy.\n* Previous pelvic or penile fracture\n* Previous surgery for ED\n* Poor quality prostate mpMRI or biparametric MRI (no contrast)\n* Established vascular disease (ischaemic heart disease, cerebrovascular disease, peripheral vascular disease)","MALE","18 Years","79 Years",{"count":21,"type":22},40,"ESTIMATED","OBSERVATIONAL","Prostate cancer is the most common cancer amongst men in the United Kingdom, and two common curative treatments are surgery to remove the prostate (radical prostatectomy) or radiotherapy. Both treatments can affect quality of life, mainly because of problems with erections and urinary leakage. Many men feel disappointed or regret their treatment choice because of changes in their sexual function. Surgeons often use a 'nerve-sparing' technique to reduce the risk of erectile dysfunction (ED), but many men still experience erection problems afterwards. A way to improve erectile function recovery after surgery further would be to identify accessory (additional) arteries to the penis. Up to one in three men have an extra artery called the accessory pudendal artery (APA). Preserving this artery during surgery may improve recovery of erections by protecting blood flow and reducing the risk or severity of ED. Until recently, surgeons could only try to see these arteries during the operation, and no study has tested whether they are preserved or whether this makes a difference. This has changed with the advent of imaging. Men already have an advanced MRI scan (called a multiparametric MRI) before prostate cancer treatment. These scans can also show whether an APA is present. In addition, robotic surgery, now the gold standard for radical prostatectomy, allows operations to be video recorded. This allows comparison of what was seen on the scan with what happened during surgery and then monitoring of recovery afterwards. Early research suggests that men with an APA have better erections before surgery. This study will test whether preserving the APA during surgery helps erections recover afterwards.\n\nIn this first phase of the research (Phase 1), a feasibility study will be carried out at University College London Hospital. The study will invite 20-40 men with good sexual function before surgery, who are having robotic prostatectomy with a nerve-sparing approach. Multiparametric MRI scans will be used to identify whether an APA is present and video recordings will be collected to see if the artery was preserved. Participants will complete simple questionnaires on erections and quality of life before and after surgery up to 1 year. To assess whether the artery was preserved, an extra MRI scan will be organised after surgery for those with an APA, as well as penile ultrasound to assess erectile machinery. Ethical approval has already been obtained from the regulatory bodies, and the study is ready to start recruiting participants.\n\nThe results will allow planning of a larger, national study (Phase 2). That study will test whether preserving the APA improves erectile recovery, reduces the severity of ED, and improves quality of life. If confirmed, this research could lead to modification in surgical approach, more personalised counselling before surgery, and reduced long-term need for costly ED treatments within the NHS.",[26,27,28,29],"Radical Prostatectomy","Erectile Dysfunction Following Radical Prostatectomy","Erectile Dysfunction Due to Arterial Insufficiency","Robotic Radical Prostatectomy",[31,32,33,34,35,36],"ED post RARP","Prostate Cancer Survivorship","Erectile dysfunction","Radical prostatectomy","Accessory pudendal artery","APA","RECRUITING","2026-05-13",{"date":40,"type":41},"2026-05-19","ACTUAL",{"date":43,"type":41},"2026-01-15",{"date":45,"type":22},"2028-01-15",{"name":47,"class":48},"University College, London","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100638434","phase-2-multimodal-prehabilitation-and-rehabilitation-for-men-undergoing-robot-assisted-radical-prostatectomy-100638434","NCT07576335","Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy","Multimodal Perioperative Optimisation for Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomised Controlled Trial Targeting Postoperative Erectile Dysfunction (ROBOPREP Trial)","ROBOPREP","Inclusion Criteria:\n\n1. Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer.\n2. Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery.\n3. Willingness to engage in prescribed self-directed interventions.\n\nExclusion Criteria:\n\n1. Cognitive impairment such that they lack capacity to provide informed consent.\n2. Currently taking intracavernosal injection therapy.\n3. Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score ≤7 or self-reported absence of erectile function.\n4. Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use.\n5. Impaired renal function (GFR \\\u003C50 mL\u002Fmin and\u002For creatinine clearance \\\u003C30 mL\u002Fmin).\n6. Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4.\n7. Loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION).\n8. Myocardial infarction within the last 90 days.\n9. Stroke within the last 6 months.\n10. Unstable angina or angina occurring during sexual intercourse.\n11. New York Heart Association (NYHA) Class II or greater heart failure in the last 6 months.\n12. Uncontrolled arrhythmias, hypotension (\\\u003C90\u002F50 mmHg), or uncontrolled hypertension.\n13. Contraindications to participating in the prescribed exercise program.\n14. No access to a device with internet connectivity.",{"count":59,"type":22},64,"INTERVENTIONAL",[62],"PHASE2","Prostate cancer is the most common cancer in Australian men. Robot-assisted radical prostatectomy (RARP) - surgical removal of the prostate - is a standard treatment, but it frequently causes erectile dysfunction (ED) and urinary incontinence that can persist for years and significantly affect quality of life.