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Clinical Trial Summary

Diabetes mellitus (DM) is known not only for its widespread prevalence, but also for its significant complications including cerebrovascular disease, coronary artery disease, renal failure, vision loss, and neuropathy. Of particular importance to sexual medicine, diabetes has also been strongly associated with erectile dysfunction (ED).ED is defined as the inability to obtain and/or maintain the erection firm enough to achieve a successful sexual intercourse on a regular basis. It is a more common condition in males with type 2 DM. In the field of sexual medicine numerous studies have shown that extracorporal shock wave therapy (ESWT) is safe, noninvasive, and, most importantly, an effective method for treating vascular ED


Clinical Trial Description

ED in DM is often complex and caused by several mechanisms including vascular disease, autonomic neuropathy, hormonal imbalance, and psychogenic factors. However, as the endothelial dysfunction is an important factor contributing to the development of ED in diabetic patients, such patients can be resistant to phosphodiesterase 5 inhibitors (PDE5I) like sildenafil therapy. There are reports of lower efficacy of sildenafil in DM patients compared to general population.In the field of sexual medicine numerous studies have shown that ESWT is safe, noninvasive, and, most importantly, an effective method for treating vascular ED

Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study. Patients will be recruited from outpatient clinic of andrology (Cairo University Hospitals). The patients were randomly divided into two equal groups:

Group (1): (Study group): Men in this group (n= 20) men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions+sildenafil 5mg) Group (2): (Control group):) will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active low intensity ESWT+sildenafil 5mg ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04219462
Study type Interventional
Source Cairo University
Contact Al shymaa s abdelazem, lecturer
Phone 02 01033771553
Email shimaashaaban30@yahoo.com
Status Recruiting
Phase N/A
Start date December 2, 2019
Completion date August 15, 2020

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