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IRCT20190824044601N1 IRCT 2019-09-25 Mashhad University of Medical Sciences The effect of low-intensity shock waves (LI-ESWT) in patients with erectile dysfunction in comparison with medical treatment LI-ESWT Study of the effect of low-intensity shock waves (LI-ESWT) in patients with erectile dysfunction in comparison with medical treatment 2019-09-01 anticipated 60 Complete https://irct.ir/trial/41788 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization individually using random number table provided by computer. N/A Male erectile dysfunction. Men over 30 years old with at least 6 months elapsed since their erectile dysfunction and vasculogenic erectile dysfunction. Yes - There is a plan to make this available What will be shared: these files will be presented upon request: Patients` data after removing their identity, Research protocol, statistical methods used in this study and written informed consent. When: data will be available 3 months after the article has been published To whom: Any researcher who needs our data to accomplish his research Conditions: The researcher should use these data only in their related research and should mention the reference Where to obtain: Researchers should send their request to Dr.Kamyar Tavakoli Tabassi via email. Email:tavakolik@mums.ac.ir How to obtain: Researchers should send their request for data that includes their reasons for using the data and their study protocols and aims. The request will be answered during 14 business days Comments:
public Seyed Hamed Ghadagami Moghaddam
No.13 ,Shahed 18 Aven.,Shahed Blvd.,Mashhad Town
Mashhad Iran (Islamic Republic of) 9189774347 +98 51 3513 3648 GhadamgahiMH951@mums.ac.ir Mashhad University of Medical Sciences scientific Kamyar Tavakoli Tabasi
Mashhad - Imam Reza Hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 tavakolik@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Men over 30 years old with at least 6 months elapsed since their erectile dysfunction and vasculogenic erectile dysfunction 30 years no limit Male Other erectile disorders include neurogenic, psychogenic and idiopathic disorders History of pelvic surgery or radiotherapy Use of anti-coagulants, use of anti-androgen Anatomic penis deformities or prosthesis Total testosterone lower than 8 nmol /dl, Advanced heart or lung disease, neurological or psychiatric illness Pregnant wife International Index of Erectile Dysfunction More Than 25 F52.2 Sexual arousal disorders Treatment - Other Men over 30 years old with at least 6 months elapsed since their erectile dysfunction and vasculogenic erectile dysfunction Increased at least 5 points on IIEF Erectile Dysfunction Questionnaire. Timepoint: The case group will be treated with ESWT weekly for 6 weeks. The control group will receive standard drug therapy (tadalafil) during this period. Patients in both groups will be evaluated at baseline, week 10 (4 weeks after treatment) and then every three months to one year. Method of measurement: International Index of Erectile Function Questionnaire. Score on Erection Hardness Score (EHS) questionnaire to over 3 in men with a lower or equal initial score. Timepoint: At baseline, 10 weeks (4 weeks after treatment) and then every three months to one year. Method of measurement: Erection Hardness Score questionnaire. Mashhad University of Medical Sciences Approved 2019-06-03 Ethics committee of Mashhad University of Medical Sciences No.13 ,Shahed 18 Aven.,Shahed Blvd.,Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)