\n\nThis trial (ROBOPREP) will test whether a multimodal program of prehabilitation (before surgery) and rehabilitation (after surgery) improves erectile function and urinary continence in men undergoing RARP, compared to standard care alone.\n\nThe program includes four components, all delivered virtually and in a self-directed manner:\n\n1. Pharmacological - tadalafil 5 mg once daily (a low-dose, TGA-approved erectile medication) beginning 4 weeks before surgery, paused during hospital admission, and resumed for 3 months following catheter removal after surgery.\n2. Exercise - pelvic floor muscle training (3 sets per day) and aerobic exercise (40 minutes, 4 times per week) to strengthen the muscles and vascular supply involved in erectile and urinary function.\n3. Nutrition - dietary guidance to support surgical recovery and vascular health.\n4. Psychological\u002Fwellbeing - relaxation techniques, psychoeducation about expected recovery, and self-compassion strategies to address cancer-related anxiety.\n\nA total of 64 men will be recruited across three major Sydney hospitals (Royal Prince Alfred Hospital, Concord Repatriation General Hospital, and Chris O'Brien Lifehouse) and randomly assigned 1:1 to the multimodal program plus standard care, or to standard care alone. Outcomes - including erectile function (primary), urinary continence, quality of life, and psychological wellbeing - are assessed at baseline and at 6 weeks, 3, 6, and 12 months following surgery. All participant-facing elements of the program are digital, low-cost, and designed for real-world scalability.",[27,65,66],"Prostate Cancer","Urinary Incontinence Following Surgical Procedure",[68,69,70,71,72,73,74,75,76,77,78,79],"robot-assisted radical prostatectomy","prehabilitation","rehabilitation","erectile dysfunction","urinary incontinence","PDE5 inhibitor","tadalafil","pelvic floor muscle training","prostate cancer","sexual rehabilitation","perioperative care","multimodal intervention","NOT_YET_RECRUITING","2026-05-04",{"date":83,"type":41},"2026-05-08",{"date":85,"type":22},"2026-05-01",{"date":87,"type":22},"2028-11-01",{"name":89,"class":90},"Surgical Outcomes Research Centre (SOuRCe)","NETWORK",3,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":60,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":49},"100632994","the-effect-of-mobile-based-perioperative-education-on-urinary-incontinence-and-erectile-function-after-radical-prostatectomy-100632994","NCT07520916","The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatectomy","The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatectomy: A Randomized Controlled Trial","MPE-RP","Inclusion Criteria:\n\n* Patients diagnosed with prostate cancer and scheduled for elective radical prostatectomy (open, laparoscopic, or robotic)\n* Aged 18 years or older\n* Planned to undergo surgery at the study center(s)\n* Able to use a smartphone and having sufficient digital literacy to operate the mobile application\n* Provided written informed consent after being informed about the study\n\nExclusion Criteria:\n\n* Pre-existing urinary incontinence or erectile dysfunction before surgery\n* Severe cognitive impairment or severe visual or hearing impairment\n* Previous pelvic radiotherapy or a history of major pelvic surgery\n* Presence of severe comorbidity or terminal illness that may interfere with adherence to the study protocol\n* Technological insufficiency preventing the use of the mobile application",{"count":101,"type":22},78,[103],"NA","This prospective randomized controlled study aims to evaluate the effect of mobile-based perioperative education on postoperative urinary incontinence and erectile function in patients undergoing radical prostatectomy. Patients scheduled for radical prostatectomy will be assigned to either an intervention group or a control group. The intervention group will receive standard care plus a structured mobile application-based perioperative education program including video-assisted pelvic floor muscle training, perioperative education modules, reminders, and follow-up components. The control group will receive routine perioperative care and standard patient education. Data will be collected preoperatively, after urinary catheter removal, and at 1 month and 3 months after surgery. The primary outcomes are urinary incontinence and erectile function, assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the International Index of Erectile Function-5 (IIEF-5), and a 24-hour pad assessment. Secondary outcomes include lower urinary tract symptoms and disease-specific quality of life assessed by the International Prostate Symptom Score (IPSS), psychological status assessed by the Depression Anxiety Stress Scale-21 (DASS-21), and system usability assessed by the Turkish version of the Computer System Usability Questionnaire-Short Version (T-CSUQ-SV)",[106,107,27],"Prostate Cancer (Post Prostatectomy)","Urinary Incontinence (UI)",[26,109,110,111,112,113,114],"Mobile Health","mHealth","Perioperative Education","Pelvic Floor Muscle Training","Urinary Incontinence","Erectile Function","2026-04-03",{"date":117,"type":41},"2026-04-09",{"date":119,"type":41},"2026-04-02",{"date":121,"type":22},"2027-04-02",{"name":123,"class":48},"Giresun University",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":60,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":148},"100489265","safety-and-tolerability-of-a-novel-implantable-device-for-the-treatment-of-erectile-dysfunction-100489265","NCT05650866","Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction","Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy","Inclusion Criteria:\n\n* Men of ages between 30-70 years;\n* Men with indication for nerve-sparing prostatectomy surgery;\n* Localised prostate cancer considered suitable for bilateral nerve sparing prostatectomy according to clinical criteria\n* International Index of Erectile Function (IIEF-15) erectile function domain score equal to or greater than 26 prior