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IRCT201208091853N9 IRCT 2016-05-13 Vice chancellor for research, Guilan University of Medical Sciences The effect of Tadalafil on night time frequency refractory to treatment with alfa-adrenergic inhibitors Evaluation and comparison of the effect of Tadalafil and placebo on nighttime frequency refractory to treatment with alfa-adrenergic inhibitors in males with LUTS/BPH referred to Razi Hospital 2014-08-06 anticipated 100 Complete https://irct.ir/trial/1436 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic. 3 Nocturnal frequency or nocturia. Intervention 1: tadalafil 5mg, daily for 12 weeks Made in Iran. Intervention 2: placebo, daily for 12 weeks Made in Iran.
public Dr. Keivan Gholamjani Moghadam
Razi Hospital, Sardar Jangal Street
Rasht Iran (Islamic Republic of) 41448-95655 +98 13 3352 5259 urc1384@yahoo.com Guilan University of Medical Sciences scientific Dr. Siavash Falahatkar
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 Iran (Islamic Republic of) Inclusion criteria: age above 50, refractory LUTS to life style change such as: quite smoking and limit consumption of liquid alcohol and caffeine before sleeping, having moderate physical activity. Exclusion criteria: BMI above 30kg/m2, surgery indication for BPH, urinary residual above 200CC, chronic pelvic pain syndrome (CPPS) over active bladder (OAB) urethral or bladder stone, history of pervious neurogenic bladder ureteral or bladder stone history of urethral bladder or prostate malignancy, PSA above 4 ng/ml or PSA between 4-10 ng/ml with positive biopsy for prostate malignancy, active urinary tract infection (UTI) or active sexual transmitted disease (STD) 50 years 149 years Male R35 Polyuria Treatment - Drugs Treatment - Drugs tadalafil 5mg, daily for 12 weeks Made in Iran placebo, daily for 12 weeks Made in Iran Nocturia. Timepoint: 2, 4, 8 and 12 weeks after intervention. Method of measurement: Examination and evaluation by Night Time Voiding Diary, SPSS and Quality of Life score questionnaires, and uroflowmetry (Maximum Flow Rate or Qmax). Vice chancellor for research, Guilan University of Medical Sciences Approved 2014-06-02 Ethics committee of Guilan University of Medical Sciences Opposite Sepah Bank, Western Shahid Beheshti Blvd., Gaz Square Rasht Iran (Islamic Republic of)