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IRCT20191230045943N1 IRCT 2020-10-03 Tehran University of Medical Sciences the effect of tamsulosin and tadalafil in response to treatment of patients with lower urinary tract symptoms Comparison of the effect of tamsulosin and tadalafil in response to treatment of patients with lower urinary tract symptoms due to the severity of atherosclerosis 2020-09-30 anticipated 200 Complete https://irct.ir/trial/44611 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: The randomization method used will be simple randomization. And the random number table will be used. If a number is randomly selected we will move to the right according to the present contract and if the number even comes in The patient will be admitted to the intervention group and if the number comes in, the patient will be included in the second group. (Assigning patients based on the severity of atherosclerosis in two general categories of low severity and high severity of atherosclerosis based on the couple and individual referral number). N/A Condition 1: Atherosclerosis. Condition 2: Obstructive and urinary tract symptoms. Intervention 1: Intervention group: Treatment with tamsulosin 0.4 mg daily one alone- (Trade names, Flomax, others )- Patients before treatment, 4, 8 and 12 weeks after starting treatment (PVR, IPSS, IPSS-QOL and IIEF-5) are evaluated. Q max is assessed before starting treatment and after 12 weeks. Intervention 2: Intervention group: Treatment with tadalafil 5 mg+tamsulosin 0.4 mg once daily - Patients before treatment, 4, 8 and 12 weeks after starting treatment (PVR, IPSS, IPSS-QOL and IIEF-5) are evaluated. Q max is assessed before starting treatment and after 12 weeks. Yes - There is a plan to make this available What will be shared: demographic information anonymously When: one year after publication To whom: register Conditions: Re-information for the purpose of clarification Where to obtain: Dr. Ali Tavoosian How to obtain: After the examination, the applicant will be provided with the advice of an epidemiologist and with the confidentiality of patient information. Comments: -
public Dr Akram Mirzaei
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mirzaee.scholar@gmail.com Tehran University of Medical Sciences scientific Dr Ali Tavoosian
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 alitavoosian@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Male patients referred to urology clinic with obstructive and urinary tract symptoms for at least 6 months Patients over 50 years of age 50 years 100 years Male Male patients referred to urology clinic less than 50 years old PSA higher than 10 Urine residue 300ml or higher determined by ultrasound Receiving Finasteride during the last 3 months Receiving anti-androgen drugs History of pelvic surgery or radiotherapy History of lower urinary tract malignancy Lower urinary tract trauma Urinary retention Bladder stones Urinary tract infection that is determined by urine culture Urethral stricture Neurological disease affecting bladder function Secondary obstruction to the median lobe of the prostate Prostate cancer Liver or kidney failure Cardiovascular diseases such as significant angina that need to be checked by a cardiologist and CHF not compensated, recent MI and uncontrolled blood pressure treatment with nitrates Uncontrolled diabetes HbAlc> 9% I70 N13.9 Atherosclerosis Obstructive and reflux uropathy, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Treatment with tamsulosin 0.4 mg daily one alone- (Trade names, Flomax, others )- Patients before treatment, 4, 8 and 12 weeks after starting treatment (PVR, IPSS, IPSS-QOL and IIEF-5) are evaluated. Q max is assessed before starting treatment and after 12 weeks. Intervention group: Treatment with tadalafil 5 mg+tamsulosin 0.4 mg once daily - Patients before treatment, 4, 8 and 12 weeks after starting treatment (PVR, IPSS, IPSS-QOL and IIEF-5) are evaluated. Q max is assessed before starting treatment and after 12 weeks. Treatment of obstructive and urinary tract symptoms. Timepoint: At one month intervals for three months. Method of measurement: Q max evaluation. Tehran University of Medical Sciences Approved 2020-09-30 Ethics Committee for Research in Tehran University of Medical Sciences Room 604, Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)