[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"benign-prostate-hypertrophybph\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:benign-prostate-hypertrophybph":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,49,79,110,138,162,184,220,246,271,293,308],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100652951","operating-room-orientation-video-education-in-patients-undergoing-prostate-surgery-100652951",false,"NCT07778355","Operating Room Orientation Video Education in Patients Undergoing Prostate Surgery","The Effect of Operating Room Orientation Video Education Applied at Different Times on Postoperative Pain and Anxiety in Patients Undergoing Prostate Surgery","Inclusion Criteria:\n\n* Being conscious and able to communicate. Being able to read and understand Turkish. Voluntarily agreeing to participate in the study and providing informed consent.\n\nHaving no visual or hearing impairment that would interfere with viewing the educational video or completing the study assessments.\n\nUndergoing prostate surgery for the first time. Being 18 years of age or older.\n\nExclusion Criteria:\n\n* Having a diagnosed psychiatric disorder. Having a chronic pain syndrome. Being scheduled for emergency surgery. Having previously received similar operating room orientation education.","MALE","18 Years",{"count":19,"type":20},126,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study aims to evaluate the effect of operating room orientation video education delivered at different time points on postoperative pain and state anxiety in patients undergoing surgery for benign prostatic hyperplasia. Patients undergoing transurethral resection of the prostate or holmium laser enucleation of the prostate will be randomly assigned to one of three groups: video education one day before surgery in the surgical ward, video education approximately 30 minutes before surgery in the operating room waiting unit, or routine preoperative information. Pain and state anxiety will be assessed at predefined preoperative and postoperative time points.",[26],"Benign Prostate Hypertrophy(BPH)",[28,29,30,31,32,33,34,35],"Benign prostatic hyperplasia","TUR-P","HoLEP","operating room orientation","video education","postoperative pain","anxiety","patient education","NOT_YET_RECRUITING","2026-08-18",{"date":39,"type":40},"2026-08-21","ACTUAL",{"date":42,"type":20},"2026-09-01",{"date":44,"type":20},"2027-03-01",{"name":46,"class":47},"Ondokuz Mayıs University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100652319","comparison-of-holmium-laser-enucleation-of-the-prostate-and-robotic-water-jet-ablation-for-benign-prostatic-hyperplasia-100652319","NCT07772232","Comparison of Holmium Laser Enucleation of the Prostate and Robotic Water Jet Ablation for Benign Prostatic Hyperplasia","Prospective Randomized Controlled Comparison of Holmium Laser Enucleation of the Prostate With Robotic Water Jet Ablation","Inclusion Criteria:\n\n1. Male, age 50-80 years\n2. International Prostate Symptom Score (IPSS) ≥ 12\n3. Prostate size (TRUS): 50-180 mL\n4. Diagnosis of LUTS due to BPH\n5. Uroflow Qmax ≤ 15 mL\u002Fsec\n6. Mentally capable, able to comply with study procedures, written informed consent provided\n7. Able to follow study instructions and complete all required visits\n\nExclusion Criteria:\n\n1. BMI ≥ 42\n2. History of prostate cancer\n3. Suspected or history of bladder cancer\n4. Active or untreated bladder stones at screening\n5. Indwelling catheter for more than 3 months before baseline\n6. Active urinary tract infection\n7. History of urethral stricture or bladder neck stenosis\n8. Damage to the external urethral sphincter\n9. Previous prostate surgery or lower urinary tract surgery\n10. Use of obligatory anticoagulants (if not stoppable) or known coagulopathy (except ASA 100 mg\u002Fd)\n11. Contraindications to general and spinal anesthesia\n12. Any condition that could interfere with study participation or outcomes, per investigator judgment\n13. Lacks legal or mental capacity to consent\n14. Simultaneous participation in another therapeutic urological trial\n15. Known or persistent abuse of medication, drugs, or alcohol","50 Years","80 Years",{"count":59,"type":20},100,[23],"This study compares two FDA-approved surgical treatments for benign prostatic hyperplasia (BPH): Holmium Laser Enucleation of the