[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"silodosin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:silodosin":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100649929","phase-4-pupil-size-and-choroidal-thickness-changes-with-tamsulosin-vs-silodosin-in-benign-prostatic-hyperplasia-patients-100649929",false,"NCT07743060","Pupil Size and Choroidal Thickness Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients","Comparison of Tamsulosin and Silodosin on Pupil Size and Choroidal Thickness in Patients With Benign Prostatic Hyperplasia","Inclusion Criteria:\n\n* Men ≥ 50 years of age with a definitive diagnosis of BPH by a collaborating urologist.\n* Patients with moderate symptoms based onthe International Prostate Symptom Score (IPSS): score 8 to 19\n* No prior use of any alpha-blocker (tamsulosin, silodosin, doxazosin, etc.)\n* Vision adequate for imaging\n* Consent to participate in the study\n* No history of any intraocular surgery; no active or structural ocular disease affecting the pupil\u002Firis, such as glaucoma, uveitis, pseudoexfoliation syndrome, pigment dispersion syndrome.\n* No use of pupil-affecting eye drops within the past 2 weeks\n\nExclusion Criteria:\n\n* High myopia (SE ≤ -6.00 D) or axial length \\> 26.5 mm, in order to control for its effect on choroidal thickness\n* History of trauma or injury to the iris\n* Insufficient image quality during assessments\n* Patient unwilling to continue participation in the study\n* Occurrence of unwanted systemic adverse effects during the study\n* Improper medication adherence during the study\n* Diabetes\n* Hypertension","MALE","50 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","Benign prostatic hyperplasia (BPH) is a common disease in men and is treated with alpha-blockers, particularly tamsulosin and silodosin. Studies suggest that these drugs may affect α1a receptors in the iris dilator muscle, causing structural changes in the iris and pupillary disturbances, and increasing the risk of intraoperative floppy iris syndrome (IFIS) during cataract surgery.\n\nMain objective: To compare the effect of tamsulosin and silodosin on pupil size and choroidal thickness in patients with BPH.\n\nMen aged 50 years and older with a definitive diagnosis of BPH who have no prior history of alpha-blocker use will be enrolled in one of the two treatment arms - tamsulosin or silodosin. Assessments will be conducted at two time points - before the start of treatment and after three months of continuous.\n\n* Pupillography will be performed at three standard illumination levels - scotopic 0.04 lux, mesopic 4 lux, and photopic 50 lux - with pupil diameter automatically recorded under each condition using the MS-39 device (manufactured by CSO, Italy).\n* Choroidal assessment will use EDI-OCT (Heidelberg) macular imaging, measuring choroidal thickness at the subfoveal position and at 500 and 1000 micron nasal and temporal points.\n\nTo reduce daily fluctuations related to circadian rhythm, all imaging will be performed within a fixed window of 9-11 a.m. by a single trained operator.\n\ndrug use.",[26,27,28,29,30,31],"Benign Prostatic Hyperplasia","Silodosin","Tamsulosin","Choroid","Iris Disease","Tomography, Optical Coherence",[26,27,28,33,34,31],"Choroid\u002Fanatomy & histology","Iris\u002Fanatomy & histology","NOT_YET_RECRUITING","2026-07-29",{"date":38,"type":39},"2026-08-03","ACTUAL",{"date":41,"type":20},"2026-08",{"date":43,"type":20},"2027-04",{"name":45,"class":46},"Mohsen Pourazizi","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":66,"locationsCount":4},"100649904","phase-4-iris-structural-changes-with-tamsulosin-vs-silodosin-in-benign-prostatic-hyperplasia-patients-100649904","NCT07743034","Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients","Comparison of the Efficacy of Tamsulosin and Silodosin on Anatomical Iris Changes in Patients With Benign Prostatic Hyperplasia: A Single-blind Randomized Clinical Trial","Inclusion Criteria:\n\n* Men ≥ 50 years old with a definitive diagnosis of BPH by a urologist colleague.\n* Patients with moderate symptoms based on the International Prostate Symptom Score (IPSS): score 8 to 19\n* No prior use of alpha-blockers (tamsulosin, silodosin, doxazosin, etc.)\n* Satisfactory vision for imaging and acceptable scan quality according to device criteria.