prostatectomy;\n* Men interested in minimizing the effect of radical prostatectomy on erectile function;\n* Ability to read and understand patient information materials and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Men with neurological disease, including a history of spinal cord injury or trauma;\n* IIEF-15 erectile function domain score less than 26 prior prostatectomy;\n* Failure to demonstrate adequate nocturnal erectile function prior prostatectomy;\n* History of erectile dysfunction, priapism and Peyronie disease;\n* History of previous pelvic surgery, trauma or irradiation therapy;\n* Currently have an active implantable device;\n* Patient diagnosed with neurologic degenerative diseases that may negatively impact erectile functions;\n* Identification of technical or clinical limitation to properly apply the use of nerve-sparing techniques during operation;\n* Inability to understand and demonstrate device use instructions;\n* Patients with insulin-dependent diabetes who suffer peripheral neuropathy or other diabetes associated complications;\n* Patient unwillingness to engage in sexual activity;\n* Patient is currently participating in another clinical investigation that would serve as a contraindication to implant a neurostimulator device to augment erectile function;\n* Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months;\n* Possess any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure\u002Fstudy;\n* Patient is a member of a vulnerable population (Vulnerable participants include those who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, and employee volunteers).","30 Years","70 Years",{"count":134,"type":22},20,[103],"The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy.\n\nThe main questions it aims to answer are:\n\n* Is the device safe?\n* Does the device works well? Are the participants satisfied with the device?\n\nParticipants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up:\n\n* Come to the hospital for follow-up visits,\n* Complete questionnaires,\n* Activate the device every day,\n* Measure erection hardness.\n\nResearchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.",[27],"2026-03-16",{"date":140,"type":41},"2026-03-18",{"date":142,"type":41},"2023-05-19",{"date":144,"type":22},"2026-08-31",{"name":146,"class":147},"Comphya Australia","INDUSTRY",4,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":60,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":49},"100607400","a-study-looking-at-a-new-nerve-surgery-to-help-men-regain-erections-after-prostate-cancer-surgery-100607400","NCT07188064","A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery","Prospective Cohort Study of Somatic-Autonomic Nerve Grafting Technique to Restore Erectile Function in Patients With Persistent Erectile Dysfunction Post Radical Prostatectomy","PRP NG PRO M","Inclusion Criteria:\n\n* Patients with persistent post prostatectomy erectile dysfunction as defined below:\n\n  1. Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR\n  2. Moderate ED (IIEF score 8-11) and more than 18 months from prostatectomy\n* Patients must have had good pre-prostatectomy erectile function with a baseline IIEF score of ≥17 on self-reported assessment of historic function.\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years at diagnosis\n* Legally incapable patients\n* Patients \\>5 years from prostatectomy.\n* Bilateral open inguinal hernia repair\n* Patients with pre-existing significant neurologic disease\n* Diabetes with evidence of peripheral nerve involvement and end organ dysfunction\n* Coronary artery disease with unstable angina\n* Mood disorder (anxiety\u002Fdepression) with change in medical therapy within last 3 months\n* Pre-existing penile base surgery which would prevent grafting technique including suprapubic liposuction, suspensory ligament release\n* Pre-existing penile prosthesis\n* Current use of androgen deprivation therapy\n* Use of medications for chronic nerve pain (gabapentin, amitriptyline, nortriptyline, pregablin)\n* Previous untreated penile trauma\n* Patients deemed medically unfit for surgery",{"count":158,"type":22},100,[103],"A single arm prospective pilot trial evaluating the 1-year erectile recovery outcomes and the safety of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 100 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).",[65,27],"2026-03-07",{"date":164,"type":41},"2026-03-10",{"date":166,"type":41},"2026-01-30",{"date":168,"type":22},"2028-12",{"name":170,"class":48},"Sir Mortimer B. Davis - Jewish General Hospital",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":179,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":60,"phases":182,"briefSummary":183,"conditions":184,"keywords":190,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":49},"100505998","efficacy-of-low-intensity-shockwave-vs-radial-wave-for-treatment-of-erectile-dysfunction-and-pelvic-pain-100505998","NCT05868668","Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain","Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Focused Shockwave and Sham Therapy for Chronic Pelvic Pain Syndrome in Patients With and Without History of Prostate Cancer","Shockwave","Erectile Dysfunction Group (ED) Inclusion Criteria (ED): (all of the following)\n\n1. Cis-gendered heterosexual adult males18 years old\n2. Stable relationship of more than 3 months duration with currently willing sexual partner and desire for penetration.\n3. Mild to moderate organic erectile dysfunction (IIEF-EF score 11-25) in the last 3 months\n4. If ED responsive or partially responsive to current use of PDE5I, participant must be willing to discontinue PDE5I for 4 weeks prior to trial and remain off PDE5I for the duration of the study. Partially responsive ED is defined as inadequate response for desired sexual activity, or poorly maintained erection despite initially good response.