Prostate (HoLEP) with MOSES 2.0 technology and Robotic Water Jet Ablation (RWJA) using the Hydros Robotic System. Men with BPH and prostate volumes between 50 and 180 mL will be randomly assigned to one of the two procedures. The study will measure changes in prostate volume, PSA, urinary flow, and bladder emptying at 12 months, along with safety, sexual function, continence, and healthcare utilization outcomes, which will be followed for up to 5 years after surgery.",[26,63],"Lower Urinary Track Symptoms",[65,66,67,68,69],"HOLEP","MOSES 2.0","Robotic Waterjet Ablation","Hydros Robotic System","Compare Effectiveness","2026-08-14",{"date":72,"type":40},"2026-08-19",{"date":74,"type":20},"2026-08-03",{"date":76,"type":20},"2033-08-03",{"name":78,"class":47},"The Methodist Hospital Research Institute",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100649472","phase-2-study-of-teverelix-dp-on-prostate-volume-urinary-function-and-clinical-outcomes-following-acute-urinary-retention-100649472","NCT07733934","Study of Teverelix DP on Prostate Volume, Urinary Function and Clinical Outcomes Following Acute Urinary Retention","A Randomized, Double-Blind, Placebo-Controlled, Multi-centre Study to Evaluate the Effects of Teverelix DP, a GnRH Antagonist, on Prostate Volume, Urinary Function and Clinical Outcomes in Men Following a First Episode of Acute Urinary Retention (AUR)","Inclusion Criteria:\n\n1. Male aged 45 years or older\n2. Having given his written consent\n3. Successful TWOC as defined by successful voiding with a minimum residual volume\n4. Having had a first episode of spontaneous acute urinary retention within 6 days of study screening visit.\n5. Prostate volume \\>40 g (assessed by TRUS)\n6. Patients may initiate or continue alpha-blocker therapy at or before randomization. The same agent and dose should be continued throughout the treatment period where possible\n7. Agrees to practice contraception during the entire study treatment period and for 3 months after the last dose of IMP is administered:\n\n   1. Either by using double barrier contraception and in compliance with local guidelines,\n   2. or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the patient\n\n   i. Note: Periodic abstinence \\[e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with childbearing potential\\] and withdrawal are not acceptable methods of contraception.\n8. Must be treatment naïve to GnRH analogues\n\nExclusion Criteria:\n\n1. Participated in another investigational study within 3 months before recruitment\n2. AUR due to i.e. postoperative retention following major abdominal\u002Fpelvis\u002Fspinal surgery\n3. Neurological related AUR\n4. Contraindication to the use of alpha blockers\n5. Previous prostate or urethral surgery\n6. Previous histological or clinical diagnosis of prostate cancer\n7. Any unstable co-existing medical condition\n8. Has abnormal screening and\u002For baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values:\n\n   1. Liver function test (aspartate aminotransferase \\[ASAT\u002FSGOT\\], alanine aminotransferase \\[ALAT\u002FSGPT\\]), exceeding \\>2X the upper limit of the normal (ULN) range\n   2. Total bilirubin exceeding \\>1.5X the upper limit of the normal (ULN) range\n   3. An estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin, based on creatinine clearance calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation normalised to an average surface area of 1.73m2, at the screening visit.\n9. Has congenital long QT syndrome or ECG abnormalities at screening of:\n\n   1. Q-wave infarction, unless identified ≥6 months before screening\n   2. Fridericia corrected QT interval (QTcF interval) \\>480 msec. If QTcF is prolonged in a patient with a pacemaker, the patient may be enrolled in the study upon discussion with the project clinician\n   3. If the QTcF interval is 450-480 msec, inclusive, in a patient with current use of medications with known effects on QT interval, the patient may be enrolled in the study following discussion with the Medical Lead\n\n   Note: Cardiac arrhythmia grading:\n   * Bradyarrhythmias (HR \\\u003C60\u002Fmin)\n   * Tachyarrhythmias (HR \\>100\u002Fmin\n   * Supraventricular arrhythmias - arrhythmias that originate in the sinoatrial node, atrial myocardium or atrioventricular node (regular QRS complex)\n   * Ventricular arrhythmias - arrhythmias that originate below the atrioventricular node (wide QRS complex)\n10. History or current evidence of alcohol or drug abuse within the last 12 months\n11. Prostate Specific Antigen (PSA) greater than 20ng\u002Fml\n12. Use of suprapubic catheterization after failed urethral catheterization\n13. Neurogenic bladder dysfunction, confirmed or suspected, irrespective of etiology\n14. Isolated bladder neck disease\n15. Acute or chronic prostatitis\n16. Confirmed or suspected urethral stricture\n17. Known bladder stones\n18. Use of the following medications prior to and during study participation:\n\n    1. Any other IMP (within 3 months of enrolment)\n    2. Herbal medications known to have anti-androgenic effects (e.g. red reishi, licorice, white peony, green tea, spearmint, black cohosh, chaste tree, saw palmetto, etc) (within 3 months of enrolment)\n    3. Anti-androgen therapy (within 3 months of enrolment)\n    4. T replacement therapy (within 3 months of enrolment)\n    5. 5α-reductase inhibitor treatment etc. (within 25 weeks prior to screening: dutasteride; within 12 weeks prior to screening: finasteride (and others))\n    6. Bethanechol chloride\n    7. Any other medication or herbal product that may affect hormone levels and might, therefore, confound interpretation of the study results (e.g. St. John's wort) (within 3 months of enrolment)","45 Years",{"count":19,"type":20},[89],"PHASE2","This randomized, double-blind, placebo-controlled Phase 2 study is evaluating Teverelix DP in men following a first episode of acute urinary retention (AUR) associated with benign prostatic hyperplasia (BPH), a population at risk of recurrent urinary retention and subsequent surgical or minimally invasive intervention.\n\nThe study is designed to evaluate the effects of Teverelix DP on total prostate volume and urinary function and to prospectively evaluate clinically meaningful outcomes including recurrent AUR, BPH-related surgical or minimally invasive intervention, protocol-defined treatment failure and clinical benefit.\n\nParticipants will be randomized to one of four treatment groups evaluating two active Teverelix DP regimens: 90 mg administered intramuscularly (IM) and 120 mg administered subcutaneously (SC) and their respective matched placebo controls.\n\nThe primary endpoint is percent change from baseline in total prostate volume (TPV) at Week 12. Participants will continue to be evaluated during the 28-week treatment period for urinary function and prospectively defined clinical outcomes, including recurrent AUR, BPH-related intervention, treatment failure and clinical benefit, and will be followed through Week 52 for protocol-defined longer-term assessments and safety follow-up.\n\nThe study is designed to characterize biological activity, urinary function, clinical outcomes, safety and the relative treatment effects of the two Teverelix DP regimens to inform dose and route selection and subsequent clinical development.",[92,26],"Acute Urinary Retention",[94,95,96,97,98,99],"Prostatic Diseases","Teverelix","Acute urinary retention","Benign Prostate Hypertrophy","AUR","BPH","2026-07-27",{"date":102,"type":40},"2026-07-29",{"date":104,"type":20},"2026-09",{"date":106,"type":20},"2028-05",{"name":108,"class":109},"Antev Ltd.","INDUSTRY",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":48},"100648525","mister-study-minimally-invasive-steam-therapy---russian-effectiveness-registry-100648525","NCT07723378","MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry","MISTER","Inclusion Criteria\n\n* Lower urinary tract symptoms (IPSS ≥8 points; QoL ≥3 points) due to BPH\n* Prostate volume of 30-150 cm³\n* Qmax ≤15 mL\u002Fs; post-void residual urine volume \\\u003C300 mL\n\nNon-Inclusion Criteria\n\n* Prostate cancer\n* Acute infections of the urinary tract, prostate, or scrotal organs\n* Neurogenic lower urinary tract dysfunction\n* Bladder stone(s)\n* Urethral stricture\n* Prior prostate surgery\n\nExclusion Criteria\n\n* Patient refusal to allow use of medical data for scientific analysis\n* Missing or lost data required for analysis","85 Years",{"count":119,"type":20},1400,[23],"Rezūm is a minimally invasive procedure that uses water vapor (steam) to treat urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia, BPH). It has been used in clinical practice since receiving FDA approval in 2015 and is recommended as a treatment option for men with moderate-to-severe urinary symptoms, including those who wish to preserve ejaculatory function. Clinical trials have shown that Rezūm improves urinary symptoms and flow rates, with benefits that last for at least five years, a low reoperation rate, and a low risk of sexual side effects.