[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07631286":3,"trial-entities:NCT07631286":92,"trial-summary:NCT07631286":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":44,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":66,"locations":69,"central_contacts":82,"overall_officials":88,"references":90,"see_also_links":91},"NCT07631286","STU00225807","Ejaculatory-Sparing HoLEP vs Standard HoLEP","Ejaculatory-sparing Holmium Laser Enucleation of the Prostate (HoLEP) vs Standard HoLEP: a Randomized Controlled Trial","RECRUITING","2028-05","2026-04","2026-06-09","2026-06","Northwestern University","OTHER",null,"The objective of this study is to compare a new surgical technique for HoLEP that will allow for sparing of ejaculation post-HoLEP.","The primary aim of this study is to assess the efficacy of ejaculatory-sparing HoLEP (ES-HoLEP) in preserving ejaculation while also maintaining good urinary outcomes.",[19,20],"Enlarged Prostate (BPH)","Enlarged Prostate With Lower Urinary Tract Symptoms",[22],"HoLEP","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},48,"ESTIMATED",[31],{"type":14,"name":32,"description":33,"armGroupLabels":34},"Ejaculatory-sparing (ES-sparing) HoLEP","The ejaculatory sparing technique involves sparing the distal apex of the prostate in particular the anterior portion of the prostate which will allow for coaptation necessary for antegrade ejaculation.",[35],"ES-HoLEP",[37,41],{"measure":38,"description":39,"timeFrame":40},"Incidence of retrograde ejaculation","Patient reported incidence of experiencing retrograde ejaculation","1 year",{"measure":42,"description":43,"timeFrame":40},"Ejaculatory satisfaction","Patient reported satisfaction of ejaculation using Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD) questionnaire. The MSHQ-EjD-SF evaluates the following parameters in regards to ejaculation: Frequency, Force, Volume and Bother (How much are you bothered by any ejaculation difficulties) on a 6-point Likert scale (typically scored 0 to 5).\n\nInterpretation: Higher scores indicate better ejaculatory function, while lower scores denote dysfunction and a greater level of personal distress regarding one's ejaculatory function.",[45,48,51],{"measure":46,"description":47,"timeFrame":40},"Sexual satisfaction","Patient reported sexual satisfaction using the Sexual Health Inventory for Men (SHIM) questionnaire.\n\nThe Sexual Health Inventory for Men (SHIM) contains 5 questions that is individually scored on a scale of 0 to 5. The SHIM score is calculated by adding up the scores of the 5 individual questions.\n\nInterpretation: Higher scores indicate better erectile function, while lower scores denote erectile dysfunction. A total score of 21 or less indicates that erectile dysfunction is present and should be addressed with a healthcare provider.",{"measure":49,"description":50,"timeFrame":40},"Urinary satisfaction","Patient reported urinary satisfaction using the International Prostate Symptom Score (IPSS) questionnaire.\n\nThe International Prostate Symptom Score (IPSS) is calculated by asking patients to rate 7 urinary symptoms over the past month on a scale from 0 to 5. These scores are simply added together to yield a total symptom severity score ranging from 0 to 35.\n\nAn 8th question measures overall Quality of Life (QoL) but is not factored into the numerical total.\n\nInterpretation: the total score range is from 0 to 35.\n\nThe total score indicates symptom severity:\n\n0-7: Mildly symptomatic 8-19: Moderately symptomatic 20-35: Severely symptomatic",{"measure":49,"description":52,"timeFrame":40},"Patient reported urinary satisfaction using the Michigan Incontinence Symptom Index (M-ISI) questionnaires.\n\nThe M-ISI (Michigan Incontinence Symptom Index) questionnaire is a 10-item clinical tool used to evaluate the severity of urinary incontinence and how much it bothers the patient. It is calculated by assigning scores (0 to 4) to each answer and summing them across two primary domains.\n\nTotal M-ISI Severity Domain (Items 1-8): Sum of the scores for the first 8 questions. This evaluates incontinence subdomains (Stress Urinary Incontinence, Urgency Urinary Incontinence, and Pad Use). Possible score range 0 to 32.\n\nBother Domain (Items 9-10): Sum of the scores for questions 9 and 10. This measures the emotional and physical impact of the leakage. Possible score range 0 to 8.\n\nInterpretation: Higher scores indicate the individual is likely incontinent or has experience with incontinence.","MALE","18 Years","100 Years",true,{"inclusion":58,"exclusion":59,"raw_text":65},[],[60,61,62,63,64],"Patients with pre-existing retrograde ejaculation","Patients who are not sexually active","Patients with indwelling urinary catheter prior to surgery, neurological disease, or history of prior prostatic\u002Furethral surgery that may impact ejaculation","Patients who lack decisional capacity","Patients unable to read\u002Fspeak English","Inclusion Criteria:\n\n\\- Patients who are sexually active with antegrade ejaculation who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms.\n\nExclusion Criteria:\n\n* Patients with pre-existing retrograde ejaculation\n* Patients who are not sexually active\n* Patients with indwelling urinary catheter prior to surgery, neurological disease, or history of prior prostatic\u002Furethral surgery that may impact ejaculation\n* Patients who lack decisional capacity\n* Patients unable to read\u002Fspeak English",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":13,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":79},"Chicago","Illinois","60611","United States",[76],{"name":77,"role":78},"Amy E Krambeck, MD","PRINCIPAL_INVESTIGATOR",{"lat":80,"lon":81},41.85003,-87.65005,[83],{"name":84,"role":85,"phone":86,"email":87},"Alyssa McDonald, MPH","CONTACT","312-695-8146","alyssa.mcdonald@northwestern.edu",[89],{"name":77,"affiliation":13,"role":78},[],[],{"nct_id":4,"conditions":93,"biomarkers":95},[94],"Benign Prostatic Hyperplasia",[],{"nct_id":4,"found":97,"summary":15,"prompt_version":15},false]