\n5. Agreeable to attempt sexual intercourse at least 4 times per month for duration of study without being under the influence of alcohol or recreational drugs\n6. Morning total testosterone level over 300ng\u002FdL\n\nExclusion Criteria (ED):\n\n1. Nerve-injury related ED (\u002Fspinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting erectile functions (e.g, multiple sclerosis, alzheimer's disease, parkinsons disease, amyotrophic lateral sclerosis)\n2. Untreated hypogonadism (morning total testosterone \\\u003C300 ng\u002FdL) or on androgen deprivation therapy in the last 12 months\n3. Predominately psychogenic ED based upon expert clinician opinion\n4. Peyronie's disease, palpable plaque or curvature\u002Fpenile anatomic abnormality that affects penetrative intercourse to any degree\n5. History of non-superficial penile surgery (e.g, penile prosthesis, penectomy, plication, grafting)\n6. History of penile injury or trauma (e.g, priapism, penile fracture)\n7. Use of intracavernosal injection for ED within the last year\n8. If diabetic, HbA1c 8% or higher within the past 12 months\n9. Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound\n10. Current tobacco smoker, or has smoked in the past year\n11. Poorly controlled hyperlipidemia\n12. Poorly controlled hypertension\n13. Severe cardiac disease or history of myocardial infarction\n14. History of psychiatric disorder including bipolar disorder, current moderate or severe depression\n15. Patients currently using SSRI or psychotropic medication\n16. Severe ED based on IIEF-EF (score 10 or below)\n17. Current acute prostatitis\n\nChronic Pelvic Pain Syndrome Group:\n\nInclusion Criteria (CPPS): (all of the following)\n\n1. Adult males ≥18 years old\n2. Chronic pelvic pain not explained by concurrent urinary tract infections. urine)\n3. Willing to do PFPT\n\nExclusion criteria (CPPS):\n\n1. Nerve-injury related pelvic pain (history of \u002Fspinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting pain in the pelvic region(Multiple sclerosis, Alzheimer's, Parkinsons disease)\n2. Acute prostatitis or any acute infection of the pelvic region\n3. History of pelvic trauma","40 Years",{"count":181,"type":22},186,[103],"The purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.",[28,185,186,187,188,27,189],"Erectile Dysfunction","Erectile Dysfunction Due to Arterial Disease","Chronic Pelvic Pain Syndrome","Chronic Prostatitis","Erectile Dysfunction Following Radiation Therapy",[191,192,193],"shockwave","radial wave","pelvic floor physical therapy","2026-01-20",{"date":196,"type":41},"2026-01-21",{"date":198,"type":41},"2023-09-19",{"date":200,"type":22},"2026-06",{"name":202,"class":48},"The Cleveland Clinic",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":131,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":60,"phases":210,"briefSummary":136,"conditions":211,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":49},"100590521","safety-and-tolerability-of-a-novel-implantable-device-for-the-treatment-of-erectile-dysfunction-100590521","NCT06968494","Inclusion Criteria:\n\n* Men of ages between 30-75 years with indication for nerve-sparing prostatectomy surgery;\n* Cancer stage T1c and T2a;\n* Grade Groups 1 and 2 as well as low volume Grade Group 3 (Gleason score 4 + 3 = 7), as determined by biopsy (2 cores or less GG3) or single index MRI lesion of GG3 disease;\n* IIEF-15 erectile function domain score equal to or greater than 26;\n* Men interested in minimizing the effect of radical prostatectomy on erectile function;\n* Ability to read and understand patient information materials and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Men with neurological disease, including a history of spinal cord injury or trauma;\n* IIEF-15 erectile function domain score less than 26;\n* Failure to demonstrate adequate nocturne erectile function prioi prostatectomy (nocturnal RigiScan measure);\n* Men with PSA \\> 20 ng\u002FmL;\n* History of ED, priapism and Peyronie disease;\n* History of previous pelvic surgery, trauma or irradiation therapy;\n* Currently have an active implantable device.\n* Patient diagnosed with neurologic degenerative diseases that may negatively impact erectile functions;\n* Identification of technical or clinical limitation to properly apply the use of nerve-sparing techniques during operation;\n* Inability to understand and demonstrate device use instructions;\n* Patients with insulin-dependent diabetes who suffer peripheral neuropathy or other diabetes associated complications;\n* Patient unwillingness to engage in sexual activity;\n* Patient is currently participating in another clinical investigation that would serve as a contraindication to implant a neurostimulator device to augment erectile function;\n* Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months;\n* Possess any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure\u002Fstudy;\n* Patient is a member of a vulnerable population (Vulnerable participants include those who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, and employee volunteers).","75 Years",{"count":134,"type":22},[103],[27],"2025-11-06",{"date":214,"type":41},"2025-11-10",{"date":216,"type":41},"2025-06-05",{"date":218,"type":22},"2027-04",{"name":220,"class":147},"Comphya Inc.",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":179,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":60,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":240,"leadSponsor":242,"locationsCount":4},"100606230","pelvic-floor-muscle-training-with-aerobic-exercise-and-relaxation-after-radical-prostatectomy-100606230","NCT07172854","Pelvic Floor Muscle Training With Aerobic Exercise and Relaxation After Radical Prostatectomy","Radikal Prostatektomi Sonrasında Aerobik Egzersiz ve Gevşeme Eğitimlerinin Pelvik Taban Kas Eğitimine İlave Etkileri","PFMTinPPUI","Inclusion Criteria:\n\n* Male participants aged 40 to 65 years\n* Underwent nerve-sparing robotic radical prostatectomy within the past 12 months\n* Ability