\n\nDespite this evidence, several important questions remain. It is not well understood which patients are more likely to experience temporary urinary retention after the procedure, need repeat treatment, or develop ejaculatory changes. Standardized criteria for defining overall treatment success are also lacking.\n\nThe MISTER study is a multicenter registry designed to evaluate real-world outcomes of Rezūm therapy in patients treated in the Russian Federation. Using data from a large patient cohort, the study aims to identify factors associated with urinary retention after catheter removal, the need for repeat treatment or return to medication, and changes in ejaculatory function. The study will also develop and test combined criteria for defining treatment success.",[26,123],"LUTS(Lower Urinary Tract Symptoms)",[99,125,126,127],"LUTS","water vapor thermal ablation","minimally invasive treatment","RECRUITING","2026-07-20",{"date":131,"type":40},"2026-07-23",{"date":133,"type":20},"2026-08-01",{"date":135,"type":20},"2027-09",{"name":137,"class":47},"Sechenov University",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":57,"enrollmentInfo":147,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":150,"conditions":151,"keywords":152,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100644203","efficacy-and-tolerability-of-treatment-with-alfalitic-plus-serenoa-repens-compared-to-alfalitic-plus-antimuscarinic-for-moderate-severe-lower-urinary-tract-symptoms-100644203","NCT07665749","Efficacy and Tolerability of Treatment With Alfalitic Plus Serenoa Repens Compared to Alfalitic Plus Antimuscarinic for Moderate-severe Lower Urinary Tract Symptoms","Efficacy and Tolerability of Treatment With Alfalitic Plus Serenoa Repens Compared to Alfalitic Plus Antimuscarinic for Moderate-severe Mixed Lower Urinary Tract Symptoms: Results of a Cross-sectional Clinical Study","FINAL","Inclusion Criteria:\n\n* Age 40-80 inclusive\n* Male\n* With moderate-to-severe LUTS from BPH according to IPSS score\n* Placed on AB+Serenoa repens or AB+antimuscarinics for 6 months\n\nExclusion Criteria:\n\n* Prostate or bladder cancer\n* History of neurogenic bladder\n* Urinary tract abnormalities (including urethral strictures)","40 Years",{"count":148,"type":20},50,"OBSERVATIONAL","The study aims to investigate, through the International Prostatic Symptoms Score (IPSS) questionnaire, the non-inferiority of the therapy with the alpha-blockers+Serenoa repens combination compared to the alpha-blockers+antimuscarinic combination on storage lower urinary tract syndrome (LUTS) in patients with moderate-severe symptomatic benign prostatic hyperplasia (BPH).",[26],[99,125],"2026-06-24",{"date":155,"type":40},"2026-06-26",{"date":157,"type":20},"2026-06-01",{"date":159,"type":20},"2026-11-01",{"name":161,"class":47},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":48},"100643352","oxiblumecoq10-ralivia-therapy-for-benign-prostatic-hyperplasia-100643352","NCT07638865","Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia:","Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia: a Double-blind Placebo-controlled Randomized Clinical Trial Assessing Treatment Efficacy and Safety.","Inclusion Criteria:\n\n1. Participant must be between 50 and 80 years old.\n2. Participant has signed and dated the appropriate Informed Consent document.\n3. International Prostate Symptom Score (IPSS) ≥8 and ≤30\n4. Prostate volume ≥30gram and ≤80gram\n5. Peak urinary flow rate (Qmax) ≥5 ml\u002Fsec and ≤15ml\u002Fsec\n6. Post void residual volume ≤150ml\n\nExclusion Criteria:\n\n1. Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary retention.\n2. Participant has a history of prostate, bladder or urethral cancer.\n3. Participant has undergone pelvic radiation or systemic chemotherapy.\n4. Participant has undergone intravesical chemotherapy.\n5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition (except from BPH) associated with LUTS, any neurological disease or disorder affecting the bladder.