]>
IRCT20170417033489N3 IRCT 2019-10-17 Mashhad University of Medical Sciences The effect of LHRH agonist on urinary retention The effect of LHRH agonist on the improvement of urinary retention compared with the effect of finasteride and tamsulosin alone 2019-10-22 anticipated 78 Complete https://irct.ir/trial/42856 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Sample size in each group was maximum predicted to be 39 people, and with predictable Decrease in the number of subjects it was 35 in each group, Randomization description: Randomization will be done using Excel software. Random numbers are inserted in odd and even codes into the envelope, after the patient arrives at the admission criteria, and, if the patient is satisfied, the envelope is opened and will be assigned to the intervention or control group according to the patient's code. Paired and odd codes represent intervention and control groups.The codes are placed separately in the envelope so that the nurse who opens each envelope will not be aware of the allocation of the next envelope (until the next envelope is opened), Blinding description: Evaluators and analysts will be unaware of intervention and control groups (the evaluator will only assess the extent of catheter release in the short term). 3 Acute urinary retention in patients with BPH. Intervention 1: Intervention group: All patients will receive routine BPH treatment including alpha-blocker tamsulosin 0.4 mg single daily oral and alpha reductase inhibitor finasteride 5 mg single daily oral.In addition, patients in the intervention group will be given a single dose of LHRH agonist loperurelin acetate 7.5 mg at baseline. Intervention 2: Control group: All patients will receive routine BPH treatment including alpha-blocker tamsulosin 0.4 mg single daily oral and alpha reductase inhibitor finasteride 5 mg single daily oral. 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 Salman Soltani
Imam Reza Hospital, Daneshgah Avenue, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3802 2553 soltanis@mums.ac.ir Mashhad University of Medical Sciences scientific Salman Soltani
Imam Reza Hospital, Daneshgah Avenue, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3802 2553 soltanis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The first acute urinary retention No other treatment No indication of surgery Patient's urinary retention is caused by BPH Minimum age of 50 years 50 years no limit Male Informed patient dissatisfaction History of any heart, liver, kidney, metabolic and seizure diseases Patients with fever mean T more than 38 degrees Celsius High PSA levels (above 4) which strengthen suspicion of prostate cancer N40 Enlarged prostate Treatment - Drugs Treatment - Drugs Intervention group: All patients will receive routine BPH treatment including alpha-blocker tamsulosin 0.4 mg single daily oral and alpha reductase inhibitor finasteride 5 mg single daily oral.In addition, patients in the intervention group will be given a single dose of LHRH agonist loperurelin acetate 7.5 mg at baseline. Control group: All patients will receive routine BPH treatment including alpha-blocker tamsulosin 0.4 mg single daily oral and alpha reductase inhibitor finasteride 5 mg single daily oral. The rate of catheter release in acute urinary retention induced by BPH. Timepoint: One month after drug injection. Method of measurement: No need for re-catheterization. IPSS Score. Timepoint: Before and one month after drug injection. Method of measurement: IPSS Questionnaire. The incidence of drug side effects. Timepoint: One month after drug injection. Method of measurement: Ask the patient. The amount of post voiding residue(PVR). Timepoint: One day after leaving the cathedral. Method of measurement: Ultrasound. Mashhad University of Medical Sciences Approved 2019-05-07 Mashhad University of Medical Sciences Qureshi building ,University Avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)