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IRCT201710024582N6 IRCT 2017-11-05 Urology Research Centre, Guilan University of Medical Sciences The effect of low-intensity shock waves (LI-ESWT) in patients with erectile dysfunction The effect of low-intensity shock waves (LI-ESWT) in improving erectile function in patients with erectile dysfunction not responding to PDE-5 inhibitors 2016-06-21 anticipated 128 Complete https://irct.ir/trial/4891 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: The study will be performed as an open clinical trial without blindness. N/A Erectile dysfunction. Low-intensity shock waves (LI-ESWT) with energy density of 0.160 mJ/mm2 and 6HZ-8HZ frequencies and the total number of 6000 shock, once a week for six consecutive weeks. 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 For ethical reasons, the data of the participants are published only in the form of results through the article resulting from the study, and if necessary by legal entities, the publication of the data is assessed.
public Dr. Mahmoud Shabanipour
Urology Research Centre, Razi Hospital, Sardar Jangal Street, Rasht
Rasht Iran (Islamic Republic of) 41448-95655 +98 13 3352 5259 mahmood19802003@yahoo.com Urology Research Center, Guilan University of Medical Sciences scientific Dr. Ali Hamidi Madani
Urology Research Centre, Razi Hospital, Sardar Jangal Street, Rasht
Rasht Iran (Islamic Republic of) 41448-95655 +98 13 3352 5259 a.hamidimadani@gmail.com Urology Research Center, Guilan University of Medical Sciences Iran (Islamic Republic of) age more than 40 years; passing more than 6 months from the onset of the disease; having a stable sex in the last three months; lack of therapeutic response to phosphodiesterase inhibitors 5; lack of experience in the use of drugs or non-medical therapies for the treatment of erectile dysfunction in the last three months 40 years 139 years Male history of psychological disorders based on the Beck standard questionnaire; history of neurological diseases; history of previous radical prostatectomy; history of pelvic radiotherapy; history of malignancy in the last five years; use of anti-androgens, anticoagulants, thiazides, non-specific antiblockers, antipsychotics, antidepressants , anxiolytics, opioids and drugs; alcohol abuse; severe lower urinary tract symptoms (LUTS); history of urethritis; coronary artery disease; heart failure; thyroid disorders; penile or urethra anomalies F52.2 Failure of genital response Rehabilitation Low-intensity shock waves (LI-ESWT) with energy density of 0.160 mJ/mm2 and 6HZ-8HZ frequencies and the total number of 6000 shock, once a week for six consecutive weeks International Index of Erectile Function. Timepoint: Before intervention, at the end of intervention, 3 and 6 months after intervention. Method of measurement: The International Index of Erectile Function (IIEF) questionnaire. Urology Research Centre, Guilan University of Medical Sciences Approved 2016-06-21 Ethics committee of Guilan University of Medical Sciences Namjoo Street Rasht Guilan Iran (Islamic Republic of)