\n6. Participant has undergone prostate surgery\n7. Participant with penile or urinary sphincter implants.\n8. Diagnosed neurological conditions known to affect bladder function (e.g., multiple sclerosis, Parkinson's disease, or neurogenic bladder).\n9. Significant medical conditions (e.g., unstable cardiac arrhythmias, uncontrolled diabetes, severe renal impairment) that pose an unreasonable risk to the patient or might interfere with study results.\n10. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.\n11. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.",{"count":59,"type":20},[23],"Objectives of the study\n\nThe aim of the study is to investigate and compare the treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy vs placebo for BPH patients\n\nStudy center\n\nThe study will be coordinated by the research office of 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. The research office will also support the project (logistics, quality control, management, data acquisition, publications).\n\nPatients visits will be carried out in the BPH Research Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece.\n\nLaboratory tests of all patients will be performed at the same microbiology laboratory.\n\nStudy population A total of 100 patients (50 in Group A and 50 in Group B) with BPH diagnosis will participate in this study.\n\nStudy design Double-blind placebo-controlled randomized clinical trial\n\nZero hypothesis (H0) and alternative hypothesis (H1):\n\n(H0): Group A demonstrates similar efficacy compared to Group B for the treatment of BPH patients.\n\n(H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment of BPH patients.\n\nStudy endpoints Primary endpoint: The difference between the Group A and Group B in the change of IPSS score from baseline to 12 weeks after treatment initiation.\n\nSecondary endpoints:\n\n* Adverse events rate in all patients during study period.\n* The difference between the Group A and Group B in the change of the IPSS score from baseline to 6 weeks after treatment initiation.\n* The difference between the Group A and Group B in the change of the following parameters from baseline to 6 and 12 weeks after treatment initiation\n\n  1. Qmax value\n  2. Prostate volume\n  3. Post void residual\n  4. IIEF-ED score\n  5. Psa value\n  6. TNFa, IL 6 values\n\nTreatment Visits :\n\nPatients accordingly to which group they will be randomized will receive:\n\n* Active treatment (Ralivia) Group : 1 pill of Ralivia per os\u002Fday for a 3-month period\n* Placebo Group : 1 placebo pill per os\u002Fday for a 3-month period\n\nAdverse events will be reported.\n\nFU Visit 1: 6 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported.\n\nPSA TNFa, IL 1β, IL 6, IL 10 will be measured through blood test.\n\nFU Visit 2: 12 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported.\n\nDRE will be performed . PSA TNFa, IL 6 will be measured through blood test.",[173,26,174],"Benign Prostate Enlargement","Benign Prostate Obstruction (BPO)","2026-06-04",{"date":177,"type":40},"2026-06-10",{"date":179,"type":20},"2026-06-08",{"date":181,"type":20},"2026-12",{"name":183,"class":47},"G.Gennimatas General Hospital",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":199,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100614737","early-versus-delayed-trial-without-catheter-in-men-with-acute-urinary-retention-100614737","NCT07283484","Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention.","Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention: a Randomized Controlled Trial (the RELIEF Study).","RELIEF","Inclusion Criteria:\n\n* Adult men (≥18 years)\n* Diagnosis of acute urinary retention (AUR) treated with a transurethral catheter (TUC) and alpha-blocker therapy (tamsulosin, silodosin, or alfuzosin)\n* Mentally competent and able to understand the potential benefits and burdens of study participation\n* Provision of written or digital informed consent\n\nExclusion Criteria:\n\n* Failed prior TWOC within the preceding 30 days\n* Initial urinary retention volume \\>1500 mL\n* Neurogenic bladder dysfunction (e.g., multiple sclerosis, spinal cord injury, spina bifida)\n* History of prostate cancer with ISUP grade group ≥2\n* History of active bladder cancer or ongoing surveillance for bladder cancer\n* Urinary retention occurring within 