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IRCT20181106041572N1 IRCT 2019-04-30 Mashhad University of Medical Sciences Effect of Cyproterone acetate in patients with Benign Prostatic Hypertrophy Determination of Cyproterone acetate effect to prevent recurrent urinary retention in patients with Benign Prostatic Hypertrophy. 2019-04-09 anticipated 84 Complete https://irct.ir/trial/35091 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a simple randomization method, With several envelopes are printed with the contents of the cards that are divided equally between the intervention and the control group, and People are evenly divided into two groups by shuffling and selecting the envelope. In order to hide Sealed and opaque envelopes with random sequences are used. 3 Benign Prostate Hypertrophy. Intervention 1: Intervention group:Patients who complained of acute urinary retention are referred to the Urology Emergency Department of Quaem Hospital with primary BPH diagnosis After insertion of a Urinary catheter, are treated with 1mg per kg per day oral Cyproterone acetate, combined with 0.4 mg per day Tamsulosin capsule for 4 weeks. Then Tamsulosin treatment is continued for up to 6 months. The urinary catheter is removed a week after insertion. Intervention 2: Control group: Patients who complained of acute urinary retention are referred to the Urology Emergency Department of Quaem Hospital with primary BPH diagnosis After insertion of a Urinary catheter, are treated with 0.4 mg per day Tamsulosin capsules for 6 months. The urinary catheter is removed a week after insertion. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Amin Korooji
No. 30 ,18th Ave , Fakoori Blvd , Abo-barq Town
Mashhad Iran (Islamic Republic of) 9178115137 +98 51 3868 9405 karojia941@mums.ac.ir Mashhad University of Medical Sciences scientific Amin Korooji
No. 30 ,18th Ave , Fakoori Blvd , Abo-barq Town
Mashhad Iran (Islamic Republic of) 9178115137 +98 51 3868 9405 karojia941@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with acute urinary retention complaints with initial diagnosis of BPH. 50 years 75 years Male Prostate cancer Urinary infections Use of sympathomimetic drugs N40 Enlarged prostate Treatment - Drugs Treatment - Drugs Intervention group:Patients who complained of acute urinary retention are referred to the Urology Emergency Department of Quaem Hospital with primary BPH diagnosis After insertion of a Urinary catheter, are treated with 1mg per kg per day oral Cyproterone acetate, combined with 0.4 mg per day Tamsulosin capsule for 4 weeks. Then Tamsulosin treatment is continued for up to 6 months. The urinary catheter is removed a week after insertion. Control group: Patients who complained of acute urinary retention are referred to the Urology Emergency Department of Quaem Hospital with primary BPH diagnosis After insertion of a Urinary catheter, are treated with 0.4 mg per day Tamsulosin capsules for 6 months. The urinary catheter is removed a week after insertion. Urinary retention. Timepoint: checking of urinary retention immediately after removal of urinary catheter 7 days after starting of cyproterone acetate with ureteral catheter and re-examination one week and 4 weeks after it and follow up to 6 months later. Method of measurement: Observation. Mashhad University of Medical Sciences Approved 2018-10-06 •Ethics committee of Mashhad University of Medical Sciences Qureishi Building, Oppsite of Daneshgah 18 Ave, Daneshgah Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)