[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostatic-hyperplasia-benign\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostatic-hyperplasia-benign":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100625039","impact-of-long-term-dutasteride-use-on-perioperative-outcomes-of-holep-100625039",false,"NCT07417449","Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP","The Impact of Long-Term Dutasteride Use on Surgical Outcomes and Perioperative Parameters in Patients Undergoing Holmium Laser Enucleation of the Prostate (HoLEP)","Inclusion Criteria:\n\n* Male patients aged 40 to 80 years.\n* Diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) and scheduled for elective Holmium Laser Enucleation of the Prostate (HoLEP).\n* For the study group: Documented continuous use of Dutasteride (0.5 mg\u002Fday) for a minimum of 6 months immediately prior to the surgical date.\n* For the control group: No history of 5-alpha reductase inhibitor (5-ARI) use within the last 12 months.\n* Patients with complete medical records available in the Hospital Information Management System (HBYS).\n\nExclusion Criteria:\n\n* Patients with a history of previous prostate surgery or pelvic radiotherapy.\n* Patients diagnosed with prostate adenocarcinoma in the pathology results or those scheduled for a biopsy due to suspicion of prostate cancer prior to the operation.\n* Cases with incomplete data in the hospital's electronic database, including missing operative notes, preoperative\u002Fpostoperative hemoglobin levels, or resected tissue weight.","MALE","40 Years","80 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","This study aims to investigate the effects of long-term dutasteride use (a 5-alpha reductase inhibitor) on surgical outcomes in patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) for benign prostatic hyperplasia (BPH).\n\nWhile some studies suggest that short-term use of these medications can reduce bleeding during surgery, there is limited data on the impact of chronic, long-term use (at least 6 months) specifically during the HoLEP procedure.\n\nThe researchers will retrospectively analyze patient records to compare two groups: those who used dutasteride for 6 months or longer before surgery, and those who did not use any 5-alpha reductase inhibitors. The primary focus is to determine whether long-term dutasteride treatment leads to a significant difference in surgical bleeding (measured by hemoglobin drop), operation time, and the efficiency of removing prostate tissue (morcellation). The findings will help surgeons better understand how preoperative medication history influences the technical aspects of HoLEP surgery.",[25],"Prostatic Hyperplasia, Benign",[27,28,29,30,31],"HoLEP","Dutasteride","5-alpha Reductase Inhibitors","Prostate Surgery","Perioperative Bleeding","RECRUITING","2026-03-31",{"date":35,"type":36},"2026-04-06","ACTUAL",{"date":38,"type":21},"2026-04-01",{"date":40,"type":21},"2027-04-01",{"name":42,"class":43},"Ankara City Hospital Bilkent","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100613733","phase-3-efficacy-safety-of-product-dnn6521005-in-patients-with-benign-prostatic-hyperplasia-100613733","NCT07270432","Efficacy\u002F Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia","Randomized Clinical Trial to Evaluate the Safety and Efficacy of Product DNN.65.21.005 in Alleviating Lower Urinary Tract Symptoms in Patients With Benign Prostatic Hyperplasia","NICCOLO","Inclusion Criteria:\n\n* Male participants aged 50 years and older.\n* Ability to understand the study and provide informed consent, documented by signing the Informed Consent Form (ICF).\n* Participants presenting lower urinary tract symptoms (LUTS) associated with prostate enlargement, without neurological or infectious causes.\n\nExclusion Criteria:\n\n* History or evidence of prostate cancer.\n* Urinary retention ≥100 mL, as assessed by abdominal prostate ultrasound.\n* Previous diagnosis of Parkinson's disease or other neurological disorders that may lead to neurogenic bladder.\n* Use of herbal treatments for prostate enlargement within 14 days prior to the screening visit.\n* Current use or use of alpha-blocker medications within 7 days prior to the start of study treatment.\n* Current use or use of 5-alpha reductase inhibitors (5ARIs) within 180 days prior to the start of study treatment.\n* Use of any prohibited medications within the timeframe specified in the study protocol.