72 hours after surgery (postoperative urinary retention)\n* History of lower urinary tract surgery (e.g., bladder augmentation, urethral surgery, or prostate surgery)\n* AUR suspected to be caused by bladder stones\n* Suspected urethral stricture, clot retention, or urosepsis\n* Contraindication to alpha-blocker therapy",{"count":193,"type":20},478,[23],"Acute urinary retention (AUR) is a sudden and painful condition. It occurs when a person is unable to urinate. In men, AUR is most often caused by an enlarged prostate, known as benign prostatic hyperplasia (BPH), which blocks the urethra. The first steps in treatment are to insert a catheter to empty the bladder and to start medication that acts on the prostate (an alpha-blocker). After some time, the catheter is removed during a so-called \"Trial Without Catheter\" (TWOC) to see whether the patient can urinate normally again.\n\nAt present, it is unclear how long a catheter should remain in place before this trial is performed. In Dutch hospitals, the duration varies widely: in some hospitals, the catheter is removed after only a few days, while in others it stays in place for two weeks or longer. A longer catheter duration can cause more discomfort and complications, such as urinary tract infections or blood in the urine. Therefore, it is important to determine whether a shorter catheterization period is equally effective and safe compared to a longer one.\n\nThe RELIEF study investigates whether a short catheter duration of three days is as safe and effective as the current average of fourteen days. A total of 478 men with acute urinary retention will participate in this nationwide randomized controlled trial. All participants will receive a catheter and start (or continue) treatment with an alpha-blocker. They will then be randomly assigned to one of two groups: one group will have the catheter removed after three days, and the other group after fourteen days.\n\nThe main question is whether a shorter catheter duration is as successful as a longer one. Success means that the patient can urinate normally after catheter removal, without needing to have the catheter replaced. The study will also compare the number of complications, patients' experiences with the catheter, their quality of life, and the overall healthcare costs.\n\nBy conducting this study, doctors will gain better evidence on the optimal timing of catheter removal in men with AUR. The goal is to avoid unnecessarily long catheterization, reduce discomfort and complications, and improve the quality of care for men with AUR. The results of the RELIEF study may help improve the management of AUR, making care more consistent, efficient, and patient-friendly both in the Netherlands and abroad.",[92,197,198,26],"Benign Prostate Obstruction","Benign Prostate Hyperplasia",[190,92,200,201,202,203,204,205,206,207,208,209,99],"Urinary Retention","TWOC","Trial Without Catheter","bladder catheter","urinary catheter","catheter removal","catheter withdrawal","Benign prostate obstruction","BPO","Benign prostate hyperplasia","2025-12-15",{"date":212,"type":40},"2025-12-22",{"date":214,"type":40},"2025-08-21",{"date":216,"type":20},"2029-03-01",{"name":218,"class":47},"Liselot Ribbert",11,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":228,"studyType":149,"phases":4,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100612586","efficacy-of-prostatic-arteries-embolization-using-squidperi-100612586","NCT07255508","Efficacy of Prostatic Arteries Embolization Using SQUIDPERI","SQUID-PAE","Inclusion Criteria:\n\n* Age ≥18 years\n* Patient scheduled for a PAE using SquidPERI as part of routine care\n* Patient informed who signed the informed consent form\n* French social security affiliation\n* Good understanding of the French language\n\nExclusion Criteria:\n\n* Patient unwilling or unlikely to comply with FU schedule\n* Known severe allergy to iodine\n* Known severe hepatic impairment\n* Vulnerable patient populations (such as patient under guardianship, curatorship, deprived of liberty)\n* Patient that already had a PAE\n* Patient on AME (state medical aid)\n* Participation in any interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable",{"count":59,"type":20},"12 Months","Prostatic Artery Embolization (PAE) is a recognized mini-invasive treatment of bothersome Lower Urinary Tract