[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-obstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-obstruction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100616622","phase-4-intermittent-vs-daily-tamsulosin-for-lutsbph-100616622",false,"NCT07308002","Intermittent vs Daily Tamsulosin for LUTS\u002FBPH","Intermittent (Every-Other-Day) vs Daily Tamsulosin for Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia (LUTS\u002FBPH) : A Multicenter, Assessor-Blinded, Randomized Non-Inferiority Trial. Arab Randomized Assessment of BPH Treatment (ARAB Trial)","ARAB","Inclusion Criteria:\n\n* • Men ≥40 years with LUTS\u002FBPH.\n\n  * IPSS ≥8, Qmax 5-15 mL\u002Fs (voided volume ≥150 mL), PVR \\\u003C200 mL.\n  * Sexually active within the past month (for ejaculatory outcomes).\n  * BPH-treatment naïve: no prior use of antimuscarinics or 5-α-reductase inhibitors (5-ARIs) and agrees not to initiate these agents during the trial.\n\nExclusion Criteria:\n\n* • PVR ≥ 200 mL.\n\n  * Prior prostate\u002F radical pelvic surgery (that affect pelvic innervation).\n  * Neurogenic bladder (atonic\u002F hypotonic bladder).\n  * Severe hepatic\u002Frenal insufficiency.\n  * Significant cardiovascular or cerebrovascular disease.\n  * Any indication of surgical treatment (vesical stones, chronic urine retention, recurrent attacks of acute urine retention, recurrent attacks of gross hematuria, hydronephrosis)","MALE","40 Years",{"count":20,"type":21},288,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Background:\n\nLower urinary tract symptoms (LUTS) are common in aging men, most often due to benign prostatic hyperplasia (BPH), and significantly impair quality of life. α1-adrenoceptor antagonists are first-line therapy, with tamsulosin being the most widely prescribed. However, ejaculatory dysfunction (EjD) is a frequent adverse effect that negatively affects adherence. Optimal dosing strategies that maintain urinary efficacy while reducing EjD are not well defined, and current guidelines provide no recommendations regarding alternate-day dosing.\n\nPatients and Methods:\n\nThis multicenter, randomized, open-label, assessor-blinded, parallel-group, non-inferiority trial will enroll men aged ≥50 years with LUTS\u002FBPH and baseline IPSS ≥8. Participants will be randomized 1:1 to receive tamsulosin 0.4 mg once daily or every other day for 24 weeks. The primary endpoint is change in International Prostate Symptom Score (IPSS) from baseline to Week 24. Non-inferiority will be concluded if the upper bound of the two-sided 95% confidence interval (CI) for the between-group difference in mean IPSS change (EOD - Daily) is ≤ +3 points.\n\nThe key secondary endpoint is change in Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) total score from baseline to Week 24, tested for superiority only if IPSS non-inferiority is established. Additional secondary endpoints include maximum urinary flow rate (Qmax), post-void residual volume (PVR), IPSS-Quality of Life score, and ejaculatory adverse-event rates.\n\nSample Size and Analysis:\n\nAssuming an SD of 6 for IPSS change, a non-inferiority margin of +3, one-sided α of 0.025, and 90% power, approximately 85 evaluable patients per arm are required for the primary endpoint. To ensure adequate power for EjD outcomes and allow for 20% attrition, 144 participants per arm (288 total) will be randomized. Analyses will follow the intention-to-treat principle with per-protocol sensitivity analyses. Primary inference will use ANCOVA or MMRM adjusted for baseline score, age, and study site, with multiple imputation for missing data.\n\nExpected Outcomes:\n\nThis trial will provide the first adequately powered multicenter evidence on whether every-other-day tamsulosin preserves non-inferior LUTS control while improving ejaculatory outcomes, potentially supporting a simple and cost-effective strategy to enhance tolerability and adherence in men with LUTS\u002FBPH.",[27,28],"Lower Urinary Tract Symptoms","Prostate Obstruction",[27,30,31,32,33],"Tamsulosin","Benign prostatic obstruction","Alternate-Day Dosing","Ejaculatory Dysfunction","NOT_YET_RECRUITING","2025-12-19",{"date":37,"type":38},"2025-12-29","ACTUAL",{"date":40,"type":21},"2026-01-01",{"date":42,"type":21},"2027-02-01",{"name":44,"class":45},"Mansoura University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100556927","laser-outcomes-associated-with-holmium-laser-enucleation-of-the-prostate-holep-procedures-100556927","NCT06531473","Laser Outcomes Associated With (Holmium Laser Enucleation of the Prostate) HoLEP Procedures","Laser Outcomes Associated With HoLEP Procedures","Inclusion Criteria:\n\n* Males 18-89 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates\n\nExclusion Criteria:\n\n* Prostates measurements over 200g\n* Patients who lack decisional capacity\n* Patients who are non-english speakers","18 Years","89 Years",{"count":57,"type":21},300,[59],"NA","The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate. There is currently no gold-standard laser settings for HoLEP procedures. In the investigator's current high-volume practice, the following settings for enucleation are: 2j 50hz. These settings are conventional settings, but there is no literature to prove optimal laser settings. The investigators hypothesizes that utilization of higher laser settings may be associated with a clinically significant (defined as \\> 10%) decrease in procedural time without any detrimental postoperative outcomes, and a utilization of lower laser settings may be associated with a clinically significant (defined as \\>10%) reduction in postoperative irritative voiding symptoms without any detrimental postoperative outcomes.",[62,28],"Urologic Diseases","RECRUITING","2024-11-12",{"date":66,"type":38},"2024-11-14",{"date":68,"type":38},"2024-03-04",{"date":70,"type":21},"2026-08-30",{"name":72,"class":45},"Northwestern University"]