\n* Any clinical findings or observations (clinical or physical evaluation) that, in the investigator's judgment, pose a risk to participation in the study.","50 Years",{"count":55,"type":21},218,"INTERVENTIONAL",[58],"PHASE3","To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of benign prostatic hyperplasia",[25],"NOT_YET_RECRUITING","2025-11-26",{"date":64,"type":36},"2025-12-08",{"date":66,"type":21},"2026-01",{"date":68,"type":21},"2027-04",{"name":70,"class":71},"Ache Laboratorios Farmaceuticos S.A.","INDUSTRY",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":56,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"100536406","phase-3-efficacy-and-safety-of-the-dtt106-in-the-treatment-of-erectile-dysfunction-associated-with-benign-prostatic-hyperplasia-100536406","NCT06264414","Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia","Phase III, Multicenter, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia","AUSTRÁLIA","Inclusion Criteria:\n\n* men aged 40 years and older.\n* Sexually active men, with a defined partner, who have engaged in an average of 1 attempt at sexual intercourse per week in the last month.\n* Participants under stable treatment with dutasteride + tamsulosin combination therapy.\n* Diagnosis of erectile dysfunction, according to criteria established by the Guideline of the Brazilian Society of Urology and the American Society of Urology (2017);\n* Erectile Function domain score of IIEF ≤ 25 and ≥ 6 points at the time of screening.\n\nExclusion Criteria:\n\n* Any clinical or physical observation noted during evaluation by the investigating physician, or any laboratory condition, which is interpreted as posing a risk to participation in the clinical trial;\n* Presence of uncontrolled chronic diseases;\n* History of alcohol or illicit drug use disorder within the past 2 years;\n* Men who are planning to impregnate their partners, or fertile men who are not using a reliable contraceptive method;\n* Known allergy or hypersensitivity to the components of the medicinal products used during the clinical trial;\n* History of pelvic surgery, prostatectomy, radiation therapy, penile implant placement surgery, urinary tract trauma, or invasive procedures for BPH treatment.\n* Diagnosis of other diseases or conditions in the urinary tract, including, but not limited to: cancer, neurogenic bladder, urinary incontinence, recurrent infection, urethral stenosis, bacterial prostatitis.\n* Clinical evidence of prostate cancer;\n* Severe renal failure;\n* Severe liver failure;\n* Hypogonadism (supported by values below normal, as established by the local laboratory, for total testosterone) or absent libido (sex drive);\n* Severe psychiatric or psychosocial disorders;\n* Primary erectile dysfunction;\n* Polyneuropathy, neurodegenerative diseases, spinal cord trauma or injury, tumors in the central nervous system, or other conditions that may affect erections;\n* History of orthostatic hypotension.\n* Expected to undergo cataract or glaucoma surgery;\n* Concomitant use of any form of organic nitrate;\n* Concomitant use of guanylate cyclase stimulators such as riociguat;\n* Anatomical deformation of the penis that can significantly impair erection, including, but not limited to: angulation, cavernous fibrosis, and Peyronie's disease.\n* Conditions that may predispose to priapism, including but not limited to: sickle cell anemia, multiple myeloma, leukemia;\n* Prior diagnosis of pulmonary hypertension;\n* Presence of anterior ischemic optic neuropathy, or degenerative diseases of the retina, including retinitis pigmentosa;\n* Diagnosis of dysautonomia.\n* Cardiovascular disease for which sexual activity is inadvisable, including but not limited to: Myocardial infarction in the last 90 days; Unstable angina or angina that occurs during sexual intercourse; Class 2 or higher heart failure according to the New York Heart Association in the last 6 months; Arrhythmias not controlled; Hypotension (\\\u003C 90\u002F50 mmHg) or uncontrolled hypertension; Stroke in the last six months.\n* Diabetics with HbA1c greater than or equal to 10%, or with a history of retinopathy and\u002For neuropathy;\n* Use of prohibited medications as per the protocol;\n* Erectile dysfunction that has not responded to phosphodiesterase inhibitors type 5 (including but not limited to: sildenafil, tadalafil, vardenafil) at the time of screening.\n* Participation in clinical trial protocols within the last 12 (twelve) months.",{"count":81,"type":21},262,[58],"The purpose of this study is to assess the safety and efficacy of the DTT106 in the treatment of erectile dysfunction associated with benign prostatic hyperplasia",[25,85],"Erectile Dysfunction","2024-02-16",{"date":88,"type":36},"2024-02-20",{"date":90,"type":21},"2025-02",{"date":92,"type":21},"2027-07",{"name":94,"class":71},"EMS"]