Symptoms (LUTS) related to Benign Prostatic Hyperplasia (BPH). Particle embolics are used almost exclusively for embolization, with wide variation in the type and size of particles showing similar performance and safety results. Even if its durability relies on multiple risk factors, LUTS recurrence-free survival probability decreases with years. It is demonstrated that recanalization of the native prostatic artery is found in 66% of patients experiencing LUTS recurrence. Artery recanalization after several months has been reported in embolization with microparticles. The investigators addressed this issue using the liquid embolic agent SQUIDPERI in a prospective cohort of patients undergoing rePAE and showed a good clinical success rate (76.7%) at 3 months. Since then, the investigators perform initial PAE using SQUIDPERI with good results.\n\nThe aim of SQUID-PAE study is to assess the efficacy of PAE using SQUIDPERI in an initial PAE setting in a multicenter prospective study.",[26],[232,233,234,235],"Prostatic Artery Embolization","PAE","SQUIDPERI","Liquid Embolic Agent","2025-11-20",{"date":238,"type":40},"2025-12-01",{"date":240,"type":20},"2025-11",{"date":242,"type":20},"2027-11",{"name":244,"class":47},"Assistance Publique - Hôpitaux de Paris",4,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":252,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":253,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100611313","application-of-quantum-detection-driven-artificial-intelligence-algorithms-for-single-molecule-cfdna-characterization-in-the-early-diagnosis-of-prostate-cancer-100611313","NCT07238959","Application of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer","Inclusion Criteria:\n\n1. Male, aged 18-80 years;\n2. PSA \\> 4 ng\u002Fml;\n3. Patients meeting criteria for prostate biopsy:\n\n   * fPSA\u002FPSA \\\u003C 0.16 or PSA D \\> 0.15 or PSA V \\> 0.75; ② Positive digital rectal examination (DRE); ③ Imaging studies (ultrasound\u002FMRI) showing suspicious lesions.\n\nExclusion Criteria:\n\n1. Patients diagnosed with any malignant tumour within the past five years;\n2. Patients who have undergone transurethral resection or enucleation of the prostate;\n3. Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy;\n4. Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week);\n5. Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy\u002Fchemotherapy, endocrine therapy, targeted therapy, or immunotherapy;\n6. Concurrent severe systemic diseases deemed by the investigator likely to interfere with trial treatment, evaluation, or compliance, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immunological, or urological disorders;\n7. Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation;\n8. Subjects who have undergone blood transfusion within one month prior to blood sampling;\n9. Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year;\n10. Patients deemed unsuitable for this clinical trial by the investigator;\n11. Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.",true,{"count":254,"type":20},1100,"This research project aims to develop a novel blood testing method integrating cutting-edge quantum sensing and artificial intelligence technologies to achieve precise, non-invasive early diagnosis of prostate cancer. The research will employ quantum sensors to perform ultra-high-sensitivity measurements of circulating free DNA (cfDNA) in blood, thereby training a dedicated AI diagnostic model. The ultimate objective is to establish the diagnostic efficacy of this approach through clinical validation, providing clinicians with a novel diagnostic tool capable of significantly reducing unnecessary prostate biopsy procedures.",[26,257,258],"Prostate Cancer (Diagnosis)","Prostate Neoplasm",[260,261],"Early diagnosis","cfDNA","2025-11-15",{"date":236,"type":40},{"date":265,"type":20},"2025-12",{"date":267,"type":20},"2027-12",{"name":269,"class":47},"Shanghai Changzheng Hospital",7,{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":252,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":21,"phases":280,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":48},"100594285","phase-3-trial-to-assess-the-efficacy-and-safety-during-convective-radiofrequency-water-vapor-thermal-therapy-rezum-for-benign-prostate-hyperplasia-100594285","NCT07017452","Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia","Methoxyflurane + Lorazepam + Percocet (Per os) vs Deep Intravenous Sedation: A Non-inferiority Randomized Controlled Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia","Inclusion Criteria:\n\n* Able to provide an informed consent.