to voluntarily contract pelvic floor muscles\n* Cognitive capacity sufficient for cooperation with study assessments and interventions, as determined by the Montreal Cognitive Assessment (MoCA)\n\nExclusion Criteria:\n\n* Presence of acute illness (e.g., urinary tract infection, respiratory infection, interstitial cystitis, bladder or gastrointestinal bleeding)\n* Within the first 3 weeks after prostatectomy surgery (acute postoperative period)\n* Neurological disorders or diagnosis of neurogenic bladder\n* Diagnosed cognitive or psychiatric disorders\n* Preoperative urinary incontinence or erectile dysfunction\n* History of prior bladder or prostate surgery before prostatectomy\n* Participation in pelvic floor muscle training within the last 6 months\n* Refusal to participate or absence of signed informed consent form","65 Years",{"count":231,"type":22},48,[103],"Post-prostatectomy urinary incontinence (PP-UI) and erectile dysfunction (ED) are common complications after radical prostatectomy, negatively affecting quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment, but recent evidence suggests that multimodal, structured rehabilitation may further improve recovery.\n\nThis randomized controlled trial will investigate the additional effects of aerobic exercise and relaxation training combined with PFMT in men following nerve-sparing robotic-assisted radical prostatectomy. Forty-eight participants aged 40-65 years, within one year post-surgery, who demonstrate voluntary pelvic floor muscle contraction and sufficient cognitive function (MoCA), will be randomly assigned (1:1) to intervention or control groups.\n\nAll participants will receive standardized education and a 12-week supervised PFMT program with biofeedback and home-based exercises. The intervention group will additionally perform treadmill-based aerobic exercise three times per week and structured relaxation training once per week.\n\nPrimary outcomes include urinary symptoms (ICIQ-MLUTS), erectile function (IIEF-15), and prostate cancer-specific quality of life (EPIC). Secondary outcomes include pad test, ICIQ-SF, 6-minute walk test, MoCA, HADS, and adherence.\n\nThis non-commercial study aims to provide high-quality evidence supporting physiotherapy-based multimodal rehabilitation for improved pelvic health and quality of life in men after prostate cancer surgery.",[235,27],"Post Prostatectomy Incontinence","2025-09-08",{"date":238,"type":41},"2025-09-15",{"date":238,"type":22},{"date":241,"type":22},"2026-09-15",{"name":243,"class":48},"Hacettepe University",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":131,"maxAge":208,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":49},"100562618","regenerative-injection-of-stem-cells-or-stem-cell-derived-exosomes-for-erectile-dysfunction-rise-100562618","NCT06605508","Regenerative Injection of Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction (RISE)","Prospective Observational Study on Intracavernosal Injection of Autologous Adipose Tissue-Derived Stem Cells (ADSC) or Stem Cell-derived Exosomes for the Treatment of Erectile Dysfunction","RISE","Inclusion Criteria:\n\n* Age: Adult males aged 30 to 75 years.\n* Diagnosis: Confirmed diagnosis of erectile dysfunction (ED) of mild to moderate severity, as defined by an International Index of Erectile Function (IIEF) score.\n* Treatment Response: Failure or suboptimal response to conventional ED treatments, such as PDE-5 inhibitors.\n* General Health: Overall good health without contraindications to stem cell therapy.\n* Informed Consent: Ability and willingness to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Severe Cardiovascular Disease: Presence of severe cardiovascular conditions, including uncontrolled hypertension or significant heart disease.\n* Active Infections: Ongoing infections that could interfere with treatment or pose a risk to the participant.\n* Malignancies: History of or current cancer, including malignancies that could affect safety or treatment outcomes.\n* Contraindications to Stem Cell Therapy: Any medical conditions or treatments that contraindicate the use of stem cell therapy.\n* Uncontrolled Diabetes: Poorly controlled diabetes or other metabolic disorders that could impact treatment efficacy or safety.\n* Psychiatric or Cognitive Impairments: Significant psychiatric or cognitive disorders that may affect the participant\\'s ability to comply with study protocols or provide informed consent.\n* Recent Surgery or Trauma: Recent major surgeries or physical trauma that could impact the study or interfere with the intervention.\n* Participation in Other Studies: Participation in other clinical trials or studies that may affect the outcomes or safety of this study.",{"count":253,"type":22},30,"The goal of this prospective observational study is to evaluate whether injections of stem cells derived from the patient's own fat tissue (adipose tissue) can improve erectile function in men aged 30 to 75 who have erectile dysfunction (ED) and have not responded well to standard treatments like PDE-5 inhibitors (e.g., Viagra).\n\nThe main questions the study aims to answer are:\n\nWill the stem cell injections improve erectile function, as measured by the International Index of Erectile Function (IIEF) score? Are there any changes in blood flow to the penis, which will be measured using a Doppler ultrasound?\n\nParticipants will:\n\nReceive injections of their own stem cells (obtained from a biopsy of fat) directly into the penis.\n\nUndergo assessments to check erectile function before and after treatment. Have follow-up visits at 3, 6, 9, and 12 months to monitor long-term effects. The study will also look for any possible side effects or complications and evaluate biological markers in the penis that may indicate the effectiveness of the treatment.