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IRCT20210729052012N1 IRCT 2022-01-20 Shiraz University of Medical Sciences Comparative efficacy assessment of Tamsulosin vs. Tamsulosin plus Pentoxifylline in the treatment of LUTS/BPH: A preliminary study Comparative efficacy assessment of Tamsulosin vs. Tamsulosin plus Pentoxifylline in the treatment of LUTS/BPH in two 30 persons groups of patients: A preliminary study 2022-02-04 anticipated 60 Complete https://irct.ir/trial/57812 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients after first visit, will be devide in two groups with randomizer by third party, Blinding description: Blinding is done so that in the group receiving Pentoxyfilline, this pill is powdered and poured into the capsules and delivered to the patients and in the group that should only receive Tamsulosin, In addition to Tamsulosin, placebo is given.Placebo so that starch is poured into the capsules and packed and delivered to the patients And finally, the patient doesn't know if he's using pentoxyfilline or placebo. 4 Benign Prostate Hyperplasia. Intervention 1: Intervention group: Tamsulosin 0.4mg everyday and Pentoxyfilline 400mg every 8 hour in 12 weeks were given. Intervention 2: Control group: Tamsulosin 0.4mg everyday and placebo every 8 hour in 12 weeks were given. Yes - There is a plan to make this available What will be shared: Study Statistical Data- The entire data of individuals can be shared after people are identifiable. When: Start accessing 6 months after the results are printed To whom: Researchers working in academic and scientific institutions Conditions: Certain conditions are not required. Where to obtain: Alireza Dehghanmanshadi Email: alireza.dehghan68@gmail.com How to obtain: The applicant sends his request via email and after reviewing the request and confirming it, the documents will be obtained within about a month. Comments:
public Alireza Dehghanmanshadi
No 41, Minor 5/3, Alley 5, Bagh Hows street, Zerehi Blv
Shiraz Iran (Islamic Republic of) 7175956585 +98 71 3820 6907 alireza.dehghan68@gmail.com Shiraz University of Medical Sciences scientific Mehdi Shirazi
Namazi hospital, Zand street
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3647 4332 shirazim@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age>40 International Prostate Symptom Score(IPSS)>13 Prostate Volume>20ml maximum urinary flow rate(Qmax)<15ml/s Voided Volume>100ml creatinine(Cr)<2 40 years no limit Male Age<40 history of prostate cancer renal dysfunction previous prostate surgery bladder calculus active UTI postvoid residual urine volume of > 250 mL exposure to sex hormone within 3 months prior history of severe liver impairment history of severe cardiovascular diseases severe hypotension history of neurogenic bladder history of urethral stricture N40.1 Enlarged prostate with lower urinary tract symptoms Treatment - Drugs Treatment - Drugs Intervention group: Tamsulosin 0.4mg everyday and Pentoxyfilline 400mg every 8 hour in 12 weeks were given. Control group: Tamsulosin 0.4mg everyday and placebo every 8 hour in 12 weeks were given. International Prostate Symptom Score. Timepoint: At the beginning of the study and 12 weeks after treatment. Method of measurement: International Prostate Symptom Score chart. Quality of Life. Timepoint: At the beginning of the study and 12 weeks after treatment. Method of measurement: Quality of life due to urinary symptoms chart. Maximum urinary flow rate. Timepoint: At the beginning of the study and 12 weeks after treatment. Method of measurement: Uroflowmetry. Voided volume. Timepoint: At the beginning of the study and 12 weeks after treatment. Method of measurement: Uroflowmetry. Shiraz University of Medical Sciences Approved 2020-08-03 Ethics Committee of Shiraz University of Medical Sciences University of Medical Sciences building, near Helal Ahmar, Zand street Shiraz Fars Iran (Islamic Republic of)