\n* Age ≥ 18 years\n* Biological males identified with male sexual organs.\n* Scheduled for convective radiofrequency water vapor thermal therapy (REZUM) for the management of benign prostate hyperplasia.\n\nExclusion Criteria:\n\n* Concomitant use of nephrotoxic and\u002For hepatoxic agents.\n* Use of ≥ 6 ml Penthrox withing the previous 3 weeks.\n* Known allergies and\u002For adverse events due to penthrox, other halogenated anesthetics, percocet (oxycodone + acetaminophen), lorazepam, lidocaine, midazolam, ketamine, remifentanil and propofol\n* History of genetic susceptibility to malignant hyperthermia.\n* Presence of clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment\n* Altered level of consciousness due to any cause.",{"count":279,"type":20},48,[281],"PHASE3","The primary aim of the study is to show that methoxyflurane-lorazepam-percocet combination administrated 'per os' is non inferior to deep intravenous sedation in achieving analgesia during Rezum convective radiofrequency water vapor thermal therapy for the management of benign prostate hyperplasia (BPH). We propose to conduct a single-centered, unblinded, randomized controlled trial designed after consulting ICH Guidelines for Good Clinical Practice as well the regulations set by the Biomedical Research Ethics Board, University of Manitoba.",[26],"2025-06-11",{"date":286,"type":40},"2025-06-12",{"date":288,"type":20},"2025-08",{"date":290,"type":20},"2026-06",{"name":292,"class":47},"University of Manitoba",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":252,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":306,"leadSponsor":307,"locationsCount":48},"100594284","phase-3-investigating-the-adjunctive-use-of-mirabegron-in-the-early-post-rezum-procedure-period-100594284","NCT07017439","Investigating the Adjunctive Use of Mirabegron in the Early Post-Rezum Procedure Period","Investigating the Adjunctive Use of B3-agonist in the Early Post-Rezum Procedure Period: A Randomized Controlled Trial","Inclusion Criteria:\n\n* age \\>50, symptomatic LUTS with IPSS ≥ 10\n* prostate volume 30-80cc on any imaging modality\n* Qmax between 5 and 15ml\u002Fs with minimum voided volume of 125cc\n* frequency ≥ 8 voids\u002Fday.\n\nExclusion Criteria:\n\n* PVR greater than 300ml\n* active UTI within past week\n* previous surgical intervention for BPH\n* documented urethral stricture disease\n* bladder stones\n* active malignancy\n* any confirmed or suspected neurologic disease\n* hypertension\n* known insensitivity to B3 agonist\n* current catheter dependence\n* currently taking anticholinergic or B3 agonist.",{"count":148,"type":20},[281],"The investigators propose conducting a randomized controlled trial at the Men's Health Clinic to evaluate whether patients who start and continue mirabegron postoperatively after undergoing Rezum therapy experience enhanced patient-reported outcomes, improved quality of life (QoL), and comparable rates of adverse events. There are no predicted adverse events of this study. There are no identified potential harms of this study.",[26],{"date":286,"type":40},{"date":288,"type":20},{"date":290,"type":20},{"name":292,"class":47},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":48},"100580628","safety-and-efficacy-of-milep-versus-standard-eep-100580628","NCT06839768","Safety and Efficacy of MILEP Versus Standard EEP","The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate","MILES","Inclusion Criteria:\n\nLUTS presence, proven by:\n\n1. IPSS questionnaire (Score \\>20);\n2. OR uroflowmetry result (Qmax \\\u003C10 ml\u002Fs);\n\nExclusion Criteria:\n\n* Prostate volume \\> 120 cc\n* Prostate cancer on pathology;\n* Urethral strictures;\n* Bladder calculi;\n* Prior prostate surgery;\n* Neurogenic bladder dysfunction.",{"count":317,"type":20},340,[23],"Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures.\n\nObjective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).",[26,123],"2025-02-17",{"date":323,"type":40},"2025-02-21",{"date":325,"type":40},"2024-03-14",{"date":327,"type":20},"2025-05",{"name":137,"class":47}]