[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostatic-hypertrophy-benign\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostatic-hypertrophy-benign":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100646684","multicenter-randomized-controlled-trial-of-thulep-versus-thulep-combined-with-bladder-neck-incision-in-patients-with-small-volume-benign-prostatic-hyperplasia-100646684",false,"NCT07688447","Multicenter Randomized Controlled Trial of ThuLEP Versus ThuLEP Combined With Bladder Neck Incision in Patients With Small-Volume Benign Prostatic Hyperplasia","Inclusion Criteria:\n\n* Male patients aged 50-85 years who meet the diagnostic criteria for benign prostatic hyperplasia (BPH), with a prostate volume ≤30 mL and requiring surgical intervention.\n* Preoperative International Prostate Symptom Score (IPSS) ≥8.\n* Preoperative maximum urinary flow rate (Qmax) ≤15 mL\u002Fs.\n* Bladder capacity ≥150 mL.\n* Willing to participate in this clinical trial and has signed the informed consent form.\n* Able to communicate well with investigators and comply with the study protocol requirements.\n\nExclusion Criteria:\n\n* Patients with urethral stricture in whom passage of surgical instruments is not feasible.\n* Total PSA \\>10 ng\u002FmL, or PSA between 4-10 ng\u002FmL with a free-to-total PSA ratio \\\u003C0.16, and confirmed malignancy on biopsy.\n* Coagulation disorders, including platelet count \\\u003C80 × 10⁹\u002FL.\n* Uncontrolled urinary tract infection.\n* Neurogenic bladder.\n* Presence of malignant tumors.\n* Urodynamic diagnosis of bladder neck sclerosis, detrusor underactivity, detrusor-sphincter dyssynergia, or unstable bladder.\n* Contraindications to surgery, such as severe cardiopulmonary disease.\n* Cognitive impairment, including senile dementia, cerebral atrophy, acute cerebrovascular disease, sequelae of cerebrovascular disease, or other conditions affecting cognitive function.\n* History of suprapubic cystostomy for benign prostatic hyperplasia.\n* Acute localized or systemic bacterial infection that has not been effectively controlled.\n* Presence of shock or other critical conditions that preclude cooperation with the procedure and outcome evaluation.\n* Psychiatric or neurological disorders preventing cooperation with the study.\n* Participation in another clinical trial within 1 month prior to enrollment.\n* Any other condition deemed inappropriate for inclusion by the investigators.","MALE","50 Years","85 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"NA","With the increasing degree of population aging, the number of patients undergoing surgical treatment for benign prostatic hyperplasia (BPH) is steadily rising. Among them, patients with small-volume prostates (≤30 mL) represent a distinct clinical subgroup.\n\nThis population has several unique characteristics:\n\n1. Approximately 17.5% of patients show suboptimal postoperative outcomes.\n2. The incidence of postoperative bladder neck contracture (BNC) is relatively high, reaching up to 19.3% in some reports.\n\nIn addition, the pathophysiological mechanisms of small-volume BPH are different from those of larger prostates. These include increased fibrotic tension of the bladder neck and bladder neck elevation.\n\nAt present, there is no clearly established surgical approach specifically designed to further improve postoperative outcomes or effectively prevent bladder neck contracture in patients with small-volume BPH.\n\nThis study primarily compares the safety and efficacy of transurethral thulium laser enucleation of the prostate (ThuLEP) versus ThuLEP combined with bladder neck incision in the treatment of small-volume benign prostatic hyperplasia (BPH), with the aim of further optimizing surgical management strategies for small prostates and reducing the incidence of postoperative complications.",[26],"Prostatic Hypertrophy, Benign",[28],"Prostatic Hypertrophy","RECRUITING","2026-07-30",{"date":32,"type":33},"2026-07-31","ACTUAL",{"date":35,"type":20},"2026-07-01",{"date":37,"type":20},"2027-12-31",{"name":39,"class":40},"Shanghai General Hospital, China","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":5},"100569074","early-phase-1-study-on-the-effectiveness-of-tranilast-in-the-treatment-of-medium-to-large-volume-benign-prostatic-hyperplasia-100569074","NCT06689514","Study on the Effectiveness of Tranilast in the Treatment of Medium to Large Volume Benign Prostatic Hyperplasia","Inclusion Criteria:\n\n* Patients with benign prostatic hyperplasia aged 55 to 75 years old;\n* The patient's prostate volume is greater than 40mL;\n* There is urinary obstruction, with an International Prostate Symptom Score (IPSS) greater than or equal to 8 points, and a maximum urinary flow rate of less than 15ml\u002Fs (urinary flow rate is not measured in patients with indwelling catheters).\n\nExclusion Criteria:\n\n* Urinary disorders caused by neurogenic diseases;\n* Acute urinary tract infections have not been effectively controlled;\n* There are factors of lower urinary tract obstruction other than BPH, such as urethral stricture;\n* History of radiation therapy or surgery in the lower urinary tract or pelvic cavity;\n* Have ever suffered from tumor of urinary system, or suspected of suffering from tumor of urinary system (such as bladder cancer cancer, prostate cancer);\n* Current or past liver function abnormalities (exceeding the test reference value limit);\n* Abnormal renal function (exceeding the test reference value limit);\n* Currently taking warfarin;\n* Allergic to tranilast or drug preparations;\n* Suffering from other major diseases (malignant tumors, autoimmune diseases, angina pectoris, heart failure, severe respiratory and digestive diseases, etc.), and not yet clinically cured;\n* Other researchers believe that patients who are not suitable to participate in this trial.","55 Years","75 Years",{"count":51,"type":20},30,[53],"EARLY_PHASE1","Benign prostatic hyperplasia (BPH) is one of the most common urinary and reproductive system diseases in elderly men. The preliminary research of the research group found that mast cells are cells that promote the progression of BPH, and the commonly used mast cell membrane stabilizer and TGF - β pathway inhibitor tranilast significantly inhibited the increase in prostate volume in animal experiments, which is considered to have potential applications in the treatment of BPH. This study plans to include 30 patients with medium to large volume BPH and experimentally explore the efficacy and safety of tranilast in the treatment of medium to large volume BPH.",[26],[28],"2026-01-06",{"date":59,"type":33},"2026-01-08",{"date":61,"type":33},"2025-01-20",{"date":63,"type":20},"2026-12-31",{"name":65,"class":40},"Yifeng Jing"]