[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bph\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bph":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,75,106,130,150,178,208,229],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100636931","high-frequency-irreversible-electroporation-vs-standard-of-care-for-benign-prostatic-hyperplasia-100636931",false,"NCT07572097","High-Frequency Irreversible Electroporation vs Standard of Care for Benign Prostatic Hyperplasia","High-Frequency Irreversible Electroporation vs Standard of Care for Benign Prostatic Hyperplasia: Adaptive Platform Study","Inclusion Criteria:\n\nModerate-to-severe symptoms, defined as IPSS ≥13. Prostate volume (PV) between 30 and 150 ml, measured by multi-parametric MRI (mpMRI) or Transrectal Ultrasound (TRUS).\n\nMaximum urinary flow rate (Qmax) ≤15 ml\u002Fs. Note: To ensure validity, the voided volume during uroflowmetry must be ≥125 ml; tests with lower volumes must be repeated.\n\nCompetency to provide informed consent and comply with long-term follow-up.\n\nExclusion Criteria:\n\nSuspected or histologically confirmed prostate cancer. Patients with PSA \\>4 ng\u002Fml must undergo mpMRI; those with PI-RADS ≥3 lesions require a negative biopsy before enrolment.\n\nNeurogenic bladder, detrusor underactivity, or active urinary tract infection (UTI).\n\nPrevious prostate surgery, pelvic irradiation, urethral stricture, or bladder neck contracture.\n\nPresence of metallic implants incompatible with H-FIRE pulse delivery (e.g., non-compatible pacemakers).\n\nInability to safely discontinue anticoagulation if required by the assigned surgical protocol.","MALE","50 Years",{"count":19,"type":20},288,"ESTIMATED","INTERVENTIONAL",[23],"NA","The study aims to find a better surgical treatment for men with an enlarged prostate (Benign Prostatic Hyperplasia, or BPH) that effectively relieves urinary symptoms without sacrificing sexual function.\n\nCurrently, standard surgeries like TURP or HoLEP are very effective at opening the blocked urinary channel. However, because they use heat or mechanical energy to remove prostate tissue, they often cause unwanted side effects, most notably the loss of normal ejaculation (retrograde ejaculation) and potential impacts on erectile function.\n\nThis study is testing a novel, minimally invasive technology called High-Frequency Irreversible Electroporation (H-FIRE). Instead of using heat to burn or cut the tissue, H-FIRE delivers ultra-short electrical pulses to destroy the blocking prostate tissue. This \"non-thermal\" (heat-free) approach is uniquely designed to spare the delicate nerves, blood vessels, and muscles surrounding the prostate, which are critical for preserving normal sexual function and bladder control.\n\nIn this clinical trial, 288 men aged 50 and older with moderate-to-severe BPH symptoms will be randomly assigned to receive either the investigational H-FIRE procedure or the Standard of Care surgery (TURP or HoLEP).\n\nThe main goal of the study is to prove that H-FIRE is just as effective as standard surgery in relieving lower urinary tract symptoms over 12 months. More importantly, the study will evaluate if H-FIRE is superior in helping patients achieve the \"BPH Trifecta\"-meaning the patient successfully achieves significant symptom relief, maintains perfect bladder control (uses zero pads), AND fully preserves normal ejaculation.\n\nBy utilizing this new tissue-sparing technology, the trial hopes to offer aging men a treatment option that restores their urinary health while fully protecting their overall quality of life.",[26],"BPH",[26,28,29,30],"h-fire","turp","holep","NOT_YET_RECRUITING","2026-04-29",{"date":34,"type":35},"2026-05-07","ACTUAL",{"date":37,"type":20},"2026-05-05",{"date":39,"type":20},"2029-05-05",{"name":41,"class":42},"Shanghai East Hospital","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100607871","high-intensity-focused-ultrasound-hifu-ablation-for-treatment-of-prostate-tissue-in-bladder-outlet-obstruction-100607871","NCT07194187","High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction","HIFU for BOO","Inclusion Criteria:\n\n* Males aged 45 - 80 diagnosed with LUTS due to BOO from BPH.\n* Prostate size \\> 30cc and \\\u003C 80cc as measured by transrectal ultrasound (TRUS) or MRI within 1 year prior to treatment.\n* A documented history of refusal to take medical therapy, inadequate or failed response to medical therapy, or contraindications to medical therapy.\n* Initial baseline International Prostate Symptom Score (IPSS) greater than or equal to 12 which denotes moderate to severe symptoms.