\n\nParticipants will be recruited from clinic where they are already receiving care for ED. To take part, they must be in good overall health, with no severe heart disease, uncontrolled diabetes, cancer, or other conditions that could make stem cell therapy unsafe for them.",[185,256,27],"Erectile Dysfunction Associated With Type 2 Diabetes Mellitus",[258,259,260,261,262],"stem cell therapy","Erectile dysfunction (ED)","Autologous adipose tissue-derived stem cells (ADSC)","Regenerative medicine for ED","Exosomes","2025-08-25",{"date":265,"type":41},"2025-08-26",{"date":267,"type":41},"2025-01-10",{"date":269,"type":22},"2029-12-31",{"name":271,"class":48},"Jumeirah American Clinic",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":60,"phases":282,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":4},"100603751","pilot-study-of-a-new-nerve-grafting-method-during-bladder-cancer-surgery-to-help-preserve-erections-100603751","NCT07140588","Pilot Study of a New Nerve Grafting Method During Bladder Cancer Surgery to Help Preserve Erections.","Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With Bladder Cancer Undergoing Radical Cystectomy","NR-RC","Inclusion Criteria:\n\n* Patients undergoing standard of care radical cystectomy for bladder cancer\n* Patients must have preoperative erectile function with a baseline IIEF score of ≥17\n\nExclusion Criteria:\n\n* Patients with previous pelvic surgery\n* Patients with previous pelvic radiotherapy\n* Patients aged \\\u003C 18 years at diagnosis\n* Legally incapable patients\n* Patients who are unable to complete questionnaires and have no companion to help complete them\n* Patients undergoing a concomitant cancer surgery\n* Patients with pre-existing neurologic disease",{"count":281,"type":22},10,[103],"This pilot study will evaluate the safety and 1-year erectile function recovery in 10 patients undergoing a novel Nerve Restoring Radical Cystectomy (NR-RC), which includes a genitofemoral nerve graft. Erectile function will be assessed using IIEF-5, SF-MPQ, and CEEF questionnaires at baseline and at multiple post-operative intervals (4 weeks, 3, 6, 12, and 18 months). Safety will be monitored through peri- and post-operative complications, and additional demographic and clinical data will be collected for analysis.",[285,27],"Bladder Cancer Requiring Cystectomy",[287,288,289,290,291,292,293,294,295],"Bladder cancer","Nerve grafting","The genitofemoral nerve","radical cystectomy","radical prostatectomy","Erectile function","International Index of Erectile Function-5","Short Form McGill Pain Questionnaire","Clinical Evolution of Erectile Function","2025-08-18",{"date":298,"type":41},"2025-08-24",{"date":300,"type":22},"2025-09",{"date":302,"type":22},"2029-02",{"name":170,"class":48},{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":311,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":60,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":49},"100600764","effects-of-hypopressive-exercises-on-urinary-incontinence-and-erectile-dysfunction-after-radical-prostatectomy-100600764","NCT07101731","Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy","The Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy: A Randomized Controlled Trial","Inclusion Criteria\n\n* Male individuals diagnosed with prostate cancer who have undergone radical prostatectomy\n* Experiencing both urinary incontinence and erectile dysfunction\n* Age \\> 55 years\n* A score of 24 or higher on the Mini-Mental State Examination (MMSE)\n* Literate (able to read and write)\n* Willingness to participate in the study (signed informed consent)\n* Ability to voluntarily contract pelvic floor muscles\n* Ability to cooperate with the assessments and interventions used in the study\n\nExclusion Criteria\n\n* History of urinary incontinence before surgery\n* Congenital abnormalities of the urinary system\n* Presence of neurological disorders\n* History of transurethral resection of the prostate (TURP)\n* Diagnosis of chronic obstructive pulmonary disease (COPD) and\u002For chronic restrictive pulmonary disease\n* History of inguinal hernia\n* Previous or current history of radiation therapy\n* Surgical or postoperative complications that prevent early physiotherapy intervention (e.g., urinary tract infection, bladder neck stenosis)","55 Years",{"count":253,"type":22},[103],"This randomized controlled trial investigates the effects of hypopressive exercises on urinary incontinence and erectile dysfunction in men following radical prostatectomy. Participants will be randomly assigned to one of two groups: a control group receiving home-based pelvic floor muscle exercises and an experimental group receiving both pelvic floor muscle exercises and supervised hypopressive exercises twice per week. The study aims to determine whether the addition of hypopressive techniques, which target coordinated activation of the pelvic floor and abdominal muscles without increasing intra-abdominal pressure, offers greater improvements in urinary and sexual function. Primary outcomes include pelvic floor muscle strength and endurance, while secondary outcomes include urinary incontinence severity, erectile function, and quality of life.",[106,113,27,112],[26,113,185,112,317],"Hypopressive Exercises","2025-07-28",{"date":320,"type":41},"2025-08-03",{"date":322,"type":41},"2024-06-01",{"date":324,"type":22},"2025-11-15",{"name":326,"class":48},"Bartın Unıversity",{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":335,"targetDuration":4,"studyType":60,"phases":337,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":91},"100583356","phase-4-penile-rehabilitation-after-nerve-sparing-robot-assisted-radical-prostatectomy-for-prostate-cancer-20-pehab-ii-100583356","NCT06875258","PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)","PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicentre, Randomized Clinical Trial (PEHAB-II)","PEHAB-II","Inclusion Criteria:\n\nPre-screening eligibility criteria\n\n* Age \\> 18 years and \\\u003C 70 years\n* Patients who have a penis that has developed naturally, without surgical interventions.