[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616622":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":38,"responsibleParty":55,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":11,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":84,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Daily arm: Tamsulosin 0.4 mg once daily.","ACTIVE_COMPARATOR",null,[13],"Drug: Daily Tamsulosin",{"label":15,"type":16,"description":11,"interventionNames":17},"EOD arm: Tamsulosin 0.4 mg every other day (no capsule on off-days)","EXPERIMENTAL",[18],"Drug: Intermittent Tamsulosin",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Daily Tamsulosin","Participants receive standard tamsulosin 0.4 mg once daily for the study duration. This arm serves as the reference for evaluating efficacy and safety compared with the intermittent regimen.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Intermittent Tamsulosin","Participants receive tamsulosin 0.4 mg every other day (intermittent regimen) for the study duration. The regimen is designed to evaluate whether reduced-frequency dosing is non-inferior to standard daily therapy in improving LUTS\u002FBPH symptoms.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Mahmoud AN Laymon, Mahmoud","CONTACT","066053151","dr_mahmoudlaymon@mans.edu.eg",{"name":36,"role":32,"phone":11,"phoneExt":11,"email":37},"Ahmed Shokeir","ahmed.shokeir@hotmail.com",[39],{"facility":40,"status":11,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Urology and nephrology center","Al Mansurah","Outside U.S.\u002FCanada","35516","Egypt","EG",{"type":47,"coordinates":48},"Point",[49,50],31.38069,31.03637,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":33,"phoneExt":11,"email":34},"Mahmoud AN Laymon",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Mahmoud Laymon","Prof.","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":70,"type":71},288,"ESTIMATED","INTERVENTIONAL",[74],"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.",[77,78],"Lower Urinary Tract Symptoms","Prostate Obstruction",[77,80,81,82,83],"Tamsulosin","Benign prostatic obstruction","Alternate-Day Dosing","Ejaculatory Dysfunction","NOT_YET_RECRUITING","2025-12-19",{"date":87,"type":88},"2025-12-29","ACTUAL",{"date":90,"type":71},"2026-01-01",{"date":92,"type":71},"2027-02-01",{"name":5,"class":6},1]