]>
IRCT20100817004582N8 IRCT 2018-02-17 Urology Research Centre, Guilan University of Medical Sciences Comparison of the efficacy and safety of tamsulosin OCAS with tamsulosin MR and placebo in improving lower urinary tract symptoms Comparative study on the effectiveness and safety of tamsulosin Oral-Controlled Absorption System (OCAS®) with tamsulosin Modified Release (MR) and placebo in improving lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) 2018-01-21 anticipated 260 Complete https://irct.ir/trial/28523 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned through random allocation method with block size 8 to 4 groups, Blinding description: Medications are separately packaged in 4 groups of 1 to 4 by one of the co-workers and delivered to the main researcher. 4 Lower Urinary Tract Symptoms (LUTS). Intervention 1: Intervention group 1: Tamsulosin capsule 0.4 mg (MR) with brand name Portral, manufacturing by Tasnim Pharmaceutical Co., daily for 12 weeks orally. Intervention 2: Intervention group 2: Tamsulosin Tablets 0.4 mg (OCAS) with brand name Protral OPAS, manufacturing by Tasnim Pharmaceutical Co., daily for 12 weeks orally. Intervention 3: Intervention group 3: Tamsulosin Tablets 0.4 mg (OCAS) with brand name Omnic OCAS, daily for 12 weeks orally. Intervention 4: Control group: Placebo, manufacturing by Tasnim Pharmaceutical Co., daily for 12 weeks orally. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is not ethically possible to release patient data. The questionnaires are kept at the Urology Research Center of Guilan University of Medical Sciences and only if necessary, natural and legal persons with legal permission will be allowed to examine them.
public Kourosh Mojtabavi
Urology Research Center, Razi Hospital, Sardar Jangal Street
Rasht Iran (Islamic Republic of) 41448-95655 +98 13 3352 5259 urc1384@yahoo.com Urology Research Center, Guilan University of Medical Sciences scientific Ali Hamidi Madani
Urology Research Center, Razi Hospital, Sardar Jangal Street
Rasht Iran (Islamic Republic of) 41448-95655 +98 13 3352 5259 a.hamidimadani@gmail.com Urology Research Center, Guilan University of Medical Sciences Iran (Islamic Republic of) Patients who are at least 40 years of age. Prostate-Specific Antigen (PSA) score should be at age-specific range. International Prostate Symptom Score (IPSS) should be greater than or equal to 8. The maximum urine flow (Qmax) should be in the range of greater than and/or equal to 4 ml/s and smaller and/or equal to 15 ml/s. The urine residual should be below 120 ml. 40 years no limit Male History of prostatectomy Severe liver dysfunction Severe renal dysfunction Severe cardiovascular dysfunction History of syncope. Other conditions that can be causing voiding dysfunction, such as neurogenic bladder, bladder or urinary stones, frequent urinary tract infection, bladder cancer, prostate cancer, urethral stenosis, and large diverticulum bladder. History of allergy to tamsulosin History of recent retention and nocturnal polyuria Patients with benign prostatic hyperplasia (BPH) who are candidates for surgery on the basis of clinical and paraclinical symptoms. History of use of 5α-reductase inhibitors in the last 3 months History of taking diuretics and hypnotic tablets Use of other therapies such as other alpha blockers or herbal extracts in the last month Use of other drugs, such as alpha-agonists, cholinergic or anticholinergic drugs that may affect the effects of tamsulosin pharmacodynamics. N40.1 Enlarged prostate with lower urinary tract symptoms Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Tamsulosin capsule 0.4 mg (MR) with brand name Portral, manufacturing by Tasnim Pharmaceutical Co., daily for 12 weeks orally Intervention group 2: Tamsulosin Tablets 0.4 mg (OCAS) with brand name Protral OPAS, manufacturing by Tasnim Pharmaceutical Co., daily for 12 weeks orally Intervention group 3: Tamsulosin Tablets 0.4 mg (OCAS) with brand name Omnic OCAS, daily for 12 weeks orally Control group: Placebo, manufacturing by Tasnim Pharmaceutical Co., daily for 12 weeks orally The International Prostate Symptom Score (IPSS) Questionnaire. Timepoint: The beginning of the study (before the intervention) and 6 and 12 weeks after the start of the intervention. Method of measurement: The International Prostate Symptom Score (IPSS) Questionnaire. Side effects. Timepoint: The beginning of the study (before the intervention) and 6 and 12 weeks after the start of the intervention. Method of measurement: Ask the patient. Tasnim Pharmaceutical Co. Urology Research Centre, Guilan University of Medical Sciences Tasnim Pharmaceutical Co. Approved 2017-11-11 Ethics committee of Guilan University of Medical Sciences Opposite of 17 Shahrivar Hospital, Shahid Siadati Street, Namjoo Street Rasht Guilan Iran (Islamic Republic of)