\n* Baseline peak urinary flow rate (Qmax) of less than 15 mL\u002Fs1\n* Baseline serum creatinine \\\u003C 2 mg\u002FdL within 30 days prior to surgery\n* Mental capacity, willingness, and ability to sign a study specific informed consent form\n\nExclusion Criteria :\n\n* BMI \\> 42\n* Patients with an obstructing prostatic median lobe as measured by baseline preliminary imaging and\u002For confirmed on cystoscopy examination.\n* Patients with latex allergies which would permit latex catheterization perioperatively as silicone catheterization is not recommended during HIFU treatment.\n* Patients with extensive calcification in the treatment area of the prostate as measured by preoperative imaging with TRUS or MRI and as evaluated by hospital radiology or the principal investigator. Extensive calcification is defined as where the calcification in posterior peripheral zone, which may interfere with experimental treatment procedure, and it is determined by hospital radiologist and further assessed by the PI.\n* Patient unable to stop anticoagulants, antiplatelet agents, or NSAIDS (including aspirin \\> 100mg) prior to treatment which is standard of care.\n* Patients using immunosuppressants including corticosteroids (except inhalants) who are unable to withhold medications prior to treatment which is standard of care.\n* Known and documented coagulopathy or platelet disorder\n* Contraindication to both general and spinal anesthesia which are standard of care.\n* Severe illness that would prevent complete study participation.\n* History of active or prior treatments for current\u002Fsuspected PCa.\n* Diagnosis of polyneuropathy\n* Bladder calculi or bladder diverticulum (pouch size \\> 20% of full bladder size)\n* Active infection, including urinary tract infection or prostatitis.\n* Evidence of hydronephrosis on imaging.\n* Pre-op urinary catheter uses daily.\n* Previous urinary tract surgeries such as, but not limited to prior surgery for LUTS, urinary diversion, artificial urinary sphincter, or penile prosthesis.\n* Diagnosis of clinically significant urethral stricture, meatal stenosis, severe phimosis, or bladder neck contracture\n* Known damage to the external urinary sphincter.\n* Open heart surgery or cardiac arrest \\\u003C 180 days prior to the date of informed consent\n* Known illicit substance abuse.\n* Use of anticholinergics (specifically for bladder problems). Use of general anticholinergics is allowed if they do not have documented adverse urinary side effects.\n* Dementia or psychiatric conditions which prevent them from completing the required follow up.\n* Prior pelvic radiotherapy\n* Participation in another ongoing investigational study that could affect responses.\n* Unwillingness to accept a transfusion should it be required.\n* No members of vulnerable populations will be included in our study.\n* History or current diagnosis of chronic prostatitis.\n* Diagnosis or prior treatment for chronic pelvic pain syndrome.","45 Years","80 Years",{"count":53,"type":20},17,[23],"Objectives: To assess the efficacy of HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO) that caused by Benign prostatic hyperplasia (BPH).\n\nThe primary objective of the study is to determine the efficacy of HIFU therapy by assessing the changes in IPSS score in 6-month post HIFU procedure for BPH with compared to baseline.\n\nThe secondary objectives of this study are as follow:\n\n* To assess any adverse events related to the procedure or device.\n* To assess the operation related characteristics including: total operation time and ablation time required in HIFU procedure for BPH, total catheterization time after the HIFU procedure for BPH, and categorical ablation zone\n* To assess the patient's post operative pain level at different post op time points.\n* To assess the urinary flow and symptoms improvement by studying the changes in IPSS, Qmax, and PVR at different post op time points compared to the baseline.\n* To assess the effectiveness of HIFU by studying the changes in PSA levels, types of medication for BPH or any urologic condition, proportion of patients who are taking BPH medication, prostate volume, and prostate calcification level and the reoperation rate within 12-month post-op.\n* To assess changes in patients' sexual function at different post op time points.