[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636760":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":52,"locations":58,"responsibleParty":73,"collaborators":36,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":36,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":104,"whyStopped":36,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"ThuLEP Combined With Bladder Neck Incision","EXPERIMENTAL","Participants assigned to this arm will undergo thulium laser enucleation of the prostate combined with bladder neck incision. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system. After enucleation and haemostasis, the bladder neck will be assessed intraoperatively, and bladder neck incision will be performed according to protocol-defined anatomical and obstructive findings when considered safe by the operating surgeon.",[13],"Procedure: Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision",{"label":15,"type":16,"description":17,"interventionNames":18},"ThuLEP Alone","ACTIVE_COMPARATOR","Participants assigned to this arm will undergo thulium laser enucleation of the prostate alone. The procedure will be performed transurethrally, and hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system, followed by haemostasis of the surgical wound.",[19],"Procedure: Thulium Laser Enucleation of the Prostate",{"label":21,"type":16,"description":22,"interventionNames":23},"Transurethral Resection of the Prostate","Participants assigned to this arm will undergo transurethral resection of the prostate using a conventional resectoscope. Obstructive hyperplastic prostatic tissue will be resected transurethrally according to standard TURP principles to relieve obstruction while avoiding excessive resection and injury to adjacent structures.",[24],"Procedure: Transurethral Resection of the Prostate",{"label":26,"type":16,"description":27,"interventionNames":28},"Transurethral Incision of the Prostate (TUIP)","Participants assigned to this arm will undergo transurethral incision of the prostate (TUIP) using standard endoscopic equipment. After endoscopic inspection of the urethra, prostatic urethra, bladder neck, and bladder, one or two longitudinal incisions will be made at the bladder neck and prostatic urethra according to prostate morphology and the degree of obstruction. The procedure aims to relieve bladder outlet obstruction without substantial prostatic tissue resection. The incision site and extent will be individualized based on intraoperative anatomy, with careful avoidance of injury to the ureteric orifices, urethral sphincter, and adjacent structures. Haemostasis will be performed when necessary.",[29],"Procedure: Transurethral Incision of the Prostate",[31,37,43,48],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision","Participants will undergo transurethral thulium laser enucleation of the prostate combined with bladder neck incision. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system. After enucleation and haemostasis, the bladder neck will be assessed intraoperatively, and bladder neck incision will be performed according to protocol-defined anatomical and obstructive findings when considered safe by the operating surgeon.",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Thulium Laser Enucleation of the Prostate","Participants will undergo transurethral thulium laser enucleation of the prostate alone. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system, followed by haemostasis of the surgical wound. No bladder neck incision will be performed as part of the assigned intervention.",[15],[42],"ThuLEP",{"type":32,"name":21,"description":44,"armGroupLabels":45,"otherNames":46},"Participants will undergo transurethral resection of the prostate using a conventional resectoscope. Obstructive hyperplastic prostatic tissue will be resected transurethrally according to standard TURP principles to relieve obstruction while avoiding excessive resection and injury to adjacent structures.",[21],[47],"TURP",{"type":32,"name":49,"description":50,"armGroupLabels":51,"otherNames":36},"Transurethral Incision of the Prostate","Participants assigned to this intervention will undergo transurethral incision of the prostate using standard endoscopic equipment. One or two longitudinal incisions will be made at the bladder neck and prostatic urethra according to prostate morphology and the degree of obstruction. The procedure aims to relieve bladder outlet obstruction without substantial prostatic tissue resection. The