\n* Histologically confirmed PCa\n* Scheduled for RP as primary treatment with the intention of at least a one-sided nerve-sparing procedure.\n* Non-metastatic disease (cN0M0)\n* Pre-operative erections good enough for intercourse (anamnestic)\n* Motivated to participate in a penile rehabilitation program\n\nInclusion criteria\n\nTo be eligible to participate in this study, a subject must meet all of the following post- operative criteria:\n\n* All of the above-mentioned pre-screening eligibility criteria\n* At least unilateral nerve-sparing or if available Fascia Preservation (FP) score =\\>5\n* A pre-diagnostic anamnestic erection that was good enough for intercourse.\n* A pre-diagnostic IIEF-EF\\>=22 with or without PDE5i. For patients without a partner or did not participate in penetrative sex we use accumulated score of EPIC- erectile function; Q8b, Q9 and Q10 \\>=83.\n* Willing to provide one blood sample to determine testosterone level, hemoglobin 1Ac, liver enzymes and lipid profile\n* Testosterone levels of at least \\>=12 nmol\u002Fl, measured pre or post-operative\n* A signed informed consent form\n\nExclusion Criteria:\n\nPre-screening exclusion criteria:\n\nRegarding history of oncological treatment\n\n* Previous pelvic radiation therapy\n* Patients on Androgen Deprivation Therapy (ADT)\n* Patients with diseases that affect the red blood cells (e.g., sickle cell anaemia), blood cancer (leukaemia) or bone marrow tumors Regarding history of cardiovascular diseases\n* Patients with heart failure New York Heart Association (NYHA) ≥ class 3\n* Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.\n* Patients with unstable angina pectoris\n* Patients using nitride oxide for coronary artery disease\n* Patients with hypotension (blood pressure \\\u003C90\u002F50 mmHg)\n* Patients with recent history of stroke or myocardial infarction\n* Patients with diseases that affect blood clotting or causes bleeding (i.e. coagulation disorders) or prolonged erections\n\nOther pre-screening exclusion criteria:\n\n* Patients with neurological diseases; such as transient ischemic attack (TIA), Cerebrovascular accident(CVA), Parkinson, and polyneuropathy.\n* Allergy regarding Sildenafil\n* Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.\n* Patients with severe hepatic impairment\n* Patients with known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).\n* Patients using alpha-blockers, but they may be eligible to participate after discontinuing alpha-blocker use.\n* The inability to speak and read in Dutch\n\nExclusion criteria\n\n* A potential subject who meets any of the following criteria will be excluded from participation in this study:\n* All of the above-mentioned pre-screening exclusion criteria\n* \\>pT3b\n* Adjuvant radiotherapy or hormonal therapy\n* Inability to use VED such as severe penile deformity causing fitting problems",{"count":336,"type":22},198,[338],"PHASE4","The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients. The two rehabilitation strategies consist of 1)12 months daily doses of 100 mg Sildenafil combined with vacuum device (VED) therapy for 10 minutes a day, five times a week or 2) Standard of care: monotherapy with an on-demand dosage of 100mg Sildenafil. The study will be performed in multiple centers in the Netherlands.",[27],[342,343,344,345,346,347,348],"Penile rehabilitation","Vacuum pump device","Sildenafil","Nerve sparing prostatectomy","Quality of life","Sexual quality of life","Prostate cancer survivorship","2025-03-07",{"date":351,"type":41},"2025-03-13",{"date":353,"type":41},"2024-01-15",{"date":355,"type":22},"2027-01-01",{"name":357,"class":48},"The Netherlands Cancer Institute",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":60,"phases":366,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":49},"100458043","efficacy-of-restorex-penile-traction-therapy-in-preserving-erectile-function-post-prostatectomy-100458043","NCT05244486","Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy","Inclusion Criteria:\n\n* Undergoing bilateral nerve-sparing prostatectomy\n* \\>18 years old\n* Have a regular sexual partner for at least 6 months prior to study enrollment\n\nExclusion Criteria:\n\n* Requiring adjuvant radiation therapy or androgen deprivation \u002F androgen blockade post-operatively (by the time of enrollment)\n* Baseline severe erectile dysfunction as measured by the IIEF-EFD\n* Urethral complications from prostatectomy at the time of baseline visit including contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vesicourethral anastomosis intra-operatively",{"count":365,"type":22},200,[103],"Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months. Secondary outcomes include differences in questionnaire outcomes at 3, 6, and 9 months.",[27],[370],"Penile traction therapy","2025-02-12",{"date":373,"type":41},"2025-02-13",{"date":375,"type":41},"2022-03-12",{"date":377,"type":22},"2030-09-14",{"name":379,"class":48},"Charitable Union for the Research and Education of Peyronie's Disease",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":179,"maxAge":229,"enrollmentInfo":387,"targetDuration":4,"studyType":60,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":49},"100482129","phase-2-safety-and-efficacy-evaluation-of-bz371a-topically-applied-on-prostatectomized-patients-100482129","NCT05558007","Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients","Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A in a Gel Applied in Patients That Performed Radical Prostatectomy","Inclusion Criteria:\n\n1. Men between the ages of 40 and 65 years;\n2. Exclusive heterosexual men, regardless of race or social class.\n3. RP due to prostate cancer without metastasis;\n4. RP performed less than 60 days before the screening visit;\n5. Erectile function prior to normal RP, defined as IIEF questionnaire with more than 22 points in domain A;\n6. Stable sexual partner (more than 2 months prior to RP), and intention to maintain the relationship during the study.