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IRCT20170417033489N5 IRCT 2020-05-08 Mashhad University of Medical Sciences Comparative study of the synergistic effect of Iso Surbide Di Nitrate on standard medical treatment in acute urinary retention compared to current standard treatment alone Comparative study of the synergistic effect of Iso Surbide Di Nitrate on standard medical treatment in acute urinary retention compared to current standard treatment alone 2019-05-22 anticipated 78 Complete https://irct.ir/trial/47587 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization using a sealed envelope whose sequence is randomly hidden from the patient and the researcher, Blinding description: Participants and researcher Participants are told that, in addition to standard treatment, additional treatment may be given at random, and that they will not know whether they will receive over-standard treatment. 3 BENIGN PROSTATE HYPERPLASIA. Intervention 1: Intervention group: In addition to standard alpha-blocker ( capsule Tamsulosin 0.4 mg Daily ) and antiandrogen ( tablet Finastride 5 mg Daily )therapyy, 10 mg of isosorbide dinitrate is used sublingualy daily for up to three weeks. Intervention 2: Control group: A group receiving standard alpha-blocker ( capsule Tamsulosin 0.4 mg Daily ) and antiandrogen ( tablet Finastride 5 mg Daily )therapy. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: starting 6 months after publication To whom: Access to data will be unlimited Conditions: Requesting data will be unlimited Where to obtain: Dr. Salman Soltani. Urology Department of Imam Reza Hospital. Mashhad. Iran Phone +98 51 3871 3638 How to obtain: After submitting the application, the information will be provided to the applicant as soon as possible Comments:
public Salman Soltani
Imam Reza Hospital, Daneshgah Avenue, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177899191 +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) 9177899191 +98 51 3802 2553 soltanis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The patient has acute urinary retention He is over 50 years old. Has experienced the first episode of urinary retention Is not undergoing another treatment or has no indication for surgery The patient's urinary retention is due to the presence of BPH 50 years no limit Male History of any heart, liver, kidney, metabolic disease and seizures Fever in the patient means T more than 38 degrees Celsius High PSA (above 4) or suspicious examination that casts doubt on prostate cancer Secondary urinary retention in other cases such as neurogenic bladder N40 Enlarged prostate Treatment - Drugs Treatment - Drugs Intervention group: In addition to standard alpha-blocker ( capsule Tamsulosin 0.4 mg Daily ) and antiandrogen ( tablet Finastride 5 mg Daily )therapyy, 10 mg of isosorbide dinitrate is used sublingualy daily for up to three weeks. Control group: A group receiving standard alpha-blocker ( capsule Tamsulosin 0.4 mg Daily ) and antiandrogen ( tablet Finastride 5 mg Daily )therapy Percentage of patients discharged from the urinary catheter. Timepoint: 21 DAYS. Method of measurement: Lack of urinary retention following urinary catheter removal. Mashhad University of Medical Sciences Approved 2019-08-26 Ethics Committee of Mashhad University of Medical Sciences Imam Reza Hospital Research Center, Mashhad, Imam Reza Square, Imam Reza Hospital Mashad Razavi Khorasan Iran (Islamic Republic of)