\n\nThe hypothesis is that a HIFU ablation is a safe and effective treatment for patients with LUTS due to BOO from BPH.",[57,26],"Bladder Outlet Obstruction",[59,60,61,62,63,64],"High-intensity focused ultrasound","Interventional","Single Arm","benign prostatic hyperplasia treatment","International Prostate Symptom Score","Device Safety","2026-04-03",{"date":67,"type":35},"2026-04-09",{"date":69,"type":20},"2026-06-01",{"date":71,"type":20},"2027-09-20",{"name":73,"class":42},"Icahn School of Medicine at Mount Sinai",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":74},"100622246","intupro-in-the-treatment-of-benign-prostatic-hyperplasia-related-symptoms-100622246","NCT07381127","INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms","A Study to Evaluate the Safety and Efficacy of Ionic Fluid in Treating Symptoms in Patients With Benign Prostatic Hyperplasia. A Prospective, Single-arm, Single-center Clinical Study.","Inclusion Criteria:\n\n* • Male patient aged 45 years or older\n\n  * Prostate volume greater than 30 grams\n  * An International Prostate Symptom Score (IPSS) of 12 or higher\n  * Presence of obstructive urinary symptoms, such as difficulty starting urination, leakage of urine after voiding, or a feeling of incomplete bladder emptying.\n\nThis criterion may include patients who have previously been diagnosed with prostate cancer and completed treatment, but are experiencing urinary problems.\n\n* Life expectancy of at least 3 months\n* Ability to understand the study information and provide written informed consent\n* Willingness and ability to comply with all study requirements, including procedures, clinical assessments, and follow-up visits\n\nExclusion Criteria:\n\n* Urethral stricture\n\n  * Bladder stones\n  * Prostate volume 120 grams or greater\n  * Presence of a prostate median lobe\n  * History of bladder cancer or kidney cancer, and\u002For prior surgery related to these conditions\n  * Previous radiation therapy to the pelvic region\n  * Prior invasive surgical treatment for BPH symptoms\n  * The Principal Investigator believes the patient would not tolerate the procedure\n  * Presence of a cognitive impairment that, in the opinion of the Principal Investigator, would interfere with the patient's ability to provide reliable data or to safely complete the study\n  * Bleeding disorders\n  * Known allergy or intolerance to MRI contrast agents required for imaging used to evaluate treatment effectiveness after ionic fluid application\n  * Other significant concurrent medical conditions that, in the investigator's judgment, could prevent clinical benefit from the procedure or could place the patient or study objectives at risk (including, but not limited to, active infection, kidney dysfunction, or significant comorbidities)\n  * Significant medical or psychiatric illness\n  * Participation in another clinical study involving a device, drug, or procedure that has not been completed or that could affect the outcomes of this study\n  * Inability or unwillingness to undergo MRI examinations during the study period for any reason",{"count":83,"type":20},31,[23],"The goal of this clinical trial is to determine whether INTUPRO can improve the quality of life in patients with Benign Prostate Hyperplasia (BPH).\n\nThe main questions it aims to answer are:\n\nCan INTUPRO treatment lead to the removal of the Foley catheter? Can INTUPRO treatment improve urinary flow? Can INTUPRO treatment lower or minimize waking during sleep to urinate? Can INTUPRO reduce urinary hesitancy, urgency and frequency?\n\nParticipants will:\n\nReceive INTUPRO treatment on Day 1. Visit at Day 30 and Day 90 for checkups, tests and Prostate MRI.",[87,26,88],"BPH (Benign Prostatic Hyperplasia)","BPH With Other Lower Urinary Tract Symptoms",[90,91,92,93,94],"procedure","needle","benign prostate hyperplasia","moderate sedation","outpatient","RECRUITING","2026-01-23",{"date":98,"type":35},"2026-02-02",{"date":100,"type":35},"2025-03-04",{"date":102,"type":20},"2027-12",{"name":104,"class":105},"inTumo Therapeutics, Inc.","INDUSTRY",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":16,"minAge":114,"maxAge":51,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":74},"100540919","us-imaging-for-the-assessment-of-luts-100540919","NCT06323109","US Imaging for the Assessment of LUTS","Ultrasound Imaging for the Assessment of Lower Urinary Tract Symptoms","Inclusion Criteria: Patients with BPH\u002FLUTS\n\n* Age 18-80 years old\n* Diagnosed with BPH\u002FLUTS with or without obstruction\n\nExclusion Criteria:\n\n* Patients with contraindication to MRI and\u002For GBCA contrast agent. Diabetic subjects will not receive contrast.\n* History of overt neurologic disease other than diabetic neuropathy, urinary tract infection within the last 4 weeks or recent history of urinary retention (within the last 4 weeks).\n\nInclusion Criteria: Healthy Volunteers\n\n\\- Age 18-80 years old not experiencing any symptoms consistent with LUTS\n\nExclusion Criteria:\n\n* Patients with contraindication to MRI and\u002For GBCA contrast agent.