incision site and extent will be individualized according to intraoperative anatomy, with careful avoidance of injury to the ureteric orifices, urethral sphincter, and adjacent structures. Haemostasis will be performed when necessary.",[26],[53],{"name":54,"role":55,"phone":56,"phoneExt":36,"email":57},"Qing Yuan, MD, PhD","CONTACT","+8618910980422","qyuanmd@outlook.com",[59],{"facility":5,"status":36,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Beijing","Beijing Municipality","100039","China","CN",{"type":66,"coordinates":67},"Point",[68,69],116.39723,39.9075,{"lat":69,"lon":68},[72],{"name":54,"role":55,"phone":56,"phoneExt":36,"email":57},{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Qing Yuan","Professor and Chief Physician","100636760","thulium-laser-enucleation-with-bladder-neck-incision-for-small-volume-benign-prostatic-hyperplasia-100636760",false,"NCT07569874","Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia","Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia: A Multicentre, Randomized, Single-Blind, Four-Arm Controlled Trial","ThuLEP-BNI","Inclusion Criteria:\n\n* Male patients aged 40-80 years.\n* Diagnosis of benign prostatic hyperplasia (BPH) and scheduled to undergo surgical treatment.\n* International Prostate Symptom Score (IPSS) of at least 12, maximum urinary flow rate of no more than 15 mL\u002Fs, with a voided volume greater than 150 mL.\n* Prostate volume of less than 30 mL measured by transrectal ultrasound (TRUS), calculated as length × width × height × 0.52.\n* Ability, as assessed by the investigator, to understand the study requirements and complete the scheduled treatment, follow-up visits, and study-related assessments.\n\nExclusion Criteria:\n\n* Inability or refusal to provide written informed consent, or inability to comply with the required follow-up schedule.\n* Prostate-specific antigen (PSA) level of 10 ng\u002FmL or higher, unless prostate cancer has been excluded by biopsy.\n* Confirmed or suspected prostate or bladder malignancy.\n* Pre-existing bladder neck contracture or urethral stricture before surgery.\n* Known coagulation disorder or abnormal coagulation function.\n* Neurogenic bladder or detrusor underactivity that may affect bladder or urethral sphincter function.\n* Benign prostatic hyperplasia (BPH) complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis.\n* History of prostate surgery, urethral stricture, or neurogenic bladder.\n* History of prostate cancer or pelvic radiotherapy.\n* Severe cardiovascular disease, pulmonary disease, or other systemic disease that, in the investigator's judgment, would make the patient unable to tolerate surgery.\n* Participation in another clinical trial related to benign prostatic hyperplasia (BPH) within 3 months before enrolment.\n* Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.","MALE","40 Years","80 Years",{"count":89,"type":90},932,"ESTIMATED","INTERVENTIONAL",[93],"NA","This study will evaluate the safety and effectiveness of different surgical treatments for men with small-volume benign prostatic hyperplasia (BPH). Men with small-volume BPH may still have bothersome lower urinary tract symptoms and bladder outlet obstruction, and the best surgical treatment for this group remains uncertain.\n\nIn this multicentre, randomized, single-blind, four-arm controlled trial, 932 eligible men aged 40 to 80 years will be assigned in a 1:1:1:1 ratio to one of four groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation of the prostate alone, transurethral resection of the prostate (TURP), or transurethral incision of the prostate (TUIP).\n\nThe main goal of the study is to compare the incidence of bladder neck contracture at 6 months after surgery. Secondary outcomes include safety outcomes and changes in urinary symptoms, urinary flow rate, pain score, and symptom response at 3 and 6 months after surgery. Exploratory outcomes include changes in post-void residual urine volume and sexual function scores. Additional exploratory long-term outcomes will also be assessed at 12 months after surgery.",[96,97,98],"Benign Prostatic Hyperplasia","Bladder Outlet Obstruction","Lower Urinary Tract Symptoms (LUTS)",[100,38,101,102,103],"Small-Volume Benign Prostatic Hyperplasia","Bladder Neck Incision","Bladder Neck Contracture","Lower Urinary Tract Symptoms","NOT_YET_RECRUITING","2026-07-18",{"date":107,"type":108},"2026-07-21","ACTUAL",{"date":110,"type":90},"2026-07",{"date":112,"type":90},"2028-12",{"name":5,"class":6},1]