\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* Insufficient image quality in assessments\n* History of intraocular surgery\n* Uncontrolled hypertension\n* Iris trauma\n* Patient unwillingness to continue participation in the study\n* Occurrence of unwanted systemic complications during the study\n* Incorrect medication adherence during the study\n* Diabetes\n* Hypertension",{"count":19,"type":20},[23],"Inhibition of alpha-1 adrenergic receptors by drugs such as tamsulosin and silodosin, which are prescribed for the treatment of benign prostatic hyperplasia, can lead to intraoperative floppy iris syndrome (IFIS) during cataract surgery. IFIS is a phenomenon characterized by a small, poorly dilating pupil and causes surgical difficulty.\n\nMain objective: To determine and compare changes in the anatomical structure of the iris in patients with BPH before and after treatment with tamsulosin and silodosin.\n\nMen aged 50 years and older with a definitive diagnosis of BPH who have no prior history of alpha-blocker use will be enrolled in one of the two treatment arms - tamsulosin or silodosin. Imaging will be performed using an MS-39 device (manufactured by CSO, Italy); assessments will be conducted at two time points - before the start of treatment and after three months of continuous drug use. At baseline and three months after treatment, using AS-OCT, the DMR and SMR regions and other ocular angle indices will be measured. Medication adherence will be assessed by counting the capsules used by each patient.\n\nSpecific Objectives:\n\n1. To determine changes in the dilator muscle region (DMR) under scotopic, mesopic, photopic, and post-dilation conditions from baseline to the third month in the tamsulosin \\& silodosin groups and compare them.\n2. To determine changes in SMR under scotopic, mesopic, photopic, and post-dilation conditions from baseline to the third month in the tamsulosin \\& silodosin groups and compare them.",[26,28,27,58,31,59],"Intraoperative Floppy Iris Syndrome","Iris Diseases",[26,28,58,31,61,27,62],"Iris","IFIS",{"date":38,"type":39},{"date":41,"type":20},{"date":43,"type":20},{"name":45,"class":46},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100592137","clinical-outcomes-and-ejaculatory-function-in-bpo-patients-treated-with-silodosin-100592137","NCT06989515","Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin","Does Anejaculation Reflect Better Clinical Outcomes in BPO Patients Receiving Silodosin?","Inclusion Criteria:\n\n* Male patients aged 40 years or older\n* Diagnosed with lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO)\n* Initiating silodosin 8 mg\u002Fday therapy for the first time\n* Able to complete IPSS and IIEF-5 questionnaires\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* History of prior treatment with silodosin or other α-blockers in the last 3 months\n* Known neurogenic bladder or history of neurological disease affecting voiding\n* History of prostate surgery or pelvic radiation\n* Diagnosed prostate or bladder malignancy\n* Use of medications affecting sexual function (e.g., PDE5 inhibitors) within the last month\n* Severe cardiovascular, hepatic, or renal comorbidities\n* Cognitive impairment preventing informed consent or questionnaire completion","40 Years",{"count":76,"type":20},100,"OBSERVATIONAL","This observational study aims to evaluate the relationship between silodosin-induced anejaculation and clinical outcomes in male patients with benign prostatic obstruction (BPO). Silodosin is a commonly used alpha-blocker for lower urinary tract symptoms (LUTS). However, it may cause ejaculatory dysfunction, particularly anejaculation. In this study, patients receiving silodosin for the first time will be grouped based on whether they experience anejaculation or not. Treatment response will be assessed using urinary flow rate, post-void residual urine, and International Prostate Symptom Score (IPSS). Sexual function will be evaluated using the International Index of Erectile Function-5 (IIEF-5) before and after treatment. The study aims to explore whether the presence of anejaculation is associated with improved symptom relief or differences in sexual health.",[80,81,82,83,27],"Benign Prostate Obstruction (BPO)","Lower Urinary Tract Symptom","Ejaculatory Dysfunction","Anejaculation",[27,82,85,86,87],"Benign Prostatic Obstruction","Lower Urinary Tract Symptoms","Alpha-blocker Side Effects","2025-06-04",{"date":90,"type":39},"2025-06-05",{"date":92,"type":20},"2025-06-15",{"date":94,"type":20},"2026-06-12",{"name":96,"class":46},"Marmara University"]