\n* Currently taking medications with known effects on the bladder, overt neurologic disease other than diabetic neuropathy, urinary tract infection within the last 4 weeks or urinary retention symptoms.",true,"18 Years",{"count":116,"type":20},80,"OBSERVATIONAL","The purpose of this research is to develop an ultrasound (US) based urodynamics (UDS) evaluation of voiding based on successful magnetic resonance imaging (MRI)-UDS evaluation. Both US and MRI are non-invasive imaging techniques, but US is a more cost-effective and widely available technology. 80 participants will be enrolled and will be on study for up to 2.5 hours (1.5 hour MRI and 1 hour US).",[120,26],"Lower Urinary Tract Symptoms","2025-12-18",{"date":123,"type":35},"2025-12-22",{"date":125,"type":35},"2023-11-28",{"date":127,"type":20},"2027-01",{"name":129,"class":42},"University of Wisconsin, Madison",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":74},"100601796","blue-diode-laser-vaporization-for-bph-100601796","NCT07115147","Blue Diode Laser Vaporization for BPH","Inclusion Criteria:\n\n* Male ≥ 50 years\n* Symptomatic BPH\n\nExclusion Criteria:\n\n* Additional procedure is needed e.g. cystolithotripsy, orchidectomy etc2. Known Ca prostate patients\n* Patients with history of TURP\n* Known Urethral stricture \u002F Bladder stone \u002F Hypercontractile bladder\n* Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke) 6. Contraindicated to undergo TURP (e.g. not fit for GA\u002FSA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)",{"count":137,"type":20},10,[23],"This is a prospective data collection of subjects using blude diode laser for the treatment of BPH.",[26],"2025-08-04",{"date":143,"type":35},"2025-08-11",{"date":145,"type":35},"2025-06-26",{"date":147,"type":20},"2027-03-31",{"name":149,"class":42},"Chinese University of Hong Kong",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":74},"100494518","effect-of-group-preoperative-pelvic-floor-training-for-holep-100494518","NCT05719220","Effect of Group Preoperative Pelvic Floor Training for HoLEP","The Effect of Group Preoperative Pelvic Floor Training on Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate: A Prospective Cohort Study","Inclusion Criteria:\n\n* Consecutive patients with a diagnosis of BPH with a plan to undergo HoLEP.\n* Between the age of 50-90.\n* Ability to understand and provide informed consent.\n\nExclusion Criteria:\n\n* Patients whom inability to carry out PFT protocol.\n* Patients unwilling or unable to complete follow up care.\n* Severe urinary incontinence due to a history of neurological diseases such as a cerebrovascular accident or spinal cord injuries.\n* Patients whom inability to read and understand the English language.","90 Years",{"count":159,"type":20},100,"The main goal of this study is to see if group pelvic floor training before surgery can help prevent urinary incontinence after Holmium laser enucleation of the prostate (HoLEP) surgery. The study has the potential to inform preoperative intervention strategies for managing incontinence after HoLEP.",[26,162],"Urinary Incontinence",[164,165,166,167,168],"benign prostatic hyperplasia","pelvic floor training","group therapy","holmium laser enucleation of the prostate","urinary incontinence","2025-01-15",{"date":171,"type":35},"2025-01-17",{"date":173,"type":35},"2024-02-07",{"date":175,"type":20},"2026-03-30",{"name":177,"class":42},"University of California, San Francisco",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":21,"phases":189,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":74},"100470069","phase-2-proof-of-concept-study-to-evaluate-the-safety-and-efficacy-of-tryptophan-in-patients-with-bph-100470069","NCT05401032","Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.","TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH","TryptoBPH","Inclusion Criteria:\n\n* Written informed consent;\n* Male patients with BPH for which tamsulosin is the therapeutic option per SoC;\n* Aged ≥50 and less than 75 years old;\n* With prostate volume ≥30 cm3 by TRUS;\n* Diagnosed with LUTS defined by a stable IPSS total score ≥13 points.