\n7. Continuous use of 5mg Tadalafil from the 30th up to the 60th day after RP.\n\nExclusion Criteria:\n\n1. Prostate cancer in TNM stage classified as T3 or T4.\n2. Perineal and\u002For open RP;\n3. Necessity of other therapy for prostate cancer than RP, including radiation therapy or hormone therapy;\n4. Uncontrolled diabetes at screening visit (HbA1C \\> 10%);\n5. Prior spinal cord injury with lower limb paralysis;\n6. Current male hormone use, or hypogonadism, defined by total testosterone below 8 nmol\u002FL (2300 pg\u002FmL) or total testosterone between 8 and 11 nmol\u002FL (2300 and 3170 pg\u002FmL) and free testosterone \\\u003C 220 pmol\u002FL (\\\u003C 64 ng\u002FdL);\n7. Patients with current depression, characterized by use or need for use of antidepressants.\n8. Presence of genital lesions (such as severe penile fibrosis or Peyronie's disease) or active sexually transmitted disease (STD) (such as herpes, gonorrhea, candidiasis, HPV, and others) that impair analysis of local adverse effects on the genitalia;\n9. Use of topical medications in the genital region that may interfere in the IP evaluation, as well as in its absorption or drug interaction;\n10. Possession of penile prosthesis;\n11. History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patient with heart diseases (including history of angina and\u002For heart failure) and nephropathies;\n12. Current use of nitrates, such as propatilnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and isosorbitol dinitrate (Isocord®);ketoconazole; ritonavir; and rifampicin.\n13. Findings on ECG and\u002For laboratory tests that, in the Investigator's criteria, are considered significant and offer risk to the research volunteer's participation or may hinder the study analyses;\n14. BP outside the limits considered safe: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg or above 100 mmHg, except situations such as \"white coat syndrome\";\n15. Diseases that can cause priapism, such as sickle cell anemia, multiple myeloma, or leukemia;\n16. Histroy of priapism, defined as painful erection from up to 6 hours.\n17. Current relevant diarrhea, defined as duration over four weeks, association with abdominal pain or dysabsortive syndrome, or presence of mucus, pus, or blood in the stool;\n18. Known hypersensitivity to tadalafil and\u002For BZ371A;\n19. History of symptomatic Lactose intolorence such as: the necessity of enzymatic treatment, abdominal distension or diarrhea when ingesting products or supplements with lactose;\n20. Low adhsesion to 5mg Tadalafil use, characterized by the use of \\\u003C80% of the pills between the 30th and 60th day post PR;.\n21. Pregnant or lacting partner.\n22. Partner in childbearing age which does not accept to get exposed to the treatment\n23. Any disease, condition or physical finding that the Investigator considers significant and that increases the risk of the research subject's participation or may interfere with the results, including severe debilitating illness, presence of cancer other than prostate cancer, severe mental illness persistent medication abuse;",{"count":388,"type":22},72,[62],"To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.",[27,185,65,26],[185,26,65],"2024-10-18",{"date":395,"type":41},"2024-10-22",{"date":397,"type":41},"2023-11-22",{"date":399,"type":22},"2025-01-31",{"name":401,"class":147},"Biozeus Biopharmaceutical S.A.",{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":60,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":49},"100531529","penile-vibratory-stimulation-in-the-prevention-of-sexual-dysfunction-and-urinary-incontinence-after-radical-prostatectomy-100531529","NCT06200987","Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy","Planned Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy: a Randomized Controlled Study","Inclusion Criteria:\n\n* Men who are undergoing nerve-sparing radical prostatectomy\n* Pre operative erectile function of IIEF-EF \\> 25\n* Sexually active . Continent before surgery defined as a score of 0 on the ICIQ-SF questionnaire\n\nExclusion Criteria:\n\n* Urinary incontinent before surgery\n* Comorbidity that prevents the patient from taking PDE5-inhibitors\n* Disease in the penis or in the penile skin (Peyronies, phimosis)\n* Problems using the vibrator ie impaired function of the hands",{"count":158,"type":22},[103],"To investigate if post-operative penile vibration stimulation kan be used to reduce or prevent sexual dysfunction and urinary incontinence after radical prostatectomy. This will be done in a randomized, controlled, non-blinded study. Men that undergo nerve preserving surgery for prostate cancer is allocated into an intervention group and a control group. A total of 100 men will be included for a power of 80%. The intervention group will be instructed to use the \"Ferticare 2.0\" vibrator for at least five minutes a day with an amplitude of 1 mm and frequency of 90 Hz (these settings were found in a pilot study) for a total of 9 months.\n\nBoth groups will do the standard pelvic floor training program and both groups will be offered regular phosphodiesterase-5-inhibitor treatment. Before surgery, 3, 6 and 10 months after the patients will have to fill out four different questionnaires regarding sexual and urinary function, including IIEF-EF, EHS, \"neglected side effects\" and ICIQ-SF. (10 months is due to a wash-out period of 1 month after the intervention).\n\nThe collected data will be analysed and the primary goal is to see if there is a significant difference in average spontaneous IIEF-EF score in the two groups 10 months after the surgery.",[27,413],"Incontinence","2024-03-08",{"date":416,"type":41},"2024-03-12",{"date":418,"type":41},"2024-02-01",{"date":420,"type":22},"2026-10",{"name":422,"class":48},"Herlev and Gentofte Hospital"]