\n\nExclusion Criteria:\n\n* Patients with post-void bladder residual volume ≥250 ml;\n* Patients with intravesical obstruction from any cause other than BPH;\n* History of any procedure considered an intervention for BPH;\n* Patients with active urinary tract infection;\n* History of recurrent urinary tract infections;\n* Current prostatitis or diagnosis of chronic prostatitis;\n* History of prostate or invasive bladder cancer;\n* Use of 5 α-reductase inhibitors within 6 months;\n* Phytotherapy within 2 weeks before entry;\n* Use of serotonin reuptake inhibitors or monoamine oxidase inhibitors;\n* Patients with acute or chronic kidney failure;\n* Patients with diagnosed or suspicion of intolerance to lactose;\n* Patients submitted to general anesthesia in the past 4 weeks;\n* Known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator.","74 Years",{"count":188,"type":20},70,[190],"PHASE2","Benign prostatic hyperplasia (BPH) is one of the most prevalent human diseases and a major cause of lower urinary tract symptoms (LUTS). Some men respond to current medical treatment (mainly α-1 adrenoreceptor antagonists and 5 α-reductase inhibitors), but a large proportion of patients continues to need a surgical procedure to treat resistant LUTS or even more serious complications of BPH, creating the emerging necessity for novel pharmacological therapies.\n\nOxitriptan may have a possible positive effect on BPH associated symptoms with probably no impact in sexual function (which is a common side effect of the current drugs for BPH associated symptoms). Also, improvement in symptoms could be higher than that of current drugs used for this condition.\n\nThis is a single-center parallel group, randomized clinical trial. The study will take place in Hospital de Braga (Urology department). Eligible patients will be randomized to receive tamsulosin 0.4mg (once a day, q.d.) or 5-HTP (5-hidroxitriptophan) 100mg (three times a day, t.i.d.), for 6 months.",[26,193],"LUTS(Lower Urinary Tract Symptoms)",[26,195,196,197,198],"LUTS","5-HTP","Oxitriptan","Tamsulosin","2025-01-03",{"date":201,"type":35},"2025-01-06",{"date":203,"type":35},"2024-12-20",{"date":205,"type":20},"2026-12-31",{"name":207,"class":42},"Clinical Academic Center (2CA-Braga)",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":114,"maxAge":51,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":4},"100558426","evaluation-of-surecore-plus-biopsy-system-100558426","NCT06550960","Evaluation of SureCore Plus Biopsy System","Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate Using Standard of Care and Artificial Intelligence (AI) Analysis","Inclusion Criteria:\n\n* Patient has BPH requiring a prostate biopsy\n* Able and willing to provide consent\n\nExclusion Criteria:\n\n* Active infection\n* Subject participating in an other device study of the prostate",{"count":216,"type":20},30,[23],"This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.",[26],"2024-08-08",{"date":222,"type":35},"2024-08-13",{"date":224,"type":20},"2024-08-05",{"date":226,"type":20},"2025-02-01",{"name":228,"class":105},"Uro-1 Medical",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":113,"sex":16,"minAge":114,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":74},"100486954","phase-3-intra-operative-loop-diuretics-to-improve-same-day-discharge-rates-after-holep-100486954","NCT05620784","Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP","Loop Diuretics During Morcellation to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)","Inclusion Criteria:\n\n* Males 18 -89 undergoing HoLEP\n* Willing to sign the Informed Consent Form\n* Able to read, understand, and complete patient questionnaires.\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity to furosemide or other loop diuretic\n* Anuric patients or patients with liver failure\n* Patients having a concurrent ureteroscopy +\u002F- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP\n* Anticipated need for perineal urethrostomy at the time of HoLEP\n* Patient not undergoing catheter removal and voiding trial at Northwestern Memorial Hospital","89 Years",{"count":238,"type":20},138,[240],"PHASE3","Holmium Laser Enucleation of the Prostate (HoLEP) is a size-independent treatment option for benign prostatic hypertrophy (BPH) as recommended by the American Urological Association (AUA) Guidelines. Loop diuretics (furosemide) have been given historically during the morcellation portion of HoLEP to promote urine production in the post-operative setting and to minimize the impact of fluid absorption during long periods of morcellation. The intra-operative use of 20mg IV furosemide in perioperative HoLEP pathways has been propagated with the dissemination of HoLEP across North America without evidence to support its routine administration. With increasing surgical efficiency from improvements in laser and morcellator technology, the role of intra-operative furosemide is unknown. This study is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP) with and without IV furosemide. .",[243,26,244,245],"BPH With Urinary Obstruction","Hematuria","Same Day Discharge","2023-09-11",{"date":248,"type":35},"2023-09-13",{"date":250,"type":35},"2023-03-01",{"date":252,"type":20},"2024-08-01",{"name":254,"class":42},"Northwestern University"]